Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.
Biogen Inc. opened the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting with data showing those treated with its multiple sclerosis (MS) therapies had an effective antibody response to COVID-19 vaccination.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Corium, Curevac, Deciphera, Gensight, Hoth, Intelgenx, Nrx, Ocular, Protara, Sofie, Viiv.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Diagnostics Research Group, Diomics, Halleck-Willard, Icecure Medical, IMA Group, Integrated Media Technology, Magnum International, Nutriband, SPT Labtech, Steripack.
Although the need for COVID-19 boosters remains a tense debate among policymakers and scientific experts worldwide, the U.S. FDA is basing its Oct. 14-15 Vaccines and Related Biologics Products Advisory Committee meeting on the premise that vaccine boosters are needed.
Curevac AG, once a forerunner in COVID-19 vaccine development but later surpassed, said it would terminate its first effort in the field, CVnCoV, withdrawing it from a rolling review at the EMA to focus instead on development of second-generation mRNA vaccine candidates with Glaxosmithkline plc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Athenex, Brii, Enzyvant, Genentech, Kintor, Merck, Protagonist, Regeneron, Ridgeback, Roche.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Aligos, Astrazeneca, Bicycle, Diurnal, Idorsia, Galmed, Oxurion, Regenxbio, Reistone, Repertoire, Sarepta.
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