StemCell Therapy

Global Cell Culture Media Market insights relating to crucial aspects of the Cell Culture Media industry influencing its growth during the forecast period to 2024. It shows the sales of various Cell Culture Media forms of product increasing or declining in various regions and countries. The regional Cell Culture Media analysis provided within the report includes an excellent assessment of geographical niches by all factor-like CAGR and market share, production, and consumption. The Cell Culture Media market is divided into quite a detail for a transparent clarification of key growth areas with leading players that can make the foremost of it.

The Cell Culture Media industry research report additionally ensures the geographical division of this market. The proposed forecast typically includes global market size, share, product demand and supply, market trends, consumer tendencies, profitability, revenue outcomes and also company profiles of the key participants operating in the global Cell Culture Media market. For long-lasting business growth and strategic management, every manufacturer/company peruses intact forecast analysis that drives their business ahead of the curve.significant players of this Cell Culture Media Market are Atlanta Biologicals, Thermo Fisher, Merck Millipore, Zenbio, Sigma-Aldrich, PromoCell, BD, CellGenix, Corning (Cellgro), Life Technologies, GE Healthcare, Lonza, Takara and HiMedia

At the company level, this report focuses on the application, classification, and forecasts pertaining to volume and value, and future predictions for each manufacturer covered in this report. The top-down approaches have been used to counter-validate the Global Cell Culture Media Market numbers, while bottom-up approaches have been used to evaluate the market numbers for each element. The data has been authenticated by using the triangulation method in this exclusive report.

Key Players Of Cell Culture Media Market:

Atlanta Biologicals, Thermo Fisher, Merck Millipore, Zenbio, Sigma-Aldrich, PromoCell, BD, CellGenix, Corning (Cellgro), Life Technologies, GE Healthcare, Lonza, Takara and HiMedia

Product Types Of Cell Culture Media Market:

Serum-free Media, Stem Cell Media and Classical Media & Salts

Cell Culture Media Market isolation based on:

Tissue Culture & Engineering, Gene Therapy, Biopharmaceutical Manufacturing and Cytogenetic

Key regions that operate Cell Culture Media market includes Latin America (Argentina, Brazil, and Colombia), North America (Canada, The United States, and Mexico), Asia-Pacific (China, Japan, Korea, India, South-East Asia, and Thailand), Cell Culture Media market in Europe (Russia, Italy, United Kingdom, Germany, and Italy), The Middle East and Africa (South Africa, UAE, Nigeria, Saudi Arabia, and Egypt). Alongside, consumption value, market share, Cell Culture Media market value, import/export details, price/cost, Cell Culture Media market gross margin analysis and SWOT analysis.

1. Product overview and scope of Cell Culture Media market

2. Revenue and sales of Cell Culture Media by type and application (20192024)

3. Major players in the Cell Culture Media industry

4. Cell Culture Media players/suppliers Profiles and Sales data

5. Marketing strategy analysis and Cell Culture Media development trends

6. Worldwide Cell Culture Media Market effect factor analysis

7. Emerging niche segments and regional Cell Culture Media markets

8. A complete framework analysis, including an assessment of the parent Cell Culture Media industry

9. An empirical assessment of the trajectory of the Cell Culture Media market

1o. Major changes in Cell Culture Media market dynamics

11. Historical, present, and prospective size of the worldwide Cell Culture Media industry from the perspective of both value and volume

12. Understanding The Current Cell Culture Media Market

In conclusion, it is an in-depth research report on Global Cell Culture Media industry. Here, we express our thanks for the support and assistance from industry chain related technical experts and Cell Culture Media marketing engineers during Research Teams survey and interviews.

We have a too many categories research reports like Consumer Goods & Retailing, Agriculture, Food & Beverage, Food Services, Energy & Resources, Manufacturing & Construction, Chemicals & Materials, Transportation & Shipping, Biotechnology, Medical Devices, Pharmaceuticals & Healthcare, Business Services & Administration, IT & Telecom, Textiles, Automobile, Electrical & Electronic Device, Ship Manufacturing, Hotel and Tourism, Petroleum Industry, Trading Industry, Technology, Aerospace & Defense, Entertainment, etc.

Read the rest here:
Global Cell Culture Media Market 2019 Analysis Sigma-Aldrich, Corning (Cellgro), Life Technologies and Thermo Fisher - Business Broker

LONDON, Dec. 18, 2019 /PRNewswire/ --GSK today announced positive headline results for intravenous (IV) Benlysta (belimumab) in the largest controlled phase 3 study in active lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE) which can lead to end-stage kidney disease.

The Efficacy and Safety of Belimumab in Patients with Active Lupus Nephritis (BLISS-LN) study, involving 448 patients, met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) over two years when treated with belimumab plus standard therapy compared to placebo plus standard therapy in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311).

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Lupus nephritis is one of the most common and serious complications of SLE, occurring in up to 60% of adult patients. The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options."

Dr Richard Furie,Chief of the Division of Rheumatology and Professor at the Feinstein Institutes atNorthwell Health and Lead Investigator of BLISS-LN said: "My journey with Benlysta began nearly twenty years ago when we performed the very first clinical research trial in lupus patients. To see it culminate in a successful phase 3 lupus nephritis study is a key achievement as the inadequate response of our patients with kidney disease to conventional treatment has long been an area in need of major improvement."

Belimumab also demonstrated statistical significance compared to placebo across all four major secondary endpoints: Complete Renal Response (CRR) after two years (the most stringent measure of renal response), Ordinal Renal Response (ORR) after two years, PERR after one year, and the time to death or renal-related event. In BLISS-LN, safety results for patients treated with belimumab were generally comparable to patients treated with placebo plus standard therapy. The safety results are consistent with the known profile of belimumab.

Benlysta is currently not recommended for use in severe active lupus nephritis anywhere in the world because it has not been previously evaluated in these patients. Based on these positive phase 3 data, GSK plans to progress regulatory submissions in the first half of 2020 to seek an update to the prescribing information.

The full results will be submitted for future presentation at upcoming scientific meetings and in peer-reviewed publications.

About lupus nephritisSystemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation, which can lead to end-stage kidney disease. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.1,2 Manifestations of LN include proteinuria, elevations in serum creatinine, and the presence of urinary sediment.

About BLISS-LNBLISS-LN,which enrolled 448 adult patients, was a phase 3, 104-week, randomised, double-blind, placebo-controlled post-approval commitment study to evaluate the efficacy and safety of IV belimumab 10 mg/kg plus standard therapy (mycophenolate mofentil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active lupus nephritis. Active lupus nephritis was confirmed by kidney biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, and clinically active kidney disease.

The primary endpoint PERR was defined as estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2 or no decrease in eGFR from pre-flare of > 20%; and urinary protein:creatinine ratio (uPCR) 0.7; and not a treatment failure. The most stringent secondary endpoint CRR was defined as eGFR is no more than 10% below the pre-flare value or within normal range; and uPCR < 0.5; and not a treatment failure. ORR was defined as complete, partial or no response.

About Benlysta (belimumab)Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

The current US and EU indication for Benlysta are summarised below:

In the US, "Benlysta is indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations."

Full US prescribing information including Medication Guide is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG.PDF

In the EU, "Benlysta is indicated as "add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy."

The Precaution and Warnings for Benlysta includes information that "Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended: severe active central nervous system lupus; severe active lupus nephritis; HIV; a history of, or current, hepatitis B or C; hypogammaglobulinaenia (IgG < 400mg/dl) or IgA deficiency (IgA < 10 mg/dl); a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant."

The EU Summary of Product Characteristics for Benlysta is available on: http://www.ema.europa.eu

Benlysta is available as an intravenous and a subcutaneous formulation. The Benlysta subcutaneous formulation is not approved for use in children.

GSK's commitment to immunologyGSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and paediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.

Important Safety Information for belimumabPlease consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab)

Contraindications:Previous anaphylaxis with BENLYSTA.

Warnings and precautions: Not recommended in adult and paediatric groups with severe active central nervous system lupus, severe active lupus nephritis, HIV, history of/current hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) and patients with a history of major organ transplant or hematopoietic stem/cell/marrow transplant or renal transplant.

Mortality:In adult intravenous (IV) clinical trials, death occurred in 0.8% of patients treated with BENLYSTA and in 0.4% of patients receiving placebo; etiologies included infection, cardiovascular disease, and suicide. In the adult SC clinical trial, death occurred in 0.5% of patients receiving BENLYSTA and in 0.7% of patients receiving placebo; infection was the most common cause of death.

Serious Infections:Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections in adults treated with BENLYSTA IV included pneumonia, urinary tract infection, cellulitis, and bronchitis. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML):Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (Including Anaphylaxis):Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.

Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.

Infusion Reactions:Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality:In clinical trials, psychiatric disorders (depression, suicidal ideation and behavior) were reported more frequently in patients receiving BENLYSTA than placebo. In adult trials, psychiatric events reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. Before adding BENLYSTA, physicians should assess patients' risk of depression and suicide and monitor them during treatment. Instruct patients to contact their HCP if they experience new/worsening depression, suicidal thoughts, or other mood changes.

Malignancy:The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies or IV Cyclophosphamide:BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide.

Adverse Reactions:The most common serious adverse reactions in adults were serious infections: BENLYSTA IV 6.0% (placebo 5.2%), some of which were fatal. Adverse reactions occurring in 3% of adults and 1% more than placebo: nausea 15% (12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9% (7%); bronchitis 9% (5%); insomnia 7% (5%); pain in extremity 6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%); cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3% (1%).

