Month: March 2021

Gustavo Aguirre and William Beltran, veterinary ophthalmologists and vision scientists at the University of Pennsylvania School of Veterinary Medicine, have studied a wide range of different retinal blinding disorders. But the one caused by mutations in the NPHP5 gene, leading to a form of Leber congenital amaurosis (LCA), is one of the most severe. Children
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VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19. Upon further statistical analysis of the critically
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vadadustat Treatment for Anemia Associated with Chronic Renal Failure Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ – Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of
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DUBLIN, March 30, 2021 /PRNewswire/ – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication
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March 24, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 24, 2021 — FDA Safety Communication Purpose: To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to include a new warning about the risk for Guillain-Barré Syndrome (GBS)
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In this article MRNA A nurse draws a Moderna coronavirus disease (COVID-19) vaccine, at East Valley Community Health Center in La Puente, California, March 5, 2021. Lucy Nicholson | Reuters The National Institutes of Health has started testing a new coronavirus vaccine from Moderna designed to protect against a problematic variant first found in South
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One of the ways we support and encourage our staff at the cancer center is to periodically offer a “blessing of the hands”. We have also offered a “blessing of the hands” to our caregivers. This is a time where we give thanks for the work and care of the hands that provide and tend to
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Stephen Manderson, aka Professor Green, is on a mission to help people improve their gut health, and being honest about what’s happening inside is a good place to start Stephen Manderson is a man on a mission. He wants more people to talk. Specifically, he wants them to talk about gut health, bowel movements and
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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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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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Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of
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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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Monoclonal antibody bamlanivimab appeared to work for end-stage renal disease (ESRD) patients in early data from dialysis providers, but there are plenty of questions that remain. The first 40 dialysis patients who got the antibody treatment at U.S. Renal Care clinics had a 7-day hospitalization rate of 15% compared with 57% among a randomly sampled
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Jon Holley is a trauma and orthopaedic surgeon and co-founder of TEDxNHS – a place for empowering talks for the NHS, by the NHS *Trigger warning: Themes around a baby’s death. My beautiful son Theo died seven years ago. Five weeks into his short life, the magical delight and abundant possibility of the night he
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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. TALLAHASSEE, Fla. (AP) — Florida Gov. Ron DeSantis said Monday that he would issue an executive order forbidding local governments and businesses from requiring so-called “vaccine passports” to show proof that customers have been inoculated against the coronavirus. He made the
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