Biologically Active Substance

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

2 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

CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks

2 days ago talkbio0Tagged drug price, Effectiveness, Inflation Reduction Act, Medicare Part D, Myasthenic Syndromes, Congenital, negotiation, Ozempic, Prices, semaglutide, Wegovy

CMS; Ozempic; Wegovy; Inflation Reduction Act; drug price negotiation; Medicare Part D; semaglutide; negotiated prices; 2027 effective date

Novo Nordisk’s Amycretin Significantly Reduces Weight and Blood Sugar in Phase 2 Type 2 Diabetes Trial

3 days ago talkbio0Tagged Administration, Oral, Agonist, amycretin, Amylin Receptor Agonists, Diabetes Mellitus, Non-Insulin-Dependent, Glucagon-Like Peptide 1, Glycosylated hemoglobin A, Novo Nordisk, Phase 2 clinical trial, subcutaneous administration, Weight Loss

Novo Nordisk; Amycretin; Type 2 diabetes; Weight loss; HbA1c reduction; GLP-1 agonist; Amylin receptor agonist; Phase 2 clinical trial; Subcutaneous administration; Oral administration

Novo Nordisk’s Semaglutide Misses Key Goals in Closely-Watched Alzheimer’s Disease Phase 3 Trials

4 days ago talkbio0Tagged Alzheimer 's disease, Biological Markers, Clinical trial failure, EVOKE trial, Glucagon-Like Peptide 1, Mental deterioration, Novo Nordisk, Phase 3, Rybelsus, semaglutide

Novo Nordisk; semaglutide; Alzheimer’s disease; EVOKE trial; EVOKE+ trial; clinical trial failure; Rybelsus; GLP-1 drugs; phase 3; biomarkers; cognitive decline

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

1 week 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

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

1 week ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

1 week 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

Genmab Discontinues ProfoundBio-Derived ADC GEN1107 After Acquisition, Paralleling J&J’s Ambrx Buyout Area Developments

1 week ago talkbio0Tagged AbbVie, Acquisition, Ambrx, Antibody-Drug Conjugates, Drug Development, GEN1107, Genmab, J&J, Johnson and Johnson, Neoplasms, ProfoundBio, PTK7, PTK7 protein, human

Genmab; ProfoundBio; antibody-drug conjugate (ADC); GEN1107; PTK7; Ambrx; Johnson & Johnson (J&J); oncology; drug development; biotech acquisition; AbbVie lawsuit

Zealand Pharma Pauses Development of GLP-1/GLP-2 Dual Agonist Dapiglutide for Obesity

2 weeks ago talkbio0Tagged Agonist, Clinical Development, Dapiglutide, drug market, GLP-1/GLP-2, Obesity, obesity therapy, petrelintide, pipeline management, Zealand Pharma

Zealand Pharma; dapiglutide; GLP-1/GLP-2 dual agonist; obesity therapy; clinical development; obesity drug market; pipeline management; petrelintide; survodutide

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

2 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