Biological Factors

FDA’s Vinay Prasad Links 10 Child Deaths to COVID-19 Vaccines, Calls for Stricter Review Guidelines

2 days ago talkbio0Tagged Biological Factors, COVID19 (disease), Death of child, Evaluation, Myocarditis, United States Food and Drug Administration, vaccine guidelines, vaccine regulation, Vaccine Safety, Vaccines, VAERS, Vinay Prasad

FDA; Vinay Prasad; COVID-19 vaccines; child deaths; myocarditis; vaccine safety; vaccine regulation; biologics evaluation; VAERS; stricter vaccine guidelines

Vera Therapeutics Appoints James R. Meyers to Its Board of Directors

7 days ago talkbio0Tagged Appointments, Atacicept, Autoimmune Diseases, Biological Factors, biotech executive, board of directors, Gilead Sciences, IGA Glomerulonephritis, IntraBio Ltd., James, Vera Therapeutics

Vera Therapeutics; James R. Meyers; Board of Directors; appointment; biotech executive; IgA nephropathy; atacicept; autoimmune diseases; Gilead Sciences; IntraBio Ltd; biopharmaceutical

Profluent Raises $106M to Accelerate Frontier AI Models for Programmable Biology, Backed by Jeff Bezos

2 weeks ago talkbio0Tagged AI biotech, Altimeter Capital, Bezos Expeditions, Biological Factors, Clustered Regularly Interspaced Short Palindromic Repeats, Drug Development, Funding, Jeff, Profluent, Programmable Biology, Protein Atlas, protein design, Synthetic Biology

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

2 weeks ago talkbio0Tagged Biological Factors, buyback, erbB-2 Receptor, Jazz, Malignant neoplasm of stomach, milestone payments, Regulatory Filing, Royalty-Driven Model, Strategy, Ziihera, Zymeworks

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

3 weeks 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

3 weeks 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 weeks 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

4 weeks 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