Biologically Active Substance

Lilly Prepares Amylin-Based Obesity Drug Eloralintide for Phase III After Strong Weight Loss Results

16 hours ago talkbio0Tagged Agonist, Amylin, Clinical Development, Eli, Eli Lilly, Eloralintide, Obesity Drug, Phase 3 Clinical Trials, Weight Loss

Eli Lilly; eloralintide; amylin agonist; obesity drug; Phase III trial; weight loss; clinical development

Pharma Investment Surge in US Manufacturing Creates Major Opportunities for CDMOs

20 hours 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

FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs

2 days ago talkbio0Tagged Biopharmaceuticals, biosimilar guidance, biosimilarity, Clinical Research, Comparative Efficacy, draft guidance, Drug Costs, four-letter suffix, naming convention, United States Food and Drug Administration

FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines

Eli Lilly Blows Past Revenue Benchmarks, Again Raises Full-Year Outlook

1 week ago talkbio0Tagged earnings, eli lilly, exophthalmos producing substance, full-year guidance, Mounjaro, pharmaceutical innovation, Q3, revenue growth, Weight-Loss Agents, Zepbound

Eli Lilly; Q2 2025 earnings; Q3 2025 earnings; Mounjaro; Zepbound; weight-loss drugs; revenue growth; EPS; full-year guidance; pharmaceutical innovation

Roche Signs $1B Licensing Deal with Qyuns Therapeutics for Preclinical COPD Bispecific Antibody

1 week ago talkbio0Tagged Antibodies, Bispecific, biobucks, China, COPD, IL33 protein, human, Preclinical, Qyuns Therapeutics, Respiration Disorders, Roche (company), TSLP gene

Roche; Qyuns Therapeutics; bispecific antibody; COPD; preclinical; TSLP; IL-33; China biotech; biobucks; respiratory disease

Vistagen Appoints Paul Edick to its Board of Directors

1 week 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

1 week 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

BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418

1 week ago talkbio0Tagged Acoramidis, Approved, BBP-418, Biological Markers, BridgeBio, commercial, disease drug, File (record), Infrequent, Limb-girdle muscular dystrophy type 2A, NDA, New Drug Application, Phase 3 success, Ribitol, United States Food and Drug Administration

BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

2 weeks ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

2 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