ORG – Page 39 – Talk Bio

Roche and AbbVie Announce Phase 3 Venclexta Trial Fails to Meet Primary Endpoint in High-Risk MDS

3 months ago talkbio0Tagged AbbVie, Antineoplastic Agents, azacitidine, Clinical Research, Clinical Trials, Miller Dieker syndrome, MYELODYSPLASTIC SYNDROME, Phase 3 trial, Roche (company), Venclexta, venetoclax, Verona

Roche; AbbVie; Venclexta; venetoclax; azacitidine; myelodysplastic syndromes; MDS; Phase 3 trial; VERONA study; clinical trial results; cancer drug

Lark Health Launches LarkVantage: AI-Powered Platform to Manage GLP-1 Costs

3 months ago talkbio0Tagged Administration occupational activities, Aortic Valve Insufficiency, authorization, cost management, Gibbs, Glucagon-Like Peptide 1, Health care facility, Health Planning, Lark Health, LarkVantage, Pharmacy Benefit Manager, utilization qualifier, Weight maintenance regimen

Lark Health; LarkVantage; GLP-1 cost management; AI healthcare; prior authorization; utilization management; PBM; health plans; weight management; Matthew Gibbs

Second Patient Dies After Receiving Sarepta’s Elevidys Gene Therapy for DMD

3 months ago talkbio0Tagged AAV-based gene therapy, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Patient Death, risk mitigation, Unable to walk (finding), United States Food and Drug Administration

Duchenne muscular dystrophy; gene therapy; Sarepta Therapeutics; Elevidys; acute liver failure; AAV-based gene therapy; patient death; non-ambulatory patients; FDA; risk mitigation

NextCure Partners with Simcere for Novel ADC in $745M Deal

3 months ago talkbio0Tagged ADC, Antibody-Drug Conjugates, CDH6 gene, cellular targeting, NextCure, SIM0505, Simcere, therapeutic autologous dendritic cells

NextCure; Simcere; Antibody-Drug Conjugate; ADC; SIM0505; CDH6 Targeting

Lilly Makes All Zepbound Doses Available via Direct Pay Program

3 months ago talkbio0Tagged Availability of, Dosage, eli lilly, LillyDirect, Obesity, pharmacy platform, Zepbound

Zepbound; Eli Lilly; direct pay; LillyDirect; tirzepatide; obesity medication; dose availability; pharmacy platform

Fauna Unveils ‘Fauna Brain’: An Agentic AI System Accelerating Drug Discovery with Proven Results in Lilly Collaboration

3 months ago talkbio0Tagged agentic AI, Aortic Valve Insufficiency, Brain, Comparative Genomics, Drug Discovery, Lilly collaboration, multi-agent system, Pharmaceutical Research

Fauna Brain; agentic AI; drug discovery; comparative genomics; Lilly collaboration; multi-agent system; pharmaceutical research; AI platform

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

3 months ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment

Sage Therapeutics Acquired by Supernus Pharmaceuticals in $561M Deal

3 months ago talkbio0Tagged Acquisition, Biogen, Deal Value, Depression, Postpartum, Drug Industry, Supernus Pharmaceuticals, Zurzuvae

Sage Therapeutics; Supernus Pharmaceuticals; acquisition; Zurzuvae; postpartum depression; biotech; pharmaceutical industry; major depressive disorder; Biogen; deal value

Sarepta Halts Duchenne Gene Therapy in Some Patients After Second Death

3 months ago talkbio0Tagged Clinical Trials, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient safety, Therapeutic immunosuppression, Unable to walk (finding), United States Food and Drug Administration

Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; Elevidys; acute liver failure; non-ambulatory patients; FDA; clinical trial pause; immunosuppression; patient safety

Lilly Posts Encouraging Early-Stage Weight Loss Data on Amylin Candidate

3 months ago talkbio0Tagged Amylin Candidate, aspects of adverse effects, Clinical Data, early-stage trial, Eli, Eli Lilly, Eloralintide, Obesity, Weight Loss

Eli Lilly; eloralintide; amylin candidate; weight loss; early-stage trial; obesity drug; clinical data; side effects