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From boosting immune system to lowering high blood pressure: Know the health benefits of spinach – Times Now

October 30th, 2020 11:58 am

From boosting immune system to lowering high blood pressure: Know the health benefits of spinach  |  Photo Credit: iStock Images

New Delhi: Spinach is loaded with vitamins, minerals and powerful antioxidants, making it a superstar among green leafy vegetables. This superfood has been shown to benefit health in several ways, from boosting the immune system to preventing heart disease and cancer. The leafy green is also a great addition to your weight loss diet as its very low in calories.

Whats more, this nutritious, versatile vegetablecan be consumed raw or cooked. Keep reading as we list some amazing health benefits that spinach can offer.

Spinach is one of the most nutritious foods that you can eat on the planet. However, the vegetable may cause some adverse effects in some people - such as those who are prone to kidney stones. The vegetable may also interfere with blood-thinning medication since its high in vitamin K1. Hence, individuals who are at risk of having kidney stones and those taking blood thinners may consult with their doctors or healthcare providers before eating large amounts of spinach.

Disclaimer: Tips and suggestions mentioned in the article are for general information purpose only and should not be construed as professional medical advice. Always consult your doctor or a dietician before starting any fitness programme or making any changes to your diet.

Get the Latest health news, healthy diet, weight loss, Yoga, and fitness tips, more updates on Times Now

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Multi-omics analyses of radiation survivors identify radioprotective microbes and metabolites – Science

October 30th, 2020 11:57 am

Radioprotective bacteria

A common symptom of radiation treatment for cancer is gastrointestinal disruption. The damage caused can become so severe and debilitating that it interrupts treatment. Guo et al. noticed that mice surviving experimental radiation exposure had distinctive taxonomic representation in their gut microbiota. A similar correlation was also observed in a small group of human subjects. Further experiments in mice revealed that some strains of bacteria produced high levels of short-chain fatty acids, which seemed to be dampening inflammatory responses and alleviating the damage caused by reactive oxygen species released by the radiation. A metabolomics analysis also implicated a role for tryptophan metabolic pathways in radiation survivorship.

Science, this issue p. eaay9097

The toxicity of high-dose ionizing radiation is associated with the induction of both chronic and acute radiation syndromes that occur after partial or total body radiation and can be further characterized into hematopoietic, gastrointestinal, and cerebrovascular syndromes. The intestine is the major target of radiation and the biggest niche for gut microbiota. Although there are sporadic descriptive studies showing a potential correlation between the gut microbiota and radiation-induced damage, the detailed underpinnings of this relationship remain obscure. In addition, medical intervention to counteract radiation injury is still a global challenge despite decades of rigorous research.

Over the last decade, numerous investigations have demonstrated highly diverse gut microbiota between individuals and significant correlations of gut microbiota with multiple diseases. Gut microbes, as well as microbe-derived metabolites represented by short-chain fatty acids (SCFAs) and tryptophan metabolites, have essential roles in regulating host metabolism and immunity. The imbalance or dysbiosis of a microbial community is associated with potential diseases, risks, or even to the clear onset of clinical symptoms. We have previously corroborated the biological importance of gut microbiota and certain bacteria (e.g., Lachnospiraceae) together with SCFAs in attenuating colitis and obesity. It has also been reported that SCFAs and tryptophan metabolites can reduce proinflammatory cytokines such as tumor necrosis factor-, interleukin-6, and interferon- and promote the anti-inflammatory cytokines, all of which are vital mediators of radiation-induced damage. These findings raise the possibility that the gut microbiota and metabolites play a key role in the regulation of disease susceptibility after radiation challenge.

We found that a small percentage of mice could survive a high dose of radiation and live a normal life span. These elite-survivors harbored a distinct gut microbiome that developed after radiation. Taking advantage of this finding, we used a combination of fecal engraftment and dirty cage sharing to demonstrate that the microbiota from elite-survivors provided substantial radioprotection in both germ-free and conventionally housed recipients, characterized by enhanced survival and ameliorated clinical scores. An unbiased microbiome analysis identified Lachnospiraceae and Enterococcaceae as the most enriched bacteria in elite-survivors. Monoassociation analysis provided direct evidence for the protective role of Lachnospiraceae and Enterococcaceae in promoting hematopoiesis and attenuating gastrointestinal damage. Clinical relevance in humans was supported by an analysis of leukemia patients who were exposed to whole-body radiation. The elevated abundance of Lachnospiraceae and Enterococcaceae was associated with fewer adverse effects in a highly statistically significant fashion. Treatment with SCFAs, especially propionate, rendered mice resistant to radiation, mediated by attenuation of DNA damage and reactive oxygen species release both in hematopoietic and gastrointestinal tissues. Further, an untargeted metabolomics study revealed a realm of metabolites that were affected by radiation and selectively increased in elite-survivors. Among these, two tryptophan pathway metabolites, 1H-indole-3-carboxaldehyde (I3A) and kynurenic acid (KYNA), provided long-term radioprotection in vivo.

Our findings emphasize a crucial role for the gut microbiota as a master regulator of host defense against radiation, capable of protecting both the hematopoietic and gastrointestinal systems. Lachnospiraceae and Enterococcaceae, together with downstream metabolites represented by propionate and tryptophan pathway members, contribute substantially to radioprotection. This study sheds light on the pivotal role that the microbiota-metabolite axis plays in generating broad protection against radiation and provides promising therapeutic targets to treat the adverse side effects of radiation exposure.

Gut microbes, especially Lachnospiraceae and Enterococcaceae along with bacteria-derived metabolites represented by SCFA (propionate) and tryptophan pathway members (I3A and KYNA), tune host resistance against high doses of radiation by facilitating hematopoiesis and gastrointestinal recovery.

Ionizing radiation causes acute radiation syndrome, which leads to hematopoietic, gastrointestinal, and cerebrovascular injuries. We investigated a population of mice that recovered from high-dose radiation to live normal life spans. These elite-survivors harbored distinct gut microbiota that developed after radiation and protected against radiation-induced damage and death in both germ-free and conventionally housed recipients. Elevated abundances of members of the bacterial taxa Lachnospiraceae and Enterococcaceae were associated with postradiation restoration of hematopoiesis and gastrointestinal repair. These bacteria were also found to be more abundant in leukemia patients undergoing radiotherapy, who also displayed milder gastrointestinal dysfunction. In our study in mice, metabolomics revealed increased fecal concentrations of microbially derived propionate and tryptophan metabolites in elite-survivors. The administration of these metabolites caused long-term radioprotection, mitigation of hematopoietic and gastrointestinal syndromes, and a reduction in proinflammatory responses.

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Coronavirus Tracker: Mayor Nirenberg says community has reached ‘critical moment’ in the pandemic while reporting 201 more cases – KENS5.com

October 30th, 2020 11:57 am

Facts, not fear: KENS 5 is tracking the latest numbers from the coronavirus (COVID-19) pandemic in San Antonio and across Texas.

SAN ANTONIO We're tracking the latest numbers from the coronavirus pandemic in San Antonio and across Texas. Here are the latest numbers reported by Bexar and surrounding counties:

How Bexar County is trending

We've tracked how many coronavirus cases have been confirmed in Bexar County from the time officials began reporting cases in March 2020. The graphic below shows the number of cases since June and charts those daily case numbers along a 7-day moving average to provide a more accurate picture of the overall coronavirus case curve in our area and the direction we're trending amid the pandemic.

On Thursday, San Antonio Mayor Ron Nirenberg reported 201 additional coronavirus cases in Bexar County, calling this "a critical moment in the course of this pandemic."

It's the second straight day with at least 200 more cases in the county, as the total number of novel coronavirus diagnoses reaches 65,423. However, no new deaths were reported; 1,250 county residents have died from COVID-19 complications in all.

Nirenberg said Metro Health is also stepping up efforts to contain the virus's spread via additional testing sites (all of which can be found here) and greater outreach from community health teams.

Meanwhile, hospitalizations related to the virus decreased ever so slightly on Thursday, to 223. That's down two from Wednesday. The number of patients on ventilators (38) and in intensive care (80) is also down from Wednesday.

Coronavirus in Texas

The number of Texans who have tested positive for the coronavirus since the pandemic began grew by 6,826 on Thursday, according to the Texas Department of State Health Services.

6,430 of those are new diagnoses over the last 24 hours, while another 396 cases stem from a number of backlogs in several counties. More details can be found at the top of this page.

In all, at least 886,820 Texans have contracted COVID-19.

State health authorities also reported 119 additional virus-related deaths on Thursday. At least 17,819 Texans have passed away from COVID-19 complications.

Meanwhile, COVID-19-related hospitalizations in Texas decreased for the first time in five days, with 5,587 Texans receiving treatment for COVID-19 symptoms63 fewer patients overall than on Wednesday. The bigger picture, however, shows a troubling trend; October has brought a reversal of flatlining numbers as hospitalizations have spiked in recent weeks for the Lone Star State. In the last seven days, the number of Texas hospitalizations have gone up by 13%; since Oct. 1, they've gone up by 75%.

Health officials warn that the state is currently in another surge. Experts attribute the spike in COVID-19 numbers to "pandemic fatigue."

The state estimates that 772,350 Texans have recovered, while 98,775 Texans remain ill with COVID-19.

Meanwhile, the Texas Education Agency updated its online coronavirus database to show that there have been 26,127 cumulative cases among staff and students across the state through Oct. 23. More information can be found here.

The TEA releases new data on school cases every Thursday.

Latest Coronavirus Headlines

Coronavirus symptoms

The symptoms of coronavirus can be similar to the flu or a bad cold. Symptoms include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell sore throat, congestion or runny nose, nausea or vomiting and diarrhea, according to the Centers for Disease Control.

Most healthy people will have mild symptoms. A study of more than 72,000 patients by the Centers for Disease Control in China showed 80 percent of the cases there were mild.

But infections can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death, according to the World Health Organization. Older people with underlying health conditions are most at risk.

But infections can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death, according to the World Health Organization. Older people with underlying health conditions are most at risk.

Experts determined there was consistent evidence these conditions increase a person's risk, regardless of age:

The CDC believes symptoms may appear anywhere from two to 14 days after being exposed.

