Policy / Regulatory

FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market

Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis
CompanyDrug

Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis

Policy / Regulatory

FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway

Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising
CompanyDeals

Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising

Policy / Regulatory

NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile

HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor
CompanyDrug

HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor

CompanyDrug

Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors

CompanyDrug

Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity

Merck KGaA Cuts SpringWorks Hippo Inhibitor and Hengrui PARP1 Program – R&D Pipeline Optimization Ditches €3.7 Billion in Acquired Assets
Company

Merck KGaA Cuts SpringWorks Hippo Inhibitor and Hengrui PARP1 Program – R&D Pipeline Optimization Ditches €3.7 Billion in Acquired Assets

Bristol Myers Squibb's Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis
CompanyDrug

Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis

CompanyDeals

Servier to Acquire Day One Biopharmaceuticals for $2.5 Billion – French Pharma Expands U.S. Oncology Presence with ADC Assets

CompanyDrug

Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers