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.

Early-stage companies pioneering new modalities discussed the future of cardiometabolic therapy and partnering with big pharma at the LSX conference in London.

Perrigo spares little about Opill’s launch, advertising and outlook in Q1 earnings briefing, but management also makes clear it’s a large firm and some other segments of its global consumer health products business are holding back overall results.

Along with latest results, Kenvue says as its “transitions services agreement” with J&J ends, its board approves reducing global workforce by around 4%. It expects around $275m in pre-tax restructuring costs in both 2024 and 2025 without changes to its capital allocation priorities.