Adverse reactions in pediatric patients aged 5 years receiving BENLYSTA IV were consistent with those observed in adults.

The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.

Pregnancy and lactation:Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for 4 months after the final treatment.

Lactation:No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric Use:The safety and effectiveness have not been established for BENLYSTA IV in patients <5 years of age and for BENLYSTA SC in patients <18 years of age.

Black/African American Patients:In clinical trials there have been mixed results regarding how well BENLYSTA works in this patient population. Consider risks and benefits when prescribing BENLYSTA.

About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com.

Trademarks are owned by or licensed to the GSK group of companies.

References

GSK enquiries:

UK Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

(London)

Tim Foley

+44 (0) 20 8047 5502

(London)

US Media enquiries:

Evan Berland

+1 215 432 0234

(Philadelphia)

Courtney Dysart

+1 215-237-7431

(Philadelphia)

Analyst/Investor enquiries:

Sarah Elton-Farr

+44 (0) 20 8047 5194

(London)

Danielle Smith

+44 (0) 20 8047 2406

(London)

James Dodwell

+44 (0) 20 8047 2406

(London)

Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

View original content to download multimedia:http://www.prnewswire.com/news-releases/gsk-announces-positive-headline-results-in-phase-3-study-of-benlysta-in-patients-with-lupus-nephritis-300976537.html

SOURCE GSK

Read this article:
GSK announces positive headline results in phase 3 study of Benlysta in patients with lupus nephritis - BioSpace

Gene therapy is fighting to enter mainstream medicine. With sickle cell disease, the fight is heating up.

Roughly two years ago, the FDA made the historic decision to approve the first gene therapy in the US, finally realizing the therapeutic potential of hacking our biological base code after decades of cycles of hope and despair. Other approvals soon followed, including Luxturna to target inherited blindness and Zolgensma, a single injection that could save children with a degenerative disease from their muscles wasting away and dying before the age of two.

Yet despite their transformative potential, gene therapy has only targeted relatively rareand often fataldisorders. Thats about to change.

This year, a handful of companies deployed gene therapy against sickle-cell anemia, a condition that affects over 20 million people worldwide and 100,000 Americans. With over a dozen therapies in the run, sickle-cell disease could be the indication that allows gene therapy to enter the mainstream. Yet because of its unique nature, sickle-cell could also be the indication that shines an unflinching spotlight on challenges to the nascent breakthrough, both ethically and technologically.

You see, sickle-cell anemia, while being one of the worlds best-known genetic diseases, and one of the best understood, also predominantly affects third-world countries and marginalized people of color in the US. So far, gene therapy has come with a hefty bill exceeding millions; few people afflicted by the condition can carry that amount. The potential treatments are enormously complex, further upping costs to include lengthy hospital stays, and increasing potential side effects. To muddy the waters even more, the disorder, though causing tremendous pain and risk of stroke, already has approved pharmaceutical treatments and isnt necessarily considered life-threatening.

How we handle gene therapies for sickle-cell could inform many other similar therapies to come. With nearly 400 clinical trials in the making and two dozen nearing approval, theres no doubt that hacking our genes will become one of the most transformative medical wonders of the new decade. The question is: will it ever be available for everyone in need?

Even those uninterested in biology have likely heard of the disorder. Sickle-cell anemia holds the crown as the first genetic disorder to be traced to its molecular roots nearly a hundred years ago.

The root of the disorder is a single genetic mutation that drastically changes the structure of the oxygen-carrying protein, beta-globin, in red blood cells. The result is that the cells, rather than forming their usual slick disc-shape, turn into jagged, sickle-shaped daggers that damage blood vessels or block them altogether. The symptoms arent always uniform; rather, they come in crisis episodes during which the pain becomes nearly intolerable.

Kids with sickle-cell disorder usually die before the age of five; those who survive suffer a lifetime of debilitating pain and increased risk of stroke and infection. The symptoms can be managed to a degree with a cocktail of drugsantibiotics, painkillers, and a drug that reduces crisis episodes but ups infection risksand frequent blood transfusions or bone marrow transplants. More recently, the FDA approved a drug that helps prevent sickled-shaped cells from forming clumps in the vessels to further combat the disorder.

To Dr. David Williams at Boston Childrens Hospital in Massachusetts, the availability of these treatmentshowever inadequatesuggests that gene therapy remains too risky for sickle-cell disease. Its not an immediately lethal diseaseit wouldnt be ethical to treat those patients with a highly risky experimental approach, he said to Nature.

Others disagree. Freeing patients from a lifetime of risks and pain seems worthy, regardless of the price tag. Inspired by recent FDA approvals, companies have jumped onto three different treatments in a bitter fight to be the first to win approval.

The complexity of sickle-cell disease also opens the door to competing ideas about how to best treat it.

The most direct approach, backed by Bluebird Bio in Cambridge, Massachusetts, uses a virus to insert a functional copy of the broken beta-globin gene into blood cells. This approach seems to be on track for winning the first FDA approval for the disorder.

The second idea is to add a beneficial oxygen-carrying protein, rather than fixing the broken one. Here, viruses carry gamma-globin, which is a variant mostly present in fetal blood cells, but shuts off production soon after birth. Gamma-globin acts as a repellent that prevents clotting, a main trigger for strokes and other dangerous vascular diseases.

Yet another idea also focuses on gamma-globin, the good guy oxygen-carrier. Here, rather than inserting genes to produce the protein, the key is to remove the breaks that halt its production after birth. Both Bluebird Bio and Sangamo Therapeutics, based in Richmond, California, are pursing this approach. The rise of CRISPR-oriented companies is especially giving the idea new promise, in which CRISPR can theoretically shut off the break without too many side effects.

But there are complications. All three approaches also tap into cell therapy: blood-producing cells are removed from the body through chemotherapy, genetically edited, and re-infused into the bone marrow to reconstruct the entire blood system.

Its a risky, costly, and lengthy solution. Nevertheless, there have already been signs of success in the US. One person in a Bluebird Bio trial remained symptom-free for a year; another, using a CRISPR-based approach, hasnt experienced a crisis in four months since leaving the hospital. For about a year, Bluebird Bio has monitored a dozen treated patients. So far, according to the company, none has reported episodes of severe pain.

Despite these early successes, advocates worry about the actual impact of a genetic approach to sickle-cell disease.

Similar to other gene therapies, the treatment is considered a last-line, hail Mary solution for the most difficult cases of sickle cell disease because of its inherent risks and costly nature. Yet end-of-the-line patients often suffer from kidney, liver, and heart damages that make chemotherapy far too dangerous.

Then theres the problem of global access. Some developing countries, where sickle-cell disease is more prevalent, dont even have consistent access to safe blood transfusions, not to mention the laboratory equipment needed for altering blood-producing stem cells. Recent efforts in education, early screening, and prevention have also allowed people to live longer and reduce the stigma of the disorder.

Is a $1 million price tag ever attainable? To combat exhorbitant costs, Bluebird Bio is offering an installment payment plan for five years, which can be terminated anytime the treatment stops working. Yet for patients in South Africa, India, or Cambodia, the costs far exceed the $3 per month price tag for standard treatment. Even hydroxyurea, the newly-approved FDA drug to reduce crisis pain episodes, is just a fraction of the price tag that comes with gene therapy.

As gene therapy technologies are further refined and their base cost reduced, its possible that overall costs will drop. Yet whether these treatments will be affordable in the long run remains questionable. Even as scientists focus on efficacy rather than price tag, NIH director Dr. Francis Collins believes not thinking about global access is almost unethical. There are historical examples for optimism: vaccines, once rather fringe, now touch almost every corner of our world with the help of scientific knowledge, advocacy groups, andfundamentallyproven efficacy.

With the rise of gene therapy, were now in an age of personalized medicine beyond imagination. Its true that perhaps sickle-cell disease genetic therapies arent quite there yet in terms of safety and efficacy; but without tackling access issues, the therapy will be stymied in its impact for global good. As genetic editing tools become more powerful, gene therapy has the potential to save even more livesif its made accessible to those who need it most.

Image Credit: Image by Narupon Promvichai from Pixabay

Go here to see the original:
Gene Therapy for Sickle-Cell Anemia Looks Promisingbut It's Riddled With Controversy - Singularity Hub

SAN DIEGO, Dec. 12, 2019 /PRNewswire/ -- Aspen Neuroscience, Inc. today announced its launch following a $6.5 million seed round led by Domain Associates and Axon Ventures and including Alexandria Venture Investments,Arch Venture Partners,OrbiMedand Section 32 to develop the first autologous cell therapies for Parkinson's disease. Aspen's proprietary approach was developed by the company's co-founders, Jeanne F. Loring, Ph.D., Professor Emeritus and founding director of the Center for Regenerative Medicine at The Scripps Research Institute, and Andres Bratt-Leal, Ph.D., a former post-doctoral researcher in Dr. Loring's lab. The company was initially supported by Summit for Stem Cell, a founding partner and non-profit organization which provides a variety of services for people with Parkinson's disease. Aspen is led by industry veteran Howard J. Federoff, M.D., Ph.D., as Chief Executive Officer.

Parkinson's disease is characterized by the loss of specific brain cells that make the chemical dopamine. Without dopamine, nerve cells cannot communicate with muscles and people are left with debilitating motor problems. Aspen is focusing on human pluripotent stem cells, cultured cells that can become any cell type in the human body. The company's research is specific to induced pluripotent stem cells (iPSCs), which it develops by taking a skin biopsy from a person with Parkinson's disease and turning the tissue into pluripotent stem cells using genetic engineering. Aspen then differentiates the pluripotent stem cells into dopamine-releasing neurons that can be transplanted into that same person (autologous), thereby restoring the types of neurons lost in Parkinson's disease.