Human coronaviruses are usually spread...

Help stop the spread of coronavirus

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Coronavirus Tracker: Mayor Nirenberg says community has reached 'critical moment' in the pandemic while reporting 201 more cases - KENS5.com

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Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia – GlobeNewswire

October 30th, 2020 11:57 am

Basel, October 30, 2020 Novartis today announced the receipt of marketing authorization from Japans Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan. This approval makes FBRI the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia.

Behind our efforts to reimagine medicine with CAR-T cell therapy lies a commitment to build a manufacturing network that brings treatment closer to patients, commented Steffen Lang, Global Head of Novartis Technical Operations. The expertise and infrastructure of FBRI, a world-leading manufacturing organization, allows us to bring CAR-T manufacturing to Asia. With the Japan MHLW commercial manufacturing approval, the recent capacity expansion in the US and our ongoing efforts to optimize and evolve our processes, we are well-positioned to deliver this potentially curative treatment option to more patients around the world.

Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) recently approved a further increase in manufacturing capacity.

Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia, which was first-of-its-kind in CAR-T research and development.

About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 26 countries and at more than 260 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut fr Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.

ImportantSafety information from the Kymriah SmPC

EU Name of the medicinal product:

Kymriah 1.2 x 106 6 x 108 cells dispersion for infusion

Important note: Before prescribing, consult full prescribing information.

Presentation: Cell dispersion for infusion in 1 or more bags for intravenous use (tisagenlecleucel).

Indications: Treatment of pediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse posttransplant or in second or later relapse. Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Dosage and administration:

B-cell patients: For patients 50 kg and below: 0.2 to 5.0 x 106 CAR-positive viable T-cells/kg body weight. For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T-cells (non-weight based).

DLBCL Patients: 0.6 to 6.0108 CAR-positive viable T-cells (non-weight based).

Pretreatment conditioning (lymphodepleting chemotherapy): Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is 1,000 cells/L. The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.

Precautions before handling or administering Kymriah: Kymriah contains genetically modified human blood cells. Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

Preparation for infusionThe timing of thaw of Kymriah and infusion should be coordinated. Once Kymriah has been thawed and is at room temperature (20C 25C), it should be infused within 30minutes to maintain maximum product viability, including any interruption during the infusion.

Administration Kymriah should be administered as an intravenous infusion through latexfree intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20mL per minute by gravity flow. If the volume of Kymriah to be administered is 20mL, intravenous push may be used as an alternative method of administration.

All contents of the infusion bag(s) should be infused.

Clinical assessment prior to infusion: Kymriah treatment should be delayed in some patient groups at risk (see Special warnings and precautions for use).

Monitoring after infusion: Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurological events. After the first 10 days following the infusion, the patient should be monitored at the physicians discretion. Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.

Elderly (above 65 years of age): Safety and efficacy have not been established in B-cell patients. No dose adjustment is required in patients over 65 years of age in DLBCL patients.

Paediatric patients: No formal studies have been performed in paediatric patients with B-cell ALL below 3 years of age. The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established in DLBCL. No data are available.

Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV): There is no experience with manufacturing Kymriah for patients with a positive test for HIV, active HBV, or active HCV infection. Leukapheresis material from these patients will not be accepted for Kymriah manufacturing.

Contraindications: Hypersensitivity to the active substance or to any of the excipients of Kymriah. Contraindications of the lymphodepleting chemotherapy must be considered.

Warnings and precautions: Reasons to delay treatment: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), significant clinical worsening of leukaemia burden or rapid progression of lymphoma following lymphodepleting chemotherapy. Blood, organ, tissue and cell donation: Patients treated with Kymriah should not donate blood, organs, tissues or cells.

Active central nervous system (CNS) leukaemia or lymphoma: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma. Therefore the risk/benefit of Kymriah has not been established in these populations. Risk of CRS: Occurred in almost all cases within 1 to 10 days post infusion with a median time to onset of 3 days and a median time to resolution of8 days. See full prescribing information for management algorithm of CRS. Risk of neurological events: Majority of events, in particular encephalopathy, confusional state or delirium, occurred within 8 weeks post infusion and were transient. The median time to onset of neurological events was 8 days in B-cell ALL and 6 days in DLBCL; the median time to resolution was 7 days for B-cell ALL and 13 days for DLBCL. Patients should be monitored for neurological events. Risk of infections: Delay start of therapy with Kymriah until active uncontrolled infections have resolved. As appropriate, administer prophylactic antibiotics and employ surveillance testing prior to and during treatment with Kymriah. Serious infections were observed in patients, some of which were life threatening or fatal. After Kymriah administration observe patient and ensure prompt management in case of signs of infection Risk of febrile neutropenia: Frequently observed after Kymriah infusion, may be concurrent with CRS. Appropriate management necessary. Risk of prolonged cytopenias: Appropriate management necessary. Prolonged cytopenia has been associated with increased risk of infections. Myeloid growth factors, particularly granulocyte macrophage colony stimulating factor (GM CSF), not recommended during the first 3 weeks after Kymriah infusion or until CRS has been resolved. Risk of secondary malignancies: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer and should be monitored lifelong for secondary malignancies. Risk of hypogammaglobulinemia or agammaglobulinemia: Infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be managed per age and standard guidelines. In patients with low immunoglobulin levels preemptive measures such as immunoglobulin replacement and rapid attention to signs and symptoms of infection should be implemented. Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment was not studied. Vaccination with live virus vaccines is not recommended at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah. Risk of tumor lysis syndrome (TLS): Patients with elevated uric acid or high tumor burden should receive allopurinol or alternative prophylaxis prior to Kymriah infusion. Continued monitoring for TLS following Kymriah administration should also be performed. Concomitant disease: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions of Kymriah and require special attention. Prior stem cell transplantation: Kymriah infusion is not recommended within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of potential risk of worsening GVHD. Leukapheresis for Kymriah manufacturing should be performed at least 12weeks after allogeneic SCT. Serological testing: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV. Screening for HBV, HCV and HIV, must be performed before collection of cells for manufacturing. Hepatitis B virus (HBV) reactivation, can occur in patients treated with medicinal products directed against B cells and could result in fulminant hepatitis, hepatic failure and death. Prior treatment with anti CD19 therapy: There is limited experience with Kymriah in patients exposed to prior CD19 directed therapy. Kymriah is not recommended if the patient has relapsed with CD19 negative leukaemia after prior anti-CD19 therapy. Interference with serological testing: Due to limited and short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result. Sodium and potassium content: This medicinal product contains 24.3 to 121.5mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2g sodium for an adult. This medicinal product contains potassium, less than 1mmol (39mg) per dose, i.e. essentially potassium free. Content of dextran 40 and dimethyl sulfoxide (DMSO): Contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration. Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.

Interaction with other medicinal products and other forms of interaction

Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females: Pregnancy status for females of reproductive potential should be verified prior to starting treatment with Kymriah. Consider the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.

Pregnancy: There are no data from the use of Kymriah in pregnant women. It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B cell lymphocytopenia. Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnant women should be advised on the potential risks to the foetus. Pregnancy after Kymriah therapy should be discussed with the treating physician. Pregnant women who have received Kymriah may have hypogammaglobulinaemia. Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.

Breast feeding: It is unknown whether Kymriah cells are excreted in human milk, a risk to the breast fed infant cannot be excluded. Women who are breast feeding should be advised of the potential risk to the breast fed infant. Breast-feeding should be discussed with the treating physician.

Fertility: There are no data on the effect of Kymriah on fertility.

Effects on ability to drive and use machinesDriving and engaging in hazardous activities in the 8 weeks following infusion should be refrained due to risks for altered or decreased consciousness or coordination.

Adverse drug reactions:

B-Cell ALL patients and DLBCL patients:

Very common (10%): Infections - pathogen unspecified, viral infections, bacterial infections, fungal infections, anaemia, haemorrhage, febrile neutropenia, neutropenia, thrombocytopenia, cytokine release syndrome, hypogammaglobulinaemia, decreased appetite, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, anxiety, delirium, sleep disorder, headache, encephalopathy, arrhythmia, hypotension, hypertension, cough, dyspnoea, hypoxia, diarrhoea, nausea, vomiting, constipation, abdominal pain, rash, arthralgia, acute kidney injury, pyrexia, fatigue, oedema, pain, chills, lymphocyte count decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, aspartate aminotransferase increased.

Common (1 to 10%): Haemophagocytic lymphohistiocytosis, leukopenia, pancytopenia, coagulopathy, lymphopenia, infusion-related reactions, graft versus host disease, hypoalbuminaemia, hyperglycaemia, hyponatraemia, hyperuricaemia, fluid overload, hypercalcemia, tumor lysis syndrome, hyperkalaemia, hyperphosphataemia, hypernatraemia, hypermagnesaemia, dizziness, peripheral neuropathy, tremor, motor dysfunction, seizure, speech disorder, neuralgia, ataxia, visual impairment, cardiac failure, cardiac arrest, thrombosis, capillary leak syndrome, oropharyngeal pain, pulmonary oedema, nasal congestion, pleural effusion, tachypnea, acute respiratory distress syndrome, stomatitis, abdominal distension, dry mouth, ascites, hyperbilirubinaemia, pruritus, erythema, hyperhidrosis, night sweats, back pain, myalgia, muscolosceletal pain, influenza-like illness, asthenia, multiple organ dysfunction syndrome, alanine aminotransferase increased, blood bilirubin increased, weight decreased, serum ferritin increased, blood fibrinogen decreased, international normalized ratio increased, fibrin D dimer increased, activated partial thromboplastin time prolonged, blood alkaline phosphate increased, prothrombin time prolonged.

Uncommon: B-cell aplasia, ischaemic cerebral infarction, flushing, lung infiltration.

Packs and prices: Country-specific.

Legal classification: Country-specific.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visithttps://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com

References

1.Kymriah (tisagenlecleucel) Summary of Product Characteristics (SmPC), 2018.

# # #

Novartis Media RelationsE-mail: media.relations@novartis.com

Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

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Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia - GlobeNewswire

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Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report – BioSpace

October 30th, 2020 11:57 am

NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. It also provided a financial report for the first quarter ended September 30, 2020.

