Biologically Active Substance – Page 4

Puma Biotechnology Reports Third Quarter 2025 Financial Results

2 months ago talkbio0Tagged beat, Clinical Trials, EPS, exophthalmos producing substance, financial results, Neoplasms, Nerlynx sales, net income, Puma Biotechnology, Q3, Revenue Decline, revenue guidance

Puma Biotechnology; Q3 2025; financial results; EPS beat; revenue decline; Nerlynx sales; net income; oncology; clinical trials; revenue guidance

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

2 months 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

2 months 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

Closed Loop Medicine Secures Additional Key GLP-1 Patent for Its AI-Based Dosing Platform: Powering Personalized, Direct-to-Patient Therapies

2 months ago talkbio0Tagged adaptive dosing, AI-based, Closed Loop Medicine, dosing, Glucagon-Like Peptide 1, incretin drugs, Legal patent, personalized therapies, semaglutide, WeDosify

Closed Loop Medicine; GLP-1; patent; AI-based dosing; personalized therapies; semaglutide; incretin drugs; WeDosify; adaptive dosing; direct-to-patient

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

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ago talkbio0Tagged Biopharmaceuticals, biosimilar guidance, biosimilarity, Clinical Research, Comparative Efficacy, draft guidance, Drug Costs, four-letter suffix, naming convention, United States Food and Drug Administration

FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines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

2 months 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

2 months 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

2 months 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 months 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

2 months 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