As an autologous cell therapy for Parkinson's disease, Aspen's treatment would eliminate the need for immunosuppression because the neurons are transplanted back into the same patient from which they were generated. The use of immunosuppression is necessary with currently available cell therapies for Parkinson's disease and when transplanting cells from one patient to another (allogeneic) to prevent rejection but can pre-dispose the patient to life-threatening complications including infection and add cost to the patient and health system. Aspen is the only company in the world offering an autologous neuron replacement therapy for Parkinson's disease.

Aspen encompasses a powerful executive leadership team including Dr. Federoff who, in addition to his leadership roles at the UC Irvine Health System, was the Executive Vice President for Health Sciences and the Executive Dean of Medicine at Georgetown University. Dr. Federoff also has significant biotech industry experience including co-founding MedGenesis Therapeutix and Brain Neurotherapy Bio, as well as leading the U.S. Parkinson's Disease Gene Therapy Study Group. The company is also proud to announce the addition of several experienced and well-known members to its leadership team including Edward Wirth, M.D., Ph.D., as Chief Medical Officer.

Dr. Wirth currently serves as the Chief Medical Ofcer for Lineage Cell Therapeutics where he oversees clinical development of its two therapeutic programs for spinal cord injuries and lung cancer. He received his M.D. and Ph.D. from the University of Florida in 1994 and remained to conduct postdoctoral research including leading the University of Florida team that performed the rst human embryonic spinal cord transplant in the U.S. Dr. Wirth went on to serve as the Medical Director for Regenerative Medicine at Geron Corporation where the world's rst clinical trial of human embryonic stem cell (hESC)-derived product occurred which demonstrated initial clinical safety.

Drs. Federoff and Wirth are joined by Dr. Loring, as Chief Scientific Officer; Jay Sial, as Chief Financial Officer; Andres Bratt-Leal, Ph.D., as Vice President of Research and Development; Thorsten Gorba, Ph.D., as Senior Director of Manufacturing and Naveen M. Krishnan, M.D., M.Phil., as Senior Director of Corporate Development.

"Aspen is developing a restorative, disease modifying autologous neuron therapy for people suffering from Parkinson's disease," said Dr. Federoff. "We are fortunate to have such a high-caliber scientific and medical leadership team to make our treatments a reality. Our cell replacement therapy, which originated in the laboratory of Dr. Jeanne Loring and was later supported by Summit for Stem Cell and its President, Ms. Jenifer Raub, has the potential to release dopamine and reconstruct neural networks where no disease-modifying therapies exist."

Aspen's lead product (ANPD001) is currently undergoing investigational new drug (IND)-enabling studies for the treatment of sporadic Parkinson's disease. Aspen is also developing a gene-edited autologous neuron therapy (ANPD002) that is in the research stage and targeted toward familial forms of Parkinson's disease beginning with the most common genetic variant in the gene encoding glucocerebrosidase (GBA). Aspen leverages proprietary machine-learning tools and artificial intelligence to ensure quality control during manufacturing and to deliver a safe and reproducible product for each cell line.

"Aspen's financial backing, combined with its experienced and proven leadership team, positions it well for future success," said Kim P. Kamdar, Ph.D., Partner at Domain Associates, one of Aspen's seed investors. "Domain prides itself on investing in companies that can translate scientific research into innovative medicines and therapies that make a difference in people's lives. We clearly see Aspen as fitting into that category, as it is the only company using a patient's own cells for replacement therapy in Parkinson's disease."

About Aspen Neuroscience

Aspen Neuroscience Inc. is a development stage, private biotechnology company that uses innovative genomic approaches combined with stem cell biology to deliver patient-specific, restorative cell therapies that modify the course of Parkinson's disease. Aspen's therapies are based upon the scientific work of world-renowned stem cell scientist, Dr. Jeanne Loring, who has developed a novel method for autologous neuron replacement. For more information and important updates, please visithttp://www.aspenneuroscience.com.

CONTACT: Jennifer Viera, AspenNeuroscience@TeamSeismic.com

SOURCE Aspen Neuroscience

http://www.aspenneuroscience.com

View original post here:
Aspen Neuroscience Launches With $6.5 Million Seed Funding to Advance First-of-its-Kind Personalized Cell Therapy for Parkinson's Disease - PRNewswire

The ODAC discussions were based on the supplemental Biologics License Application (sBLA), currently under priority review at the FDA, seeking approval of KEYTRUDA monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). This application is based on results from the Phase 2 KEYNOTE-057 trial.

The positive vote from todays ODAC meeting supports the potential for KEYTRUDA in certain patients with high-risk, non-muscle invasive bladder cancer, who currently have limited non-surgical treatment options approved by the FDA, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. We are encouraged by todays productive discussion and look forward to working with the FDA as they continue their review of our supplemental application for KEYTRUDA in this patient population.

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committees guidance but takes its advice into consideration. Merck anticipates a Prescription Drug User Fee Act (PDUFA), or target action date, in January 2020, based on priority review.

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumor and spread to other areas of the body. Bladder cancers are described based on how far they have invaded into the wall of the bladder. NMIBC occurs when the cancer has not grown into the main muscle layer of the bladder. It is estimated that more than 80,000 new cases of bladder cancer will be diagnosed in 2019 in the United States. Approximately 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC patients who are BCG-unresponsive with persistent or recurrent disease, treatment guidelines recommend radical cystectomy, a surgery to remove the entire bladder that often requires removal of other surrounding organs and tissues. In men, removal of the prostate is common, and in women, surgeons may also remove the uterus, fallopian tubes, ovaries and cervix, and occasionally a portion of the vagina.

About KEYNOTE-057

The filing was based on data from KEYNOTE-057 (NCT02625961), a Phase 2, multicenter, open-label, single-arm trial in 102 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 were ineligible for or had elected not to undergo cystectomy (Cohort A). In this study, BCG-unresponsive high-risk NMIBC is defined as persistent disease despite adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG. Patients received KEYTRUDA 200 mg every three weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease. Assessment of tumor status was performed every 12 weeks, and patients without disease progression could be treated for up to 24 months. The major efficacy outcome measures were complete response (as defined by negative results for cystoscopy [with transurethral resection of bladder tumor (TURBT)/biopsies as applicable], urine cytology, and computed tomography urography [CTU] imaging) and duration of response.

About KEYTRUDA (pembrolizumab) Injection, 100mg

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 1,000 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

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 one 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 head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines 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 the confirmatory trials.

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. 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. 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 [combined positive score (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.

Microsatellite Instability-High (MSI-H) 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.

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).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes 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.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

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 a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

See original here:
FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle...

New technologies that could soon diagnose Alzheimers and restore speech to the paralyzed; potential new avenues in treating diabetes, multiple sclerosis and Down syndrome; and a genetic test that dramatically saved a babys life these were among the science and health topics that most engaged our readers in 2019.

Look back at these 11 stories of the past year or discover them for the first time they reflect the exciting, transformative research that takes place at UC San Francisco every day of the year.

Researchers trained a machine-learning algorithm on nearly 2,000 brain scans and then challenged it to detect early-stage Alzheimers disease in other scans. The algorithm performed with flying colors, catching the disease six years before a clinical diagnosis a lead time that may eventually help doctors treat the disease.

Continue reading

For California, a 1 percent drop in the smoking rate could mean $630 million of Medicaid savings the following year. Thats because quitting smoking can reduce many health risks relatively quickly, including heart attacks, lung disease and pregnancy complications, as well as cut long-term health risks such as cancer.

Continue reading

For the first time, researchers were able to transform human stem cells into mature insulin-producing cells similar to the pancreatic beta cells destroyed by type 1 diabetes. The breakthrough came after the team applied a key tenet of biology, that form follows function, to the way they were growing the cells in the lab.

Continue reading

Researchers took a new approach to studying Down syndrome focusing on the conditions effect on the protein-making machinery inside cells. In a mouse model of Down syndrome, they found that cells in the brain were tamping down on protein production, leading to cognitive deficits. They were able to activate protein production and improve memory and learning with a drug called ISRIB.

Continue reading

A sophisticated brain-machine interface could one day give voice to people who have lost the ability to speak due to paralysis or other neurological damage. Researchers first mapped participants brain activity to their vocal tract movements as they made various sounds. An algorithm could then translate new brain activity into movements of the virtual vocal tract and produce realistic speech.

Continue reading

Whats the best way to eat your vegetables? Should you take supplements? Low-fat, low-carb, intermittent fasting do any diets actually work? Experts weigh in on the latest science behind healthy eating and separate food fact from food fiction. Keep these evidence-based tips in mind for the holidays and in the years to come.

Continue reading

Baby Quincy was deteriorating fast from an aggressive blood cancer and too sick to undergo a stem cell transplant, his only chance at a cure. Determined to leave no stone unturned, Quincys doctors ordered the UCSF500 a new comprehensive cancer gene panel test that helped to reveal an unusual genetic alteration in his cancer and identified a long-shot therapy.

Continue reading

Multiple sclerosis (MS) is an autoimmune disease caused by immune cells that attack the protective coating around nerve cells. In a surprise, researchers discovered that other immune cells in the gut, known as plasma cells, can reduce the brain inflammation that results from the disease. Expanding these gut plasma cells may be a new therapeutic approach to treating MS.

