It’s decision time for oral drugs that could help the world return to normal even in the midst of the COVID-19 pandemic. The U.K. already has granted emergency authorization to Merck & Co. Inc. and Ridgeback Biotherapeutics Inc.’s antiviral, Lagevrio (molnupiravir), and the EMA is expected to complete its evaluation of the oral drug within the next few weeks. In the U.S., the FDA could announce its decision on Lagevrio shortly after its Antimicrobial Drugs Advisory Committee weighs in Nov. 30 on emergency use authorization.
Emergent Biosolutions Inc.’s Bayview facility in Baltimore passed its manufacturing inspection with international regulators, clearing the way for shipment of batches of Johnson & Johnson’s (J&J) COVID-19 vaccine containing drug substance made at the plant.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aadi, AB, Amryt, BMS, Gilead, Janssen, Neonmind, RDIF, Revive, Seqirus, Sterna, Tonix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aligos, Astrocyte, Bluebird, Curative, Dragonfly, Evrys, Kancera, Marvel, Merck & Co., Qurient, Sellas, Simcere, Tonix, Vipergen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptevo, Dnatrix, Galapagos, Ocuphire, Oncotelic, Oramed, Santhera, Scynexis, Transgene.
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.
The Pan American Health Organization is echoing fears that the COVID-19 pandemic will result in a surge of drug-resistant infections, saying surges already are being seen in several countries in the Americas, including Argentina, Ecuador, Guatemala, Paraguay and Uruguay.
U.S. trading partners are raising concerns about the FDA’s continued delays in inspecting foreign drug manufacturing facilities due to the COVID-19 pandemic and related travel restrictions.
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide Clover Biopharmaceuticals Ltd. with an additional $36.9 million to support development of SCB-2019, a recombinant trimeric Spike-protein subunit COVID-19 vaccine.
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