talkbio – Page 8

Sarepta Halts Duchenne Gene Therapy in Some Patients After Second Death

3 weeks 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

Sage Therapeutics Acquired by Supernus Pharmaceuticals in $561M Deal

3 weeks 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

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

3 weeks 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

Gilead Lays Off 36 Employees After Cancelling Oceanside, California Expansion

3 weeks ago talkbio0Tagged Biological Factors, biotech industry, California, co-location, expansion, Facility (object), Foster City, Gilead Sciences, layoffs, Oceanside

Gilead Sciences; layoffs; Oceanside; California; biologics; facility expansion; job cuts; biotech industry; co-location; Foster City

Illuminating the CKD Patient Journey: Clinicogenomic Data Reshapes Research & Drug Discovery

3 weeks ago talkbio0Tagged Cell Therapy, Chronic Kidney Diseases, Clinical Trials, clinicogenomics, Drug Discovery, gene therapy, Precision Medicine

chronic kidney disease; CKD; clinicogenomics; drug discovery; cell therapy; gene therapy; clinical trials; personalized medicine

AstraZeneca and CSPC Enter $5.3B AI-Driven Drug Discovery Pact in China

3 weeks ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, AstraZeneca, China, Chronic disease, Dosage Forms, Drug Discovery, GZMH gene, Investments, oral therapies, Partnership, R&D, research

AstraZeneca; CSPC Pharmaceutical; AI research; drug discovery; chronic diseases; China; $5.3 billion; oral therapies; partnership; R&D investment

UCB Announces Major Investment to Expand US Biologics Manufacturing Capacity

3 weeks ago talkbio0Tagged Biological Factors, biomanufacturing, economic impact, expansion, Investments, Manufacturing, U.S., UCB

UCB; biologics manufacturing; US expansion; biomanufacturing; biopharmaceutical; investment; jobs; economic impact

AstraZeneca Signs $110M AI-Driven R&D Deal with CSPC Pharmaceutical for Chronic Disease Drugs

3 weeks ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, AstraZeneca, China pharma, Chronic disease, Collaboration, Dosage Forms, Drug Discovery, Drug Industry, GZMH gene, Immune System Diseases, milestone payments, oral therapies

AstraZeneca; CSPC Pharmaceutical; AI drug discovery; chronic diseases; immunological diseases; oral therapies; R&D collaboration; China pharma; milestone payments; pharmaceutical industry

Moderna Wins Expanded FDA Approval for RSV Vaccine in At-Risk Younger Adults

3 weeks ago talkbio0Tagged Adult, Approved, At-Risk, chronic health conditions, expanded label, Moderna, mRESVIA, RSV vaccine, United States Food and Drug Administration

Moderna; RSV vaccine; FDA approval; mRESVIA; at-risk adults; 18 to 59 years; expanded label; chronic health conditions

J&J CAR-T Therapy Achieves 100% Response Rate in Early-Stage Lymphoma Trial

3 weeks ago talkbio0Tagged CAR-T therapy, CD19 Antigens, CD20 Antigens, Clinical Trials, dual-targeting, Early-stage, Frequency of Responses, J&J, JNJ-4496, Lymphoma, Phase 1b, relapsed/refractory large-B-cell lymphoma

J&J; CAR-T therapy; lymphoma; early-stage; clinical trial; dual-targeting; CD19; CD20; objective response rate; Phase 1b; JNJ-4496; relapsed/refractory large B-cell lymphoma