Mesoblast Chief Executive Dr Silviu Itescu stated: We believe the immunomodulatory properties of remestemcel-L position this potential therapy at the forefront of treatment for severe and life-threatening inflammatory conditions, including COVID-19 acute respiratory distress syndrome (ARDS) and steroid-refractory acute graft versus host disease (SR-aGVHD). We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.

Children with Steroid-Refractory Acute Graft Versus Host DiseaseIn August, the Oncologic Drugs Advisory Committee (ODAC)1 of the United States Food and Drug Administration (FDA) voted 9:1 that the available data from a single-arm Phase 3 trial and evidence from additional studies support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD. Despite the overwhelming ODAC vote, in September the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

Mesoblast believes that remestemcel-L meets the criteria for accelerated approval as there are currently no approved treatments for this life-threatening condition in children under 12. Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement. Mesoblast expects this meeting will occur in November.

Adults with COVID-19 ARDSAs cases of COVID-19 surge in the United States and globally, deaths continue to increase from ARDS in ventilator-dependent patients as a result of an overactive immune response in the lungs to COVID-19. It is now evident that in both adults and children COVID-19 causes severe inflammation of other organ systems in addition to the lungs, including the heart, brain and kidneys. The immunomodulatory mechanism of action of remestemcel-L may be beneficial in the treatment of ARDS as well as in involvement of other organ systems.

Indeed, nine of 12 ventilator-dependent adult patients with COVID-19 ARDS who received two doses of remestemcel-L under emergency compassionate use at New Yorks Mt Sinai Hospital were successfully discharged within a median of 10 days. Additionally, two COVID-19 infected children with multisystem inflammatory syndrome (MIS-C) who received remestemcel-L for severe heart failure fully recovered heart function and were discharged within 30 hours of the second dose.

To confirm these pilot data, remestemcel-L is being evaluated for its potential to reduce mortality in a Phase 3 randomized controlled trial of up to 300 ventilator-dependent adults with moderate or severe COVID-19 ARDS. The dosing regimen in the Phase 3 is the same as in the pilot trial. Trial enrollment across more than 20 hospitals in the United States has surpassed 50% of the total 300 patient target. The trials first 135 patients will complete 30 days of follow up during October, after which the independent Data Safety Monitoring Board (DSMB) will perform an interim analysis of the trials primary endpoint of all-cause mortality within 30 days of randomization. The DSMB is expected to inform Mesoblast in early November on whether the trial should proceed as planned, or should stop early. A further interim analysis is planned after 60% of the trial has been enrolled.

Crohns DiseaseAccording to recent estimates, more than three million people (1.3%) in the United States alone have inflammatory bowel disease, with more than 33,000 new cases of Crohns disease and 38,000 new cases of ulcerative colitis diagnosed every year.2-4 Despite recent advances, approximately 30% of patients are primarily unresponsive to anti-TNF agents and even among responders, up to 10% will lose their response to the drug every year. Up to 80% of patients with medically-refractory Crohns disease eventually require surgical treatment of their disease,5 which can have a devastating impact on quality of life.

A randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohns disease and ulcerative colitis has commenced at Cleveland Clinic. Mesoblasts objective is to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to SR-aGVHD. The investigator-initiated study at Cleveland Clinic is the first in humans using local cell delivery in the gut, and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohns disease where remestemcel-L was administered intravenously.

Chronic Heart FailureIn the United States alone, of more than 6.5 million patients with chronic heart failure, there are more than 1.3 million patients with advanced stage of the disease.6 The objective of treatment with Mesoblasts allogeneic cellular product candidate REVASCOR is to reduce or reverse the severe inflammatory process in the damaged heart of these patients, and thereby prevent or delay further progression of heart failure or death. In an earlier randomized placebo-controlled 60-patient Phase 2 trial, a single intra-myocardial injection of REVASCOR at the dose administered in the subsequent Phase 3 trial prevented any hospitalizations or deaths over three years of follow-up in patients with advanced chronic heart failure. Results from Mesoblasts randomized placebo-controlled Phase 3 trial in patients with advanced forms of New York Heart Association Class II or Class III disease are expected during Q4 CY2020.

Chronic Low Back PainThere is a significant need for a safe, efficacious and durable treatment in patients with chronic low back pain due to severely inflamed degenerative disc disease, affecting over 3.2 million patients in the United States and approximately 4 million in the EU5.7 Results from a Phase 3 randomized placebo-controlled trial evaluating Mesoblasts product candidate in patients with chronic low back pain due to degenerative disc disease are expected during Q4 CY2020. In parallel, Mesoblast and its partner Grnenthal GmbH are collaborating on the clinical protocol for a confirmatory Phase 3 trial in Europe.

Cash Flow Report for the First Quarter FY2021Cash on hand at the end of the quarter was US$108.1 million. Over the next 12 months, Mesoblast may have access to an additional US$67.5 million through existing financing facilities and strategic partnerships.

Total Operating Activities excluding product inventory resulted in net cash usage of US$23.0 million in the quarter ended September 30, 2020. In addition, $5.2 million was invested in RYONCIL (remestemcel-L) commercial inventory in anticipation of product launch for either children with SR-aGVHD or COVID-19 patients with moderate to severe ARDS.

About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

1.This vote includes a change to the original vote by one of the ODAC panel members after electronic voting closed.2.CDC Facts and Figures 2015.3.Globaldata Pharmapoint 2018.4.Dahlhamer JM, MMWR Morb Mortal Wkly Rep. 2016;65(42):11661169.5.Crohns and Colitis Foundation6.AHAs 2017 Heart Disease and Stroke Statistics7.Decision Resources: Chronic Pain December 20158.TEMCELL HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

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Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report - BioSpace

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Therapeutic Solutions International Launches Clinical Trial to Validate First Blood Based Predicator of Suicidal Ideation: The Campbell Score -…

October 30th, 2020 11:57 am

OCEANSIDE, Calif., Oct. 29, 2020 /PRNewswire/ --Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today publication on the NIH clinical trials website1 of its newly initiated trial aiming to validate a blood-based diagnostic for predicting suicide risk.

The Campbell Score, which is a patent-pending method of quantifying inflammatory-associated biological markers, has previously been shown in pilot investigator-initiated studies to correlate with propensity for suicide. Based on positive feedback from collaborators, the Company decided to initiate a formal clinical trial to validate correlations between the Campbell Score and established psychiatric assessment tools of suicidal propensity. Currently the only means of quantifying predisposition to suicide is based on psychological, question-based techniques. These tests are highly subjective and biased based on desire of questionee to avoid being labeled as "crazy."

"I am thankful for Timothy Dixon and the team at TSOI for working to establish a biological basis of suicide as a disease and not a choice," said Kalina O'Connor, Director of the Campbell Neurosciences Division of the Company. "Rigorous scientific validation of the Campbell Score, will be the first step in establishing a foundation for a paradigm shift in the way that suicide is approached."

Therapeutic Solutions International has previously filed patents for diagnosing people at high risk of suicide and intervening using immunotherapy and stem cell based approaches.

"According to the World Health Organization, suicide is the #2 cause of death for people between the ages of 15 and 29,"2 said Famela Ramos, Director of Business Development of the Company. "I am honored to be involved with a company that not only is working on developing the first objective means of quantifying suicidal thoughts, but also is the first to believe that taking one's life occurs because of a biochemical abnormality and not "taking the easy way out."

"The Campbell Score is named after Kathleen Campbell, the mother of Kalina O'Connor who was victim of suicide. We strive in her name, and the name of the multiple victims of suicide, to lay down the scientific basis, and intellectual property foundation, for repositioning suicide from a stigma to a bona fide medical condition," said Timothy Dixon, President and CEO of Therapeutic Solutions International.

About Therapeutic Solutions International, Inc.Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/ and Campbell Neurosciences at https://www.campbellneurosciences.com

1https://clinicaltrials.gov/ct2/show/NCT046068752https://www.who.int/mental_health/prevention/suicide/suicideprevent/en/

ir@tsoimail.com

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FACE TO FACE: Shining a light on those living with blindness – Bahamas Tribune

October 30th, 2020 11:55 am

By FELICITY DARVILLE

As October comes to an end, I wanted to recognise a group that deserves just as much attention as other NGOs celebrating important causes this month.

The Bahamas Alliance for the Blind and Visually Impaired (BABVI) recognises October as Blindness Awareness Month. This year, BABVI celebrates 30 years in existence and 23 years as a legal entity for the blind in The Bahamas.

The fact that members of the alliance are blind or visually impaired have not stopped them from being active this month despite the restrictions of the pandemic.

In fact, members have been more active on social media than ever before. This was in keeping with this years theme: Our Vision Still Strong; Pandemic or Not!

BABVI president Ken Rolle said the organisation launched an aggressive campaign via social media platforms centred on eye care tips, breaking barriers in blindness, and living with blindness.

There were also media house interviews, talk show appearances and presentations to civic organisations via Zoom. Since Ken has been president, he has brought a lot of young people to the alliance and they, in turn, have been using their social media platforms to promote their cause.

They celebrated World Sight Day on Thursday, October 8, and International White Cane Day on October 15, pushing the message to friends, family members and followers to get their eyes tested and be conscious of the needs of blind and visually impaired people like them.

The month of celebrations culminated last night with the Vision 2020 Virtual Summit which featured presentations from BABVI members along with representatives from the Caribbean Council for the Blind; Disability Affairs Division; Department of Social Services; The Eye Care Services Department of Public Health and The Erin H Gilmour School for the Blind.

The Alliance remains the trailblazers in the country sensitising the general public on the importance of eye protection, sight preservation and blindness prevention, Ken said.

Additionally, the organisation is still focused on its mission and goals as outlined in the Constitution, employing members to remain vocal, advocating for the rights, dignity, and wellbeing of the blind in the Bahamian society.

This years Blindness Awareness Month highlights included three BABVI members: Jermaine Clarke, Rickia Pratt and Akemi Kenaz Thompson.

Jermaine Clarke is a husband and father of three. He has been blind for over 25 years. Despite this challenge, Jermaine is independent and is a daily provider for his family. He has been employed at the Salvation Armys mop factory for years now.

