October 15, 2025 – Talk Bio

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

23 hours ago talkbio0Tagged ACHIEVE-1, ATTAIN-2, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Effectiveness, Eli Lilly, Farxiga, Glucagon-Like Peptide 1, Oral cavity, orforglipron, regulatory submission, Safety, semaglutide, Weight Loss

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Former FDA Deputy Dr. Namandjé N. Bumpus to Lead Charles River’s New Scientific Advisory Board

23 hours ago talkbio0Tagged alternative testing, Animal Welfare, biopharmaceutical innovation, Charles River Laboratories, Drug Development, Namandjé Bumpus, NAMs, New Approach Methodologies, Scientific Advisory Board, United States Food and Drug Administration

Namandjé Bumpus; Charles River Laboratories; Scientific Advisory Board; FDA; New Approach Methodologies; NAMs; alternative testing; drug development; animal welfare; biopharmaceutical innovation

Are the Good Times in Biotech Back? – Insights from Post-Hoc Live’s 2025 Industry Sentiment

23 hours ago talkbio0Tagged Aggressive Periodontitis, delays, executive survey, Funding, Industry, M&A, Post-Hoc Live, public biotech, Sentiment, United States Food and Drug Administration

biotech sentiment; Post-Hoc Live; 2025 industry outlook; biotech M&A; FDA delays; executive survey; public biotech companies; JP Morgan effect; biotech funding

Unlocking Access: Navigating Pharma’s Regulatory Crossroads – Recent Updates (2025)

1 day ago talkbio0Tagged Access, access strategy, Biosimilars, CRLs, drug importation, drug price, executive actions, Market, Patient access, pharmaceutical regulation, United States Food and Drug Administration

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

1 day ago talkbio0Tagged Alopecia, Androgenetic Alopecia, Pelage, Phase 3 clinical trial, PP405, Regenerative Medicine, Series B financing, Stem Cell Therapy

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

1 day ago talkbio0Tagged Acquisition, Angioedemas, Hereditary, Astria, BioCryst, Cash, Drug Industry, navenibart, Rare Diseases

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

1 day ago talkbio0Tagged Brain Research, organ donor, Spinout, Yale

Yale; Spinout; Brain Research; Organ Donors

Tubulis Secures $361 Million Series C to Advance Clinical-Stage Antibody-Drug Conjugates (ADCs)

1 day ago talkbio0Tagged Antibody-Drug Conjugates, cancer therapeutics, Clinical Trials, Optimization, precision oncology, Series C funding, Solid Neoplasm, therapeutic autologous dendritic cells, TUB-030, TUB-040, Tubulis

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

1 day ago talkbio0Tagged Andy Thomas, Bicycle Health, Business Development, Criminal Justice, executive team, Leadership, Opioid Use Disorder, Steve Tomlin, virtual care

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

1 day ago talkbio0Tagged Biological Markers, Colorectal Carcinoma, Immunotherapy, Lunit AI, Malignant neoplasm of kidney, Malignant neoplasm of lung, Pathology, SCOPE IO, treatment prediction

Lunit AI; SCOPE IO; immunotherapy; colorectal cancer; kidney cancer; lung cancer; biomarkers; ESMO 2025; treatment prediction; AI pathology