Start-Up Previews (11/04)
A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, Biotechs Battle Bacteria, features profiles of AureoGen Biosciences, Biovertis, Inimex Pharmaceuticals and Prolysis. Plus these Start-Ups across Health Care: Afmedica, Intercept Pharmaceuticals and MAP Pharmaceuticals.
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Vigorous regulatory scrutiny is a given, but opinions vary about how much the companies’ respective PBM businesses present a major antitrust risk.
Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.
FDA’s Bumpus Will Be Principal Deputy Commissioner; Cosmetics Industry Reacts With Congratulations, Questions
Chief scientist Namandjé Bumpus will replace Janet Woodcock as principal deputy commissioner at the US FDA when the latter steps down in early 2024. The Personal Care Products Council says Bumpus will continue to lead MoCRA implementation efforts while a new chief scientist is sought, but those and other details remain fuzzy.