Drugs

June 11, 2021 Audience:  Patient, Health Professional, Pharmacy  Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits.
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The partnership will focus on a portfolio of NK-based cell therapeutics, using San Diego, California-headquartered Shoreline’s iPSC-derived NK cell tech. Shoreline will receive an upfront cash payment of $45m from BeiGene with the potential for additional development, regulatory and commercial milestone payments. Shoreline’s proprietary platform focuses on iPSC-derived natural killer (NK) cells and macrophages that
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Those efforts are reflected in a newly revised INN application form for cell therapy substances, which was officially approved during the 70th INN Consultation in April 2020. That version is now mandatory for all new INN applications for gene therapy (GT), cell therapy (CT) and cell-based gene therapy (CGT) substances. “The work was initiated based
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FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 10, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV
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Michel Vounatos, CEO, Biogen, said he was ‘incredibly humbled’ to share that the therapy had been granted accelerated approval.​​ The monoclonal antibody is the first new treatment approved for Alzheimer’s since 2003. Unlike currently available therapies – which only treat symptoms of the disease – Aduhelm is the first therapy to target and affect the
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Aducanumab approval: ‘We anticipate demand will be high’, says Alzheimer’s Association Biogen’s Aduhelm (aducanumab) yesterday became the first new treatment approved for the disease since 2003.​​ The FDA approved Biogen’s monoclonal antibody Aduhelm for treating Alzheimer’s under the accelerated approval pathway (for drugs that ‘provide meaningful therapeutic advantages over existing treatments’). On this path, Biogen
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BOSTON–(BUSINESS WIRE)–Jun. 9, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a
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The Phase III TULIP study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement of its [Vic-]Trastuzumab Duocarmazine (SYD985) over physician’s choice, said the developer. PFS is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever
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FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Helps protect against more serotypes
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FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s
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Unlike currently available therapies – which only treat symptoms of the diseases – Aduhelm is the first therapy to target and affect the underlying diseases process of Alzheimer’s, notes the FDA. “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and
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Novartis and Molecular Partners have announced the start of their EMPATHY Phase II/III study to explore the use of its DARPin (designed ankyrin repeat proteins) therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis reportedly will run the trial program, with Molecular Partners serving as sponsor. The EMPATHY clinical trial program is intended to
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Bristol Myers Squibb (BMS) announced the US Food and Drug Administration (FDAP has approved Opdivo (nivolumab, injection for intravenous use) for adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based upon results from the recent Phase III
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Mike Brewer, director, global principal consultant, regulatory, bioproduction, Thermo Fisher Scientific, spoke to BioPharma-Reporter about some of dos and don’ts on starter materials for CGT manufacturing. His advice is particularly targeted at newer entrants to the CGT space, those at the at the preclinical stage, that might not have the same level of regulatory expertise
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FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Tembexa (brincidofovir) tablets and oral suspension approval
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FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1 LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”) announced today that the U.S. Food & Drug Administration (FDA) has approved Ryplazim (plasminogen, human-tvmh) (“Ryplazim”) for the treatment of patients
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FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ — Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is used with a reduced calorie meal plan and
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