Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alx, Bristol Myers Squibb, Endevica, Freya, Inflarx, Ipsen, Obseva, Regeneron, Sanofi, Santhera, Teraimmune, Unibio.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Biolinerx, Eli Lilly, Generian, Genfleet, Mitobridge, Novavax, Oyster Point, Scorpion.
Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moleculight, Seegene.
COVID-19 boosters for the fall should contain an omicron component, the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) said June 28, voting 19-2 to make that recommendation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Bristol Myers Squibb, Curium, Cybin, Daiichi, Eli Lilly, Innovent, Jiangsu Recbio, Kiora, Kyowa Kirin, Merck, Noema, Prestige, Relay, Sinovac, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adelia, Confo, Cybin, Engeneic, Evofem, Fate, Ono.
Armed with data but no crystal ball, the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will be asked June 28 to predict the next-generation vaccines that will be needed to best respond to the COVID-19 futurescape. While Moderna Inc., Pfizer Inc. and Novavax Inc. will briefly present clinical data for their variant vaccines at the VRBPAC meeting, the discussion will be about the future of all COVID-19 vaccines being developed or authorized for the U.S. market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Amryt, Argenx, Basilea, Biomarin, Croma, Cytokinetics, Daewoong, Emergent, Gilead, Janssen, Kyowa Kirin, Merck, Novartis, Novavax, Oncopeptides, Sarepta.
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