Continue reading

Cooking food changes not only how it tastes but how our gut microbial ecosystems respond. In mice, researchers found that cooked vegetables altered their gut microbiome and caused them to lose weight. In human participants, three days of raw or cooked diets prepared by a professional chef also changed gut microbiomes, but in different ways perhaps holding clues to how our microbes have adapted to human culinary culture.

Continue reading

Alcohol-associated liver disease has become the top reason for U.S. liver transplants, making up more than one-third of liver transplants in 2016. The increase is largely due to a shift away from a common rule that required patients to abstain from alcohol and drug use for at least six months prior to transplant. A 2011 study found that transplants could be successful without this minimum sobriety period, changing the policy at many centers.

Continue reading

The emotional tumult of teenage years may in part be due to transformations in the brain. Most human brain cells mature in the first years of life, but a group of neurons in the amygdala, which controls emotional responses, dont mature until adolescence and a small number remain immature throughout life. The brain may hold on to these Peter Pan neurons to keep the brains emotional responses flexible and adaptable into old age.

Continue reading

In 2019, UCSF drove advancements in care delivery, scientific discovery, education, public service, and more. See the highlights

Go here to see the original:
UCSF's 11 Most Popular Health and Science Stories of 2019 - UCSF News Services

Specializing in innovative cosmetic applications for the face, eyes, and body, Dr. Zamora is a leader in minimally invasive treatments.

DENVER (PRWEB) December 18, 2019

Dr. Jack Zamora, a renowned face expert in Denver, Colorado has joined the esteemed Haute Beauty network.

The Haute Beauty Network, well known for its exclusive and luxurious lifestyle publication Haute Living is privileged to present Dr. Jack Zamora as a face expert and our newest addition to the Haute Beauty members-only network.

Haute Beauty offers a prominent collective of leading doctors. The invitation-only exclusive publication maintains elite as ever, with only two doctors in every market. This partnership allows Haute Beauty to connect its affluent readers with industry-leading aesthetic surgeons located in their area.

ABOUT DR. ZAMORADr. Jack Zamora is an oculofacial plastic surgeon, and a pioneer in plasma treatments and stem cell technology. Specializing in innovative cosmetic applications for the face, eyes, and body, Dr. Zamora is a leader in minimally invasive treatments. Graduating from Tulane University in New Orleans, he received a doctorate degree in medicine and completed his internship at Boston Medical Center (internal medicine), his residency at Boston University (ophthalmology department), and completed his fellowship at Boston University (ophthalmology and oculoplastics).

Dr. Zamora is the medical director of several locations throughout Colorado offering select surgical and non-surgical facial refinement, skin rejuvenation, and body sculpting services. Known for exceptional patient care and state-of-the-art procedures that achieve natural-looking results with as little downtime as possible, Dr. Zamora and his team work with each patient to tailor a combination of treatments for long-term results.

As the creator of J-Plazty, Dr. Zamora has received national and international attention for his revolutionary technique. J-Plazty is a minimally invasive procedure that uses Renuvion plasma energy sub-dermally to instantly tighten and rejuvenate skin anywhere on the face and body without large incisions, downtime, or the complications of traditional surgery. As an authority on skin tightening applications, Dr. Zamora has seen remarkable results with plasma and often combines it with other radiofrequency (RF) modalities for superior rejuvenation. Utilizing his plasma techniques with micro and macro-needling radiofrequency (RF), Dr. Zamora is seeing unparalleled skin shrinkage as well as tightening of extremely delicate tissue allowing for long-term improvement with less downtime

In an effort to improve the outcome of aesthetic procedures, Dr. Zamora has partnered with Vitro BioPharma to develop the worlds first ultra pure cosmetic stem cell serum, InfiniVive MD, to be used topically by plastic surgeons, cosmetic surgeons, and aestheticians throughout the United States. InfiniVive MD is the highest quality cGMP-grade cosmetic stem cell serum containing ultra pure mesenchymal stem cells and exosomes. InfiniVive MD is to be used with ablative and non- ablative lasers, plasma energy technologies, and microneedling radiofrequency. The serum provides an unprecedented improvement in fine lines and wrinkles, helps reduce the signs of aging, and helps promote accelerated healing.

Being an international trainer for J-Plazty, Apyx Medical, and Bausch Health Companies Inc., and a luminary for AMP Medical, Lutronic Medical, and Syneron ELOS, Dr. Zamora offers his expertise to physicians from around the globe. He is a regular speaker and consultant, has been featured on The Doctors TV Show, and has written on the techniques and parameters of soft tissue coagulation and subcutaneous neck skin plasma tightening. Valuing continued education, Dr. Zamora created the Jack Zamora MD Aesthetic Institute, which offers advanced aesthetic training to medical professionals and licensed aestheticians.

Share article on social media or email:

See original here:
Dr. Jack Zamora Partners with the Exclusive Haute Beauty Network - PR Web

ACLT (THE African Caribbean Leukaemia Trust) has been honoured by blood cancer charity Anthony Nolan, at an awards ceremony held at the Tower of London.

ACLT took home the award for the black, Asian and minority ethnic advocate of the year, in recognition of the work they have done to recruit more donors from these backgrounds to the stem cell register.

The charity is committed to providing hope to patients living with blood cancer and illnesses where a matched donor (stem cell, blood or organ) is required to save a life.

The prestigious Anthony Nolan Supporter Awards were back for their seventh year to recognise the outstanding achievements of the volunteers, fundraisers, and campaigners who help the pioneering blood cancer charity save lives.

Over 23 years, ACLT have recruited thousands of potential donors from African and Caribbean descent to the Anthony Nolan stem cell register, with many people going on to donate to patients in desperate need of a life-saving stem cell transplant.

ACLT was founded IN 1996 by Beverley De Gale OBE and Orin Lewis OBE while they were searching for a matching donor for their 6-year-old son, Daniel.

Daniel had Acute Lymphoblastic Leukaemia and needed a life-saving stem cell transplant, but at the time of his diagnosis in 1993, the number of potential donors on the register from BAME backgrounds was remarkably low. His parents were told Daniel had a 1 in 250,000 change of finding a match.

Beverley and Orin could not sit back and watch this. They got in touch with Anthony Nolan to find out how they could help, and soon after, ACLT was born. From comedy clubs, to churches, to schools, Beverley and Orin organised recruitment events far and wide to reach out to the communities most underrepresented on the stem cell register.

In 1999, Daniel De Gale was the first black person in the UK to receive a stem cell transplant from an unrelated donor. He went on to live a full and busy life, but sadly died from multiple organ failure in 2008, due to complications with his health sustained while waiting for a transplant.

ACLT is Daniels legacy, and his parents have been committed to recruiting donors and raising awareness ever since.

In the last year alone, ACLT have run 13 recruitment events to register potential donors to the Anthony Nolan Stem Cell Register, which have seen over 800 people join. Around 75% of those donors were from BAME backgrounds, and 8 people went on to donate their stem cells to patients in need.

Beverley De Gale OBE said: ACLT have been working in partnership with Anthony Nolan since the charity was formed over 23 years ago. In this time the relationship between ACLT and Anthony Nolan has grown exponentially. Were honoured to have our work of raising awareness and registering lifesaving donors recognised with the prestigious award of BAME Advocate of the Year.

Henny Braund, Chief Executive at Anthony Nolan, said: ACLT is a hugely deserving winner of this award; their incredible support and passion for our work is a fantastic example of our charity, which is built on making lifesaving connections. It was lovely to meet some of ACLTs volunteers at the ceremony and I continue to find myself inspired and humbled by the dedication and strength of supporters like them.

By recruiting potential donors, we are curing blood cancer together. We can give families hope, and give more people a future. But without supporters like ACLT lives cant be saved. Without them, there is no cure.

The awards took place on Thursday 28 November at the Tower of London and were hosted by comedian Nish Kumar.

Anthony Nolan is the charity that finds matching stem cell donors for people with blood cancer and blood disorders and gives them a second chance at life. It also carries out ground-breaking research to save more lives and provide information and support to patients after a stem cell transplant, through its clinical nurse specialists and psychologists, who help guide patients through their recovery.

See the rest here:
ACLT wins National Charity Award - The Voice Online

Nonalcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease. It is diagnosed by conditions such as a fatty liver, liver cell damage, and inflammation. If it is not treated on time, NASH can lead to further complications such as liver fibrosis. As it is essential to cure NASH in real-time, many companies focus on the same and Promethera Biosciences based in Wallonia, Belgium is one of them.

Take a look at winners of EIT Digital Challenge 2019.

Belgian biotech startup Promethera Biosciences is one of the leading innovators in the world specialised in liver therapeutics. The company operates with the mission to bring life-saving treatments that will reduce the need for liver transplantation. It is one of the pioneers in the development of cell-based therapies that will provide both anti-fibrotic and immunomodulatory effects in the liver.

Promethera Biosciences just announced that it secured 7.5 million additional Series D funding, which adds to the recently raised 39.7 million funding. This investment was led by Sony Innovation Fund of IGV and Pegasus Tech Ventures along with MEDIPAL Holdings, the family office Six Snow, a Japanese private investor and a Belgian private investor.

With the fresh round of investment, Promethera Biosciences aims to advance its clinical programs in NASH (Non-alcoholic steatohepatitis) and ACLF (Acute-on-Chronic Liver Failure). Besides these advancements, the Belgian startup also plans to accelerate growth in the Asian markets. It is in plans to initiate clinical trials outside of Europe in NASH and ACLF in 2020.

