Biological Factors
About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds
FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process
Teva plots thousands of job cuts as restructuring drive enters ‘acceleration’ phase
Workforce reduction (8%), $700 million cost savings, Strategic overhaul, Generics to biopharmaceuticals pivot, Operational streamlining, R&D investment
Merck & Co. breaks ground on $1B future US home of Keytruda
United States, Keytruda, Home environment, Merck, Wilmington, Biological Factors
Lotte Bio launches ADC services; Ypsomed to focus on self-injection business
Antibody-Drug Conjugates, Lotte, Ypsomed, Services, Biological Factors, Manufacture, self-injection business
Regeneron turns to CDMO Fujifilm to boost US manufacturing capacity
Regeneron, Manufacture, Fujifilm, CDMO, Biological Factors, Capacity, United States, Boost
Trump pledges his support for a change to the IRA long sought by drugmakers
IRA, Medicare, Contraceptives, Oral, Mediation, Industry, drug price, Biological Factors, Prices, drugmakers, Medicare
Sandoz Challenges Amgen in Antitrust Lawsuit to Launch Enbrel Biosimilar in the U.S.
Sandoz, Amgen, Enbrel, Erelzi, antitrust, biosimilar, etanercept, patent thicket, U.S. market, rheumatoid arthritis, competition, biologics, FDA approval.
Amgen Secures Phase 3 Survival Data for Imdelltra in Small-Cell Lung Cancer, Strengthening Its Case for Full FDA Approval
Imdelltra, Amgen, Small-cell lung cancer (SCLC), Phase 3 trial, Overall survival, DLL3-targeting therapy, Immunotherapy, Biopharmaceuticals
Novartis to invest $23B in manufacturing so ‘all key medicines’ can be made in the US
Novartis, United States, Investments, Manufacture, production, Biological Factors, Novartis
Chiesi unveils 430M investment to revitalize Italian production site for inhaler, biologics manufacturing
Investments, Inhaler, Biological Factors, production