Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Janssen, Nrx, RDIF, Statera, Tryp.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Ionis, Oramed, Oravax, Rational Vaccines, Tan Thanh.
The U.S. FDA’s emergency use authorization for two oral antivirals to be used to treat individuals at high risk of progressing to severe disease is just one hurdle cleared, as Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir still have many more laps to run.
The Russian Ministry of Health issued the 14th version of its guidelines on preventing, diagnosing and treating COVID-19 infections. Released Dec. 28, the latest version includes information about the Omicron variant and provides updates on new therapies, including two new oral drugs: Pfizer Inc.’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s siRNA drug molnupiravir, which will be marketed in Russia as Mir-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, Astrazeneca, Cstone, Daiichi, Leo, Novavax, Regor.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Aipharma, Collegium, Dicerna, Immuneoncia, Moderna, Novo Nordisk, Wuxi.
As global demand for rapid testing soars due to a new variant of COVID-19, one company is shaking up the diagnostics market with an at-home rapid PCR solution. Founded in 2017 by scientist and entrepreneur Jonathan Rothberg, Detect Inc. is the developer of Detect COVID-19, a direct-to-consumer PCR test that provides results within one hour.
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