But thats not all Jermaine is a lumberjack. He is skilled at what he does and because of it, members of his community know who to call after a hurricane to help with clean up, or just to cut down overgrown trees in their yard.

For people without any disabilities, holding down two jobs is quite a feat. But being a lumberjack and a factory worker only scratches the surface of what this talented man can do. Jermaine also has skills in plumbing as well as auto mechanics.

So, his community members, family and friends call on him for all sorts of odd jobs. When he isnt getting his hands dirty and earning money, Jermaine turns to something he loves music.

His passion for music has blossomed into another career. Jermaine is a DJ who specialises in events like birthdays and weddings.

Challenge me to do something and I will find a way to do it, he said.

Anything to feed my family.

Ken called his BABVI colleague a great supporter of all of the organisations initiatives, and a true model of a man who is blind.

The spotlight is also on Rickia Pratt for Blindness Awareness month. Rickia has been visually impaired all her life. She attended the Salvation Army School for the Blind, where she graduated with 6 BJCs and 6 BGCSEs.

At the age of ten, Rickia developed a love for foreign languages. That love blossomed as she pursued tertiary education. She attended Eastern Washington University and successfully pursued a degree in foreign languages.

When Rickia returned home, her skills were put to good use. She made history by being the only person with disability to be accepted into the Ministry of Tourisms Foreign Language Cadet Programme in 2008. She was afforded the opportunity to attend a summer-abroad programme in Costa Rica, one of many places she has travelled to perfect the Spanish language.

Rickia is a seasoned liturgical dancer. She has been dancing from she was eight years old. Today, Rickia is an activist for local people with disabilities. Her personal motto is: All things are possible with hard work and determination.

The youngest to be highlighted this month is Akemi Kenaz Thompson. She is one of the bright stars at the Erin H Gilmour School for the Blind and Visually Impaired.

Now in her late teens, Akemi was diagnosed at birth with a condition called Hydrocephalus, which is a build-up of fluid within the cavities of the brain. Treatment was administered; however, by sixth grade, Akemis condition took a turn for the worse, leaving her with chronic visual impairment, mostly in her right eye.

Despite this, Akemi still continues to thrive and blossom, obtaining four BJCs due to her hard work and dedication to her studies.

She is now attending classes at RM Bailey Senior High School on a quest to obtain her BGCSEs, with a focus on English Language. Akemi has learned to navigate independently with low vision using the white cane, an essential tool for blind and visually impaired people all around the world.

A white cane primarily allows its user to scan their surroundings for obstacles or orientation marks. As an onlooker, it is important to take notice when you see the white cane, so that you can identify the user as blind or visually impaired and take appropriate care. This becomes very important when you are a motorist and someone is using the white cane and crossing the street, for example. For BABVI, white cane also symbolises self-reliance and accomplishment.

Akemi has a love for reading, traveling and experiencing new cultures. One day, she hopes to be a college graduate and she aspires to become an author. She is confident she can achieve her goals because of her strong support system her parents and three brothers.

Congratulations goes out to the Alliance as it celebrates another milestone in the organisations life, Ken said in an address to his members.

Remain resilient, press on towards your goals, persevere in these unprecedented times despite the emergency orders. As our theme suggests let your vision remain strong, pandemic or not!

For donations to help the causes of the blind and visually impaired, or for general information, BABVI can be contacted through the Disability Affairs Division, telephone 325-2252 or email babvi.101@gmail.com.

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Retinal diseases often lead to blindness, but a new treatment shows promise – TheHealthSite

October 30th, 2020 11:55 am

There are many different types of retinal diseases, but almost all of them lead to damage of the retinal and vision loss. The retinal is a thin layer of tissue on the inside back wall of your eye, which contains millions of light-sensitive cells and nerve cells that receive and send visual information to the brain through the optic nerve. This is what enables you to see. If there are any problems with the retina, available treatment options will stop the progress of the disease and preserve and restore vision. But this is not always successful. Also Read - Working from home? You may be at risk of developing computer vision syndrome

Now researchers have uncovered a potential new strategy for treating eye diseases that affect millions of people around the world, often resulting in blindness. Many serious eye diseases including age-related macular degeneration, diabetic retinopathy and related disorders of the retina feature abnormal overgrowth of new retinal blood vessel branches, which can lead to progressive loss of vision. Its a phenomenon called neovascularization. Also Read - 5 everyday bad habits that are hurting your eyes

For the past decade and a half, eye doctors have been treating these conditions with drugs that block a protein, VEGF, thats responsible for spurring new vessel growth. Such drugs have improved the treatment of these conditions, but dont always work well and have potential safety issues. The current study, published in the journal Proceedings of the National Academy of Sciences, showed that a new approach that doesnt target VEGF directly is highly effective in mice and has broader benefits than a standard VEGF-blocking treatment. Also Read - Dont rub your itchy eyes: Try these effective home remedies instead

Researchers from Scripps Research Institute in the US were thrilled to see how well this worked in the animal model. There really is a need for another way to treat patients who do not respond well to anti-VEGF treatments, they say. For the findings, the research team conducted tests in a mouse model of retinal hypoxia and neovascularization, using a fragment of CITED2 that contains its functional, hypoxic-response-blocking elements. They showed that when a solution of the CITED2 fragment was injected into the eye, it lowered the activity of genes that are normally switched on by HIF-1a in retinal cells, and significantly reduced neovascularization. Moreover, it did so while preserving, or allowing to re-grow, the healthy capillaries in the retina that would otherwise have been destroyed researchers call it vaso-obliteration in this model of retinal disease.

In the same mouse model, the researchers tested a drug called aflibercept, a standard anti-VEGF treatment. It helped reduce neovascularization but did not prevent the destruction of retinal capillaries. However, reducing the dose of aflibercept and combining it with the CITED2 fragment yielded better results than either alone, strongly reducing neovascularization while preserving and restoring retinal capillaries. CITED2s ability to combine these two benefits appears to represent a key advance, the researchers concluded. The researchers now hope to develop the CITED2-based treatment further, with the ultimate goal of testing it in human clinical trials.

(With inputs from IANS)

Published : October 28, 2020 10:31 pm | Updated:October 29, 2020 9:28 am

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Glaucoma and Diabetes: Is There a Connection? – Healthline

October 30th, 2020 11:55 am

Glaucoma is an eye condition that can cause damage to the optic nerve. This nerve is essential for your eye health. If it becomes damaged, it can cause permanent vision loss and, in some cases, it may even lead to blindness.

Glaucoma is typically caused by high pressure inside your eyes. However, diabetes can also be a risk factor for glaucoma.

In this article, well take a closer look at the link between diabetes and glaucoma, and the steps you can take to help protect your eye health.

Your eyes continuously produce a clear fluid known as the aqueous humor that fills the inside of your eye. New fluid constantly replaces the older fluid, which leaves your eye through a meshwork drainage field and channels.

If something obstructs this drainage mechanism, the natural pressure inside your eye known as your intraocular pressure (IOP) can increase. If your IOP increases too much, it can damage the fibers of your optic nerve.

As damage to this nerve progresses, you may begin losing sight in your eye, especially in your peripheral vision.

There are two primary types of glaucoma: open-angle and closed-angle.

According to a 2017 study, diabetes may raise your risk of open-angle glaucoma by approximately 36 percent. Closed-angle glaucoma does not seem to have a known connection with diabetes.

Diabetic retinopathy, which is a complication of diabetes and the most common form of diabetic eye disease, can increase your risk of glaucoma.

Diabetic retinopathy usually affects people who have had diabetes for a long time. The risk of this condition increases with:

With diabetic retinopathy, changes in your glucose levels can cause the blood vessels in your retina to weaken and become damaged. This can eventually lead to glaucoma.

The leading theory is that when the blood vessels in your retina become damaged, it can cause abnormal blood vessels to grow in your eye, known as neurovascular glaucoma. These blood vessels can block your eyes natural drainage system. When this happens, it can cause your eye pressure to increase, which can lead to glaucoma.

Another theory as to how diabetic retinopathy increases the risk of glaucoma points to high blood sugar as the direct cause. According to this theory, high blood sugar can cause an increase in a specific glycoprotein, called fibronectin, to form in your eye. Having more fibronectin in your eye may block your eyes natural drainage system, which can lead to glaucoma.

Glaucoma typically doesnt have any symptoms, especially in the early stages. Because glaucoma causes gradual changes in your vision, you might not notice any symptoms until its more advanced. If left untreated, glaucoma can lead to severe vision loss or blindness.

If you do have symptoms of glaucoma, the symptoms will vary depending on the type of glaucoma and how advanced the disease is.

Symptoms may include:

This type of glaucoma is a medical emergency and requires immediate treatment. Symptoms may include:

Symptoms may include:

Because glaucoma often doesnt have symptoms in the early stages, its important to get regular eye exams. This is especially important if you have any risk factors, including diabetes.

According to the Centers for Disease Control and Prevention (CDC), people with diabetes should get a dilated eye exam every year. Having your eyes dilated can help your eye doctor to more easily check for optic nerve damage or other issues.

During your eye exam, your doctor will also measure the pressure in your eyes. Depending on your risk, you might need other tests, such as checking for areas of vision loss, measuring the thickness of your cornea, and looking at the angle at which your eye drains fluid.

If you receive a glaucoma diagnosis, prescription eye drops are usually the first treatment option.

If the eye drops dont help reduce the pressure buildup in your eye, your doctor may suggest medication or surgery.

Surgery options for glaucoma include:

Depending on your diabetes management and other risk factors, you may be at a higher risk of developing other eye issues, too.

Short-term spikes in your blood sugar, which can happen when youre changing your treatment, can cause swelling or high fluid levels in your eye. This can cause temporary blurry vision. This will likely go away once your blood sugar stabilizes.

Long-term elevated blood sugar levels can damage the blood vessels in your eye and lead to conditions, such as:

If you have diabetes, its very important to protect your eye health, as well as your general health. To lower your risk of glaucoma and other eye issues with diabetes, be sure to:

Diabetes can increase your risk of several eye diseases, including glaucoma.

Diabetic retinopathy, which is a complication of diabetes, can result in damage to the blood vessels in your retina. This can cause abnormal blood vessels to grow in your eye, which can block your eyes natural drainage system and eventually lead to glaucoma.

