Biological Factors
Profluent Raises $106M to Accelerate Frontier AI Models for Programmable Biology, Backed by Jeff Bezos
Profluent; AI biotech; protein design; programmable biology; Jeff Bezos; Altimeter Capital; $106M funding; Bezos Expeditions; CRISPR; biologics; Protein Atlas; synthetic biology; drug development
Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer
Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing
Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025
Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis
Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development
Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical
Eli Lilly Hires Denali Therapeutics Executive Carole Ho to Lead Neuroscience Division
Eli Lilly; Denali Therapeutics; Carole Ho; neuroscience division; executive leadership; biopharmaceuticals; leadership changes
Pharma Investment Surge in US Manufacturing Creates Major Opportunities for CDMOs
US pharmaceutical manufacturing; CDMOs; capital investment; Johnson & Johnson; Eli Lilly; biologics; API production; supply chain; advanced therapies; market growth
Vistagen Appoints Paul Edick to its Board of Directors
Vistagen; Paul Edick; Board of Directors; Audit Committee; Compensation Committee; Biopharmaceutical; Pharmaceutical industry; Corporate governance
Step Pharma Appoints Dr. Karen L. Smith as Chief Medical Officer
Step Pharma; Karen Smith; Chief Medical Officer; CTPS1 inhibitor; dencatistat; oncology; clinical development; biopharmaceutical; regulatory affairs
Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart
Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity
Rani Therapeutics Appoints Abe Bassan and Vasudev Bailey to Board of Directors
Rani Therapeutics; Board of Directors; Abe Bassan; Vasudev Bailey; biotherapeutics; oral biologics delivery; Samsara BioCapital; Anomaly Ventures; Chugai collaboration; Board change