StemCell Therapy

Dr. Faye Yin

Dr. Faye Yin

Melanoma is a serious and life-threatening form of cancer that begins in the skin but can spread rapidly if not treated early. We sat down with board-certified oncologist Dr. Faye Yin, an oncologist at Jersey City Medical Center, to learn more about this disease, its causes and risk factors, and why its important to protect yourself from excessive sun exposure even during the cold winter months.

What are the main risk factors for developing melanoma?

Ultraviolet, or UV, light exposure is the major risk factor. Melanoma is associated with both UVB rays, which are present in sunlight, and UVA rays, which are generated by tanning beds. Other risk factors include the presence of moles on the skin. Most are benign, but those with excessive moles should consult a dermatologist, especially if they observe any changes. Often, a mole will be removed as a precautionary measure. Age is also a risk factor; the older the person, the higher the risk. People with fair skin, freckles, and lighter hair are also more susceptible, which is why melanoma is more common in white and light-skinned people. Other risk factors include family history and the presence of a weakened immune system. Those with xeroderma pigmentosum, or XP, a rare genetic disorder, are particularly at risk because the condition affects the ability of skin cells to repair themselves after UV light exposure.

What should people do if they have any of these risk factors?

As with most risk factors impacting health, there are things you can change, and things you cannot. You cant change your skin color or family history, and you cant avoid getting older. But you can limit your exposure to UV rays. A popular catchphrase that I tell my patients, which has been promoted by the American Cancer Society, is Slip, Slop, Slap, and Wrap. Slip on a shirt, slop on some sunscreen, slap on a hat, and wrap on some sunglasses. I also recommend that people avoid using tanning beds and sun lamps. Teaching children about sun safety is especially important, because they tend to spend more time outdoors and can burn more easily. It is also important for people with risk factors to pay closer attention to their skin. Keep an eye out for abnormal moles or other skin features that appear to be unusual or changing over time, and consult a dermatologist if necessary.

Can sunlight still be dangerous during winter?

Yes whether youre skiing or just going for a walk, it is great to enjoy the sun and being outdoors in the winter, but its just as important to protect yourself from excess sun exposure in winter as it is in summer. Harmful ultraviolet rays are present year-round. They can even filter through dark cloud coverage to reach your skin, increasing your risk of melanoma. Some people may experience a bad sunburn on a winter vacation, especially if they ski in high altitudes, because UV rays are usually more intense in higher regions with a thinner atmosphere. When youre outside, any uncovered areas of your body are exposed to UV rays. So, its important to wear sunscreen even in the winter months.

Is smoking a risk factor for developing melanoma, and if so, is it mostly if youre currently smoking (for instance, what if you smoked for years and stopped?)

As an oncologist, every day I tell my patients: dont smoke! Smoking is a contributing factor for many cancers, and I believe that it also affects overall skin health; I can often look at someones skin and tell whether they smoke. That having been said, we dont have evidence that smoking directly contributes to melanoma. But I always encourage patients not to smoke to stay healthy and minimize their cancer risk.

Why does having a weakened immune system count as a risk factor for melanoma?

Having a weakened immune system increases the risk of melanoma and other cancers. I have worked with many patients whose immune systems have been compromised, either by illness or in some cases due to medical treatment for other conditions. For example, immunosuppressive drugs are used after stem cell and organ transplants, to prevent the body from rejecting the transplant. Certain diseases also compromise the immune system, such as HIV. A weakened immune system increases cancer risk for two reasons. First, because the body has less ability to detect and destroy cancer cells. And secondly, because the body is more susceptible to infections that may lead to cancer.

Is gender a risk factor? If so, do we know why?

In the United States, men typically have a higher rate of melanoma than women, though this varies by age. Before age 50, the risk is higher for women, and after age 50, the risk is higher in men. We believe that this discrepancy relates to the fact that men are likely to spend more time in the sun over the course of their lifetimes. I also think that women are more likely to wear sunscreen than men, so this may play a role. In addition, men tend to have thicker skin with less fat beneath it and more collagen, and some research shows that this can make the skin more susceptible to sunlight damage. Also, some studies have shown that estrogen, which is more prevalent in women, can increase resistance to melanoma.

Are older people at higher risk for melanoma?

The risk of melanoma increases as you age. The average age for a melanoma diagnosis is age 65. But melanoma is not uncommon even among those younger than age 30. In fact, it is one of the most common cancers in young adults, especially young women. Melanoma is also more common in younger people whose families have a history of melanoma.

How does having a family history of having melanoma impact someone?

Family history is definitely a melanoma risk factor; the risk is higher among those who have one or more first-degree relatives who have had melanoma. About 10 percent of people diagnosed with melanoma have a family history. Families tend to have shared lifestyle habits, such as more frequent sun exposure, and in addition they typically have similar skin types and share certain genetic characteristics. You cant change your skin color or your genes, but you can change some factors. If you know that you are higher risk, and have a family history, pay close attention to your skin. Avoid excessive sunlight and tanning beds, and consult a dermatologist if you have concerns.

Why is UV light exposure a risk factor?

Numerous studies have shown that sun and UV light exposure is a major melanoma risk factor, especially for children and teens. Research shows that early sun exposure can damage the DNA in skin cells. Melanocytes are the cells that produce melanin, which gives skin its pigmentation, and damaging these cells can start the path to melanoma. Melanoma commonly occurs on the thighs of women, and on the trunks of men, as well as on arms and faces, which are the areas that most often receive chronic sun exposure in young people. In addition to limiting UV light exposure, people should also examine their own skin at least monthly, especially if there are high risk factors. If you see something unusual, such as a large mole or a spot youre not sure about, I will often encourage patients to take a photograph of it. You might not notice small changes over time because you get accustomed to them. But if you take a picture of a spot on your skin and compare it a month or a few months later, and you see a change, you should see a dermatologist.

See more here:
The facts about the danger of melanoma - The Hudson Reporter

Following the Food and Drug Administration (FDA)s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine on Friday, many patients with cancer who are actively receiving treatment, and those who no longer have signs of active disease, are sure to have questions as to what they should know about the vaccine.

In fact, Dr. Debu Tripathy, chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center and editor in chief of CURE, said he and his colleagues were getting questions about the distribution of the vaccine prior to its authorization by the FDA and Centers for Disease Control and Prevention.

We have been getting questions more and more frequently; all our patients want to know what the schedule is for when they might get a vaccine, said Tripathy in an interview with CURE.

To address any questions patients with cancer and survivors may have regarding the vaccine, CURE recently spoke with Drs. Debu Tripathy and Roy Chemaly, chief infection control officer and a professor in the department of infectious diseases, infection control and employee health at The University of Texas MD Anderson Cancer Center.

On Monday, the first of many high-risk health care workers started receiving the vaccine across the United States. Many frontline workers will continue to receive it over the next several weeks, including those who work directly with patients with cancer who are at a high risk for infection.

After those frontline workers, there is a process for which patients will begin to receive the vaccine, according to Tripathy.

Patients with underlying conditions at high risk for complications of COVID-19 infection will likely be a top priority to receive the vaccine. However, for patients with cancer receiving therapy, in particular, those receiving more intensive therapies like a stem cell transplant, there are still some details that need to be ironed out.

We haven't gotten into the nitty gritty in terms of how we're going to divide (the vaccine) to some extent, said Tripathy. We're going to have the physicians be involved in prioritizing this based on their knowledge because they're the ones who know the patients the best.

Chemaly also noted that the vaccine will likely be administered to patients on a case-by-case basis.

Now for cancer patients who are still under active treatment with chemo or radiation, or early after stem cell transplantation, there is no data on how effective the vaccine is, and should it be used, he said. So we're going to be a little bit more cautious and take it case by case to recommend these vaccines to our cancer patients, as we wait for more data to come out from the general population, then see how safe it is and how effective (it is) in order to really extrapolate to our cancer patients.

If a patient is no longer receiving active treatment and there are no signs of active cancer, Chemaly said, they should have a good response to the vaccine, and it will likely be safe for them to receive it as well.

Now, for other patients who (are) still in the follow-up period, not really called survivors of cancer, we're going to probably provide some guidance, for example, for recipients of a stem cell transplantation. If it's been six months from allogeneic transplantation, they're stable and recovering well from after transplant, then it is probably be safe to give it to these patients, he said. Autologous transplant could be three months from the transplantation if they have no active issues, if they are still in remission and they're stable enough to receive a vaccine.

As with any vaccine, Tripathy said, some people will have reactions, but at least there are data from healthy individuals that can be shared with patients with cancer. When those data are shared with patients with cancer, however, there will be some unknowns. For instance, will patients with cancer be able to generate antibodies and develop the same protection, and might there be unique side effects that this patient population will experience.

These are things that we will have to learn as we go, and we will, Tripathy said. As the cancer centers and practices start immunizing their patients, were going to be tracking their outcomes.

In fact, just like with any drug that receives FDA approval, there will be a process for reporting and compiling any side effects that occur when a patient receives the vaccine.

As for the individuals who developed severe allergic reactions to the vaccine in the United Kingdom, Chemaly noted that those individuals had a history of anaphylaxis, or severe allergic reactions to different antigens. And two out of those three individuals who experienced the severe reactions were already carrying an EpiPen (epinephrine), which helps to combat serious allergic reactions.

And we're prepared to intervene if someone develop(s) this kind of reaction when we give the vaccine, Chemaly said.

Everyone not just patients with cancer should expect to follow all the public health measures from wearing a mask to social distancing and frequent hand hygiene for at least another six months to one year even if vaccinated, according to Chemaly.

We need to create herd immunity (because) without herd immunity, we're not going to eliminate this virus, he said. Second, even if (you) get (a) vaccine, (it) doesn't mean (youre) not going to be exposed to the virus in the community or in your workplace. At that point, you may carry the virus and not getting sick from it or get admitted to the hospital but (you) can still transmit the virus to other people. This why masking is still so important.

Chemaly said hes received questions from patients and employees every day about their worry of receiving the vaccine. And while he said its understandable, he assures the public that the trials have been conducted under a microscope, meaning so many eyes have been watching everything that has happened.

No one is hiding anything, he said. Based on that, I advise my patients, my colleagues (and) other health care workers in the health care setting, that, what we know is (the vaccine is) safe and is effective there is no long-term side effect up to two or three months from receiving the vaccine. I, myself, feel very comfortable taking it, and I'm going to be lining up to get the vaccine as soon as it is available.

I think that we are witnessing an incredible moment in history where we rallied to do something that had never been done, and that is to get a vaccine from scratch in less than one year, Tripathy said. That is a pretty astounding technologic feat that not many people would have believed it was possible when all this started that in this short period of time; we did it.

Now, its up to patients to make an informed decision as to whether to get the vaccine, although the available data point to its potential effectiveness.

Nothing works unless you get the vaccine, he said. If you don't get the vaccine, all of this was for nothing.

However, Tripathy acknowledged why some people may be concerned and reluctant to receive the vaccine.

Things have happened in medical history where that might give some people pause, he said. There's a lot of concern about people that are underserved and minorities because there is a history of them not receiving fair treatment when it comes to medicine and clinical trials. And so, we have to go the extra mile to reassure patients. But we can't pretend that we can reassure people 100%. Just like many other decisions you make in life, you take the best information you have and you make a recommendation for other people or for yourself. All we can do is be truthful, present our recommendations and hope that a majority of people do get vaccinated.

For more news on cancer updates, research and education, dont forget tosubscribe to CUREs newsletters here.

