Unlocking Access: Navigating Pharma’s Regulatory Crossroads – Recent Updates (2025)
pharmaceutical regulation; market access; drug pricing; FDA transparency; biosimilars; executive actions; market access strategy; drug importation; CRLs; patient access
Pelage Pharmaceuticals Raises $120M to Advance Hair Loss Regenerative Therapy to Phase 3 Trials
Pelage Pharmaceuticals; hair loss; regenerative medicine; PP405; Phase 3 clinical trial; Series B financing; stem cell therapy; androgenetic alopecia
BioCryst Snaps Up Fellow Angioedema Player Astria for $700M
BioCryst; Astria Therapeutics; acquisition; hereditary angioedema (HAE); navenibart; rare disease; pharmaceutical industry; cash and stock deal; Jill Milne; $700 million
Yale Spinout Raises $23M to Test Drugs on Rebooted Human Brains
Yale; Spinout; Brain Research; Organ Donors
Tubulis Secures $361 Million Series C to Advance Clinical-Stage Antibody-Drug Conjugates (ADCs)
Tubulis; Series C funding; antibody-drug conjugates; ADC; precision oncology; cancer therapeutics; TUB-040; TUB-030; solid tumors; clinical trials; biotech; platform optimization
Bicycle Health Grows Leadership Team to Expand Access for Justice-Involved Populations
Bicycle Health; Leadership team; Executive team; Steve Tomlin; Business development; Criminal justice; Opioid use disorder; Virtual care; Manu Kuppalli; Andy Thomas
Lunit AI Predicts Immunotherapy Outcomes in Colorectal, Kidney, and Lung Cancer at ESMO 2025
Lunit AI; SCOPE IO; immunotherapy; colorectal cancer; kidney cancer; lung cancer; biomarkers; ESMO 2025; treatment prediction; AI pathology
Spotlight On: Cabaletta Bio’s Small but Mighty Breakthrough for CAR-T in Autoimmune Arena
Cabaletta Bio; CAR-T therapy; rese-cel; autoimmune diseases; B cell depletion; myositis; systemic lupus erythematosus; systemic sclerosis; pemphigus vulgaris; preconditioning; clinical trial; FDA
Kailera Raises $600 Million to Launch Global Phase III Program for Obesity Drug
Kailera; obesity drug; Phase III clinical trial; KAI-9531; GLP-1/GIP dual agonist; Series B financing; Bain Capital; weight loss therapy; clinical pipeline; biotech funding