Promethera Biosciences lead clinical program is derived from its patented allogenic live-cell platform dubbed HepaStem. The biotech startup has developed its cell therapy technologies using allogeneic stem and progenitor liver cells that are isolated, expanded, and purified from healthy human livers unsuitable for transplantation.

Besides the cell-based therapies, this startup also develops antibody technologies such as the anti TNF-R1 antibody Atrosimab in order to complement and diversify the therapeutic options.

Main image picture credits: Promethera Biosciences

Stay tuned toSilicon Canalsfor more European technology news.

Excerpt from:
Promethera Biosciences, a Belgian startup that works on treating liver diseases secures funding - Silicon Canals

WeTheTrillions wants to make it easier for people - especially women - to eat healthier, with an ... [+] emphasis on fruits, vegetables, and other plant-based foods.

Its long been said that food is medicine, but the healthcare system doesnt always treat it as such. Despite the fact that we need to eat every day, multiple times a day, just to stay alive, medical schools in the U.S. provide on average only 19 hours of nutritional education throughout a doctors training.

As a result, your doctor may be able to prescribe you a medicine to treat high blood pressure, diabetes, or any number of other conditions, but they simply might not know how to advise you to try to prevent illness in the first place.

But some folks are trying to change that. WeTheTrillions is a public benefit corporation that is approaching nutritious food as not just part of a healthy lifestyle, but as one of the first to leverage technology and prescription-grade delivered meals as the frontlines of preventative healthcare to stop the epidemic of chronic conditions touching more than 60 percent of adults in the US. The company is named for the trillions of microbes in each of our gut biomes along with trillions of cells, which make up the central focus of the companys food-as-medicine because of the gut biomes role in well, virtually every part of our lives and bodies.

WeTheTrillions main product is ready-to-eat customized meal and snack options, and those who subscribe to their weekly meal plans also have access to health specialists to discuss and stay on top of their goals and concerns. They also provide software to clinicians so they can track progress and help patients reach tangible results through a customized food program. This could be for patients suffering from IBS, diabetes, anemia or any other female-related hormonal imbalances.

According to the Centers for Disease Control and Prevention, 50 percent of doctors recommendations to patients with chronic illnesses are not followed and this number goes up to more than 70 percent when it comes to lifestyle changes like dietary guidelines, says Lamiaa Bounahmidi, Founder and CEO of WeTheTrillions. Closing that gap is already making WeTheTrillions an appealing solution to hundreds of doctors across the US who see this as an immediate intervention to leverage theory and practice for preventative healthcare and help save trillions of dollars in healthcare bills - effectively staunching the leading public health crisis of the 21st century: chronic disease.

To know your eligibility for a WeTheTrillions program, you first start by filling out a 3-minute online intake quiz and then have a 20-min call with a health specialist to fully customize your plan and agree on clear target biomarkers levels to reach. The process is based on an aggregation of evidence-based randomized controlled trials to provide a fully science-driven approach beyond fad diets.

Notably, theyre also looking to set up machines in urban and rural food deserts that offer affordable options via subsidization through the Supplemental Nutrition Assistance Program and other government assistance programs. And all the food is 100% plant-based, a choice justified by medical evidence that currently points to a veggie-heavy diet for its abilities to fight heart disease, diabetes, and strokes as well as hormonal balance and gut health.

But their approach to food as preventative medicine is more specific and science-backed than simply offering healthy plant-based foods. While the meals are, theoretically, for anyone looking to eat well and improve their health, much of the emphasis is on using food to treat Polycystic ovary syndrome, menopause symptoms, fertility, and other issues pertaining to womens reproductive health. Even the general health issues WeTheTrillions seeks to address, like anemia, often disproportionately affect women, especially women of color.

Theres a reason to believe that this method of specifically targeting womens reproductive and general health could be an effective strategy in improving the overall health of society. Overwhelming evidence links maternal health to that of children, which together affect the overall health of society. A society with healthy women is more likely to have healthy children who will grow into healthy adults. WeTheTrillions emphasis on the health of female-sexed people is not exclusive, but it is strong and forward-thinking.

There are a plethora of premade or prepped meal kits on the market now, many of which are vegan, organic, and health-focused. Not all of them, however, can claim to have the medical emphasis of WeTheTrillions, with its specific issue-based meal plans and grand focus on making food accessible via work, school, physicians, and public assistance.In a way, its simplicity is inspiring: to improve the health of society at large, eat plants. The work of doctors, scientists, and public health experts boil down to some tasty vegetables on your plate customized to your unique health needs.

Read the rest here:
WeTheTrillions Says The Future Of Public Health Is Female And Plant-Based - Forbes

BILLERICA, Mass.--(BUSINESS WIRE)--Powering Precision Health (PPH), the internationally acclaimed Summit focused on precision health and the latest in biomarker research, drew record attendance at its fourth-annual event held Nov. 19 in Barcelona, Spain, convening the worlds foremost scientists and medical leaders in precision health to introduce novel and disruptive research across the fields of neurology and oncology.

The PPH Summit continues to evolve and grow as the global epicenter for transforming healthcare with the use of non-invasive biochemical biomarkers, and this years event was no exception, said Kevin Hrusovsky, PPH Founder. PPH Summit is a unique opportunity to collaborate on the many seminal advances in measuring biomarkers minimally invasively, understanding their role in health, personalized treatment and disease prevention from a global community of scientific leaders. The research around blood-based biomarkers is gaining significant traction in the healthcare industry. The 2019 Summit offered us the chance to discuss and debate credible advances toward the clinic in drug development utilizing biomarkers and the mounting body of evidence these breakthroughs are advancing in preventative medicine around the world. We are excited to see so many of todays leading medical innovators, investors and patient advocates focused on utilizing disruptive biomarker technologies to advance the science that powers precision health.

Hrusovsky kicked off the Summit with a talk entitled, Vision to Reality: Disrupting Healthcare with Digital Biomarkers, highlighting the growing clinical evidence for neurofilament light (Nf-L) as a blood biomarker for detecting, prognosing and monitoring neurodegenerative conditions, and driving new biomarker research breakthroughs in oncology and immuno-oncology. The attendees were energized for an important day of discussions, tackling high-priority disease areas such as cancer and neurodegeneration with blood-based biomarkers as evidenced by the more than 40 research presentations shared at the event alone. There are now over 650 third-party peer-reviewed publications highlighting disruptive biomarker technologies for early disease detection, drug development and disease prevention.

Attendees were also treated to a fireside chat-style Q&A, Fraud is Not a Trade Secret, with Tyler Shultz, CEO of Flux Biosciences, Inc., widely known as the Theranos whistleblower, which highlighted the importance of PPHs impact on restoring transparency and investor trust. Hosted by Nasdaq Spotlight correspondent Lyanne Alfaro, Shultz and Hrusovsky discussed the importance of ethics, accountability and nurturing a culture of transparency and open debate in medical innovation and entrepreneurship.

Highlights from PPH 2019 Neurology Track include research presentations further revealing the advantages of Quanterix Simoa technology in enabling sensitive detection of important biomarkers in many neurological diseases. In particular, several talks highlighted the role of Nf-L as a promising diagnosis and treatment monitoring biomarker in Multiple Sclerosis (MS), and suggested that it is getting close to becoming a clinically relevant tool. Nf-L was also reported as a promising biomarker for several other neurodegenerative diseases such as traumatic brain injury (TBI), frontotemporal dementia (FTD), Parkinsons disease, ALS, Huntington disease and peripheral neuropathies. In one of the presentations, new data revealed that Nf-L levels were elevated in mutation carriers several years prior to clinical symptoms of Huntington disease, observations similar to those published earlier for ALS, AD, FTD and MS. The collective data suggests that Nf-L may become a screening tool for people at risk for developing neurodegenerative diseases earlier, and will in turn facilitate clinical trials, and eventually a better chance for people suffering from those diseases, to be treated earlier and more successfully. Additionally, new data was also presented on phosphorylated tau and its potential to aid in detection of amyloid pathologies when used in combination with other biomarkers, such as amyloid beta isoforms 40 and 42. Many PPH speakers continuously emphasized the importance of panels of biomarkers that allow identification of specific disease mechanisms and endophenotypes in the future.

Andrew Beard, Head of Business Development and Companion Diagnostics, Molecular Services US at Siemens Healthineers, talked about the transition of a biomarker from research to clinical use. He also described the importance of combining imaging with molecular measurements, including Nf-L. Beard described development of the Nf-L assay on the automated immunoanalyzer to support future global use of Nf-L in clinic.

The PPH 2019 Oncology Track featured research extolling the benefits of ultra-sensitive immunoassays for biomarker analysis in clinical samples, as well as analytical and diagnostic validation of single and multiplex protein biomarkers for the detection of cancer. The expert panel discussion, Applying Digital Protein Biomarkers to Oncology & Immuno-Oncology: Is the Time Now? addressed the critical nature of using fit for purpose validated biomarkers to advance drug discovery and development efforts for anti-angiogenesis inhibitors, immuno-oncology and other key inflammatory applications, breast cancer, and how to choose and implement relevant biomarkers in clinical practice.

PPH is about collaboration; its what we can learn from each other. Thats going to get us answers much faster than working independently, continued Hrusovsky. Scientific breakthroughs shared at this years event are creating a groundswell of new opportunities for seeing disease earlier in the cascade and long before symptoms present and hopefully leading to new strategies for drug development, therapy response and prevention.