Because glaucoma often has no symptoms, especially in the early stages, its important to get annual eye exams if you have diabetes.

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New Christchurch Art Gallery exhibition aims to include those with blindness or low vision – New Zealand Herald

October 30th, 2020 11:55 am

A new Christchurch art exhibition will give people with blindness or low vision the chance to experience the work with a number of pieces that you can 'touch' and 'feel'.

The Touching Sight exhibition showcases new work by three contemporary Christchurch artists.

"Each of the artists who've contributed to Touching Sight work in different mediums, and we've brought them together for a playful exhibition that celebrates different ways of making and seeing art," said art gallery curator Melanie Oliver.

Being unable to see doesn't need to be a barrier to appreciating visual art, the exhibition includes some works that people can touch and feel.

Photographer Conor Clarke (Ngi Tahu) has worked with participants from the blind and low vision community to make a series of large, touchable photographs that represent landscapes described as they remember them.

Emma Fitts has made brightly coloured, voluminous sculptural textiles, inspired by the form, colour and composition of twentieth-century paintings.

Oliver Perkins's paintings are the result of restless experimentation in the studio.

These works challenge our contemporary understanding of abstraction and how it can represent or reflect our experience.

"We have a reference room at the heart of Touching Sight that includes audio descriptions of each work. They don't describe things in the way a sighted person would, but in a way that would let someone with low vision understand and appreciate them.

"We've tried to talk about things like colour for someone who may never have actually seen one before how do you do that? We've brought in the other senses as much as we can, things like texture and feeling," Oliver said.

"And the title of the exhibition also comes into play, because some of the artworks have been specially crafted so that visitors can touch them and experience art in a way that people don't often get to."

Touching Sight runs from October 31 2020 to February 21 2021 at Christchurch Art Gallery.

There will also be an artist floortalk, where visitors can join the three artists and curator Melanie Oliver for a conversation about their projects.

Touching Sight is one of several exhibitions in the Gallery's All Art All Summer season, designed to make everyone feel welcome this summer.

The season will launch officially on 5 December 2020.

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New Christchurch Art Gallery exhibition aims to include those with blindness or low vision - New Zealand Herald

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Mass Eye and Ear Capital Campaign Concludes with $252 Million Raised to Advance Research and Patient Care – Newswise

October 30th, 2020 11:55 am

Newswise Mass Eye and Ear is proud to announce the successful conclusion of its historic campaign, Bold Science. Life-Changing Cures. which raised $252M from philanthropy to advance research to treat and cure diseases of vision, hearing, and the head and neck.

The campaign was led by co-chair Wyc Grousbeck, Boston Celtics CEO and Lead Owner and former Chairman of Mass Eye and Ear. Grousbeck was elected Chairman of the Foundation and Board of Directors of the Massachusetts Eye and Ear in 2010, and stepped down from the position earlier this year. He will continue to serve as a trustee and contribute to advancing Mass Eye and Ears mission, with a lasting legacy that includes two endowed chairs and a gene therapy research center he and his family established.

The campaigns finale culminated in a virtual celebration as part of the hospitals annual Sense-ation! Gala on Wednesday, October 28, 2020 at 7:30 PM EST. This years gala was held online due to the COVID-19 pandemic, and was hosted by longtime Mass Eye and Ear friends, Billy Costa, (Co-Host of KISS 108s Matty in the Morning and NESNs Dining Playbook) and founding gala chair Joey McIntrye (New Kids on the Block).

[Watch the entire 11th Annual Sense-ation Gala!]

Bold Science. Life-Changing Cures. Ends with Enduring Legacy

The Bold Science. Life-Changing Cures. campaign was launched with the goal of expediting cures for blindness, deafness and diseases of the head and neck by investing in three key areas: people, programs and places (our facilities). Through this campaign, the generosity of donors and organizations infused significant financial resources into Mass Eye and Ears cutting-edge research programs, and supported the facilities needed by the leading physicians and scientists in Ophthalmology and Otolaryngology-Head and Neck Surgery to conduct their world-class work.

The campaign resulted in a powerful and far-reaching impact on research at Mass Eye and Ear by faculty, including:

Additionally, new Research Centers were launched in gene therapy, tinnitus, and head and neck cancer and two world-class surgical training laboratories were built.

The campaign also will leave a lasting legacy of fourteen endowed Chairs for leading physicians and scientists that will remain for generations. The endowment of a Chair provides financial support for researchers, allowing them to focus on their efforts to develop treatments and cures.

Wyc Grousbeck Honored for Dedication to Mass Eye and Ear During 10 years as Chairman

Grousbeck, who served as Board Chairman at Mass Eye and Ear for the past decade, was honored at this years Sense-ation! Gala for his many contributions. During his tenure, he led the organization through remarkable growth, both clinically and as a world-renowned research center. Mass Eye and Ear surgical volume doubled and the number of clinical locations grew from 9 to 21 throughout the region. Grousbecks leadership played critical roles in two highly successful mergers: Schepens Eye Research Institute joining Mass Eye and Ear in 2012 and Mass Eye and Ear joining Mass General Brigham (formerly Partners HealthCare) in 2018. He also initiated and served as co-chair of the Bold Science. Life-Changing Cures. campaign.

Wycs leadership during the campaign has been nothing short of magnificent; he has showed us anything is possible, said John Fernandez, President of Mass Eye and Ear. When we first reached our $100M goal in the campaign, Wyc called on us to double that amount by 2020. With Wycs guidance, we were able to exceed that ambitious goal by more than $50M by the campaigns end.

Grousbeck first became involved with Mass Eye and Ear because his family has been touched by blindness, and since then, they have been devoted to research and educational initiatives relating to blindness and other vision-related conditions for many years.

Grousbeck and his familys philanthropic support established the Grousbeck Center for Gene Therapy at Mass Eye and Ear as well as the Grousbeck Family Chair in Gene Therapy, held by Luk H. Vandenberghe, PhD. Additionally, Wyc and his wife, Emilia Fazzalari, funded the Fazzalari-Grousbeck Chair in Otolaryngology-Head and Neck Surgery held by Tessa Hadlock, MD. Most recently, they seeded Dr. Vandenberghes work to develop an experimental and novel genetic vaccine for COVID-19.

Grousbeck was a driving force around establishing the first Sense-ation Gala 11 years ago, which brought celebrities, musicians, philanthropists, and scientists together to help raise funds for Mass Eye and Ear research and patient care. The gala to date has raised more than $12M for the Mass Eye and Ear Curing Kids Fund.

About Mass Eye and Ear

Massachusetts Eye and Ear, founded in 1824, is an international center for treatment and research and a teaching hospital of Harvard Medical School. A member ofMass General Brigham, Mass Eye and Ear specializes in ophthalmology (eye care) and otolaryngologyhead and neck surgery (ear, nose and throat care). Mass Eye and Ear clinicians provide care ranging from the routine to the very complex. Also home to the world's largest community of hearing and vision researchers, Mass Eye and Ear scientists are driven by a mission to discover the basic biology underlying conditions affecting the eyes, ears, nose, throat, head and neck and to develop new treatments and cures. In the 20202021 Best Hospitals Survey,U.S. News & World Reportranked Mass Eye and Ear #4 in the nation for eye care and #6 for ear, nose and throat care.For more information about life-changing care and research at Mass Eye and Ear, visit our blog,Focus, and follow us onInstagram,TwitterandFacebook.

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Mass Eye and Ear Capital Campaign Concludes with $252 Million Raised to Advance Research and Patient Care - Newswise

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Election Ballots Aren’t Accessible to People With Low Vision – The Mighty

October 30th, 2020 11:55 am

By Carmen Heredia Rodriguez, Kaiser Health News

Norma Crosby remembers when she relied on blind faith to cast her vote.

The 64-year-old Texan was born virtually without sight, a side effect of her mother catching rubella while pregnant with her. Friends and relatives stood beside her and filled out her ballot at polling precincts for more than half of her voting life. Then, accessible voting machines rolled out around the year 2000, enabling her to vote in person on her own.

Now, the COVID-19 pandemic makes going to the polls a risky proposition for Crosby. She also has a condition called sarcoidosis that requires her to take immunosuppressant drugs, she said. However, the state does not have a mail-in voting system that accommodates Crosbys visual impairment.

It communicates to me that Im not valued as much as other citizens, said Crosby, president of the National Federation of the Blind of Texas, that Im a second-class citizen.

A projected 7 million Americans who are eligible to vote in the presidential election live with visual impairments, according to researchers from Rutgers university. For those, like Crosby, who also deal with illnesses that place them at a higher risk of falling seriously ill with COVID-19, voting this year will be especially difficult.

The pandemic exposed glaring holes in absentee and mail-in voting systems around the nation. In some jurisdictions, voters who have whats known as print disabilities conditions that make it difficult to process printed content, such as blindness, low vision or learning or physical disabilities could not cast a ballot remotely without asking for help, thereby compromising their privacy.

Outcry and lawsuits from disability advocates prompted at least 11 states to update their mail-in and absentee ballot systems in an attempt to accommodate these voters. Some changes enable voters to use text-reading software with their ballots and submit them online through a secure portal.

However, some states have been slow to address these needs. In Iowa, voters cannot vote confidentially using the mail-in system because the state requires the use of paper ballots. Texas residents like Crosby must find someone to fill out their ballot and mail it in or take it to the sole drop box in the county all during a pandemic that has required people to physically distance themselves to stay safe.

We should not have to choose, said Chris Danielsen, director of public relations for the National Federation of the Blind, between endangering our health and going to the polls in person, or not voting at all.

Several federal laws affirm the right of all people, regardless of disability, to vote in an accessible manner. The Americans with Disabilities Act, passed in 1990, requires state and local governments to make the voting process user-friendly to voters of various abilities. This includes providing accessible parking spaces and placing voting machines where people using wheelchairs have enough space to move and at a height reachable by all.

In 2002, Congress passed the Help America Vote Act. The law built on the previous legislation by requiring every polling place to have at least one voting machine available during federal elections that accommodates a range of disabilities. These gadgets vary in features by manufacturer, but they can include touch screens, buttons labeled in Braille and audio capabilities. Voters using them must have the same privacy and independence enjoyed by people who dont have such challenges.

