The U.K. government recently released its first ever medical technology strategy which aims to accelerate access to innovative medical technologies in the NHS. Although it was welcomed by the industry, and questions remain as to whether it goes far enough to address some of the challenges to the adoption of medical devices, eyes are on its implementation and whether it will achieve its aims.
After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia.
Thylacine Biotherapeutics Inc. has entered into a license agreement with Columbia University for worldwide exclusive rights to develop and commercialize a novel antiviral peptide platform invented and refined at Columbia.
Tonix Pharmaceuticals Holding Corp. has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection.
Scientists at the University of Sydney have discovered a protein in the lung that blocks SARS-CoV-2 infection and forms a natural protective barrier in the human body. Leucine-rich repeat-containing protein 15 (LRRC15) is an inbuilt receptor that binds the SARS-CoV-2 virus without passing on the infection. The discovery opens a new area of immunology research around LRRC15 and suggests a pathway to develop new drugs to prevent viral infection from coronaviruses like COVID-19, but also to deal with fibrosis in the lungs.
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
Japan's National Center for Global Health and Medicine (NCGM) has divulged 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infections (COVID-19).
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
It’s the season for reevaluation as companies weed out programs that don’t offer much promise. At the head of the line is Sanofi SA’s once-potential myasthenia gravis blockbuster tolebrutinib. A partial clinical hold on the phase III study is part of the reasoning for stopping its development. But so is competition, the company said. Other companies eliminating development programs include Roche Holding AG, Gilead Sciences Inc., AB Science SA and Merck & Co. Inc.