The PPH 2019 Summit was made possible thanks to the generosity of multiple sponsors who embraced the vision of precision health, including: Biogen, Novartis, BTIG, Quanterix, Canaccord Genuity, Cowen Group, C2N, Adx NeuroSciences, Leerink, JP Morgan, Avison Young, Mintz Levin and Octave BioSciences.

Presentations are available for viewing here and in addition, watch the panel discussion on Challenges and Opportunities for Blood Tests for Alzheimers, MS, Parkinsons, and ALS, featuring several of todays leading scientific minds hailing from the University Hospital of Basel, the University of Gothenburg, Memorial Healthcare and the Michael J. Fox Foundation. To learn more about the PPH Summit, visit: https://poweringprecisionhealth.org.

About Powering Precision HealthPowering Precision Health is the world's first independent, non-profit organization dedicated to bringing the world's leading physicians, scientists, innovators, investors and patient advocates together to unveil their latest research on new biomarkers that are revolutionizing precision health. Founded by Kevin Hrusovsky, a widely acclaimed thought leader and visionary in life sciences and personalized medicine, Powering Precision Health is a movement that represents the intersection of new technological capabilities with the latest medical research. Its rooted in the science of precision medicine, which shows personalized treatments to be an increasingly more effective way to maximize drug efficacy and minimize toxicity. In addition to the impact environmental and lifestyle factors can have on minimizing disease triggers, precision health marks an evolution in the way we approach disease and aims to inspire a full healthcare transformation, from philosophy to approach to outcome. In an industry often plagued by skepticism and marred by false promises, PPH puts science first and brings together stakeholders that span from fundamental research to clinical practice, investors, policy makers, patient advocacy groups, and anyone who embraces the vision of Powering Precision Health. Featuring a distinguished keynote lineup of dignitaries, the Summit unveils groundbreaking approaches to prevention, early diagnosis, and next-generation treatments. Powering Precision Health is supported thanks to the generous contributions of sponsors from a wide range of companies and organizations committed to advancing precision health.

Twitter:@KevinHrusovsky @PPHSUMMIT

Facebook:@PoweringPrecisionHealth

LinkedIn:@PoweringPrecisionHealth

The rest is here:
Powering Precision Health Summit Convenes the World's Most Renowned Scientific Innovators Advancing Biomarker Technologies - Business Wire

We all know that high blood pressure increases the risk of coronary artery disease and stroke but rarely is information presented on the risks of low blood pressure. A number of medical studies have claimed little or no serious medical risk associated with low blood pressure with serious medical risk only being defined as a heart attack and stroke. Other medical studies suggest that low blood pressure does increase the risk of coronary artery disease, falling and even increases the risk of dementia and Alzheimer's disease. In both traditional and on-traditional medicine, low blood pressure is usually ignored even if there are clinical findings of the blood pressure being too low.

The medical risks of chronic high blood pressure are now well defined. But it was not always the case. At the turn of the century, high blood pressure was so common in the elderly that it was considered the natural result of aging. The famous Framingham Heart Study (1949-1952) showed that those with a systolic blood pressure over 159 had a three to six times increased of heart disease. Since then the relationship between high blood pressure and illnesses has been clearly delineated. As a result, many medications are available to lower high blood pressure are available and numerous lives saved.

Low blood pressure is not uncommon but with the increasing use of medications, not limited to blood pressure medications, low blood pressure has become a relatively common. Besides high blood pressure medications, drugs often used for Parkinson's disease, depression/anxiety, sedative-hypnotics, pain medications and muscle relaxants all can cause low blood pressure. This effect can be intensified when specific medications are used in combination.

There is limited clinical research on low blood pressure but two recent medical studies are pertinent today. One large study in the American Journal of Preventative Medicine looked at the risk of falls and loss of consciousness in almost one half a million people with low blood pressure. The concluded that a systolic blood pressure less than 110 significantly increased the risk of serious falls and loss of consciousness.

Another study in the Indian Heart Journal found that there is an increased risk of atrial fibrillation in people who had a history of dizziness with standing (serious low blood pressure). Atrial fibrillation is an irregular heartbeat that increases the risk of blood clots, stroke and heart failure. It most commonly occurs in the elderly as does low blood pressure. Interestingly high blood pressure is also a risk factor for atrial fibrillation. In this study low blood pressure also increased the risk of stroke and a 50 to 100 percent increased mortality rate probably secondary to a higher incidence of coronary heart disease and heart failure.

Traditional therapy for low blood pressure includes graded exercise, generous salt intake and caution going from sitting/laying to standing. I have found that a critical review of a patient's medications, select herbs and regular meditation can be curative. Low blood pressure should be taken as seriously as high blood pressure.

Dr. Patrick Massey, M.D., Ph.D., is medical director of complementary and alternative medicine at Alexian Brothers Hospital Network, and president of ALT-MED Medical and Physical Therapy, 1544 Nerge Road, Elk Grove Village.

Follow this link:
Low blood pressure is a risk and should be taken seriously - Chicago Daily Herald

Women have more control over their healthcare journeys when they can access preventative services, and have opportunities to detect and treat adverse conditions early."

ASHEVILLE, N.C. (PRWEB) December 12, 2019

Aeroflow Healthcare, a leading durable medical equipment (DME) provider and Inc. 5000 fastest growing company, and its executive leadership announced their continued support and public advocacy for female and mother/baby health rights via the Affordable Healthcare Act.

Aeroflow emphasizes the ACAs purpose of protecting many groups, including women, and under it, making preventative health services accessible for women with no cost-sharing meaning complete insurance coverage. These services include mammograms, cervical cancer screenings, prenatal care, and breastfeeding supplies, support and services, among many others.

It is Aeroflow Healthcares position that preventative healthcare is of utmost importance for the women in our lives, not only for their own livelihood, but for that of the children they bear and are often the primary caregiver and guardian of. U.S. healthcare is littered with statistics highlighting a much higher than expected infant mortality rate and an unacceptable number of complications and health scares both pre- and post-childbirth. The protection of the ACA should be reflective of the overwhelming support for legislature that provides preventative medicine and additional womens and family rights, ultimately saving patients and providers money.

Aeroflow stands in staunch support of the rights and welfare of expectant mothers, families, and women and men responsible for the guardianship of children, said Amanda Baethke, Director of Corporate Development. Women have more control over their healthcare journeys when they can access preventative services, and have opportunities to detect and treat adverse conditions early. As the ACA makes provisions for these services, we stand with the majority of American citizens who seek to protect it, and encourage the public to contact your representative in congress and tell them that the women in your life are far too important to lose healthcare options.

About Aeroflow Healthcare

Aeroflow Healthcare was founded Asheville, NC in 2001 as a home oxygen provider, and has since grown to become one of the leading durable medical equipment providers nationwide. For three consecutive years, Aeroflow has been ranked on Inc. Magazines List of 5000 Fastest Growing Companies. In 2017, Aeroflow was also awarded the HME Excellence Award for Best Home Medical Equipment Provider and has been recognized as a business offering top-notch benefits to employees with the Great Place to Work Award. Aeroflow is an accredited Medicare and Medicaid provider and accepts most commercial insurance. To learn more about Aeroflow Healthcare and getting medical equipment through insurance, visit http://www.Aeroflowinc.com.

Share article on social media or email:

See the original post here:
Aeroflow Healthcare: In Defense of the ACA, and Women and Family Healthcare Rights - PR Web

Such conservative bromides ignore the evidence that SNAP beneficiaries by and large do not want to depend on government difficult circumstances in their lives make it necessary and that the program does not dissuade them from working. Depriving them of assistance will only exacerbate their poverty, and cost Americans in other ways.

The policy change, effective April 1, will oust nearly 700,000 people from food stamps nationwide and cut $5.5 billion in SNAP spending over five years. Approximately 35,000 of those affected live in Massachusetts. They are underemployed adults who have no children and are not disabled generally, a group of people not eligible for the benefit. But a longstanding waiver program has allowed the Commonwealth and other states to enroll such people in SNAP for more than three months in a three-year period if they live in localities with high unemployment or a tight job market. A recent study revealed that nationwide this group of childless individuals has received an average of $181 every month in SNAP benefits due to the state waivers.

The new rule will impose stricter criteria for issuing the state waivers. The government wants to move more able-bodied SNAP beneficiaries toward self-sufficiency and into employment. These waivers have long been seen a weakness of the program a loophole exploited by low-income individuals who simply dont want to work at a time when there are 7 million job openings nationwide and the unemployment rate is at 3.6 percent.

But, the Trump Administration is ignoring . . . the connection between geography and employment opportunities, said Georgia Katsoulomitis, executive director of the Massachusetts Law Reform Institute, in a statement. "For example, this rule will disproportionately harm communities of color that are already struggling with economic instability and limited employment opportunities resulting from decades of explicit and implicit labor and housing discrimination.

Requiring some recipients of SNAP benefits to work more is a dramatic change from longstanding policy, one that Congress itself rejected twice last year when it was proposed in Trumps budget and in the farm bill the latter by a bipartisan House vote of 330-83. The new rule also rests on a grave misconception about the food assistance program: SNAP is intended to address hunger and help people rise out of poverty, not to compel them to work.

Indeed, there is no evidence that the new SNAP rule will result in more people gaining steady jobs. Instead, research has shown that nondisabled, low-income individuals face a complex set of barriers to self-sufficiency that have nothing to do with whether they get food stamps. Some cycle in and out of low-paying jobs or can only get irregular hours, while others are noncustodial parents who support children in their extended family as grandparents or uncles.

