Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Beigene, Canbridge, Cstone, Esteve, Stealth, Vectivbio.
The FDA issued an Oct. 18 reminder to the diagnostics industry that the agency still requires test developers to register with an institutional review board (IRB) for all studies of human subjects. This still pertains to studies that make use of leftover, de-identified specimens in FDA-regulated studies, an alert to industry which suggests that enforcement actions may be in the near offing.
As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally.
Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.
Stealth Biotherapeutics Corp.’s refusal to file (RTF) letter from the FDA regarding the NDA for elamipretide, a candidate that targets mitochondria in the treatment of Barth syndrome, hardly knocked the stock, as investors likely saw the bad news coming.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Aim, Alphageneron, Ambulero, Biogen, Biontech, Chipscreen, First Wave, Genmab, Janssen, Innocare, Moleculin, Pfizer, Plus, Sage.
The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: SPR Therapeutics, Venus Concept.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Avadel, Avidity, Boehringer, Enochian, Gilead, I-Mab, Leo, Omeros, Oyster Point, Regeneron, Revance, Roche, Saniona, Sanofi, Som, United, UCB, Xilio.