Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic.
Patent disputes between developers of medical software might not have kept pace with the rate of disputes over in vitro diagnostic patents, but Alivecor Inc. and Apple Inc. are doing their share to keep software patents in the news. In the latest development, Mountain View, Calif.-based Alivecor reported that it won an initial determination of infringement of one of its patents by Apple Inc., of Cupertino, Calif., which could lead to an exclusion order for Apple watches if the case ultimately goes Alivecor’s way.
Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.
COVID-19 boosters for the fall should contain an omicron component, the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) said June 28, voting 19-2 to make that recommendation.
Sounds like Eargo Inc. received good news as Patient Square Capital signed a definitive agreement to purchase $100 million in senior secured convertible notes plus an additional $25 million in future investment subject to certain conditions. The new funds provide some breathing room for the hearing aid company, which has been rocked by a $34.37 million settlement with the Department of Justice (DOJ), questions about its ability to remain on the Nasdaq exchange following delayed filings of its 2021 annual report and first quarter 2022 report and a 97% drop in its stock price since its high in February 2021.
Analysts have warned that the medical device industry is not completely immune from any effects of a potential recession. With fears that a recession is looming, investment firm Needham said companies with capital equipment exposure could be the most vulnerable as hospitals look to repair equipment, instead of replacing it. During the 2008-2009 recession, sales in capital equipment declined for about 12 months, while procedure growth slowed for several years.
Axsome Therapeutics Inc. and the U.S. FDA appear to be working out their differences. The company said it received the proposed labeling from the agency for AXS-05 (dextromethorphan + bupropion), an oral NMDA receptor antagonist with multimodal activity, for treating major depressive disorder.
Armed with data but no crystal ball, the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will be asked June 28 to predict the next-generation vaccines that will be needed to best respond to the COVID-19 futurescape. While Moderna Inc., Pfizer Inc. and Novavax Inc. will briefly present clinical data for their variant vaccines at the VRBPAC meeting, the discussion will be about the future of all COVID-19 vaccines being developed or authorized for the U.S. market.
Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter.
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
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