Originally posted here:
What Patients With Cancer, Survivors Need to Know About the Emergency Use Authorization of COVID-19 Vaccine - Curetoday.com

18 months into the first serious clinical trials of CRISPR gene therapy for sickle cell disease and beta-thalassemiaand all patients are free from symptoms and have not needed blood transfusions.

Sickle cell disease (SCD) can cause a variety of health problems including episodes of severe pain, called vaso-occlusive crises, as well as organ damage and strokes.

Patients with transfusion-dependent thalassemia (TDT) are dependent on blood transfusions from early childhood.

The only available cure for both diseases is a bone marrow transplant from a closely related donor, an option that is not available for the vast majority of patients because of difficulty locating matched donors, the cost, and the risk of complications.

In the studies, the researchers goal is to functionally cure the blood disorders using CRISPR/Cas9 gene-editing by increasing the production of fetal hemoglobin, which produces normal, healthy red blood cells as opposed to the misshapen cells produced by faulty hemoglobin in the bodies of individuals with the disorders.

The clinical trials involve collecting stem cells from the patients. Researchers edit the stem cells using CRISPR-Cas9 and infuse the gene-modified cells into the patients. Patients remain in the hospital for approximately one month following the infusion.

Prior to receiving their modified cells, the seven patients with beta thalassemia required blood transfusions approximately every three to four weeks and the three patients with SCD suffered episodes of severe pain roughly every other month.

All the individuals with beta thalassemia have been transfusion independent since receiving the treatment, a period ranging between two and 18 months.

Similarly, none of the individuals with SCD have experienced vaso-occlusive crises since CTX001 infusion. All patients showed a substantial and sustained increase in the production of fetal hemoglobin.

15 months on, and the first patient to receive the treatment for SCD, Victoria Gray, has even been on a plane for the first time.

Before receiving CRISPR gene therapy, Gray worried that the altitude change would cause an excruciating pain attack while flying. Now she no longer worries about such things.

She told NPR of her trip to Washington, D.C: It was one of those things I was waiting to get a chance to do It was exciting. I had a window. And I got to look out the window and see the clouds and everything.

MORE: MIT Researchers Believe Theyve Developed a New Treatment for Easing the Passage of Kidney Stones

This December, theNew England Journal of Medicinepublishedthe first peer-reviewed research paperfrom the studyit focuses on Gray and the first TDT patient who was treated with an infusion of billions of edited cells into their body.

There is a great need to find new therapies for beta thalassemia and sickle cell disease, saidHaydar Frangoul, MD,Medical Director of Pediatric Hematology and Oncology at Sarah Cannon Research Institute, HCA Healthcares TriStar Centennial Medical Center. What we have been able to do through this study is a tremendous achievement. By gene editing the patients own stem cells we may have the potential to make this therapy an option for many patients facing these blood diseases.

READ: For the First Time in the US, Surgeons Pump New Life into Dead Donor Heart for Life-Saving Transplant

Because of the precise way CRISPR-Cas9 gene editing works, Dr. Frangoul suggested the technique could potentially cure or ameliorate a variety of diseases that have genetic origins.

As GNN has reported, researchers are already using CRISPR to try and treat cancer, Parkinsons, heart disease, and HIV, as well.

Source: American Society of Hematology

Read the original here:
Every Patient Treated With CRISPR Gene Therapy for Blood Diseases Continues to Thrive, More Than a Year On - Good News Network

In March 2020, the World Health Organization declared COVID-19, the disease caused by the SARS-CoV-2 virus, a pandemic.

Since then, COVID-19 has affected tens of millions of people around the world, leading to new discoveries about the symptoms that can accompany the disease.

Recently, multiple case studies have suggested that persistent hiccups may be a potentially rare and unusual manifestation of COVID-19.

In this article, well discuss whether hiccups are a sign of the new coronavirus, when to contact your doctor about frequent hiccups, and other important information you should know about COVID-19.

According to the research, it is possible that hiccups are a rare sign of COVID-19.

In one recent 2020 case study, a 64-year-old man was found to have persistent hiccups as the only symptom of COVID-19.

In this situation, the subject of the study visited an outpatient clinic after experiencing a bout of hiccups for 72 hours.

Both blood testing and lung imaging were performed. They revealed evidence of infection in both lungs and low white blood cells. Follow-up testing for COVID-19 revealed a positive diagnosis.

In a different 2020 case study, a 62-year-old man was also found to have experienced hiccups as a symptom of the new coronavirus.

In this case, the subject had been experiencing hiccups for a period of 4 days before presentation to the emergency room.

Upon admission, further testing showed similar findings in their lungs, as well as low white blood cells and platelets. Again, testing for COVID-19 confirmed a positive diagnosis.

It is important to note that the studies mentioned above are only two individual case studies. They only demonstrate a potentially rare side effect of COVID-19.

More research is still needed to determine the link between chronic hiccups and the new coronavirus.

Hiccups are quite common and happen when your diaphragm involuntarily spasms or contracts. Your diaphragm is your muscle directly beneath your lungs that separates your chest from your abdomen.

Hiccups can be caused by everything from eating to swallowing air to stress, and much more.

While they can be somewhat annoying, hiccups are rarely a sign of anything dangerous. Generally, hiccups only last a few minutes although in some cases, they have been known to last for hours.

According to the National Health Service, hiccups that last longer than 48 hours are considered a cause for concern and should be addressed by a doctor.

Medical treatment options for hiccups are generally reserved for people with chronic hiccups that dont resolve on their own. Some of these treatment options may include:

For most people, hiccups will resolve on their own they generally only become a concern if they become chronic or cause other health concerns.

You should talk with a doctor if your hiccups last longer than 48 hours, as this may be a sign of an underlying health condition.

You may also need to talk with a doctor if your hiccups cause you to be unable to eat, breathe, or do anything else you would typically be able to do.

According to the Centers for Disease Control and Prevention (CDC), the most common symptoms of COVID-19 include:

Symptoms of COVID-19 can appear anywhere from 2 to 14 days after exposure to the SARS-CoV-2 virus. Depending on the severity of the disease, the symptoms can range from asymptomatic (no symptoms at all) to severe.

In some situations, COVID-19 can cause uncommon symptoms that are not listed above, such as dizziness or rash.

Even rarer, case studies like those mentioned above have shown how other unusual symptoms can be a sign of the new coronavirus.

If you are experiencing new symptoms and concerned that you may have developed COVID-19, speak with your doctor as soon as possible for testing.

While not everyone needs to be tested for COVID-19, the CDC recommends getting tested if:

There are two types of testing available for COVID-19: viral testing and antibody testing. Viral testing is used to diagnose a current infection, while antibody testing can be used to detect a past infection.

Tests are available nationwide at most local or state health departments, doctors offices, and pharmacies. Some states also currently offer drive-thru testing and 24-hour emergency testing when necessary.

We all play an important role in preventing the spread of the SARS-CoV-2 virus. The best way to reduce your risk of contracting, or spreading, this new coronavirus is to practice personal hygiene and physical distancing.

This means following the CDC guidelines for preventing the spread of COVID-19 and being mindful of your own health and testing status.

Staying informed about current and developing COVID-19 news is also important you can keep up to date with Healthlines live coronavirus updates here.

Below, youll find some CDC recommended guidelines to protect yourself and prevent the spread of COVID-19:

According to the CDC, in December 2020, a vaccine from Pfizer was granted emergency use authorization and approval for a vaccine from Moderna is expected to follow.

It may take months before most people have access to this vaccine, but there are also treatment options available.

The current treatment recommendation for mild cases of COVID-19 is recovery at home. In more severe cases, certain medical treatments may be used, such as:

As the COVID-19 situation continues to develop, so do new treatment options to help combat the disease.

Many of the symptoms of COVID-19 are commonly experienced among people who have developed the disease. However, research has suggested that some people may experience other rare and unusual symptoms.

In two recent case studies, persistent hiccups were the only outward sign of the new coronavirus. While this indicates that hiccups may be a potential symptom of COVID-19, more research is needed on this rare side effect.

Excerpt from:
Are Hiccups a Sign of the New Coronavirus? - Healthline

The Covid-19 can damage the heart both directly and indirectly, and lead to complications ranging from inflammation of the heart (myocarditis), injury to heart cells (necrosis), heart rhythm disorders (arrhythmias), heart attack, and muscle dysfunction that can lead to acute or protracted heart failure, experts said.

Covid-19 is a vascular disease that injures heart cells and muscle. It also leads to the formation of blood clots, both in the microvasculature and large vessels, which can block blood supply to the heart, brain and lungs and lead to stroke, heart attack and respiratory failure, said Dr Ravi R Kasliwal, chairman of clinical and preventive cardiology department at Medanta -The Medicity Hospital.

Also Read: Few Covid-19 deaths in Indias old-age homes, survey finds

A US study using MRI found cardiac abnormalities in 78 of 100 patients who had recently recovered from Covid-19, including 12 of 18 asymptomatic patients. Sixty patients had ongoing myocardial inflammation consistent with myocarditis, found the study, which was published in the Journal of American Medical Association Cardiology in July.

Even people with mild disease or no symptoms can develop life-threatening cardiovascular complications. Whats worrying is that this holds true for healthy adults with no pre-existing risk factors, which raise their risk of complications, said Dr Kasliwal, who recommends that everyone who has recovered from Covid-19 be screened for heart damage

Cardiac trouble

Extensive cardiac involvement is what differentiates Sars-CoV-2, the virus that causes Covid-19, from the six other coronaviruses that cause infection in humans, writes cardiologist Dr Eric J Topol, founder, director and professor of molecular medicine at the Scripps Research Translational Institute in La Jolla, California, in the journal Science.

The four human coronaviruses that cause cold-like symptoms have not been associated with heart abnormalities, though there have been isolated reports linking the Middle East Respiratory Syndrome (MERS) caused by MERS-CoV) with myocarditis, and cardiac disease with the Severe Acute Respiratory Syndrome (SARS) caused by Sars-CoV.

Also Read| Extraordinary uncertainties: Harvard prof on Covid-19, impact on mental health

Sars-CoV-2 is structurally different from Sars-CoV. The virus targets the angiotensin-converting enzyme 2 (Ace2) receptor throughout the body, facilitating cell entry by way of its spike protein, along with the cooperation of proteases. The heart is one of the many organs with high expression of Ace2. The affinity of Sars-CoV-2 to Ace2 is significantly greater than that of SARS, according to Dr Topol.

Topol notes the ease with which Sars-CoV-2 infects heart cells derived from induced pluripotent stem cells (iPSCs) in vitro, leading to a distinctive pattern of heart muscle cell fragmentation evident in autopsy reports. Besides directly infecting heart muscle cells, Sars-CoV-2 also enters and infects the endothelial cells that line the blood vessels to the heart and multiple vascular beds, leading to a secondary immune response. This causes blood pressure dysregulation, and activation of a proinflammatory response leading to a cytokine storm, which is a potentially fatal systemic inflammatory syndrome associated with Covid-19.

Persisting problems

Studies have found that injury to heart cells reflected in blood concentrations of a cardiac muscle-specific enzyme called troponin affects at least one in five hospitalised patients and more than half of those with pre-existing heart conditions, which raises the risk of death. Patients with higher troponin amounts also have high markers of inflammation (including C-reactive protein, interleukin-6, ferritin, lactate dehydrogenase), high neutrophil count, and heart dysfunction, all of which heighten immune response.

The heightened systemic inflammatory responses and diminished blood supply because of clotting, endotheliitis (blood vessel inflammation), sepsis, or hypoxemia (oxygen deprivation) because of acute lung infection leads to indirect cardiac damage, said Dr Kasliwal.

