Biological Factors

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

6 hours ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

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

16 hours ago talkbio0Tagged Autoimmune Diseases, Biological Factors, Dennis Dean, Drug Development, executive vice president, Head of Non-Clinical Development, Odyssey Therapeutics, preclinical research

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

3 days ago talkbio0Tagged Biological Factors, Carole Ho, Changing, Denali, eli lilly, executive leadership, Leadership, 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

6 days ago talkbio0Tagged Advanced therapies, alpha 1-antitrypsin, Biological Factors, capital investment, CDMOs, eli lilly, Growth, Johnson & Johnson, Market, pharmaceutical manufacturing, production, supply chain, U.S.

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

2 weeks ago talkbio0Tagged Audit Committee, Biological Factors, board of directors, Compensation Committee, Corporate governance, Drug Industry, Paul Edick, Vistagen

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

2 weeks ago talkbio0Tagged Biological Factors, Chief Medical Officer, Clinical Development, CTPS1 inhibitor, dencatistat, Karen Smith, Neoplasms, Regulatory Affairs, Step Pharma

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

3 weeks ago talkbio0Tagged Anti-DR5 Agonistic Monoclonal Antibody INBRX-109, Biological Factors, Chondrosarcoma, Infrequent, Inhibrx, Liver, Malignant Bone Neoplasm, Malignant Neoplasms, ozekibart, Progression-Free Survival, Receptors, Tumor Necrosis Factor, Member 10b, Submission, Toxicity aspects, United States Food and Drug Administration

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

3 weeks ago talkbio0Tagged Abe Bassan, Anomaly Ventures, BioCapital, Biological Factors, biotherapeutics, Board change, board of directors, Chugai, Collaboration, Obstetric Delivery, Oral cavity, Rani Therapeutics, Samsara, Vasudev Bailey

Rani Therapeutics; Board of Directors; Abe Bassan; Vasudev Bailey; biotherapeutics; oral biologics delivery; Samsara BioCapital; Anomaly Ventures; Chugai collaboration; Board change

RAPT Therapeutics Announces Proposed Public Offering of Common Stock

3 weeks ago talkbio0Tagged Biological Factors, conditions, Dilution technique, Gross (qualifier value), Immunology, Market, Pricing, public entity, RAPT

RAPT Therapeutics; public offering; common stock; underwritten offering; biopharmaceutical; immunology; market conditions; share dilution; offering pricing; gross proceeds

Alkermes Acquires Avadel Pharmaceuticals for $2.1B, Gaining Sleep Drug LUMRYZ and Setting Strategic Evolution

3 weeks ago talkbio0Tagged Acquisition, Alkermes, Avadel Pharmaceuticals, Biological Factors, LUMRYZ, Narcolepsy, portfolio, premium, Rare Diseases, Sleep medicine specialist, strategic

Alkermes; Avadel Pharmaceuticals; acquisition; LUMRYZ; narcolepsy; sleep medicine; strategic portfolio; biopharmaceuticals; rare disease; deal premium