Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Direct, Genetx, Moderna, Purdue, Soligenix, Ultragenyx.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astra, Biovie, Campbell, Innocan, Lysogene, Mayo, Moderna, Modus, Neurmedix, Recode, Satt Conectus, Splisense, Tel Aviv University, Sorrento, Tabuk, Therapeutic Solutions.
The FDA has authorized two batches of Johnson & Johnson’s COVID-19 vaccine from a troubled Emergent Biosolutions Inc. manufacturing facility to be made available under emergency use authorization (EUA) while determining that several other batches were unsuitable for use. While the FDA would not confirm the number of unsuitable batches, the newly authorized batches, however, can be used in the U.S. or exported.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Advanced Human Imaging, Arya III, Autolomous, Avantor, Bio-Techne, C2i, Echonous, Eko, Fittrack, Gynesonics, Inqb8, Intervenn, Nautilus Biotechnology, New England Biolabs, Novogeneait, Paxman Coolers, Peijia, Portal Bioscience, Ritter, Trxade Health, Veranome Biosystems.
The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Arena, Coordination, Dynacure, Lyra, Moderna, Ocugen, Scynexis, Vertex.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Able Medical Devices, Canon Medical Systems, Caremax Medical Group, Cathx Medical, Dedalus Group, Deerfield Healthcare Technology Acquisitions, Global Access Diagnostics, IMC Medical Group Holdings, Kumocare, Livful, Medline, Neupath Health, Obviohealth, Sofinnova Partners, Spectramed, Syntheticmr, Visionquest Biomedical, Zeus Industrial Products.
Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients.
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