Month: March 2021

Two drugs, a dietary supplement, and some devices have been recalled for mislabeled dosages, hidden ingredients, possible injuries and more. The recalled items span uses for high blood pressure, herpes infections, sexual enhancement, pre-surgical swabs and children’s cardiac surgery The first recall is for telmisartan, brand name Micardis, which is used to control high blood
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Intravitreal injections with aflibercept (Eylea) don’t improve the visual acuity of people with nonproliferative diabetic retinopathy (NPDR), researchers say. The treatments do reduce the risk for center-involved diabetic macular edema and proliferative diabetic retinopathy, however, said Adam R. Glassman, MS, principal investigator of the DRCR Retina Network Coordinating Center, Tampa, Florida. “Some clinicians may decide
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HOUSTON, March 30, 2021 /PRNewswire/ – Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its request for Fast Track Designation for its drug, Annamycin, for
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maralixibat Treatment for Cholestatic Pruritus in Patients with Alagille Syndrome Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome FOSTER CITY, Calif.–(BUSINESS WIRE)–Mar. 29, 2021– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced today that its New Drug Application (NDA) for maralixibat, an oral apical sodium dependent bile acid transporter (ASBT)
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TOKYO, March 26, 2021 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules
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News FDA Alerts Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil March 26, 2021 Audience: Consumer March 26, 2021 — Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA
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Mirimus lab scientists preparing to test COVID-19 samples from recovered patients on April 8, 2020 in Brooklyn, New York. Misha Friedman | Getty Images A type of T-cell responsible for destroying cells infected with virus was able to recognize three Covid-19 variants in a small U.S. study, a promising sign that the vaccines should still
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About 61% of Americans have had at least one Adverse Childhood Experience (ACE), experts’ formal term for a traumatic childhood event. ACEs–which may include abuse, neglect and severe household dysfunction–often lead to psychological and social struggles that reach into adulthood, making ACEs a major public health challenge. But the long-term consequences of ACEs are just
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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Two-thirds of epidemiologists from leading academic institutions say the world will need new or modified vaccines for COVID-19 within a year, new research show.. In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted the
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Prophylactic anti-VEGF therapy with aflibercept (Eylea) slowed the progression of diabetic eye disease but did not preserve visual acuity any better than deferred treatment, a randomized trial showed. After 2 years of follow-up, patients randomized to aflibercept had a 16.3% probability of developing center-involved diabetic macular edema (CI-DME) with vision loss or proliferative diabetic retinopathy
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Since the early days of Donald Trump’s campaign, mental health professionals have come forth in unprecedented ways to warn against entrusting the U.S. presidency to someone whose mental fitness for the Oval Office was more than suspect.  In early 2017, I organized an ethics conference at Yale School of Medicine to clarify our public health duty,
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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Obesity rates among children jumped substantially in the first months of the COVID-19 pandemic, according to a study published online in Pediatrics. Experts worry the excess weight will be a continuing problem for these children. “Across the board in the span
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In their clinical trials, the Pfizer and Moderna vaccines did okay, well enough for the FDA to grant emergency use authorization. But in a real-world study, where participants were all on the front lines fighting Covid, the vaccines proved 90% effective against the virus – not just the symptomatic disease. In the clinical studies, Pfizer
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A team led by scientists at the UNC School of Medicine discovered an important vulnerability of the AIDS-causing retrovirus HIV, and has shown in preclinical experiments that a widely used diabetes drug, metformin, seems able to exploit this vulnerability. The scientists, whose study is published in Nature Immunology, found that HIV, when it infects immune
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March 25, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 25, 2021 — Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials. Administration of crystalized Acyclovir Sodium Injection, 50
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President Joe Biden delivers remarks on Covid-19 response and vaccinations in the South Court Auditorium of the White House in Washington DC, on March 29, 2021. Jim Watson | AFP | Getty Images President Joe Biden on Monday urged governors and local leaders who dropped sweeping mask mandates to reinstate their orders, indicated some states
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Leigh syndrome is the most severe mitochondrial disease in children. It causes severe muscle weakness, movement defects, and intellectual disabilities. It usually leads to death within the first years of life. No causative treatment is currently available. One of the genes frequently mutated in patients is SURF1, which encodes for a protein involved in the
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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center. As the virus that causes COVID-19 continues to evolve, drugmakers are racing to adapt their vaccines to the changes in the virus’ genetic code that appear to help it escape our immune defenses. Of the three “variants of concern” recognized by
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The US Food and Drug Administration (FDA) has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System to treat severe pulmonary regurgitation in pediatric and adult patients who have a native or surgically repaired right ventricular outflow tract (RVOT). The Harmony TPV is the first nonsurgical heart valve to treat severe pulmonary valve regurgitation, which is
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PRINCETON, N.J.–(BUSINESS WIRE) March 25, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free
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FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE) March 26, 2021 — Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel;
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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, testifies during a Senate Health, Education, Labor and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021 in Washington, DC. Susan Walsh | Pool | Getty Images The latest rise in new Covid-19 infections can’t be
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Child development can be vastly improved by providing pregnant women and caregivers of children with an integrated intervention that consists of improved water, sanitation, hygiene (WASH), nutrition, mental health care and lead exposure prevention, says a study conducted in Bangladesh. Published this March in BMJ Global Health, the study noted that children in low- and
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