However, states largely retained the power to decide how to comply with these federal mandates, said Lisa Schur, co-director of the Program for Disability Research at Rutgers. The result, she said, is an uneven patchwork that voters with disabilities must navigate.

With COVID-19 creating a reason to avoid in-person voting, some states, such as Texas, still failed to take steps to make it possible for a voter with visual or print impairments to fill out a mail-in ballot without assistance. The state government is also embroiled in a lawsuit regarding its decision to limit ballot drop-off boxes to one per county.

Harris County, where Houston is located, covers more than 1,700 square miles and is home to 4.7 million people. The distance becomes an added hardship for voters who opted to vote remotely and would prefer to drop off their ballot to make sure it is counted.

The state declined to comment due to the pending litigation.

Iowa also has fallen short in making systemic changes to improve access, according to disability advocates. Like Texas, the state provides only paper ballots for voters wishing to vote absentee.

Scott Van Gorp, president of the National Federation of the Blind in Iowa, said he initially felt resigned to his lack of privacy when he started voting. He was born three months early, leaving him with little more than light perception for sight. As a college student in the 1990s, Van Gorp rallied his friends to help him cast his vote.

I kept thinking, Thats not a secret ballot. Why?

In a written statement, a spokesperson for the Iowa secretary of state said it has made efforts to even the field by creating a large-print voter registration form and how-to videos on using accessible voting machines at polling locations. It cannot unilaterally make a change to improve accessibility without legislative approval, he added.

Election officials in several other states, though, including the battlegrounds of Nevada, Pennsylvania and Michigan, adopted changes this year to their mail-in ballot systems to accommodate people with visual disabilities.

In Maine, voters with impairments can request, fill out and submit their votes electronically through a new online platform. The ballots are compatible with various types of screen-reader software and will be counted through the same system used for absentee and overseas military voters.

This option became available in early October after the state was notified of confidentiality issues with paper ballots and sued by disability advocates.

Kristen Muszynski, a spokesperson for Maines secretary of state office, said some of the plaintiffs named in the lawsuit helped test the system. Litigation is now on hold, she said, and she is hopeful the new voting option will help resolve some of the issues.

Were hopeful that the word is starting to get out, Muszynski said.

A few jurisdictions around the nation offer Braille ballots. However, said Douglas Kruse, co-director of the Program for Disability Research at Rutgers, voters may still need someone to help them fill one out and submit it. These ballots would also need to be counted separately, compromising the voters privacy.

One of the few states that have not needed to make drastic changes to accommodate voters with disabilities during the pandemic is Oregon, where mail-in ballots have been the primary form of voting for years.

Voters with disabilities can access and fill out ballots electronically using assistive technology like screen readers and sip-and-puff systems through which a person with limited mobility controls the device using their breath and a straw to vote. Then, the ballots must be mailed in.

Sean Carlson, 42, president of the Portland Central Chapter of the National Federation of the Blind, said he has never encountered issues while voting in his home state. He and his colleagues are focused on bringing awareness to the importance of having a say in our democracy, he said.

It should not be that if someone has a disability that they should be locked out of that process.

For now, Norma Crosby, who lives outside Houston, plans to vote in person, and she will need to bring a sighted friend to make sure she maintains social distance. After all, she cant see whether other people are wearing masks.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Is Trump the candidate of peace? – The Week Magazine

October 30th, 2020 11:55 am

There are cases for re-electing President Trump that make sense in their own terms. If your top priorities are tax cuts, immigration restriction, or conservative judges, for example, Trump has proven a remarkably reliable vehicle for achieving those ends. Other cases reflect a willful blindness to reality. Far from draining the swamp, for example, Trump has turned himself into the capital's premier swamp-dweller.

But most voters in the middle care about practical results, and from health care to infrastructure to trade, Trump's efforts have been largely feckless and incompetent. Even discounting the glaring failure of his response to COVID-19, an area where plenty of peer countries have not exactly covered themselves with glory, the administration has a very thin record of accomplishment to run on.

There's one area, though, where Trump can argue he has genuinely distinguished himself from prior administrations, Democratic and Republican, in a way that should matter deeply to the American people. Trump ran in both the primaries and the general election as the man who would keep America out of unnecessary wars and who would end the ones we were in. He hasn't ended any of our wars yet, but Trump is in fact the first president since Jimmy Carter not to have sent American troops into a new conflict.

So it's at least worth hearing out the idea: Is Trump the peace candidate?

The claim, made most prominently by Modern Age editor and The Week contributor Daniel McCarthy, rests on three arguments. First, as noted, Trump did not involve America in any new conflicts. For a normal nation, this would not be an extraordinary accomplishment but for America, it might be. Military intervention has long-since become a way of life in American foreign policy. Even Barack Obama, who was elected on a promise not to get involved in "stupid wars," was convinced to intervene in Libya, with catastrophic results, and it was only at the last moment that he pulled back from a comparable effort in Syria. By contrast, Trump, while he appointed super-hawks like Mike Pompeo and John Bolton to be his advisors, declined to be talked into war with Iran. Shouldn't he get credit for that?

Second, while Trump is the last person anyone would call diplomatic, he has been a promiscuous globe-trotter in search of peace deals. He long advocated a rapprochement with Russia, initiated personal diplomacy with North Korea for the first time at the presidential level, and, most notably, facilitated peace agreements between Israel and three Arab states the United Arab Emirates, Bahrain, and Sudan with the potential for more to come. If this is not the record of a peace-maker, what is it?

The third argument is the most important, because it speaks to overall philosophy, not generally considered this president's strong point. But if Trump has a theory of the world, it is that you should make deals that benefit yourself. Applied to foreign policy, this suggests the goal of American foreign policy should not be to improve other countries or to advance some values we hold dear, but to get the best possible deals for America. So if, for example, we can woo North Korea away from confrontation (and out of a pro-Chinese alignment) by soft-pedaling concerns about human rights or missile development, why not do it?

Is that peace? If so, Trump has a case. But I don't think it's peace.

For one thing, while it's true that Trump did not start a war with Iran, he did take a high-risk gamble in assassinating terrorist mastermind General Qassem Soleimani, and the fact that the gamble has so far paid off doesn't invalidate how risky it was at the time, nor the fact that, in that instance, he did listen to his extremely hawkish advisors. Moreover, Trump pulled out of the nuclear deal that was one of Obama's notable accomplishments, which has, predictably, led Iran to move further toward nuclear potential while shredding any American diplomatic leverage. While Trump has not started any new wars, one of his first acts was to dramatically escalate America's involvement in Saudi Arabia's near-genocidal war in Yemen, a war so unpopular that he had to veto a bi-partisan war-powers resolution to keep fighting. Meanwhile, from North Korea to China to Venezuela, Trump has been as promiscuous with his threats as he has been with his praise of foreign dictators. If he has rarely backed those threats up with military action, that is not a sign of a dove but of a paper tiger.

As for diplomacy, while Trump has claimed to want better relations with Russia, it's hard to discern any actual improvement there. Instead, America has torn up arms agreements with Russia in the hopes of adding China to them, a gambit which failed, leaving the future of New Start in serious question. The same can be said about North Korea, where Trump's bold diplomatic opening has led nowhere. Chalk these failures up to conflict between Trump and his subordinates, or to Russian and North Korean determination to pursue their own interests, or what have you regardless, a stated eagerness for better relations is not the same thing as achieving them, and the achievement is what's lacking.

The only area where Trump can legitimately point to peacemaking is between Israel and some of its erstwhile adversaries. But it's important to understand what underwrites this peace. In the case of the Gulf States, it was mutual fear of Iran stoked by Obama's nuclear deal that led to a behind-the-scenes working relationship with Israel. And what made it possible to bring that relationship into the open is the weakness of the Palestinian position, and their consequent inability to shape events in the Arab world. Trump surely revealed that weakness by moving the American embassy to Jerusalem, so the world could see that nothing much happened in consequence. If he contributed beyond this, it was by being prepared to ask less than most American presidents would of either party, and to offer more. How is that "America First?"

Which leads me to my largest objection to the characterization of Trump as the peace candidate. It's not just that Trump hasn't actually reduced America's military commitments, or ended any of our ongoing conflicts, or improved American relations with any other powers. It's not just that his idea of a good deal is one that benefits America's defense contractors while leaving us more beholden to allies who can offer us little in exchange for our support. It's that the conception of peace implied by this characterization is too thin to deserve the term. Peace is not merely the absence of current conflict. It is the establishment of relations with other powers on a basis that makes conflict less likely over the long term.

That is an idea that strikes me as entirely beyond President Trump's comprehension, convinced as he is that life is a constant zero-sum struggle for dominance. Of course, that's one way to characterize international relations as well perhaps the most realistic one in our fallen world. But it's one that declares "peace" an impossibility, the only hope being either global hegemony, or a dynamic balancing between different powers punctuated by conflict. If the former is no longer realistic (and I agree it's not), then America needs more than ever a shrewd, knowledgeable statesman at the helm, capable of discerning where our true interests lie and maneuvering to advance them as peacefully and cooperatively as possible. A statesman who will only threaten when necessary, but whose threats are always taken seriously.

If that sounds like Trump to you, then I've got a heck of a deal on a swamp to sell you.

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Is Trump the candidate of peace? - The Week Magazine

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Common Treatment for Diabetic Macular Edema Not Effective in Black Individuals – InvisionMag

October 30th, 2020 11:55 am

(PRESS RELEASE) BOSOTON A medication frequently used to treat diabetic macular edema, which is the most common cause of blindness in people with diabetes, is less effective when used to treat the condition in Black patients, new study results show. Led by researchers at Boston Medical Center, the study demonstrated that Black patients were significantly less likely than white patients to show short-term visual improvement after both a single injection and a series of three injections with the drug bevacizumab (Avastin), the most common treatment in the U.S. for diabetic macular edema. Published in the American Journal of Ophthalmology, the results underscore the need to increase diversity in participation in clinical trials for the treatment of diabetic macular edema in order to develop treatments that are effective for all patients.