Whats more, Stephanie Ettinger de Cuba, executive director of Childrens HealthWatch at Boston Medical Center, warns that reducing SNAP benefits could increase health costs in the long run. SNAP acts as important medicine across the lifespan, she said. Food insecurity and hunger are highly correlated with negative health outcomes, such as depression, diabetes, and anemia. One study showed that participation in SNAP was associated with a reduction in health care expenditures by roughly $1,400 per person per year. In Massachusetts, health care costs related to food insecurity and hunger were estimated at $2.4 billion in 2016. Food, in this way, is like preventative medicine or primary care.

The move to curb the SNAP state waiver program is misguided, and ought to be reversed by the next president. Denying help getting food to the poor wont do much to help them find full-time work. More likely, it will have a damaging impact on public health, which ultimately affects us all.

Visit link:
Trumps holiday gift: Cutting off help to the poor - The Boston Globe

GLEN COVE, NY A $5.5-million makeover and expansion is underway at Glen Cove Hospital. The hospital is overhauling its outpatient Family Medicine Center, which was built in the 1970s and is located on the first floor. The practice will be moved to a modernized space on the third floor.

The new, 6,660 square-foot center will provide personalized medical services to patients of all ages, offering primary, prenatal and pediatric care, preventative services, behavioral health and gynecological services to underserved populations and other residents.

Kerri Anne Scanlon, Glen Cove Hospital's executive director, called the center "state-of-the-art." Meanwhile, Barbara Keber, chair of family medicine at the hospital and vice chair of family medicine at Northwell Health, said the new center will not only accommodate more patients, but will create a "welcoming and modern environment." It will also improve clinical care and collaboration, she said.

Here are five things to know about the renovation project.

1. The new center will feature 12 exam rooms, bedside ultrasound machines, a procedure room, laboratory and medication room and modern reception and seating areas.

2. A large, glass enclosed area will be the focal point of the space, offering central views and monitoring of the center. It will also allow clinical team members to huddle before visiting patients in a confidential setting.

3. More than 18,500 patients are expected to be served by the new center, an increase in patient volume of 40 percent.

4. The hospital expects the center will open in late spring.

5. The expansion comes after three years of focused fundraising efforts by community members. To date, the community has raised $3.5 million.

See the article here:
Glen Cove Hospital Renovation And Expansion: 5 Things To Know - Glen Cove, NY Patch

From ancient China to your kitchen, tea has shaped our culture and our brains. Lillian Loescher describes what this could indicate.

That cuppa you have in the morning may be more beneficial to your health than you think. A study recently published in the scientific journal, Aging, describes the positive effects of regular tea consumption on brain structure and touted its protective impacts on age-related decline in brain organization. This comes as no surprise as there have been decades of scientific research about the positive effects of tea consumption on the brain.

Scientist Junhua Li and colleagues showed the first evidence of the positive contribution of tea drinking to brain structure and [their research] suggests a protective effect on age-related decline in brain organization. Junhua Li and colleagues found that those who habitually drank tea had better functional connectivity within the default mode network (DMN) in their brains as compared to those who did not drink tea habitually. The DMN is an interconnected set of structures in the brain between the dorsal medial system and the medial temporal system. These structures are responsible for attention, memory, awareness and spatial navigation as well as higher level thought processes including predicting the future actions of people around you and an ability to reflect on others thought processes and beliefs.

The ability to reflect on others thought processes and beliefs is what psychologists call having a theory of mind. It has been well documented that people on the autism spectrum as well as those with Alzheimers disease have an impaired theory of mind. One large medical review looking at the effect of tea on the prevention of Alzheimers disease found that 8 out of 9 studies concluded that herbal tea had a neuroprotective role and contributed to the prevention of Alzheimers disease. Thus, showing further evidence supporting the positive role of habitual tea consumption on the DMN.

The article produced by Junhua and colleagues has also shown that between the group of older adults who drink tea regularly and the group of older adults who do not drink tea regularly there was higher structural network efficiency found in older adults who had habitual tea drinking. Relative to the non-tea drinking group, the tea drinking group had less topological distance between brain regions and more efficient interregional connectivity.

One of the hallmarks of an aging brain is leftward asymmetry in structural connectivity within the hemispheres of the brain, this can be observed using magnetic resonance imaging (MRI). Scientists have shown that the suppression of hemispheric asymmetry in structural connectivity was associated with tea drinking, tending to be more symmetric in structural connectivity. Specifically, the non-tea drinking group exhibited significantly leftward asymmetryThis hemispheric asymmetry in structural connectivity has been associated with brain ageing.

A separate study looking at the effects of tea on the brain in both humans and animals found that an antioxidant in tea (called catechin) to be extremely beneficial for cognition. As compared to placebo groups, enhancements in memory recognition and working memory were observed following tea consumption over extended periods of time.

Since tea consumption has been shown to be beneficial to brain function, connectivity and symmetry throughout lifetime one must wonder how tea came to be.

The first known monograph of tea was written by LuYu between 760CE and 762CE and is titled: The Classic of Tea. The book describes how to create the perfect cup of tea as well as the therapeutic benefits that tea has. It is said that tea originated in the Yuunan region of China around 4,000 years ago as a medical drink that was believed to represent the harmony and mysterious unity of the universe. Legend has it that tea was discovered by accident by an emperor of China around 2737BC when he was drinking a bowl of boiled water. A breeze hit and some leaves landed in his bowl. Noting the colour change and good taste the emperor was surprised and thus tea became part of the culture. Thousands of years would pass before tea would make its way over to Ireland and the UK.

The first advertisement for tea in the UK appeared in 1658 and officially the tea trade began in 1664. The exact date when tea consumption became popular in Ireland is not known, but the existence of silver teapots from the 1720s suggests that it was well-established by then. For thousands of years across the world tea has been consumed for medicinal and social purposes. The scientific interest in the health benefits of tea will continue to percolate our cultural milieu and perhaps the nature of preventative medicine will be partly shaped by tea consumption.

See the rest here:
Your Brain on Tea - University Observer Online

Researchers at Stanford University have found a way to reliably predict the age of people based on the levels of 373 proteins circulating in their blood. The team created this physiological clock by analysing blood samples from 4263 study participants aged 18 to 95.

The Stanford investigators built their blood plasmaprotein clock by looking at composite levels of proteins within groups of people instead of in individuals, and they say that the resulting formula can usually estimate a persons age to within three years. The team found that a subset of just nine or 10 proteins could form the basis of a very accurate age test, with the assistance of machine learning.

Those whose predicted age was significantly below their real age were remarkably healthy for their age. Nearly two-thirds of the proteins that the researchers found changed with age were significantly more predictive for one sex than for the other.

Overall, the researchers observed that there are three waves of changes in human plasma proteome throughout life occurring around ages 34, 60 and 78. This is because the levels of many proteins remain constant in the human body for a while and then undergo sudden shifts up or down, rather than slowly changing or remaining constant throughout life.

Identifying plasma proteins that promote or antagonise ageing could lead to more targeted and preventative therapies, the researchers suggest. In the future, they say, plasma proteome changes could be identified that predict subjects transitioning to disease. The Stanford team notes that Alzheimers disease is of particular interest because there are currently no blood-based markers for that health condition, and it can produce clinical symptom as much as 20 years after disease onset.

Alireza Delfarah from the University of Southern California, who studies specific mechanisms in ageing, agrees that the new research findings are significant. It is a big step forward in identifying plasma markers of ageing in the future, potentially we can just take plasma samples from people and do a test based on some of these proteins that have been identified, and probably need to be further validated, he says.

However, the Stanford team acknowledges that this work is still in its infancy, and that clinical applications are likely five to 10 years away.

Lizzy Ostler, an expert on the chemistry of human ageing from the University of Brighton in the UK, says the Stanford study is appropriately and rigorously designed, and offers valuable insights into age-related changes. We have known for some time that chronological and biological age are not the same thing, she says. Lifestyle and genetics alter the rate of ageing in the same way that the way you drive your car will change its condition irrespective of mileage.

Broad spectrum interventions that could slow the biological clocks of humans need to be prioritised by global licensing authorities and funders in order to ensure that the field of anti-degenerative medicine comes of age and helps people live healthy lives for longer, Ostler suggests.

Read more:
Blood test picks out proteins that accurately predict age - Chemistry World

Brenna Norman/Reuters Democratic presidential candidate Andrew Yang arrives before he plays basketball with former congressional candidate J.D. Scholten in Ames, Iowa, on Dec. 12, 2019.

Andrew Yang released his health care plan Monday morning, a proposal with elements of Medicare for All, but without the public option plan that even moderate candidates like former Vice President Joe Biden and South Bend, Indiana, Mayor Pete Buttigieg have committed to implementing.

"To be clear, I support the spirit of Medicare for All," Yang said in outlining his plan, before adding, "Swiftly reformatting 18% of our economy and eliminating private insurance for millions of Americans is not a realistic strategy, so we need to provide a new way forward on healthcare for all Americans."

In a statement to ABC News, a Yang campaign spokesperson said, "The U.S. is on track to spend a total of $60 trillion on healthcare between 2022-2031. Andrew Yangs plan will cut about $9.7 trillion over this time period by tackling the root problems in the system, including prescription drug costs, utilizing tele-health, decreasing unnecessary medical services, diminishing billing and insurance related waste, minimizing doctor burnout, improving end of life care, and reducing poverty.

His "A New Way Forward" plan includes pieces already in his competitors' plans, but it differs dramatically from other candidates in several key ways too.

"Yangs proposal does not include provisions targeted at expanding insurance coverage," said Matt Fiedler, a fellow with University of Southern California's nonpartisan Brookings Schaeffer Initiative for Health Policy.

