Month: March 2021

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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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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Too often, contends UMass Lowell faculty researcher Brenna Morse, children with complex chronic medical conditions spend days in the hospital undergoing tests for what could be a simple diagnosis. The challenges include, she says, some children with medical complexities, such as severe neurological conditions and functional impairments, cannot easily signal that they are in pain
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Cancer diagnoses at advanced stages became a serious problem during the COVID-19 pandemic and it hasn’t abated yet, according to a survey of oncology specialists. Two-thirds of radiation oncologists said new patients more often have advanced-stage disease at their initial clinic visit as compared with prior years. Consistent with data from multiple other sources, three-fourths
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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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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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For people with diabetes, eating habits need to be strictly monitored or they risk experiencing damaging and even fatal health effects. High sugar foods in particular, are very risky for diabetics. So, is honey good for diabetics? Mismanagement of diabetes can be fatal Diabetes is a disease where your body is unable to regulate 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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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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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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Actress Portia de Rossi was hospitalized in March with severe abdominal pain. The “Arrested Development” star underwent emergency surgery for appendicitis. According to her wife, Ellen DeGeneres, Portia said she wasn’t feeling well and went to bed at about 7:30 p.m. Sometime later, as Ellen related, she woke up abruptly, saying: “I look over and
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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. 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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