This is the first study looking at race as a factor in the treatment of diabetic macular edema, a condition that results from fluid build-up around the macula, producing blurry and distorted vision. Diabetic macular edema is caused by diabetic retinopathy, a complication of diabetes that is the leading cause of blindness among working-age adults in the U.S. Of the approximately 7.7 million Americans who have diabetic retinopathy, it is estimated that 775,000 of those individuals also have diabetic macular edema, which is the leading cause of vision loss for those with diabetes.

The three medications that are most commonly used to treat diabetic macular edema aflibercept, bevacizumab, and ranibizumab were initially developed to treat age related macular degeneration (AMD), which is the number one cause of blindness in older patients and a condition that primarily affects white individuals. After these medications were found to be effective for AMD, they were then studied for the treatment of diabetic eye disease, which disproportionately affects Black patients.

The results from our study show a gap in treatment for Black individuals with diabetic macular edema, despite the fact that they are more heavily impacted by this disease, said Manju Subramanian, MD, an ophthalmologic surgeon at Boston Medical Center and the studys senior and corresponding author. When clinical research trials dont include enough diversity, it will not provide comprehensive data about the efficacy across different racial and ethnic groups, which as we can see, results in disparities in care.

For this study, the researchers focused on bevacizumab (Avastin), given that it is a first-line treatment for diabetic macular edema. They used data from electronic medical records of patients treated for the condition at Boston Medical Center 314 received one injection of the medication, and 151 received the series of three injections of the same medication. After the first injection, 26.71 percent of Black patients compared to 39.39 percent of Hispanic and 50 percent of White patients experienced improved visual acuity. For those who received three injections, 33.82 percent of Black patients compared to 54.76 percent of Hispanic patients and 58.54 percent of white patients experienced improvements in their visual acuity.

According to the U. S. Department of Health and Human Services Office of Minority Health, African American and Black adults are 60 percent more likely to have been diagnosed with diabetes than white, non-Hispanic adults. Evidence points to a variety of factors that play a role in the increased diabetes incidence in Black Americans, including biological risk factors, lower access to health care, and socioeconomic status.

Black individuals represent 13.4 percent of the US population but carry at least twice the prevalence of diabetic macular edema compared to white individuals, and should be represented in future research accordingly, said Subramanian, also an associate professor of ophthalmology at Boston University School of Medicine.

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Americans in the Dark on Diabetic Retinopathy Symptoms, Risks, Survey Finds – Newswise

October 30th, 2020 11:55 am

Newswise CHICAGO (October 29, 2020) Diabetic retinopathy is the leading cause of blindness among working-age adults, yet most Americans over 40 dont know its symptoms or the risk factors for this common sight-threatening condition, according to a survey commissioned by the American Society of Retina Specialists (ASRS).

The condition affects nearly 8 million Americans, and that number is expected to double by 2050, but adults over 40 lack fundamental knowledge about diabetic retinopathy that could help save their sight. In fact, the survey found fewer than half of those polled (47%) knew that blurry central vision can be a symptom of diabetic retinopathy and only 37% identified seeing spots or floaters as a known symptom.

While most know that having Type 1, Type 2, or gestational diabetes puts patients at risk of diabetic retinopathy, other risk factors fly under the publics radar. Of those polled, nearly two-thirds (64%) did not know that elevated cholesterol increases the risk of diabetic retinopathy, and nearly half (48%) did not identify high blood pressure as a contributing risk factor.

During Novembers Diabetic Eye Disease Awareness Month, Americas retina specialists urge the public to protect their vision by learning the facts about diabetic retinopathy and adopting healthy habits to preserve healthy sight.

Diabetic retinopathy is a preventable cause of blindness, so early identification and treatment is critical, said ASRS president Carl C. Awh, MD. All health care providers who care for diabetic patients should emphasize the importance of controlling known risk factors and the need for regular dilated retina examinations to identify diabetic retinopathy at an early stage. Many patients with sight-threatening diabetic retinopathy have excellent vision and no symptoms, which is the ideal time for a retina specialist to begin treatment. Diabetic patients with vision loss or symptoms should be evaluated more urgently.

Erik Elliott knows all too well how diabetic retinopathy can steal sight. The 39-year-old father of three was diagnosed with diabetes at age two. Over the years, he made his vision a priority, seeing a retina specialist for regular dilated retina exams since he was a teen. Even still, poor control of his blood sugar over time led to symptoms such as floaters and resulted in severe bleeding in his eye called a vitreous hemorrhage.

He lost significant vision in his right eye and had difficulty reading, driving, and working. He also couldnt help coach his sons baseball team as he struggled with his sight.

Thankfully, Erik contacted his retina specialist immediately when the symptoms occurred, and his vision was restored through surgery and ongoing management of his condition. For Erik, losing vision, even temporarily, has reinforced how critical it is to manage his diabetes and care for his sight to avoid future vision loss.

The ASRS encourages the public to take the following steps to safeguard their sight:

Know the risk factors Anyone who has diabetesincluding Type 1, Type 2, and gestational diabetesis at risk of developing diabetic retinopathy. Additional factors that can increase the risk include:

Know the symptoms Many people have diabetic retinopathy for a long time without symptoms. By the time symptoms occur, substantial damage may have occurred. Symptoms may include:

Protect your vision through prevention Retina specialists encourage those at risk for diabetic retinopathy to actively manage their health and protect their vision by:

Advances in early detection and treatment of diabetic eye disease made possible by retina specialists can preserve sight and virtually eliminate vision loss, said ASRS Foundation President Timothy G. Murray, MD, MBA. If you have diabetes and experience issues with your sight, partner with a retina specialist for expert care that can prevent, treat or reverse damage to the retina from diabetes.

For more information about diabetic retinopathy, visit asrs.org/DiabeticRetinopathy, and tune into ASRSs Retina Health for Life podcast for new episodes on the condition at asrs.org/RetinaPodcast. To find your retina specialist, visit asrs.org/FindYourRetinaSpecialist.

The ASRS survey was conducted by Wakefield Research among 1,000 nationally representative U.S. adults ages 40 and older, between July 20 and July 27, 2020, using an email invitation and an online survey.The data was weighted to ensure an accurate representation of adults ages 40 and older.

###

About ASRS

The American Society of Retina Specialists (ASRS)is the largest retinal organization in the world, representing more than 3,000 members in all 50 states, theDistrict of Columbia,Puerto Rico, and 63 countries. Retina specialists are board-certified ophthalmologists who have completed fellowship training in the medical and surgical treatment of retinal diseases. The mission of the ASRS is to provide a collegial and open forum for education, to advance the understanding and treatment of vitreoretinal diseases, and to enhance the ability of its members to provide the highest quality of patient care. Learn more atASRS.org. Like ASRS on Facebook, subscribe to our YouTube channel, and follow us on Twitter for the latest retina health information.

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Black History Month: Why would we want to be colour blind when it comes to race? – The Lawyer

October 30th, 2020 11:55 am

Being colour blind in the context of race, or anywhere else, is not something I would choose.

Colour vision deficiency to give it its medical name means that people find it hard to tell the difference between certain colours. In its most common red-green form, this means that oranges, yellows, browns, reds and greens appear duller than they would to someone with normal vision; red is easily confused with black, purple becomes hard to distinguish.

Think about what that means for peoples experiences of life. Simple activities throw up challenges: picking out which clothes to wear, telling the difference between a ripe or unripe tomato, knowing whether meat is cooked through, identifying traffic light colours and making sense of devices with red/green/orange LED displays.

Think about school for children with colour blindness (often undiagnosed in the early years) where colours are used for learning; or encouraging a child to eat green vegetables when they all look brown. In more severe cases, certain career choices becoming a pilot, electrician or train driver, for example are harder, too.

Around three million people mostly men and boys live with some form of colour blindness in Britain. The majority of people are born with it and usually there is no treatment people just have to find ways to adapt to the condition. Colour blindness impacts arguably our most important sense sight. It limits what we see in the colours of nature and the world around us.

So why would we want to be colour blind when it comes to race?

When I hear people claim not to see a persons colour, I question how that can be true. And then I question why someone would make that claim.

It might seem like a progressive, liberal view one that exists a world where weve moved beyond the debate about race, where people just see people. But we dont live in that world I know that from seeing the experiences of my wife and my four mixed-race children growing up.

Instead, claiming to be colour blind shuts down the discussion. It silences people of colour from articulating their experiences and provides a shortcut to avoid a conversation that many people still find uncomfortable.

Far from being a positive, supportive sentiment, it reveals the (conscious or subconscious) prejudices that make people not want to talk about race in the first place. As a consequence, it blocks attempts to build a better understanding of race and ethnicity, which is the first step in tackling the systemic inequalities that persist in our profession and many others like it.

In journalist Reni Eddo-Lodges words: Not seeing race does little to deconstruct racist structures or materially improve the conditions which people of colour are subject to daily.

When you think about it, it really says to a person of colour that its not ok to be different its not ok to take pride in being black. That essentially implies a need for assimilation.

In the context of Black History Month, it must also mean that we cant celebrate the huge amount of black British culture around us. Do we really want to live in a society where we dont appreciate the heritage and influences in the art, music, film, theatre, writing everything that people of colour contribute to Britain because we dont acknowledge different races and ethnicities? Our heritage is surely a hugely important part of all of us.

I know some people dismiss these arguments as another example of political correctness. But look at the anti-racism demonstrations that have spread across the country this year, listen to peoples real experiences and fears and it becomes clear, I hope, that this is not about wokeness or cancel culture. It is about understanding those different experiences and treating people with humanity and respect.

Black History Month is also, of course, about history understanding the story of race in Britain, both in the distant and recent past. Large chunks of this, as historian David Olusoga writes, have been wilfully forgotten. Most of us know about the civil rights movement in America we know about Martin Luther King Jr and Rosa Parks but we dont know about black British history. This creates a sense that we dont have the same problem with racism here and therefore should stop talking about it. But we cant move forwards unless we understand the past.

So while there is no cure for the medical condition that causes people to see the world with less colour, when it comes to race we have a choice. Each of us as individuals can choose to ignore colour to avoid conversations and stifle understanding or we can choose both to see and celebrate our differences. In my experience, it is seeing and listening that drives us to act.

Paul Flanagan is a partner with Allen & Overy and co-chair of the firms Race and Ethnicity network in London.

