Roche in Talks With US on Drug Pricing; Sets Out Pipeline and Dealmaking Ambitions

Roche; drug pricing; US government; pharmacy benefit managers; direct-to-consumer sales; pipeline; dealmaking; US investment; manufacturing; gene therapy; R&D; Ocrevus; Hemlibra; Vabysmo

Companies Struggle to Accelerate Production of Bespoke mRNA Therapies

bespoke mRNA therapies; personalized medicine; manufacturing challenges; cancer vaccines; scalability; manufacturing efficiency; cold chain logistics; regulatory complexity; mRNA production innovation; AI optimization

Ypsomed Invests $248 Million to Establish First U.S. Manufacturing Site in North Carolina

Ypsomed; manufacturing expansion; U.S. facility; Holly Springs; North Carolina; CHF 200 million; self-injection systems; job creation; global growth strategy; medical technology

Vaxcyte Strikes up to $1B Fill-Finish Manufacturing Deal with Thermo Fisher at North Carolina Facility

Vaxcyte; Thermo Fisher Scientific; fill-finish manufacturing; North Carolina; pneumococcal conjugate vaccines; PCVs; VAX-31; VAX-24; commercial supply chain; biomanufacturing; U.S. vaccine production; $1 billion deal

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback

Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe

Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA