Biologically Active Substance

Biogen, Stoke Boost Epilepsy Drug’s Blockbuster Potential With Early Seizure Reduction Data

10 hours ago talkbio0Tagged American Epilepsy Society 2025, Antisense Oligonucleotides, Biogen, blockbuster drug, EMPEROR Phase III trial, Epilepsy, Infantile Severe Myoclonic Epilepsy, Jefferies analysts, natural history controls, SCN1A gene, Seizures, Stoke Therapeutics, Zorevunersen

Biogen; Stoke Therapeutics; zorevunersen; Dravet syndrome; epilepsy; antisense oligonucleotide; seizure reduction; blockbuster drug; EMPEROR Phase III trial; American Epilepsy Society 2025; Jefferies analysts; natural history controls; SCN1A

mAbxience and HP Drive the Use of Artificial Intelligence in Biomanufacturing and Biosimilar Development

5 days ago talkbio0Tagged Artificial Intelligence, Biological Factors, biomanufacturing, Biosimilars, development aspects, digital twin, Fresenius, Hereditary pancreatitis, mAbxience, Monoclonal Antibodies, Neural Network Simulation

mAbxience; HP; artificial intelligence; biomanufacturing; biosimilar development; digital twin; monoclonal antibodies; neural network models; biologics; Fresenius

Alkeus Pharmaceuticals Appoints Carlos Quezada-Ruiz as Chief Medical Officer

6 days ago talkbio0Tagged Alkeus, Biological Factors, Carlos Quezada-Ruiz, Chief Medical Officer, Clinical Research, gildeuretinol, Ophthalmology specialty, Retinal Diseases, Stargardt's disease

Alkeus Pharmaceuticals; Carlos Quezada-Ruiz; Chief Medical Officer; Stargardt disease; gildeuretinol; retinal diseases; ophthalmology; clinical research; biopharmaceutical leadership

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

1 week 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

2 weeks 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 weeks 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

2 weeks 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

2 weeks 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

3 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

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

3 weeks 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