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.
The U.S. Department of Health and Human Services (HHS) has withdrawn its August 2020 rescission of the FDA’s authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic. However, the non-COVID implications are not clear as the FDA is not widely seen as having the capacity to regulate LDTs for non-pandemic purposes, while pending legislation would dramatically overhaul the agency’s approach to LDT regulation, making the current regulatory environment an unstable environment at best. The FDA accompanied the announcement with a statement that the emphasis at the agency is on tests that do not require that the patient sample be sent to a lab for processing.