New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bharat, Novavax, Nrx, Ocugen, Opiant, Tris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bluestar Genomics, Orchestra Biomed, Penumbra, Proteomics International, Seastar Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Achiko, Magforce, Nexstim, Thomas Scientific, Veracyte, Zealand Pharma, Deka.
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
Sichuan Clover Biopharmaceuticals Inc. raised HK$2.03 billion (US$260.17 million) in its Hong Kong Stock Exchange debut. Shares closed at HK$12.98 (US$1.67) on Nov. 5 after trading as high as HK$13.56 earlier.
LONDON – Researchers have pinpointed a little-studied gene as responsible for doubling the risk of respiratory failure in COVID-19 and shown exactly how it exerts its effect. The gene, leucine zipper transcription factor like 1, is activated by a single base pair change on chromosome 3 that occurs in 60% of people of South Asian ancestry and 15% of people of European ancestry.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ares, Omeros, Oncopeptides, Resverlogix, Reven Holdings, Spirovant Sciences, Tranquis.
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