The cardiovascular damage associated with Sars-CoV-2 infection can persist beyond recovery. Since the virus affects the heart as much as the respiratory tract, further research is needed to understand why some people are more vulnerable to heart damage than others.

See the rest here:
Covid-19 can have impact on heart too, say experts - Hindustan Times

First Overall Survival Analysis for KEYTRUDA Plus LENVIMA Combination in a Phase 3 Study in Advanced Endometrial Cancer

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, KEYTRUDA plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in OS, PFS and ORR versus chemotherapy (treatment of physicians choice [TPC] of doxorubicin or paclitaxel). The safety profile of the KEYTRUDA plus LENVIMA combination was consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, and plan to present these results at an upcoming medical meeting.

Women with advanced endometrial cancer are faced with high mortality rates and limited treatment options following initial systemic therapy, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. These are the first results from a Phase 3 trial of a combination regimen including immunotherapy in advanced endometrial carcinoma that have shown a statistically significant improvement in overall survival, progression-free survival and objective response rate versus chemotherapy. Merck and Eisai are dedicated to continuing to research the KEYTRUDA plus LENVIMA combination and discover new approaches to address unmet needs for devastating diseases such as endometrial carcinoma.

We are encouraged by the data observed in KEYNOTE-775/Study 309, which represent a possible step forward for patients impacted by advanced endometrial carcinoma and support the results seen in the advanced endometrial cancer cohort of KEYNOTE-146/Study 111, said Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. As more clinical data from the LEAP (LEnvatinib And Pembrolizumab) program are revealed, we cannot help but be energized by the trajectory of our collaboration with Merck and the benefits we hope to provide to patients together. Most importantly, we are grateful for the trust that the patients and healthcare professionals who participated in this trial have shown us.

KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administrations (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This accelerated approval was based on tumor response rate and durability of response and was the first approval granted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Under Project Orbis, Health Canada and Australias Therapeutic Goods Administration (TGA) granted conditional and provisional approvals, respectively, for this indication.

Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in 13 different tumor types across 20 clinical trials, including a Phase 3 trial evaluating the combination in the first-line setting for patients with advanced endometrial carcinoma (LEAP-001).

About KEYNOTE-775/Study 309

KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial ( ClinicalTrials.gov , NCT03517449 ) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following at least one prior platinum-based regimen. The dual primary endpoints are OS and PFS, as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1. Select secondary endpoints include objective response rate (ORR) by BICR per RECIST v1.1 and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were non-MSI-H or pMMR, and 130 patients had tumors that were MSI-H or dMMR. Patients were randomized 1:1 to receive:

About Endometrial Cancer

Endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. In 2018, it was estimated there were more than 382,000 new cases and nearly 90,000 deaths from uterine body cancers worldwide (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). In the U.S., it is estimated there will be almost 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

See the original post:
KEYTRUDA Plus LENVIMA Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective...

COVID-19 is currently the leading cause of death in the United States killing more people each day than heart disease or cancer.

To help stem the tide of this life-threatening disease, scientists around the world have been working to develop vaccines.

Last week, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first of these vaccines, developed by Pfizer and BioNTech.

The EUA allows for the distribution of the Pfizer-BioNTech COVID-19 vaccine across the United States. This vaccine has been developed to prevent COVID-19 in people age 16 years and older.

Getting 2 doses of the vaccine may drastically reduce your chances of developing COVID-19.

Even if youve had COVID-19, getting the vaccine may help prevent reinfection and lower your risk of getting sick again.

Were really happy to have a safe and effective tool [against COVID-19], Dr. Iahn Gonsenhauser, chief quality and patient safety officer at The Ohio State University Wexner Medical Center in Columbus, Ohio, told Healthline.

Were encouraging everybody to explore their opportunity to access the COVID vaccine as soon as thats made available to them, he said.

When someone develops COVID-19, their immune system learns to recognize the virus and begins to produce antibodies to fight against it.

If that person recovers from the disease, they may have immunity against reinfection with the virus for a period of time afterwards.

However, questions remain about how long that immunity lasts.

We dont know how long the immunity triggered by infection persists, and someone infected in the spring may no longer be immunologically protected now in December, Dr. David Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, New York, told Healthline.

It does stand to reason that somebody with COVID-19 infection is likely immune for 3 to 4 months at least, he said, but we dont have firm data to support this yet.

Cases of reinfection with the virus that causes COVID-19 have been reported.

Getting vaccinated may help to strengthen immunity against COVID-19.

In an ongoing clinical trial, Pfizer and BioNTech have studied their vaccine in people with and without a history of exposure to the virus.

Their research to date has found the vaccine is 95 percent effective at preventing COVID-19.

Their findings suggest it may help prevent reinfection in people who have already been exposed to the virus, as well as lowering the risk of infection in people with no history of exposure.

Data from the phase 2/3 trial for the Pfizer-BioNTech vaccine suggest that the vaccine is safe and likely effective in persons with previous evidence of SARS-CoV-2 infection, said Dr. Miriam Smith, chief of infectious disease at Long Island Jewish Forest Hills in Queens, New York.

[The] vaccine should be offered to all persons regardless of history of prior symptomatic or asymptomatic infection, she said.

The Centers for Disease Control and Prevention (CDC) currently advises that people with a known history of COVID-19 may wait up to nearly 90 days after their prior infection to get vaccinated, if they prefer to do so.

While more research is needed, available evidence suggests that reinfection with this virus is rare within 90 days of initial infection.

If someone currently has active symptoms of COVID-19, the CDC recommends they wait to get vaccinated until theyve recovered and met the criteria for ending isolation.

The Pfizer-BioNTech COVID-19 vaccine carries some risk of side effects.

However, ongoing research suggests the side effects tend to be mild and short-lived.

The way that we generally approach these questions in healthcare is through risk-benefit analysis, Gonsenhauser said.

In this case, the risk of some adverse response to the vaccine is low, and the benefit of knowing that you have a potentially extended or refreshed immunity to COVID is significant, he said.

With that, were recommending that people get the vaccine, even if theyve already had a COVID exposure and infection, he continued.

The most commonly reported side effect associated with the Pfizer-BioNTech COVID-19 vaccine is pain around the injection site.

Some people who received the vaccine developed other side effects such as fatigue, headache, and muscle aches, which tend to resolve within a day or so.

The risk of severe adverse events following the vaccine appears to be very low. However, some groups of people might face higher risk of adverse reactions than others.

For example, if you have a history of severe allergic reaction to any of the ingredients contained in the vaccine, the FDA recommends that you not receive it.

Talk with your doctor to learn more about the potential benefits and risks of getting vaccinated against COVID-19.

More here:
Even if You've Had COVID-19 You Still Need the Vaccine - Healthline

SynDevRx is working to address the unmet medical need in the field of metabo-oncology by developing treatments for cancer patients who are overweight or have systemic metabolic dysfunction. Technology Networks recently spoke with Jim Shanahan,co-founder, vice president of business development and director of SynDevRx, to explore the impact of metabolic dysfunction on treatment outcomes and learn more about the companys lead compound SDX-7320.Laura Lansdowne (LL): Could you tell us about the link between cancer and metabolic hormone dysfunction?Jim Shanahan (JS): It is commonly understood that obesity increases the risk for certain cancers. What drives this effect has to do with adipose (fat) tissue, which produces a variety of hormones and cytokines that, when dysregulated (as in obesity), stimulate tumor growth and metastasis. Two of the most common and potent metabolic drivers of cancer are insulin and leptin.Insulin, produced by the pancreas in response to elevated blood glucose, stimulates tumor growth via the PI3K/Akt/mTOR pathway. Insulin resistance, often seen in people who are obese or even simply those who have excess visceral adipose tissue (i.e., belly fat) is a pathological state where peripheral tissues (i.e., liver, adipose tissue, skeletal muscle) are less responsive or unresponsive to insulin, leading to chronically high levels of fasting insulin. In the US, an estimated 88 million people have insulin resistance and in the UK, an estimated 12 million are at risk for Type 2 diabetes. This is not a new problem; almost 20 years ago, Dr Pamela Goodwin, a leader in the field, reported that High levels of fasting insulin identify women with poor outcomes in whom more effective treatment strategies should be explored. A large recent study of > 20,000 post-menopausal women showed a significantly increased risk of cancer-specific mortality with elevated insulin resistance. Despite the abundance of research showing insulin is a bad actor in cancer, insulin levels are rarely ever measured in cancer patients.Leptin is an adipocyte-derived hormone whose levels are in direct proportion to fat mass. Leptin acts as a primary regulator of normal metabolic physiology and energy metabolism. The binding of leptin to its specific receptor activates multiple signaling pathways, including the Janus kinase 2(JAK2)/ signal transducer and activator of transcription 3 (STAT3), insulin receptor substrate (IRS)/phosphatidylinositol 3 kinase (PI3K), SH2-containing protein tyrosine phosphatase 2 (SHP2)/mitogen-activated protein kinase (MAPK) and 5' adenosine monophosphate-activated protein kinase (AMPK)/ acetyl-CoA carboxylase (ACC), in the central nervous system and peripheral tissues. Importantly many of these pathways are validated oncogenic pathways commonly targeted by cancer drugs since they overlap with growth factor signaling (e.g., VEGF and bFGF, Her2). More recently it was found that leptin receptors are highly expressed on cancer cells and leptin has been shown to increase cell proliferation, inhibit apoptosis, promote angiogenesis and induce anti-cancer drug resistance. These characteristics are associated with a subset of cells in both liquid and solid tumors known as cancer stem cells (CSCs), or tumor-initiating cells, leading to the formation of metastatic lesions.Conversely, in patients with metabolic dysfunction, the secretion of a key protective adipokine called adiponectin, is reduced. Adiponectin increases insulin sensitivity, thereby reducing levels of fasting insulin. Through its receptor interactions, adiponectin may exert its anti-carcinogenic effects including regulating cell survival, apoptosis and metastasis via a plethora of signaling pathways. Adiponectin has also been shown to directly inhibit tumor growth and counter-act the tumor-promoting effects of leptin. Furthermore, levels of circulating adiponectin are inversely associated with survival outcomes in breast cancer.The role that metabolic syndrome and metabolic hormones play in cancer is significant yet frequently ignored and entirely underappreciated.LL: Some anti-cancer drugs can cause metabolic dysfunction what impact does this have on efficacy and overall treatment success?JS: The short answer is that metabolic dysfunction (independent of origin) has a decidedly negative impact on treatment outcomes and patient quality of life. Many common anti-cancer treatments induce insulin resistance, obesity, Type 2 diabetes and metabolic syndrome, such as doxorubicin, Taxol, platinum-based drugs, aromatase inhibitors, gonadotropin-releasing hormone agonist as well as newer targeted therapies, such as the PI3K inhibitor Piqray (alpelisib, Novartis), mTOR inhibitors and steroids among others. What is emerging is an understanding that these treatment-induced metabolic complications blunt the impact of the anti-cancer treatment itself and can even cause treatment resistance. Hyperglycemia and the subsequent hyperinsulinemia are common in cancer treatment. Yet, insulin levels, which are highly stimulative to many cancers, are rarely monitored and therefore rarely treated. Its an oversight in clinical practice that needs to be remedied urgently.LL: How can metabolic dysfunction and cancer growth be counteracted pharmacologically?JS: At the moment, there are no drugs for targeting tumors sensitive to metabolic hormones. This is the gap in cancer treatment we are targeting with our lead drug SDX-7320. As a stopgap, many oncologists give their patients metformin, as it has been shown to have a modest effect on cancer treatment-induced metabolic dysfunction and may even improve cancer outcomes. Occasionally, oncologists refer their cancer patients to endocrinologists for more acute metabolic care via anti-diabetic drugs like SGLT2 inhibitors. While these anti-diabetics may have clinical utility in helping control hyperglycemia, they generally have only a modest effect on hyperinsulinemia/insulin resistance or high circulating leptin levels. As difficult as they are to maintain, diet and exercise are still the best weapons in the battle against cancer treatment-induced metabolic dysfunction.LL: Can you tell us more about the companys lead compound SDX-7320, in terms of its design, mechanism of action, the indications it is being investigated for and the clinical programs currently underway?JS: SynDevRxs lead compound is SDX-7320 a polymer-drug conjugate consisting of a small molecule MetAP2 inhibitor attached via a peptide linker to a high molecular weight polymer backbone. SDX-7320 is itself inert, but in vivo, the pharmacologically active small molecule fumagillol-derivative is released from the polymer/peptide linker upon contact with lysosomal enzymes. The concept behind the drugs design was to improve the safety profile of the active small molecule by preventing it from crossing the bloodbrain barrier a known and challenging side effect of MetAP2 inhibitors. Another objective of the polymer-conjugation approach was to improve its drug-like properties, as fumagillin is unstable and poorly soluble.The active small molecule is based on fumagillin, a natural product isolated from the fungus Aspergillus fumigatus Fresenius. Fumagillin and its derivatives are potent and selective inhibitors of the enzyme, MetAP2. Covalent modification of MetAP2 by the fumagillin pharmacophore not only inhibits the aminopeptidase activity of MetAP2, but also results in decreased turnover and thus the accumulation of the inhibited protein. This results in multiple beneficial downstream effects including cell cycle arrest, modified angiogenic growth factors, improvements to the tumor immune micro-environment and amelioration of dysregulated metabolic hormones.The polymer conjugation technology yields a number of advantages of SDX-7320 over traditional small molecule fumagillin-based MetAP2 inhibitors, for example dramatically superior water solubility, excellent stability, and a highly favorable PK profile which allows for a patient-friendly dosing schedule and administration by subcutaneous injection a first for a polymer-drug conjugate. Additionally, the high average molecular weight of SDX-7320 has proven effective at minimizing the historic, class-specific CNS adverse effect observed with small-molecule fumagillin analogs.Interestingly, our expectations for the polymer-drug conjugate were that we would see absolute doses increase significantly, with respect to the small molecule doses. Decades of polymer-drug conjugation research suggested doses should increase by as much as 10x (compared to the small molecule) with little to no change in safety. In fact, we saw the opposite. In multiple head-to-head experiments, we saw greater activity with lower doses of the conjugate (in absolute drug weight terms) compared to the small molecule and with a better safety profile.SDX-7320 is being developed for the treatment of cancers that are sensitive to metabolic hormones, with our first indication being breast cancer. A Phase 1 trial of SDX-7320 was completed in 2020, in patients with advanced solid tumors. The results of this trial defined the recommended Phase 2 dose and schedule as well as demonstrated favorable effects on metabolic and angiogenic biomarkers. Clinical trials are planned in combination with standards of care in triple-negative breast cancer (TNBC) as well as in ER+/Her2- breast cancer in combination with a PI3K inhibitor (Piqray/alpelisib) in patients with a PIK3CA mutation.Jim Shanahan was speaking with Laura Elizabeth Lansdowne, Senior Science Writer for Technology Networks.

