Usama Malik, Immunomedics Inc.’s former chief financial officer, and his former partner, Lauren Wood, face SEC charges related to insider trading in Immunomedics’ stock.
The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance.
The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine.
The FDA’s device center is required to develop and publish special controls for devices that are deemed class II items via the de novo petition process, and five such declarations were posted Dec. 1 to the Federal Register. One of these de novo classifications, for conditioning tools for eating disorders, was the subject of a de novo petition filed in 2007 and granted in 2011.
Device makers have historically struggled to maintain adequate procedures for corrective and preventive action (CAPA) and complaint handling (CH), and two warning letters posted to the FDA website suggest these are still sore spots. Invacare Corp., of Elyria, Ohio, and Smiths Medical ASD Inc., of Minneapolis, were both cited for CAPA and CH deficiencies.
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.
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