A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Lumos Diagnostics, Mim Software.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Betternight, Clario, Cytek Biosciences, Exact Sciences, Heartflow, Innovia, Molex, Nanostring Technologies, Peerbridge Health, Phillips-Medize, Sleep Data Services.
A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin.
Although the BioWorld Biopharmaceutical Index has recovered slightly within the last month, it is showing only a small gain since the start of the year. Up by 2.82%, it is somewhat in line with the Nasdaq Biotechnology Index gain of 4.83%, but significantly beneath the broader markets. The Dow Jones Industrial Average, for example, was up by 17.03% at the end of October.
Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines from the U.S. government. Indianapolis-based Lilly began filing data from the combination of bamlanivimab and etesevimab in March to enable a fast authorization by the European Medicines Agency.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autobahn, Biomunex, Cytovant, Defence, Eisbach, Flagship Pioneering, Gb, Medigene, Pharmather, Reithera, Resverlogix, Revive, Roivant, Tessera.
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