There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
Reata Pharmaceuticals Inc.’s hopes, as well as those of many people living with Alport syndrome, were dashed Dec. 8 when the FDA’s 13-member Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the available evidence doesn’t show that the benefits of bardoxolone methyl outweighed its risks in treating the rare genetic condition.
The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc., of Plano, Texas.
Longeveron Inc.’s share price (NASDAQ:LGVN) jumped 11.7% on Dec. 3 after the FDA awarded orphan designation to Lomecel-B, allogeneic bone marrow-derived mesenchymal stem cells, for treating hypoplastic left heart syndrome. The designation came two weeks after the FDA granted rare pediatric disease designation for Lomecel-B to treat the life-threatening congenital heart defect in infants.
One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.”
While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season, and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies.
Fennec Inc. received the complete response letter (CRL) it had expected from the FDA, sidelining U.S. development of Pedmark, a formulation of sodium thiosulfate for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than 1 month to those 18 years of age with localized, non-metastatic, solid tumors.
A divided FDA advisory committee voted 13-10 Nov. 30 that the known and potential benefits of the Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, outweighs its known and potential risks. If granted an emergency use authorization (EUA), molnupiravir would become the first take-at-home oral drug in the U.S. to keep mild and moderate COVID-19 infections from becoming severe in high-risk adults.
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