Uncategorized – Page 8

Sanofi’s Wayrilz Receives FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

1 week ago talkbio0Tagged Approved, Autoimmune thrombocytopenia, BTK inhibitor, Inosine Triphosphate, LUNA 3 trial, Rilzabrutinib, sanofi, United States Food and Drug Administration, Wayrilz

Wayrilz; rilzabrutinib; FDA approval; immune thrombocytopenia; ITP; BTK inhibitor; Sanofi; LUNA 3 trial

Servier Pays $210M Upfront for Ex-US Rights to Ideaya’s PKC Inhibitor Darovasertib

1 week ago talkbio0Tagged Clinical Trials, Darovasertib, Ideaya Biosciences, Inhibitor, milestone payments, oncology licensing deal, Protein Kinase C, Protein Kinase C Inhibitor, royalties, Servier, uveal melanoma

Servier; Ideaya Biosciences; darovasertib; protein kinase C inhibitor; PKC inhibitor; uveal melanoma; oncology licensing deal; clinical trials; milestone payments; royalties

Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos

1 week ago talkbio0Tagged Child, COVID19 (disease), Evidence, Prasad, regulatory decisions, risk-benefit analysis, Spikevax, United States Food and Drug Administration, vaccine approval, Vaccine Safety, Vaccines, Vinay

Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis

United Therapeutics’ Tyvaso Succeeds in Phase 3 IPF Trial, Marking Major Advance in Lung Disease Treatment

1 week ago talkbio0Tagged Clinical Trials, Forced Vital Capacity, Idiopathic Pulmonary Fibrosis, IPF, Lung diseases, nebulized body site, Pulmonary Fibrosis, TETON-2, Tyvaso, United States Food and Drug Administration, United Therapeutics, Vital capacity test

Tyvaso; United Therapeutics; idiopathic pulmonary fibrosis; IPF; Phase 3 trial; TETON-2; lung disease; forced vital capacity; FVC; clinical trial; FDA; nebulized treprostinil

Ionis Posts Strong Results for Tryngolza in Severe Blood Fat Disease

1 week ago talkbio0Tagged Approved, cardiovascular risk reduction, drug launch, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Olezarsen, Phase III Essence study, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; hypertriglyceridemia; triglycerides; Phase III Essence study; FDA approval; familial chylomicronemia syndrome; cardiovascular risk reduction; drug launch

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

1 week 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

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

1 week 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

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

1 week 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

Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile

1 week ago talkbio0Tagged benefit-risk profile, Clinical Trials, Dose-Limiting, Drug Development, Malignant Neoplasms, mesothelin, T-Cell engager, Toxicity aspects, ZW171, Zymeworks

Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity

Zenas BioPharma Secures $300M Royalty Deal for Obexelimab FDA Approvals

1 week ago talkbio0Tagged Approved, Autoimmune Diseases, IgG4-Related Disease, Lupus Erythematosus, Systemic, Obexelimab, Phase 3 INDIGO trial, Royalty, Royalty Pharma, United States Food and Drug Administration, Zenas BioPharma

Zenas BioPharma; Royalty Pharma; Obexelimab; autoimmune diseases; IgG4-Related Disease; Systemic Lupus Erythematosus; FDA approval; royalty agreement; Phase 3 INDIGO trial; funding