The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve access to lifesaving therapies. Payers and politicians must be persuaded to loosen their purse strings – and open their minds.

The Sweden-headquartered biotech has emphasized the promising survival data in a head and neck cancer study of setanaxib rather than the NOX inhibitor’s inability to shrink tumors.

At-home fertility-related hormone test developer Proov sells equity stake to entertainers and expectant parents Ashanti and Nelly; sexual and vaginal health product firm Good Clean Love moves from its founder as leader to a consumer health industry executive.