talkbio – Page 30

AstraZeneca gears up for FDA filing after baxdrostat’s phase 3 hypertension success

2 months ago talkbio0Tagged aldosterone synthase inhibitor, AstraZeneca, baxdrostat, File (record), Hypertensive disease, regulatory approval, United States Food and Drug Administration

AstraZeneca; baxdrostat; hypertension; FDA filing; aldosterone synthase inhibitor; phase 3 trial; regulatory approval

Genentech (Roche) Signs $420 Million Deal With OMass Therapeutics for Preclinical IBD Program

2 months ago talkbio0Tagged Drug Discovery, genentech, Inflammatory Bowel Diseases, milestone payments, OdyssION platform, OMass, Partnership, preclinical program, Roche (company), small molecule therapy

Genentech; Roche; OMass Therapeutics; inflammatory bowel disease (IBD); preclinical program; biotech partnership; OdyssION platform; small molecule therapy; drug discovery; milestone payments

Roche and Alnylam Push Zilebesiran into Phase III Trial Despite Mixed Phase II Hypertension Data

2 months ago talkbio0Tagged Alnylam, Cardiovascular system, Hypertensive disease, KARDIA-3, outcomes, Phase 2 Clinical Trials, Phase 3 Clinical Trials, RNA Interference, Roche (company), ZENITH trial, Zilebesiran

Roche; Alnylam; zilebesiran; hypertension; RNAi therapeutics; KARDIA-3; Phase II trial; Phase III trial; cardiovascular outcomes; ZENITH trial

Teva Launches First Generic GLP-1 Weight-Loss Drug in the US

2 months ago talkbio0Tagged Approved, Generic Drugs, Glucagon-Like Peptide 1, liraglutide, Obesity, Saxenda, Teva, United States, United States Food and Drug Administration, Weight Loss

Teva; GLP-1; generic; weight loss; liraglutide; FDA approval; Saxenda; obesity treatment; United States

J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results

2 months ago talkbio0Tagged Autoimmune Diseases, Clinical Research, Clinical trial failure, daisy, Imaavy, Johnson and Johnson, Nipocalimab, Phase 2a Trial, Rheumatoid Arthritis

Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases

FDA Approves Updated COVID-19 Shots from Pfizer, Moderna, Novavax with New Restrictions

2 months ago talkbio0Tagged COVID19 (disease), high-risk groups, LP.8.1 sublineage, Moderna, Novavax, Pfizer, restrictions, United States Food and Drug Administration, Vaccines

FDA; COVID-19 vaccine; Pfizer; Moderna; Novavax; vaccine restrictions; high-risk groups; 2025-2026 booster; LP.8.1 sublineage

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

2 months ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial

Stockpiling Frenzy Prompts Lilly to Suspend UK Mounjaro Supply

2 months ago talkbio0Tagged eli lilly, Mounjaro, price hike, stockpiling, supply suspension, UK, Weight-Loss Agents

Eli Lilly; Mounjaro; stockpiling; UK; supply suspension; price hike; weight loss drug; tirzepatide

ESC25: GE HealthCare Showcases AI Cardiology Innovations for Earlier and More Accurate Diagnoses

2 months ago talkbio0Tagged Artificial Intelligence, authorization, Cardiac imaging, Cardiology discipline, CardIQ, Diagnostic Accuracy, Electrophysiology (science), ESC25, GE HealthCare, Molecular Imaging, Revolution Vibe CT, United States Food and Drug Administration, ViewPoint EchoPilot, workflow automation

GE HealthCare; ESC25; AI cardiology; diagnostic accuracy; ViewPoint EchoPilot; CardIQ Suite; Revolution Vibe CT; molecular imaging; workflow automation; electrophysiology; cardiac imaging; FDA authorization

Prothena’s Alzheimer’s Trial Hit by High ARIA-E Rates, Resulting in ‘Non-Competitive’ Profile

2 months ago talkbio0Tagged Alzheimer 's disease, amyloid beta antibody, ARIA-E, ASCENT, Cerebral Edema, clinical program, non-competitive profile, Prothena, PRX012, subcutaneous administration

Prothena; PRX012; Alzheimer’s disease; ARIA-E; brain swelling; phase 1 trial; non-competitive profile; amyloid beta antibody; ASCENT clinical program; subcutaneous administration