Fiedler pointed to Yang's suggestion that coverage cannot extend to everyone in a practical way, and said that's not likely correct.

"While reducing the underlying cost of care is a meritorious goal, it is also quite feasible to achieve universal coverage even as we continue to work on reducing costs," said Fiedler.

While Yang's six-pronged plan doesn't work to expand the current system, it does attempt to revamp it in a way that weaves in his previous policy pitches.

Just last week, Yang released his plan to lower prescription drug costs. His health care plan builds on some of his earlier promises to hold pharmaceutical companies accountable by directing the Food and Drug Administration and Department of Justice to work together in bringing criminal cases against pharmaceutical execs who use misleading marketing tactics.

Yang also commits to investing in telehealth, information and services given over the phone or internet, noting that the demand for physicians is outpacing the available supply.

His third prong also touches on the demand for doctors, and proposes forgiving their student loans and moving them through a fee-for-service system to a salary system.

He also wants to do more to shield doctors from malpractice lawsuits arguing, "We need to allow doctors to practice medicine that prioritizes their patients health without legal fear in the back of their minds."

Yang's last points focus on preventative care, and putting health care resources into suicide prevention, mental health checkups, handicapped patients and treatment for HIV/AIDS patients.

He closes the plan by explaining how he would minimize lobbyist influence in the health care industry, saying in part, he will refuse to hire anyone who previously worked at a pharmaceutical industry as a lobbyist.

Read the original post:
Yang draws contrasts with rest of field on health care plan - msnNOW

LOS ANGELES (PRWEB) December 11, 2019

Circularity is partnering with Telly Award-Winning Behind the Scenes to provide regular, ongoing, high-quality content from leading experts in a variety of fields with an initial focus on microcirculation science, regenerative medicine, and advanced wound healing and related symptoms. The show reaches 60 million households domestically.

Behind The Scenes with Host Laurence Fishburne is a public television icon that has won numerous awards and delivers precision idea-telling at its best. Circularity is an innovative healthcare organization that is health-bent on their trademarked slogan: Improving Lives by Improving Blood Flow. Their coming together to bring forward the ideas of modern health science on a stellar entertainment platform can only make for riveting content going forward. Viewers will find themselves in a win-win situation.

Watching informative content via this stylized venue will leave viewers feeling quite satisfied with their television watching experience. It is time well spent and information precisely delivered.

A Little More About Circularity

Circularity is concerned with bringing the very best in healthcare innovation to the public. In so doing, they have manufactured a product called DOXYVA. This product has a two-pronged approach to health. First, it can be quite effective in reducing the debilitative effects of many of the diseases that are affecting the world today, such as COPD, diabetes, and cardiovascular illnesses. Secondly, Circularitys DOXYVA can be used in a preventative capacity to improve microcirculation. The concept of microcirculation has far-reaching implications in neurology, oncology, endocrinology, cardiovascular health, respiratory health, dermatology, diabetic wound healing or diabetic wound care and other major fields.

Circularity Healthcare, LLC is the power behind DOXYVA. This noninvasive trans-dermal and circulatory health technology is just the first product to be offered. Circularity is invested in revolutionizing the healthcare space. They plan to do this by creating cutting edge medical products and procedures that are both patient and physician friendly while being effective in minimizing and eradicating diseases.

What Behind The Scenes with Host Laurence Fishburne Will Bring to the Table

Behind The Scenes has been an innovator in bringing information to the forefront in the public television space. The award-winning series features segments on the newest technologies, as well as fresh takes on existing entities, phenomenon, and natural occurrences. The shows website boasts that the television series highlights the evolution of education, medicine, science, technology and industry through inspiring stories.

Aside from the Emmy-winning and Academy Award nominated actor Lawrence Fishburne as host, the program has an award-winning creative development team. Viewers walk away with a rich knowledge of the subject. Viewers may have known about this subject their whole lives, or it may be about something completely new. Viewers learn an evolving aspect of the topic which keeps the perspective fresh.

The dawning of a new age has appeared with this collaboration. Individuals who want to know more about what the health science field is bringing into our hospitals and doctors offices will not be disappointed. In todays world, it is imperative that we are advocates for our own health.

Coming Soon: Miami ReLifes Dr. Steven Gelbard

The first series is with Dr. Steven Gelbard, a nationally-famed authority with his ReLife Miami Institute on stem cells. Dr. Gelbard presents DOXYVAs Nobel Prize-winning science as a regenerative medicine. Dr. Gelbard is involving his direct contacts with top NFL players and other top sports celebrities in the monthly series, along with 2540 top neurosurgeons and other experts working under ReLife.

Imagine having the ability to receive DOXYVA and other innovative treatments and non-invasive procedures for chronic wound care amid the luxury of a five-star hotel. Behind The Scenes guest, Dr. Gelbard, a Tufts School of Medicine educated neurosurgeon, makes it happen right now. Medicine has left the hospital building and has become the proactive choice of the health conscious. We can all look forward to learning more about how to live a healthier and more informed lifestyle from this awe-inspiring episode.

According to Norbert Kiss, President and CEO of Circularity Healthcare, this collaboration is door busting. Mr. Kiss tells us, [We] can offer unprecedented access to this amazing Emmy-winning show called Behind the Scenes with very amazing terms due to our strategic involvement. We welcome any expert.

Laurence Fishburne, host of Behind The Scenes, beckons, Join me as we all discover the endless ways to enjoy the skills and imagination.

Dont miss the evolution. Its being televised. Circularity and Behind The ScenesStay tuned for a mind-fortifying experience!

Circularity Values:

We, at Circularity believe in a long-sought-after goal in health care; people should have access to one health application that solves most of their short and long term health issues without compromising other aspects of their health while doing this quickly, affordably, and without pain.Circularity develops, manufactures and markets advanced technologies that significantly improve quality of life by improving some of the most essential physiological functions in the body.

About Behind The Scenes With Laurence Fishburne

Behind The Scenes is an award-winning program that highlights new stories and innovative concepts through groundbreaking short-form and long-form documentary presentation. The program, which is anchored by a veteran production team with decades of industry experience, is able to effectively communicate the most critical stories to a wide and diverse audience.

Behind The Scenes with Laurence Fishburne, has established an impressive and heralded career, amassing over one-hundred credits across the varied platforms of stage, television and film. Hes well known for major for roles in such films as; John Wick 2, Fantastic 4 Rise of the Silver Surfer, Mission Impossible III, Mystic River, Boyz n the Hood, Whats Love Got to Do With It, and Apocalypse Now. On the small screen, the award-winning and versatile actor played compelling roles in shows such as CSI: Crime Scene Investigation, CSI: Miami, CSI: New York and Hannibal. The Behind The Scenes Actor currently stars as Pops on the hit TV comedy Black-ish.

About Circularity Healthcare, LLC

Circularity Healthcare, LLC, located in Los Angeles, CA is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes and licenses its own patented and patent pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D'OXYVA. One of the main mechanisms underlying D'OXYVA's science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products and with large and small clinics and hospitals in order to help them enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital and also patient financing at industry-leading terms and speed.

For more information, please visit http://www.circularityhealthcare.com or http://doxyva.com or doctors (Rx only) visit http://wound.doxyva.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care at info(at)doxyva(dot)com info(at)circularityhealthcare(dot)com or by phone toll free at 1-855-5DOXYVA or at 1-626-240-0956.

Forward-Looking Information

This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to managements expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

Read the original here:
Innovative Collaboration: The Cutting Edge of Medicine Goes Behind The Scenes - PR Web

Doctor visits can be annoying, especially if you have to take several blood samples to test for a handful of common ailments, not to mention to look for something that might be hard to diagnose.But a new study advises that a novel technique could make this whole process much easier.The research and development that has set the tone for advancements in modern medicine are also helping to make medicine and other treatments more efficient across the board.

For example, health researchers now say they have developed a straightforward blood test that could allow physicians to assess a wide range of ailments and health factors from just one blood sample.Scientists at the University of Cambridge and the University of California-San Franciscoin partnership with biotech SomaLogic HQused several blood samples (from a total of approximately 17,000 patients) to scan 5,000 proteins.

The researchers processed this data using statistical analysis as well as machine learning technology to develop predictive models for a variety of common health problems.

Study author Claudia Langenberg, of the University of Cambridge, explains, Proteins circulating in our blood are a manifestation of our genetic make-up as well as many other factors, such as behaviors or the presence of disease, even if not yet diagnosed.

This is why, she further notes, proteins are known to be such effective indicators of both our present and future health states.With this data we are able to better improve clinical prediction of a handful of different diseases.

Reinforcing her statement, SomaLogic CEO Stephen Williams comments, Its remarkable that plasma protein patterns alone can faithfully represent such a wide variety of common and important health issues, and we think that this is just the tip of the iceberg.

Indeed, this is only the beginning for this method of diagnostics.With more in-depth research and scanning of proteins, there is great potential to map fully individualized health assessments for all patients.

Finally, co-lead author Peter Ganz, University of California-San Francisco comments that this new research marks a crucial milestone in the scientific development of personalized preventative medicine.Ganz is a member of SomaLogics Medical Advisory board, but is not compensated for holding the position.

He explains, This proof-of-concept study demonstrates a new paradigm that measurement of blood proteins can accurately deliver health information that spans across numerous medical specialties and that should be actionable for patients and their health care providers.

See the article here:
New Study Says that A Single Blood Test Could Soon Predict Your Future Disease Risk - Jamestown Journal