Read more here:
The Link Between Cancer and Metabolic Dysfunction - Technology Networks

STOCKHOLM, Dec. 16, 2020 /PRNewswire/ -- Diamyd Medical and the Critical Path Institute (C-Path) are proud to announce their collaboration to significantly improve the scientific community's insight into type 1 diabetes (T1D) through Diamyd Medical's contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Measures Initiative (TOMI) T1D integrated database.

The Phase III trial evaluated the use of the diabetes vaccine Diamyd, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. It is funded by the world's leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations' strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D. TOMI-T1D aims to create a clinical trial simulation tool (CTST) with large and diverse clinical datasets from the T1D community. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design. Contribution of these robust data sets from industry led trials is critical to TOMI-T1D's work in developing innovative and quantitative tools that can facilitate clinical development efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials.

"Progress towards the establishment of approved therapies for people with T1D is critically reliant on participation from our partners in industry with their data", said Simi Ahmed and Elizabeth Robertson, on behalf of the charity partnership.

"This is indeed a right step in that direction", said Colin Dayan, lead PI at Cardiff University.

"We are thrilled that Diamyd Medical is taking a leading role and championing precompetitive collaborations advancing type 1 diabetes regulatory science solutions", said Inish O'Doherty Executive Director at C-Path. "Their data will help in the construction and evaluation of a clinical trial simulation tool to assist in the development of novel therapies for type 1 diabetes patients".

"We are very honored to be part of this important collaboration -involving key stakeholders within the type 1 diabetes landscape, said Ulf Hannelius, President & CEO of Diamyd Medical. "As we are moving into an era of precision medicine in type 1 diabetes, we can expect to see significant therapeutic advances, and access to high quality data will be integral to maximizing these efforts".

To learn more about the TOMI-T1D project visit: https://c-path.org/programs/tomi-t1d/

About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

About JDRF

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent, and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact and uniting on a national stage to pool resources, passion and energy. We collaborate with academic institutions, policymakers and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

About Diabetes UK

1. Diabetes UK's aim is creating a world where diabetes can do no harm. Diabetes is the most devastating and fastest growing health crisis of our time, affecting more people than any other serious health condition in the UK - more than dementia and cancer combined. There is currently no known cure for any type of diabetes. With the right treatment, knowledge and support people living with diabetes can lead a long, full and healthy life. For more information about diabetes and the charity's work, visit http://www.diabetes.org.uk

2. Diabetes is a condition where there is too much glucose in the blood because the body cannot use it properly. If not managed well, both type 1 and type 2 diabetes can lead to devastating complications. Diabetes is one of the leading causes of preventable sight loss in people of working age in the UK and is a major cause of lower limb amputation, kidney failure and stroke.

3. People with type 1 diabetes cannot produce insulin. About 10 per cent of people with diabetes have type 1. No one knows exactly what causes it, but it's not to do with being overweight and it isn't currently preventable. It's the most common type of diabetes in children and young adults, starting suddenly and getting worse quickly. Type 1 diabetes is treated by daily insulin doses - taken either by injections or via an insulin pump. It is also recommended to follow a healthy diet and take regular physical activity.

4. People with type 2 diabetes don't produce enough insulin or the insulin they produce doesn't work properly (known as insulin resistance). Around 90 per cent of people with diabetes have type 2. They might get type 2 diabetes because of their family history, age and ethnic background puts them at increased risk. They are also more likely to get type 2 diabetes if they are overweight. It starts gradually, usually later in life, and it can be years before they realise they have it. Type 2 diabetes is treated with a healthy diet and increased physical activity. In addition, tablets and/or insulin can be required.

For more information on reporting on diabetes, download our journalists' guide: Diabetes in the News: A Guide for Journalists on Reporting on Diabetes (PDF, 3MB).

About Diamyd Medical

Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a genetically predefined patient group in a large-scale metastudy as well as in the Company's European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd. Diamyd Medical also develops the GABA-based investigational drug Remygen as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se

CONTACT:

For further information, please contact:

Ulf Hannelius, President and CEO

Phone: +46 736 35 42 41

E-mail: ulf.hannelius@diamyd.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-and-critical-path-institute-announce-data-sharing-collaboration-to-develop-advanced-d,c3255392

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SOURCE Diamyd Medical AB

Company Codes: Frankfurt:DMN, ISIN:SE0005162880, Munich:DMN, Stockholm:DMYD, Stockholm:DMYD-B.ST

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes -...

Adroit Market Research published a new research report of Global Opthalmology Pacs Market 2020-2026 presents a widespread and elementary study of the market including key business insights and the analysis of subjective views related to the market. The global Opthalmology Pacs market report examines the market position and viewpoint of the market worldwide, from various angles, such as from the key players point, geological regions, types of product and application. This Opthalmology Pacs report highlights the key driving factors, constraint, opportunities, challenges in the competitive market. It also offers thorough Opthalmology Pacs analysis on the market stake, classification, and revenue projection. The Opthalmology Pacs market report delivers market status from the readers point of view, providing certain market stats and business intuitions. The global Opthalmology Pacs industry includes historical and futuristic data related to the industry. It also includes company information of each market player, capacity, profit, Opthalmology Pacs product information, price, and so on.

The report includes the most important industry information while highlighting vital and valuable data. The report provides learning of various factors such as Opthalmology Pacs market growth, consumption volume, market trends, and business price structures throughout the forecast amount from 2020 to 2026. A detailed study report is accessible for the beneficial of audience and stakeholders. It studies the market dynamic factors including the drivers, restraints, trends, and opportunities of the global market. The report also analyze the competitive landscape of the business. Opthalmology Pacs Market is growing at high CAGR during the forecast period 20212027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Get the PDF Sample Copy of this report @ https://www.adroitmarketresearch.com/contacts/request-sample/608?utm_source=PT

Highlights of The Global Opthalmology Pacs Market Report: A clear understanding of the Opthalmology Pacs market supported growth, constraints, opportunities, encountered challenges, technological advancements, practicable study. The market review for the global market is done in context to region, share, and size. Analysis of evolving market segments in addition to a complete study of existing market segments. The performance of the market throughout 2020-2026 is being forecasted during this report. The data has been categorized and summarized based on types, regions, companies, and applications of the product. The report has examined cutthroat developments such as agreements, expansions, new product launches, and mergers in the market

Global Opthalmology Pacs market is segmented based by type, application and region.Based on Type, the market has been segmented into:

By End-Use, market is segmented into:

HospitalsAmbulatory Surgical Center (ASCS) & Specialty ClinicsOthersBy Type, market is segmented into:

Standalone PACSIntegrated PACSBy Delivery Model, market is segmented into:

Cloud/ web based modelsOn-premise modelsOthers

Browse the complete report @ https://www.adroitmarketresearch.com/industry-reports/opthalmology-pacs-market?utm_source=PT

Top Leading Key Players are:

Topcon Corporation, IBM corporation, Carl Zeiss Meditec AG, EyePACS, Heidelberg Engineering and more.

This detailed report also highlights key insights on the factors that drive the growth of the market as well key challenges that are expected to hamper the market growth in the forecast period. Keeping a view to provide a holistic market view, the report describes the market components such as product types and end users in details with explaining which component is expected to expand significantly and which region is emerging as the key potential destination of the Opthalmology Pacs market. Moreover, it provides a critical assessment of the emerging competitive landscape of the manufacturers as the demand for the Opthalmology Pacs is projected to increase substantially across the different regions.