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Thatcham campaign launched for 4-year-old with ultra-rare Batten’s Disease – Newbury Weekly News Group

October 30th, 2020 11:55 am

A THATCHAM woman has launched a campaign with local traders to wrap support around a little girl diagnosed with an ultra-rare condition.

Nicole Gallaugher is asking people to buy a bow for Addy Clarke a unicorn-loving, smiley, laughy girl with Battens Disease.

Addy, aged four, was diagnosed with the incredibly rare genetic disease that causes dementia, immobility, blindness and early death, a month ago.

There is currently no cure for the disease, which affects roughly 100 children in the world, but a procedure may preserve Addys sight, which Great Ormond Street say could be lost before she turns seven.

Addy is Mrs Gallaughers best friends daughter.

Her parents Hayley and Dave Clarke used to live in Thatcham and were church workers for Glendale Church, but now live in Swindon.

Addy now needs enzyme injections every two weeks for the rest of her life, which may only be another four to six years.

Great Ormond Street could offer the treatment to Addy, as well as the nine other families in the UK facing a Battens CLN2 diagnosis.

Mrs Gallaugher has started a campaign called Bows for Battens, trying to raise 80,000 for the treatment that could preserve Addys eyesight.

She said: Eyesight is particularly important because when Addy is not able to communicate in any other way with her parents any more, its still an important method of communication.

Its not just blindness, its blindness in conjunction with other losses.

Hayley has been my best friend since we were little kids. We have kind of done everything together.

Now we are taking a totally new journey.

Mrs Clarke said: The bows are such a powerful visual symbol of love for our little Addy.

It is a thrill to see cars with bows on knowing that as they go on their journey, they are journeying with us.

It means so very much.

Mrs Gallaugher has teamed up with Best Buds Florist in Thatcham Broadway to kickstart the campaign and is asking people to put a bow on their car bumper as a show of support.

She said: The bows are 5 each; a steep price for a bit of ribbon, a small price for a childs eyesight.

Sweet Imagination in the Kingsland Centre, SA Zim and The White Hart in Thatcham High Street and the Ugly Duckling in Newbury are also selling the ribbons.

One hundred have been made and 30 sold so far, raising more than 500.

Owner of Best Buds Amanda Smith said she felt compelled to help as soon as she heard Addys story.

She said: Being a mum and a nana, you just dontwant to think of any child suffering.

Every spare minute Im making bows.

You just have to try and do your best dont you?

Mrs Gallaugher urged people to back the campaign by either buying a bow from Best Buds Florist or messaging her on Facebook, offering to make bows, or, if shops were able to sell bows on their premises, get in touch.

All money raised will be paid into http://www.justgiving.com/fundraising/nicole-gallaugher

A separate account to support the family has raised more than 56,000 and donations can be made athttps://uk.gofundme.com/f/support-for-addy-and-her-family

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Global Proliferative Diabetic Retinopathy Market: Emerging Trends, Business Growth Opportunities, Major Driving Factors – The Think Curiouser

October 30th, 2020 11:55 am

Proliferative diabetic retinopathy prevails as leading cause of blindness across industrialized countries worldwide. Although remarkable advancements have been made in the diagnosis and treatment of the disease, several imperative management questions as well as treatment deficiencies continue to persist unanswered. The diabetic pandemic has threatened overwhelming resources and increasing incidences of blindness, which in turn has necessitated the development of actionable programs for diagnosis and treatment of the disease as well as the diseases caused as a consequence of diabetes such as proliferative diabetic retinopathy.

The global proliferative diabetic retinopathy market has been thoroughly analyzed in the latest research report developed by Transparency Market Research, which issues in-depth insights on prominent factors impacting growth of the market. Growth prospects offered in the report are assessed for the period between 2017 and 2026, and the historical analysis on the market has been delivered for the period between 2012 and 2016.

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Global Proliferative Diabetic Retinopathy Market Witness Most Promising Rise in Demand:

As a consequence of the pandemic of type 2 diabetes, an outbreak of several diabetic complications, particularly diabetic retinopathy is foreseen by several healthcare institutions and pharmaceutical companies across the globe. Among complications of diabetic retinopathy, proliferative diabetic retinopathy has witnessed a relatively more significant surge worldwide. For example, roughly 1.5% adults suffering from diabetes were affected from proliferative diabetic retinopathy in the U.S. in the recent past.

A recently composed research report of Transparency Market Research has envisaged the global market for proliferative diabetic retinopathy to register a high single-digit CAGR through the forecast period (2017-2026). Revenues from treatment of proliferative diabetic retinopathy around the world are poised to reach roughly US$ 1,000 Mn by 2026-end.

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The rise in disposable income of consumers, coupled with concerns regarding vision loss has rubbed off on spending by patients for availing necessary treatment of diabetic retinopathy. Availability of advanced technology & minimally invasive laser technique that complements faster recovery time is likely to encourage willingness of patients affected from proliferative diabetic retinopathy in adopting surgical treatments.

Key Players of Global Proliferative Diabetic Retinopathy Market:

Key companies significantly contributing to growth of the global proliferative diabetic retinopathy market include Intas Pharmaceuticals Limited, Santen Pharmaceutical Co., Ltd., Valeant Pharmaceuticals International, Inc., Allergan Plc, Regeneron Pharmaceuticals, Inc., Merck KGaA, Cipla, Ltd., Genentech, Inc. (Roche Holdings), Novartis AG, and Pfizer, Inc.

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ISET test results show substantial improvement in early detection of prostate cancer by identifying PSA-positive Circulating Tumor Cells – WFMZ…

October 29th, 2020 11:00 pm

PARIS, Oct. 28, 2020 /PRNewswire/ -- Rarecells, Inc. (USA), a leading Liquid Biopsy company, is pleased to announce thatNational Institute of Integrative Medicine's (Melbourne, Australia) researchers obtained striking results in a group of Australian men using the ISET test for early prostate cancer diagnosis through the detection of Prostate-Specific Antigen (PSA)positive Circulating Tumor Cells (CTC).

The peer-reviewed article published in the journalFrontiers in Oncology (article), shows that the prostate cancer test based on CTC harvested with the ISET technology and identified by the Immuno-Cytochemistry (ICC) PSA marker has an estimated positive-predictive-value (PPV) of 99% and negative-predictive-value (NPV) of 97%, providing a more reliable screening test for prostate cancer than the standard PSA blood test (PPV = 25%; NPV = 15.5%).

Prostate cancer is the second most common cancer and the fifth leading cause of cancer deaths in men worldwide. Due to the limited sensitivity and specificity of the standard PSA test, a relevant proportion, close to 75%, of unnecessary prostate biopsies are performed every year, generating avoidable costs and suffering.

"This new non-invasive test based on ISET technology allows for early detection of prostate cancer more accurately than the standard PSA test. Improving the accuracy of tests for early cancer detection may reduce the burden of unnecessary biopsies," said NIIM Director of Research, and Chief Investigator Associate Professor Karin Ried.

Davide Brechot, Deputy Director and CTO at Rarecells commented: "NIIM's preliminary data obtained with the ISET technology opens the way to a more reliable prostate cancer screening test driving earlier curative interventions while reducing unnecessary, painful and costly prostate biopsies.They add to the body of published evidence of ISET technology's excellence in cancer diagnostics and management"

ISET has been validated by more than 85 independent scientific publications on 3,400 cancer patients and more than 1,200 cancer-free individuals (see http://www.rarecells.com). It demonstrates unparalleled performance for the isolation and characterization of individual CTC and CTC clusters.

About RARECELLS (www.rarecells.com)

Rarecells develops high value, innovative diagnostic tests in the fields of liquid biopsy and early cancer diagnostics. The company is the exclusive licensee of the ISET patent portfolios owned by University of Paris, INSERM and Assistance Publique-Hpitaux de Paris (AP-HP).

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The best anti-inflammatory diets – Harvard Health – Harvard Health

October 29th, 2020 11:00 pm

When it comes to fighting inflammation with diet, following a specific program is not a necessity. In fact, many of the so-called anti-inflammatory diets are more hype than real science. That said, a couple of diets round up all the anti-inflammatory elements into one eating plan and have more evidence of benefit than other diets. If you aren't sure where to start, these diets are good choices.

People who live in countries ringing the Mediterranean Sea, like Italy and Greece, have traditionally eaten a diet consisting mainly of fruits and vegetables, nuts and seeds, whole grains, fish, and olive oil the same foods that experts recommend to bring down inflammation. Over the years, researchers began to discover that people who followed this style of eating had lower rates of disease and lived longer than people in the United States who ate a Western-style diet.

The Mediterranean diet is ranked high among doctors and dietitians, and for good reason. Studies show it protects against diseases linked to inflammation, including cardiovascular disease, metabolic syndrome, and type 2 diabetes. And, because it includes a variety of foods, the Mediterranean diet is relatively easy to follow and stick with.

Although its name may suggest the "grab-and-go" section of the supermarket, DASH is anything but a fast-food regimen. DASH stands for Dietary Approaches to Stop Hypertension. It was originally developed to lower blood pressure without medication, but is now widely considered to be one of the healthiest eating patterns around. It includes foods low in total fat, saturated fat, and cholesterol, and lots of fruits, vegetables, and whole grains. Protein is supplied by low-fat dairy, fish, poultry, and nuts. Red meat, sweets, and sugary drinks are limited. DASH is high in fiber, potassium, calcium, and magnesium and low in sodium.

Another anti-inflammatory diet with science to back it up comes from Harvard-educated integrative medicine practitioner Dr. Andrew Weil. He started talking up anti-inflammatory measures decades ago, long before the idea began trending. His anti-inflammatory diet could be described as a Mediterranean diet with Asian influences. About 40% to 50% of calories come from carbohydrates, 30% from fat, and 20% to 30% from protein.

Where Dr. Weil's diet wins is in its emphasis on plant-based foods and healthy protein sources, as well as specific elements (fatty fish, fruits, vegetables, oils, nuts, and seeds) that help to reduce inflammation. It also minimizes highly processed foods, which can contribute to inflammation.

For additional advice about ways to reduce inflammation, read Fighting Inflammation, Special Health Report from Harvard Medical School.

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Disclaimer:As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

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