Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biogen, Biohaven, Cytodyn, Eisai, Mirati, Moderna, Novavax, Owp, Pfizer, Prilenia, Santhera, Serum Institute, Zentalis.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Aglaia, Arcus, Artizan, Biohaven, Clover, Entheotech, Enveric, Eqrx, Filament, Genomma, Gilead, Linus, Mymd, Oramed, Oravax, Owkin, Pierre Fabre, Ribonexus, Sanofi.
Roche Holding AG is walking away from a deal with Atea Pharmaceuticals Inc. to co-develop the COVID-19 oral antiviral treatment AT-527 after the mid-October failure of a global phase II study testing the medicine in non-hospitalized adults with mild or moderate disease missed its primary endpoint. Roche’s decision tosses the rights and licenses back to Atea so it can continue its development and commercialization efforts.
A research report by global investment bank Jefferies has found increased investor optimism in the health care market amid COVID-19, with respondents expecting stocks to rise throughout 2022. The Jefferies Healthcare Temperature Check summarizes the views of 500 leaders across the health care sector. Sixty percent of respondents said they believed the MSCI World Health Care Index would be higher by the end of 2022 than at present.
A busy regulatory environment globally throughout most of 2021 has translated into more than 15% of all actions taken relating to the COVID-19 pandemic, yet only one product has been approved in the U.S. for the SARS-CoV-2 virus.
A futility analysis of Molecular Partners AG’s ensovibep for treating hospitalized COVID-19 adults prompted an independent data safety monitoring board to recommend discontinuing recruitment of patients in the phase III ACTIV-3 study.
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
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