Key Questions Answered in the Report:1. What is the size of the overall Opthalmology Pacs market and its segments?2. What are the key segments and sub-segments in the market?3. What are the key drivers, restraints, opportunities and challenges of the Opthalmology Pacs market and how they are expected to impact the market?4. What are the attractive investment opportunities within the Market?5. What is the Opthalmology Pacs market size at the regional and country-level?6. Who are the key market players and their key competitors?7. Market value- chain and key trends impacting every node with reference to companies8. What are the strategies for growth adopted by the key players in Opthalmology Pacs market?9. How does a particular company rank against its competitors with respect to revenue, profit comparison, operational efficiency, cost competitiveness and market capitalization?10. How financially strong are the key players in Opthalmology Pacs market (revenue and profit margin, market capitalization, expenditure analysis, investment analysis)?11. What are the recent trends in Opthalmology Pacs market? (M&A, partnerships, new product developments, expansions)

Table of Content:1. Industry Overview of Opthalmology Pacs.2. Manufacturing Cost Structure Analysis of Opthalmology Pacs market.3. Specialized Information and Manufacturing Plants Investigation of Opthalmology Pacs.4. Capacity, Production and Revenue Analysis.5. Price, Cost, Gross and Gross Margin Analysis of Opthalmology Pacs by Regions, Types and Manufacturers.6. Consumption Volume, Consumption Value and Sale Price Analysis of Opthalmology Pacs industry by Regions, Types and Applications.7. Supply, Import, Export and Consumption Analysis of Opthalmology Pacs Market.8. Major Manufacturers Analysis of Opthalmology Pacs industry.9. Marketing Trader or Distributor Analysis of Opthalmology Pacs.10. Industry Chain Analysis of Opthalmology Pacs.11. Development Trend Analysis of Opthalmology Pacs Market.12. New Project Investment Feasibility Analysis of Opthalmology Pacs.13. Conclusion of the Opthalmology Pacs Industry.

For Any Query on the Opthalmology Pacs Market: https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/608?utm_source=PT

About Us :

Contact Us :

Ryan JohnsonAccount Manager Global3131 McKinney Ave Ste 600, Dallas,TX 75204, U.S.APhone No.: USA: +1 972-362 -8199 / +91 9665341414

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Opthalmology Pacs Market Global Innovations, Competitive Analysis, New Business Developments and Top Companies Global Forecast to 2026 - LionLowdown

In a bid to give access to health services to people belonging to every strata of the society, December 12 is celebrated as the Universal Health Coverage Day all across the world. The theme of 2020 is Health for all: protect everyone. To end this crisis and build a safer and health systems that protect us all now. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana is the Government of Indias attempt in the direction of Universal Health Coverage and it bridges the gender gap by providing access to healthcare services to women. It is to be noted that of all the hospital admissions, 49.8% of the treatment(insights.pmjay.gov.in) hasbeen availed by women.

The 2018 Gender Gap Index of the World Economic Forum and its sub-index, Health and Survival ranked India at 108th position in the overall index and 147th out of 149 in the sub-index. Here is how Ayushman Bharat PM-JAY is empowering women in accessing healthcare services

* Families with no adult male members is one of the deprivation criteria foridentifying target beneficiaries, which will ensure the reach of the scheme to a large number of women.

* Cap of five beneficiaries from a family in earlier schemes worked against women. It was seen that families prefer to prioritise the male members over females, excluding them from availing free health care benefits. Ayushman Bharat PM-JAY does not have any ceiling on number of family members hence the right to free healthcare under the scheme is being equally exercised by male and female members of the family.

* Being a man or a woman has significant impact on health due to biological and gender related differences. The packages include a large number of health conditions that exclusively, or primarily, affect women.

* Under Ayushman Bharat, individual e-cards are being issued which gives every female beneficiary an individual sense of entitlement to claim their right to free healthcare.

Women-specific DATA points:

* Top 5 states, where women are availing higher number of treatments:

1. Tamil Nadu

2. Kerala

3. Chhattisgarh

4. Karnataka

5. Andhra Pradesh

* Top 5 specialities availed by women:

1. General Medicine

2. Obstetrics & Gynaecology

3. General Surgery

4. Medical Oncology

5. Opthalmology

6. Infectious Diseases

A lot of beneficiaries feel grateful to have been given a new lease on life and resident of Gurgaon, Santosh is one of them. Aged 44, she, her three children and her ageing in-laws were all dependent on her husband, whose sudden demise further threw the family into distress. Santosh took up the baton, where her husband left off and filled the void. The family slowly began healing and on the road to recovery. Just when things were getting back to normal, Santosh noticed that she was finding it hard to climb up and down the stairs.

However, a sense of sacrifice and service prevented her from doing anything about it. Besides, she did not want to cause anxiety in the family again. She continued as if nothing had happen, hiding her pain and discomfort and turning a blind eye to her condition.

Soon, she got to know about Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY); Haryana Health Protection Mission and the various benefits that were available under this health scheme. Since, her pain was becoming unbearable, she decided to go to a hospital and get checked. She found out that she had two blocked valves in her heart and needed immediate surgery. This timely intervention truly saved her and helped her secure the future of her children.

Besides bridging gender gap, PM JAY has been immensely successful in providinghealthcare services to the needy. As per the latest government data, 1.4 crore cashless treatments worth INR. 17, 535 crores across 24,653 (Public: Private = 54:46) empaneled hospitals have been approved under the scheme. Also, the scheme is at the forefront of battling the pandemic right now. Currently, the COVID 19 testing and treatment numbers are 10,23,651.

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Universal Health Coverage Day: Nearly 50% of the treatments under PMJAY are availed by women! - Zee Business

Milestone Scientific Inc (NYSEAMERICAN: MLSS) is a medical device research and development (R&D) group.

It designs and patents innovative injection technology and specializes in dynamic pressure sensing, which allows medics to know what the pressure at the tip of needle is at any time.

The company is advancing computer-controlled drug delivery systems that offer significant efficiency and patient comfort gains in the medical and dentistry fields.

Its wand product for dentistry, which is the group's biggest revenue earner, makes an injection at the dentist a lot more comfortable. The numbness is contained on a single tooth rather than a whole portion of the mouth.

In the medical solutions space, the firm has a CompuFlo Epidural Instrument for epidural injections, which has a 99% success in locating the epidural space on the first attempt. Done manually, the procedure can be cumbersome and time-consuming. The company believes the epidural system will become the new standard of care.

The addition to the system (for catheter patients) is its CathCheck technology which is also gaining traction.

Milestone also has a Compuflo training product to help medical students master epidurals. Milestone's CompuFlo Intra-Articular Instrument has been proven successful in administering medicaments into the intra-articular space.

The group is also looking at future products in the cosmetic surgery, opthalmic and neurosurgical sectors.

In a statement at the end of November, the group's president Arjan Haverhals said the firm's dental business continued to recover and he saw growth in dental sales during the fourth quarter of 2020.

"While we are not back to pre-pandemic levels, I am pleased to report our sales continue trending in the right direction and we anticipate revenue in the fourth quarter of 2020 to be a minimum of $1.7 million," he said.

Haverhals said such a haul in revenue would represent a 40% sequential increase versus the 3Q, which follows a 718% increase for the 3Q compared to the 2Q of 2020. And this does not include recent sales to the companys Chinese distributor of about $450,000, which will be recorded as revenue when the inventory is resold by the distributor.

We are encouraged by the current trends in both the USA and around the world, which has improved our cash flow and provides us greater financial stability along with the necessary funds for marketing and sales to continue the growth in the dental sector, he told investors.

Earlier last month, the group posted third quarter financials (to September 30), which showed revenue of $1.2 million compared to the $1.9 million it posted in the same quarter in 2019. The net loss was narrowed to $1.5 million, or $0.02 per share, versus the $2.8 million, or $0.06 a share, it posted in the comparable year-ago quarter.

In October, Milestone was awarded a group purchasing agreement with Premier, a leading group purchasing organization, with around 4,100 US hospitals and 200,000 other providers within its network.

Milestoneis also expanding its trials in major hospitals and medical schools and partnering with key opinion leaders to approach the purchasing departments of hospitals together

The company ended the three-month period with over $14 million of cash on hand, which will support marketing and other ongoing activities, it added.

President Arjan Haverhals spoke to Proactive in November this year and said the company was in good financial shape with no plans to raise capital in the short, or mid-term.

"With the cash at hand, the recovery of the dental business, we have a burn rate of about US$320,000 per quarter, and hen also with the anticipated sales of the CompuFlow, the epidural system, and the CathCheck, we really look forward to become cash positive next year."

Contact the author at [emailprotected]

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Milestone Scientific, the pressure sensing specialist, has cash in bank and eyeing growing dental sales - Proactive Investors USA & Canada

NHS Lothian revealed yesterday it had been informed that despite an agreement in 2018, the government was not in a position to fund a replacement for Edinburghs Princess Alexandra Eye Pavilion now or in the foreseeable future.

At First Ministers Questions, Lothian Conservative MSP Miles Briggs said: Plans for a replacement for the 50 year-old Eye Pavilion were at an advanced stage and contracts were awarded some two years ago. Will the First Minister personally intervene today and restore this vital funding for our NHS?

Ms Sturgeon said she was not sure the situation was quite as Mr Briggs had described. But she said she would look into it further and write to him.

She added: As is the case for governments across the UK, funding is constrained, we have to make difficult choices about funding but making sure we have fit-for-purpose, state-of-the art health facilities in every part of the country is a priority.

The new hospital was planned to be located close to the Royal Infirmary at Little France, replacing the existing pavilion in Chalmers Street, which was opened in 1969. The current building was deemed unfit for purpose several years ago.

In an email to key groups yesterday, NHS Lothian opthalmology programme manager Kathleen Imrie said in 2018 the health board had been invited by the Scottish Government to prepare an outline business case, hew hospital design plans were developed and the business case was submitted in May 2019.

We have now received the formal response from the Scottish Governments which is that unfortunately, they are not in a position to fund a new Eye Hospital now or in the foreseeable future.

I am sure you will share our disappointment at this news, especially given the enthusiasm and commitment shown by yourselves as service users, carers, and partner organisations and staff in progressing the design in support of the business case.

Despite this setback, delivery of safe, effective and efficient eye care, remains a key priority for NHS Lothian. Alternative accommodation options will be looked at, including a review of feasible modern service models. The input from service users and the significant multi-professional redesign work undertaken to date will act as a solid foundation for this.

After the festive period we will re-group to agree how we now move forward.

Mr Briggs said it was totally unacceptable that the government had refused funding for the re-provision of the Princess Alexandra Eye Pavilion.

NHS Lothian have made it clear to SNP ministers that a new eye hospital is urgently needed in Lothian.

SNP ministers have received record funding from the UK government for our health service, which they have mismanaged and not used on vital services such as a new Princess Alexandra Eye Pavilion hospital.

For too long SNP ministers have underfunded NHS Lothian and it is now clear that patients are paying the price.

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Plea to Nicola Sturgeon after Scottish Government withdraws funding for Edinburgh's new eye hospital - Edinburgh News

In this episode, were all about regeneration. We talk with a Tufts biologist about the ways some animals regrow lost body parts, and the real possibility of science helping humans do the same one day. An ecologist explains how forests have the capacity to recover from even the most devastating wildfiresan ability theyve honed over thousands of years.

We hear how some species have come back from near extinction with a little attention from their human counterparts, and some enthusiastic farmers show that even something as basic as dirt can come alive with the right care. We share one experts vision for growing a better, greener economy in the wake of the pandemic, before taking a detour for the tale of some long-lost paintings given a second chance for appreciation.

Finally, we talk with an alumna who suffered a great physical loss, but went on to build a new career and a new outlook for herself. As she says, Theres always an opportunity for renewal.

Subscribe toTell Me MoreonApple Podcasts,Google Play Music,Spotify,Stitcher, andSoundCloud.

Read the Full Transcript

Read More About Regenerative Medicine

Michael Levin, A92, is the director of the Allen Discovery Center at Tufts University and the Tufts Center for Regenerative and Developmental Biology. He is also Vannevar Bush Professor and Distinguished Professor of Biology. Read about frogs starting to regrow limbs, tadpoles prompted to grow extra eyes, and some other recent research from his lab on Tufts Now.

Michael Reed, professor of biology, studies avian ecology and conservation biology. He looks at how habitat loss and fragmentation affect extinction risk and population viability, as well as the role of animal behavior in extinction risk and conservation.To get a feel for why species regeneration is so urgent, read about the UN report on species extinction rates, the report on species population size decline, and the 3 billion North American birds that have vanished since 1970.

