See No Evil

Dave Maraldo, Ph.D., president of manufacturing at Merck, explains how flexible capacity, earlier input from manufacturing in R&D, and digital tools are helping the organization keep up with a faster, more varied portfolio.

The Treasury Department is proposing rules to add biotechnology to its Outbound Investment Security Program under the COINS Act.

Gilead agrees to acquire an oral IL-23R inhibitor from PepStar, while Zymeworks licenses its DLL3-targeting T cell engager ZW209 to Roche.

Incubate’s John Stanford on why MFN is voluntary in name only — and why the moonshot is the first casualty of drug pricing pressure.

FDA grants Ultomiris accelerated approval for primary immunoglobulin A nephropathy, a pharma funding roundup covers Alcon’s $550 million acquisition of Neurotech and AI Proteins’ collaboration with Astellas, and Incubate’s John Stanford on which therapeutic areas MFN deals might hit hardest.

Alcon is acquiring Neurotech Pharmaceuticals to add the only FDA-approved MacTel cell therapy to its retina portfolio, while AI Proteins has enters a collaboration with Astellas to design novel miniprotein therapeutics.

FDA has granted accelerated approval to Ultomiris based on Phase III data showing a 43.4% placebo-adjusted reduction at 34 weeks.

A new ICER and West Health report finds median drug launch prices climbed to $257,000, the FDA approves GSK’s Hibsago as the first functional-cure therapy for chronic hepatitis B, and CSL names Deborah Waterhouse as CEO and managing director.