Disease or Syndrome – Page 20

Merck’s Oral PCSK9 Inhibitor Enlicitide Decanoate Achieves Third Consecutive Phase 3 Success

2 months ago talkbio0Tagged Administration of prophylactic statin, Clinical Trials, CORALreef Lipids, enlicitide decanoate, Hypercholesterolemia, LDL Cholesterol Lipoproteins, Merck, Oral cavity, oral PCSK9, PCSK9 inhibitor

Merck; oral PCSK9 inhibitor; enlicitide decanoate; Phase 3 trials; CORALreef Lipids; hypercholesterolemia; lowering LDL cholesterol; statin therapy; first oral PCSK9; clinical trial results

Vertex forges $2B-plus alliance with Enlaza to create new autoimmune drugs, improve conditioning methods

2 months ago talkbio0Tagged Autoimmune Diseases, conditioning regimens, covalent biologics, drug conjugates, engagers, Enlaza, gene therapy, T-Lymphocyte, War-Lock platform

Vertex Pharmaceuticals; Enlaza Therapeutics; autoimmune diseases; gene therapy; conditioning regimens; War-Lock platform; covalent biologics; drug conjugates; T-cell engagers; biotech alliance

Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

2 months ago talkbio0Tagged Aficamten, Approved, Cytokinetics, Hypertrophic obstructive cardiomyopathy, PDUFA, Performance, REMS, United States Food and Drug Administration

Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance

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

2 months 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

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

2 months 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

2 months 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

2 months 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

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

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

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