Erica Smithwick, J95, majored in geology and environmental studies at Tufts. She is now a professor of geography at Penn State, where she is director of the Ecology Institute. A landscape and ecosystem ecologist, she is involved in understanding how a wide range of disturbances, especially fire, affect ecosystem function.

Rachel Kyte is the dean of The Fletcher School. A 2002 graduate ofFletchers Global Master of Arts program, Kyte served as special representative of the UN secretary-general and chief executive officer ofSustainable Energy for All. Previously, she was the World Bank Group vice president and special envoy for climate change. Read more about her call for a green recovery in the New York Times.

Meghan Powers and Elliot Rossow started their cultivation careers through a course with the New Entry Sustainable Farming Project at the Friedman School of Nutrition Science and Policy, later applying for a plot of land through NESFPs incubator program. They now run Kona Farms as a living laboratory for environmental stewardship. Reach them at konafarmsma@gmail.com or on Instagram.

Christina Maranci is chair of the department of history of art and architecture in the School of Arts and Sciences. She is also the Arthur H. Dadian and Ara Oztemel Professor of Armenian Art and Architecture. Maranci's research is mainly onmedieval Armenian history and the relationship with the Sasanian, Byzantine, and Islamic empires. See some of her photos of the art of Ani Cathedral on Tufts Now.

Maggie Baumer, A04, studied clinical psychology at Tufts before graduating from law school. She manages the Springfield, Mass., location of Hanger Clinic, the nations largest provider of state-of-the-art prostheses. She is also a certified peer visitor for theAMPOWER program, a peer-to-peer network designed to empower and strengthen those affected by amputation or limb difference.

Transcript

JULIE FLAHERTY: 2020 has been a really rough year, which is why everyone is hoping that a new year will bring brighter times.

ANNA MILLER: And that got us thinkingabout renewal, about starting over, about rising from the ashes. This is Tell Me More, the Tufts University podcast. Im Anna Miller.

FLAHERTY: And Im Julie Flaherty. In this episode, were all about regeneration. Were talking forests that bounce back after massive wildfires, animals that regrow lost limbs, and people who manage to rebuild their lives after calamity.

MILLER: They are just the kind of inspiring stories we need right now.

FLAHERTY: If you want to be encouraged about the possibility of regeneration, just talk to Michael Levin. Levin is the director of the Allen Discovery Center at Tufts and the Tufts Center for Regenerative and Developmental Biology. I asked him about the most impressive examples of regeneration he knows.

MICHAEL LEVIN: Many people know about things like the axolotl, which is a salamander that will regenerate almost any organ. So they regenerate their eyes, their jaws, their limbs, their ovaries, portions of their brain and heart. But some other cool ones are, for example, deer. So deer are a large adult mammal, and every year they regenerate their antlers. And antlers have bone and skin and vasculature and nerve, and they will regenerate those antlers at a rate of about a centimeter and a half per day. So think about that. Every day, that thing adds a centimeter and a half of new bone.

FLAHERTY: But even more impressive might be a creature Levin uses in a lot of his worka little guy called the flatworm.

LEVIN: Well, the planaria, the flatworms are an amazing model system. They combine most of the interesting problems of biology are found in this animal. Its just remarkable. First of all, they regenerate from any piece of the body. The record, I think is something like 275 pieces. You can cut the worm in any way you want. Every piece knows exactly what a correct worm looks like, and it will build exactly whats needed, no more, no less, to give you a tiny, perfect little worm. So they hold the secret to regeneration. So thats the first thing.

The second thing is theyre also immortal. They have no lifespan limits. So theres no such thing as an old planarian. They live forever, and thats telling us that in fact aging is not an inescapable part of life. These animals have been with us for probably 400 million years. And these are the exact same worms. They just do not age. So thats telling us that immortality is possible for a complex creature.

FLAHERTY: Thats all very well for the worms. But what about people?

LEVIN: The other thing a lot of people may not know is that even human children can regenerate their fingertips. So somewhere between the age of 7 and 11, most of us lose this. There used to be more of this back in the 70s, when fans werent covered with the metal grates and everything. But a clean amputation of a digit for a small child usually just grows back perfectly.

FLAHERTY: No one knows for sure why we lose the ability to regenerate as we get older. But Levin says that all of the information for how to do it is still inside us. We just need to figure out how to turn it back on. And Levin thinks it has something to do with bioelectricity, the flow of ions between cells in the body. Thats how cells communicate with each other.

Levin, who studied both biology and computer science as an undergrad at Tufts, likens it to software. If we can find the code that the cells use to communicate about regeneration, we can run that program, and get the cells to do the work of building a new finger or what have you.

LEVIN: So all of those kinds of computations, when the cells join together to say, what should we be building? Are we done yet? Is there a finger missing? How many fingers should there be? That kind of thing. All of that is mediated electrically.

So if we understood how that worked, we could artificially inject electrical information to get the cells to do whatever we wanted them to do. And so this means kickstart a normal regenerative cascade, or reprogram a tumor into normal tissues, or build a completely new anatomical structure thats never been seen before, some sort of synthetic living device. All of that is possible if we understand how cells cooperate towards these kinds of outcomes.

What weve developed are some of the first tools to listen in on, and then modify, the natural electrical conversations that cells are having with each other. We basically go in and we open and close the ion channels that are in those cells, to modify how they talk to each other.

FLAHERTY: Levins lab has conducted many groundbreaking experiments over the years. They have coaxed a mature frog, which typically does not have the ability to regenerate its limbs, to begin to grow a new leg. Another experiment involved convincing a tadpole to grow an eye. But they didnt want the eye in the usual place.

LEVIN: We observed that there was a special electrical pattern that was present in the embryo where the eye was going to form. So what we simply did was reproduce that same pattern somewhere else. What we found is that, sure enough, the cells know that that pattern means make an eye here. And if you make that electrical distribution in the gut, then you will have an eye in the gut, and if you make it in the tail, you will have an eye in the tail.

FLAHERTY: Yes, a tadpole with eyes on its tail is weird, but it showed something important. To use that software analogy again, it showed that cells can be reprogrammed. You dont have to rewire the hardware to make an eye.

LEVIN: We dont know how to make an eye ourselves. The eye has many different cell types, arranged in a really exquisite pattern. We cant reproduce any of that by hand. Its way too complex. But we found that with a very simple trigger, the whole eye is formed. So that told us that theres a path towards regenerative medicine where you dont need to try to micromanage the whole process. You need to find the logic of the natural software thats being used, and you can take advantage of it.

FLAHERTY: Levin believes that one day, humans are going to be able to regrow eyes, limbs, hearts, and other useful things.

And you think youre going to see this happen in your lifetime?

LEVIN: I hope I not only to see it happen, I hope I help make it happen. Were working very hard towards this now. Im optimistic. I think were going to see amazing things out of regenerative medicine in the next decade or two.

MILLER: So some animals are pretty good at regenerating body parts. But what happens when a whole group of animals is threatened with extinction? Is there any way to regrow a species? We put that question to someone who studies animal populations.

MICHAEL REED: My name is Michael Reed, Im a professor in the biology department at Tufts University.

MILLER: There is an urgency behind this question. Right now, were in an environmental crisis. And a lot of animals are disappearing.

REED: Were now moving into a sixth mass extinction thats, if continued, would build to be similar to one of the mass extinctions during geologic time, the last of which was the disappearance of most of the dinosaurs.

MILLER: This time, theres no meteor. Instead, its us. Simply put, our actions are killing animals around the globe in shocking numbers. Since the 1970s, 68 percent of all animal populations have been wiped out.

REED: If you were paying attention to the news a year ago, you would have seen around the world headline news of 3 billion birds lost in North America.

MILLER: A report delivered by the United Nations estimates that within the next 30 years, anywhere from a third to half of all species on the planet might go extinct. So what are humans doing to cause this? Its climate change, its wildlife trafficking, its use of pesticidesbut the biggest killer, says Reed, these animals have run out of places to live.

REED: The number one problem globally is habitat loss, habitat fragmentation, and degradation of habitat. If you take away a species habitat, the species doesnt exist anymore.

MILLER: So can we even turn this around? I asked Reed if he knows of a species that people have successfully brought back from the brink of extinction.

REED: Yeah. Fortunately there are examples, otherwise I think people would give up in despair.

We kept bison from going extinct in the U.S. Theyre not anywhere near the numbers they were at one time. There used to be hundreds of millions of them and their range actually extended into the middle of New York state. In Pennsylvania you could see bison. Their numbers are extremely low compared to that. But since we were down to dozens, I think the tens of thousands we have now is pretty good. So at that stage, it depends on exactly how youre defining success.

MILLER: When we stopped using the pesticide DDT, which turned out to be damaging to eggs, some bird species bounced back.

REED: The bald eagle has moved off of the endangered species list. The peregrine falcon has moved off the endangered species list. Osprey are returning to many of their haunts on the East Coast of the U.S. and Northern Europe with the cessation of the use of DDT.

Ironically, the one large group of birds thats doing really well, and their numbers are going up instead of down, is waterfowl. And we hunt them. Animals were going out and shooting, harvesting, their numbers are going up, while the animals that were not harvesting are going down. The big difference is for harvested animals, people are putting their money where their mouth is and says, Id like more of them. Lets spend millions of dollars recreating habitat, bolstering populations.

Frankly, any of you who go to national wildlife refuges, those were paid for by duck hunters. Thats why we have these refuges. It demonstrates that with interest and money, we can turn these around really well, even for harvested things. Looking at examples like that gives me a lot of hope.

MILLER: There are simple things people can do to boost wildlife populations.

REED: So if youre cutting down lots of habitat and the species are disappearing, quit wrecking so much habitat, or find ways to leave patches behind that are sufficient for species or corridors that connect one reserve to another reserve. Or in your yard, instead of having a bunch of grass, let some wildflowers grow and bring back native pollinators.

We have proven that we have the capacity to make a difference and to turn things around and that it just requires some awareness and some thoughtfulness.

FLAHERTY: We humans can take all the blame for habitat loss. But sometimes destruction and regeneration are just part of the natural cycle.

Erica Smithwick has made a career studying how ecosystems recover from traumas like insect infestations and wildfires. Smithwick, who graduated from Tufts in 1995 and is now a professor of geography at Penn State, has extensively studied the 1988 wildfires in Yellowstone National Park. More than 40 percent of the park was burned, and news accounts at the time made it seem like the park might not survive.

NEWS ANCHOR: Our oldest National Park is under siege tonight...

NEWS ANCHOR #2: The president to declare Yellowstone National Park a national disaster area...

ERICA SMITHWICK: The media coverage at the time was really alarmist. It was talking about the destruction and all these D words, death, destruction, disaster. It really was portrayed in that way. And actually what the science showed us was completely the opposite. And its one of the lessons we learned from studying the Yellowstone landscape over decades, frankly, is that the system recovered, it had the potential to recover.

And if you go to Yellowstone today, you probably wouldnt know that it once was a blackened landscape because its completely green, you see all of the trees coming back, a carpet of trees really just covering the whole landscape. And you have to dig deeper to understand that a lot of that regeneration was because the trees have the capacity to recover from severe fire.

FLAHERTY: In fact, the trees depend on fire to reproduce. They need the heat of a large fire to melt the resin in their pinecones and release seeds of new plants.

SMITHWICK: And it turns out that the lodgepole pine trees that are dominating a lot of the Yellowstone landscapes have this trait because they have adapted to severe fires over the past 10,000 years, the entire quaternary period. Theres memory in the system of these large wildfires. And the fires that occurred in 1988 were basically on cue.

