Commission
Biotech Restructuring and European Regulatory Setbacks
LifeMine Therapeutics, layoffs, PTC Therapeutics, Translarna, Duchenne muscular dystrophy, European Commission, regulatory decision
Gilead’s Seladelpar Receives Conditional EU Approval for Primary Biliary Cholangitis Treatment
Seladelpar, Gilead Sciences, primary biliary cholangitis, PBC, European Commission, conditional marketing authorization, RESPONSE trial, ursodeoxycholic acid (UDCA)
Trump Establishes Make America Healthy Again Commission to Combat Childhood Chronic Diseases
MAHA Commission, Robert F. Kennedy Jr., childhood chronic diseases, HHS Secretary, Executive Order, public health, chronic illness, disease prevention
European Commission Approves Novo Holdings’ $16.5B Acquisition of Catalent
Novo Holdings, Catalent, European Commission, Acquisition, Pharmaceutical Industry
Novo Holdings Receives Unconditional EU Approval for $16.5 Billion Acquisition of Catalent
Novo Holdings, Catalent, European Commission, Acquisition, EU Approval, Pharmaceutical Services
European Commission Revokes Marketing Authorization for Ocaliva, a Liver Disease Drug, Amid Regulatory Dispute
Ocaliva, European Commission, Marketing Authorization, Liver Disease, Primary Biliary Cholangitis (PBC), Advanz Pharma
European Commission Imposes €463 Million Fine on Teva for Anti-Competitive Practices in MS Drug Market
Teva, European Commission, fine, MS drug, competition tactics, Copaxone, market dominance
Merck’s KEYTRUDA Receives 30th European Approval for Gynecologic Cancers
KEYTRUDA, pembrolizumab, European Commission, gynecologic cancers, endometrial cancer, cervical cancer, cancer treatment, immunotherapy.
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
Biogen and Ionis’ ALS Treatment Qalsody Receives European Commission Approval
Biogen, Ionis, Qalsody, ALS, European Commission, Marketing Authorization, Rare Disease, SOD1-ALS, Neurofilament, Clinical Trials