It was about time for one of these large fires. Now, they dont come often, they come every 150 to 300 years. Thats why it wasnt part of our social memory of what the park should be experiencing. But within the context of what we can tell by paleo records of ash and pollen, this was fitting right in with a normal fire cycle of the park.

FLAHERTY: Almost as soon as the fires ended, seedling began to appear. Within a decade, trees rose up, and became what you see now as large mature trees. The recovery was also picturesque, as wildflowers took advantage of newfound sunlight.

SMITHWICK: Fireweed is a particular plant that is very beautiful. Its this purple-pink color and it just is covering the entire understory of the forest. And along with that comes the understory plants that bring nitrogen to the soil. This is a very impoverished nutrient poor ecosystem. And these understory plants bring a lot of nutrients back into the soil.

FLAHERTY Smithwicks research has shown that the fire itself brought a pulse of nitrogen to the soil, in part by breaking down organic matter on the forest floor, making nutrients for the next forest. And as Yellowstone came back, it came back different. Like aspen trees that sprang up where they hadnt been any before. In fact, fires are known for creating biodiversity.

SMITHWICK: Well, this is the thing about disturbances generally in forest city ecosystems is that they do create surprises. They create opportunities for new organisms to persist and even get reintroduced into a certain area.

There are a lot of birds that really enjoy post-fire landscapes or burned landscapes. So black-backed woodpecker would be one Kirtlands warbler in other parts of the U.S. A number of these birds will come into burned environments because the burned ecosystem has lots of cavity in the trees for nesting. And it also has a lot of bugs and beetles. The insects in that forest are actually just presenting a smorgasbord to sunbirds. The sunbirds, they depend on these burned ecosystems for survival, and will seek them out.

FLAHERTY: So forests can recover from massive wildfires. They just need time to do it. And its the lack of time that worries Smithwick right now. These big fires that usually happen hundreds of years apart are now happening every 15 or 30 years.

SMITHWICK: When we see fires like we have in the West, 8.6 million acres burned this year in 2020, and actually five times that amount in the Australian fires, just enormous areas burning. This is out of the realm of what we would expect to be normal. Thats concerning in terms of the ability of those forests to be able to recover.

We want an ecosystem that constantly is renewing itself. We have to learn to live with fire. And we all also have to learn to give our systems time to recover, because they have the capacity to do so.

There is nothing more important right now than fixing the climate situation. And so buying time to do that. And frankly, a lot of the climate work suggests that we do have the potential, if we make the right decisions now, to move the needle and that the earth system, the climate system, will actually respond very quickly.

MILLER: So forests can literally rise from the ashes, and often come back differentmaybe even better. Rachel Kyte, dean of The Fletcher School, thinks that the same is true for economies. Right now, in the midst of the pandemic, economies worldwide are hanging by a string. But Kyte is already thinking about the recovery, and the opportunity it presents to do something for the climate situation Smithwick was just talking about.

RACHEL KYTE: I think its really important to remember that before COVID hit, and I know that feels like a very long time ago, the economy wasnt working for everybody and it wasnt working for the planet.

When we think now about recovery, we have to recover, and through recovery, get ourselves on a trajectory for net-zero emissions by 2050. We have to recover clean and we have to recover in a way that we don't leave people behind. The good news is that thats entirely possible. They are not in opposition to each other.

MILLER: Kyte says that people are going to need jobs, and those jobs could easily be a part of building a greener economy.

KYTE: Whats been interesting through the pandemic is to see that we can agree, the economists worldwide, every international organization that we used to govern the global economy, that there are things that governments can do that will spur short-term income generation, short-term jobs, as well as mid-term growth and long-term emissions reduction.

For example, here in the Northeast of the United States, one of the most important things we could do is massively invest in programs to refurbish, deeply refurbish the built environment. Every time we make a building energy-efficient, those are good, local, skilled, and semi-skilled jobs, we reduce the emissions from this part of the United States, and we build our resilience to the next shocks.

We also know that investing in the infrastructure we need to drive electric cars and hydrogen fuel cells will be important. We also know that investing in the clean energy infrastructure that will allow us to use much more renewable energy will be important. These are good local jobs. Good, local jobs, well-paid put us on a better trajectory and put us on track for zero-net emissions.

MILLER: One way to help reduce carbon emissions is by fixing how we grow food. And thats where something called regenerative farming comes into play. Elliot Rossow is a soil microbiologist. And he cares so much about the earth, he can actually taste it.

ELLIOTROSSOW: Theres this entire classification system of soils and so I can grab some in my hand and put a little bit on my tongue and I can tell you, to a very specific content, how much sand, silt, and clay is in that soil. Which is awesome, its a great party trick.

MILLER:What does good soil taste like?

ROSSOW:Well, no soil really tastes good.

MILLER: Rossow and fellow soil-enthusiast Meghan Powers are incubator farmers with the New Entry Sustainable Farming Projectrun by the Friedman School of Nutrition Science and Policy.

They farm a small plot of land in Beverly, Massachusetts, where they groworganicvegetablesmost of which they donate to charity. But their real aim is figuring out how to bring life back to depleted soil.Heres Powers:

MEGHAN POWERS: So the main purpose of the farm is to test out new and really interesting sustainable management practices and sustainable inputs with the goal of regenerating the land and the soil itself.

MILLER: Why regenerate the land? Powers says the problem is that our agricultural system tends to treat soil like an inert thingput enough chemical fertilizers into it and plants will grow. But chemicals also break down the soil, degrading it. And over time, once you put in enough chemicals, the soil can become unusable.

POWERS:Its really important to start from this holistic perspective that we are working with the soil, and the soil is a living thing.

MILLER: Healthy soil is actually alive with active microbial communitiesmicrobes that help plants and make the soil more resilient. Rossow says you can actually see when dirt is thriving.

ROSSOW:You can definitely feel when soil is alive and intense, and if youve ever played in dirt, played in soil, you notice that it comes in different clumps. Theyre called aggregates, these big clods of dirt you see kids throwing at each other or people break it when they step on them.

But really, the more aggregates and the larger the aggregates means that theres more biological activity happening and flowing through that entire system. And so the more aggregates you have, and the healthier it is, you can see that they kind of grow in size. Whenever were soil sampling out there, and we find it, Oh, my gosh. Look at this one, its as big as my hand. Theyre massive.

MILLER: For the next three years, theyll be using their farm as a living laboratory, testing what works best to produce crops while still making the soil healthy. Because ultimately, healthy soil is a defense against climate change.

POWERS: And the great thing about soil is that you can regenerate it, you can build it back up, its not one and done, you can put carbon back in. And I think thats one of the few solutions that we have really for the climate problem is that we can put carbon in the soil, and we can recharge this system and doing that would take it out of the air and make itmore healthy.Soits really a win-win.

Excerpt from:
Seven Stories of Regeneration | Tufts Now - Tufts Now

Avery Therapeutics is projected to be one of the first companies in the US to seek approval for a clinical trial using iPSC-derived technology for heart failure. The goal of this collaboration is to develop a new off-the-shelf treatment to improve the quality of life of patients suffering from heart failure, a debilitating disease that affects tens of millions of people worldwide.

The iPSCs are manufactured at I Peace's state-of-the-art GMP facility in Kyoto, Japan, under comprehensive validation programs of the facility, equipment, and processes including donor recruiting, screening, blood draw, iPSC generation, storage, and distribution. I Peace has obtained a US-based independent institutional review board (IRB) approval for its process of donor sourcing for commercial-use iPSCs. The facility is designed to be PMDA and USFDA compliant.

As Avery Therapeutics expects to expand the application of its regenerative medicine technology to various types of heart diseases and beyond, iPSCs are the key enabling technology for quality and future scalability. This agreement provides a solid foundation to improve the welfare of those suffering from diseases through advancement of tissue-engineered therapeutics.

"We are thrilled to announce this collaboration with I Peace. It is a big step forward in the development of novel cell-based therapeutics for unmet medical needs. Through this collaboration, I Peace brings deep iPSC development and manufacturing expertise to enable Avery's proprietary MyCardia cell delivery platform technology. Together we hope to positively impact millions of patients worldwide in the near future," Said Jordan Lancaster, PhD, Avery Therapeutics' CEO.

This agreement reflects an innovative collaboration involving multiple locations internationally and marks a significant milestone for both I Peace, Inc. and Avery Therapeutics to pursue one of the first US clinical trials using iPSC technology in the area of heart diseases. Koji Tanabe, PhD, founder and CEO of I Peace stated: "By combining I Peace's proprietary clinical grade iPSC technology and Avery's tissue engineering technology, we can bring the regenerative medicine dream closer to reality. We are very excited by Avery's technology and look forward to continue working together."

About I Peace, Inc

I Peace, Inc. is a global supplier of clinical and research grade iPSCs. It was founded in 2015 in Palo Alto, California, USA by Dr. Tanabe, who earned his doctorate at Kyoto University under Nobel laureate Dr. Shinya Yamanaka. I Peace's mission is to alleviate the suffering of diseased patients and help healthy people maintain a high quality of life by making cell therapy accessible to all. I Peace's state-of-the-art GMP facility and proprietary manufacturing platform enables the fully-automated mass production of discrete iPSCs from multiple donors in a single room. Increasing the available number of clinical-grade iPSC lines allows I Peace customers to take differentiation propensity into account to select the most appropriate iPSC line for their clinical research at significantly reduced cost. I Peace aims to create iPSCs for every individual that become their stem cell for life.

Founder, CEO: Koji TanabeSince: 2015Head Quarter: Palo Alto, CaliforniaJapan subsidiary: I Peace, Ltd. (Kyoto, Japan)Cell Manufacturing Facility: Kyoto, JapanWeb: https://www.ipeace.com

About Avery Therapeutics

Avery Therapeutics is a company developing advanced therapies for patients suffering from cardiovascular diseases. Avery's lead candidate is an allogeneic tissue engineered cardiac graft, MyCardia in development for treatment of chronic heart failure. Using Avery's proprietary manufacturing process MyCardia can be manufactured at scale, cryopreserved, and shipped ready to use. Avery is leveraging its proprietary tissue platform to pursue other cardiovascular indications. For more information visit: AveryThera.com. Follow Avery Therapeutics on LinkedInand Twitter.Since: 2016Headquarter: Tucson, AZWebsite: https://www.AveryThera.com

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I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic - PRNewswire

Global Regenerative Medicine Products Market analysis report speaks about the manufacturing process. Global Regenerative Medicine Products market report analyses the market growth, trends, overview & forecast to 2026.The report covers key technological developments in the recent times and profiles leading players in the market and analyzes their key strategies.

The research study on Regenerative Medicine Products market boasts of a detailed analysis of this industry vertical, alongside a robust gist of its segmentation. The report is inclusive of a highly viable analysis of the current status of the Regenerative Medicine Products market as well as the market size in terms of the valuation and the volume. Additionally, the research study encompasses a collective summary of vital information with regards to the regional terrain and the companies that have established their stance across this business space.

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Latest Study explores the Regenerative Medicine Products Market Witness Highest - GroundAlerts.com

TRUMBULL, Conn., Dec. 15, 2020 /PRNewswire/ --ZetrOZ Systems, developers of the Sustained Acoustic Medicine (SAM) wearable ultrasound, an FDA-cleared bio regenerative medical device, was recently evaluated in a research study published in the Global Journal of Orthopedics Research, which measured the effectiveness of SAM treatment to reduce pain and improve function in athletes in conjunction with traditional therapies following sports-related musculoskeletal injuries. According to the study, the data "confirms the effectiveness of the application of SAM ultrasound in reducing pain as adjunct therapy or standalone therapy."

"The study confirms the effectiveness and benefits for home users, both athletes and non-athletes, who have sustained some kind of musculoskeletal injury," according to Dr. George Lewis, Founder and CEO of ZetrOZ. "The cases referenced in the study indicate SAM's ability to penetrate deep into muscle tissue and provide relief from pain and injury with regular treatment, helping accelerate the healing process and decrease the time it takes to recover."

The study included a case series of 18 professional and collegiate athletes who suffered a musculoskeletal, sports-related injury. The athletes were treated with SAM as supplementary therapy at a specified sports medicine rehabilitation clinic. Regular treatments resulted in 'reduced pain and improved function across numerous muscles, ligament, and tendon conditions.' Most of the athletes in the study were able to return to normal activity, including sports, during their treatment period.

The athletes in the study had previously undergone surgeries or were being considered for surgery. By utilizing sustained acoustic medicine as a long-duration continuous ultrasound therapy, users can accelerate the natural process of healing by inhibiting inflammation, increase the rate of tissue regeneration, angiogenesis, and nutrient exchange.

To read the study in full, visit:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544191/.

To learn more about ZetrOZ Systems and the company's SAM line of products, visitsamrecover.com.

About ZetrOZ Systems

ZetrOZ Systems is an FDA cGMP and ISO 13585 medical technology company headquartered in the southern coastal region of Connecticut. The organization also has manufacturing facilities across the United States. ZetrOZ Systems produced UltrOZ, samSport and samPro 2.0 to provide safe and effective treatment options for prevalent conditions such as arthritis. Learn more atzetroz.comandsamrecover.com.

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real-world-outcomes-study-on-sam.jpg Real-world outcomes study on SAM wearable ultrasound treatment published in the Global Journal of Orthopedic Research 2020

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New Research Study Shows Efficacy of Sustained Acoustic Medicine as Add-on Therapy in Treating Sport-Related Injuries and Returning Athletes to Play -...

HELSINKI, Dec. 17, 2020 /PRNewswire/ -- Nanoform Finland Plc, an innovative nanoparticle medicine enabling company, and Herantis Pharma Plc, an innovative drug development company, today announced that they have signed a letter of intent to collaborate to seek to enhance nasal drug delivery to the brain of Herantis' CDNF and xCDNF therapies (Parkinson's disease) using Nanoform's proprietary biological nanoparticle technology.

The planned and non-exclusive collaboration is intended to assess the utility of Nanoform's latest platform technology for biologic drugs. The technology was recently launched, post filing of a provisional patent application with the US Patent Office, to enable production of biological nanoparticles as small as 50 nm.

Subject to finalizing definitive agreements, Nanoform will in this partnership carry out, for compensation on standard commercial terms, two Proof of Concept studies on Herantis' CDNF and xCDNF molecules leveraging Nanoform's novel platform and its in-house formulation expertise. The goal of the planned collaboration is to increase the probability of success for enhanced BBB (Blood-Brain-Barrier) penetration in the nasal drug delivery route for CDNF and x-CDNF.

Nanoform is committed to supporting Herantis in the development of these programs and has undertaken to invest, subject to certain customary conditions, 1,600,000 euros in a planned immediate directed share issue by Herantis.

"We are delighted to support Herantis Pharma in their development programs in CDNF and latest generation xCDNF molecules. Completing this deal validates the strong market interest in, and potential value that, Nanoform's platform technologies can add to pharmaceutical development programs and to the patient" said Prof. Edward Hggstrm, CEO of Nanoform.

"We look forward to working together to enhance and enable superior formulations of the pioneering new drugs we have developed. Nanoform's technologies show much promise for enhanced drug delivery applications in this complex and challenging field. It is our hope that this will open up new possibilities for improving the lives of patients with Parkinson's and other related diseases. We value the opportunity to enter into collaboration with Nanoform and look forward to what the future brings." said Dr. Craig Cook, CEO, Herantis Pharma.

For further information, please contact:

Prof. Edward Hggstrm, CEO

[emailprotected]/ +358 29 415 0684

For investor relations queries, please contact:

Henri von Haartman, Director of Investor Relations

[emailprotected]/ +46 7686 650 11

About Nanoform

Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform's platform technologies. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules' formulation performance through its nanoforming services. Nanoform's capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806.

For more information please visit http://www.nanoform.com

About Herantis Pharma Plc

Herantis Pharma Plc is an innovative drug development company looking to break the boundaries of standard therapeutic approaches. Our regenerative medicine drug candidates include i. CDNF biological therapy that acts on the proteostatic mechanisms of disease for the treatment of Parkinson's disease and other neurodegenerative diseases, and ii. Lymfactin VEGF-C gene therapy for restoring lymphatic structure and function for the treatment of oncology related secondary Lymphedema and other lymphatic based diseases. The Herantis programs are potentially disease modifying that treat the cause as well as symptoms of disease, and bring the innovation necessary to provide further treatment options in underserved diseases. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

For more information please visit https://www.herantis.com

Forward-Looking Statements (Nanoform)

This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform's strategy, business plans and focus. The words may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks specified in Nanoform's prospectus published (on May 22, 2020) in connection with Nanoform's initial public offering (the "Prospectus") under "Risk Factors" and in our other filings or documents furnished to the Finnish Financial Supervisory Authority in connection with the Prospectus. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

This information was brought to you by Cision http://news.cision.com

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Nanoform and Herantis partner to look for opportunities to enhance BBB penetration of CDNF and xCDNF molecules - PRNewswire

Ashok Shetty is a professor in the Department of Molecular and Cellular Medicine and associate director for the Institute for Regenerative Medicine at the Texas A&M University College of Medicine.

Texas A&M Health Science Center

Thousands of American troops who were deployed in theFirst Gulf War were exposed to a variety of chemicals that resulted in psychological and physiological symptoms that health experts call Gulf War illness (GWI), previously called Gulf War syndrome.

Ashok Shetty, professor in the Department of Molecular and Cellular Medicineand associate director for the Institute for Regenerative Medicine at theTexas A&M University College of Medicine, has teamed up withKimberly Sullivan from the Boston University School of Public Health and Dr. Nancy Klimas Nova Southeastern University to investigate the extent and mechanisms of brain inflammation in veterans with GWI through a liquid biopsy approach. Their research efforts are being funded by a $1 million grant from the Department of Defense(DOD) over a three-year period.

The condition is characterized by a collection of unexplained chronic symptoms that can include gastrointestinal problems and dermatitis(a skin disorder) or central nervous system problems such ascognitive dysfunction, neuroinflammation, memory problems and depression.Nearly 30% of Gulf War veterans suffer from chronic GWI.Currently, the mechanisms underlying these persistent issues are unknown.

Shettysearlier studies on GWIfocused on theanimal model of GWI, recreating the conditions and chemicals veterans were exposed to during the war. He found that the animal models developed cognitive problems and had increased behavior that was associated with inflammation in the brain. His studies showed that the neuroinflammation in the brains of the animal models was progressive and had gotten worse over time, which explains why GWI is still prevalent in Gulf War veterans 30 years after the war.

Compared to an animal model approach, studying the brain in veterans with GWI is difficult. Therefore, most research with humans has been done through blood sampling, but its difficult to see if the results actually reflected what was happening in the brain. As a result, Shetty developed a liquid biopsy approach, which involves the characterization of the composition of brain-derived extracellular vesicles in the blood.

Shetty and his team will use this liquid biopsy approach to study neuroinflammation in the blood of Gulf War veterans beginning in early 2021.

The Sullivan and Klimas laboratories will collect blood samples of 50 veterans with GWI (patients) and 50 veterans without GWI (controls). Once the blood samples are collected, they will send the samples to Shettys laboratory. Shetty will then use the blood samples to isolate the extracellular vesicles (EV) membrane-enclosed nanosized vesicles that carry cargo such as proteins, lipids and micro-RNAs that come from the brain.

Once the extracellular vesicles are isolated, he will classify each one as a neuron-derived extracellular vesicle (NDEVs) or an astrocyte-derived extracellular vesicle (ADEVs) using a specific tagging technology. Then, Shetty will examine the cargo in the NDEVs and ADEVs, particularlyproinflammatory mediatorsand microRNAs using biochemical assays and RNA sequencing.

Because the composition of EVs reflects the physiological or pathological state of cells from which they are derived at the time of secretion, analysis of EVs derived from specific brain cells in the blood would help in the identification of biomarkers linked to chronic brain impairments, Shetty said.

What this approach means is by just looking at the vesicles, one can tell what is going on in the brain, even the brain cannot be directly studies. This technique of isolating extracellular vesicles was developed by Shetty in 2019, when he used an animal model approach.

Whatever is happening in the brain can be determined by characterizing brain-derived vesicles in the blood, Shetty said. It can be neuron-derived vesicles and astrocyte-derived vesicles, so this project is about that. But now, instead of animal models, we are studying actual veterans. From this human study, we can identify the extent of neuroinflammation in veterans.

Ultimately, this study will likely provide evidence as to why GWI is worse for some veterans compared to others, help diagnose the extent of brain inflammation in veterans with GWI and help determine whether GWI puts veterans at a higher risk for developing other neurological diseases.

The approach is also efficient in future clinical trials for monitoring the remission or progression of brain inflammation with apt treatment strategies, Shetty said.

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Texas A&M Professor Awarded Department Of Defense Grant For Gulf War Illness Research - Texas A&M University Today

-Funding from the Bill & Melinda Gates Foundation will support research to enable CRISPR/Cas9-based therapies for HIV that can benefit patients worldwide-

ZUG, Switzerland and CAMBRIDGE, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics(Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced the receipt of a grant from the Bill & Melinda Gates Foundation to research in vivo gene editing therapies for the treatment of HIV.

While we have demonstrated the promise of CRISPR/Cas9 gene editing ex vivo in sickle cell disease and beta thalassemia, an in vivo approach to editing hematopoietic stem cells could allow the transformative benefit of CRISPR/Cas9 to reach a broader array of patients, including those in low resource settings that lack sufficient infrastructure for stem cell transplantation, said Tony Ho, M.D., Executive Vice President and Head of Research & Development at CRISPR Therapeutics. We look forward to working on new therapies that could contribute to the global effort to reduce the burden of HIV.

The grant builds upon CRISPR Therapeutics proprietary CRISPR/Cas9 gene editing technology and expertise in editing hematopoietic stem cells and contributes to efforts to accelerate transformative medicines for global health.

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Forward-Looking StatementThis press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements made by Dr. Ho in this press release, as well as regarding CRISPR Therapeutics expectations about any or all of the following: (i) the expected benefits of CRISPR Therapeutics research funded by the Bill & Melinda Gates Foundation and (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: uncertainties inherent in the initiation and completion of preclinical studies for CRISPR Therapeutics product candidates; availability and timing of results from preclinical studies; whether results from a preclinical trial will be favorable and predictive of future results of the future trials; uncertainties about regulatory approvals to conduct trials or to market products; that future competitive or other market factors may adversely affect the commercial potential for CRISPR Therapeutics product candidates; potential impacts due to the coronavirus pandemic, such as the timing and progress of preclinical studies; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

CRISPR THERAPEUTICS word mark and design logo are registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

Investor Contact:Susan Kim+1-617-307-7503susan.kim@crisprtx.com

Media Contact:Rachel EidesWCG on behalf of CRISPR+1-617-337-4167reides@wcgworld.com

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CRISPR Therapeutics Receives Grant to Advance In Vivo CRISPR/Cas9 Gene Editing Therapies for HIV - GlobeNewswire