trials – Talk Bio

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

5 days ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

Boston Pharmaceuticals Achieves Phase 2 Success with Efimosfermin Alfa for MASH Treatment, Paving Way for Pivotal Trials

8 months ago talkbio0Tagged Analog, BOS-580, Clinical Trials, efimosfermin alfa, fibroblast growth factor 21, Liver diseases, MASH, metabolic dysfunction-associated steatohepatitis, Nonalcoholic Steatohepatitis, Phase 2, trials

Efimosfermin alfa (BOS-580), Metabolic dysfunction-associated steatohepatitis (MASH), Non-alcoholic steatohepatitis (NASH), Phase 2 clinical trials, FGF21 analogue, Liver disease treatment, Pivotal trials

Medidata Introduces Bundled Solutions for Oncology and Vaccine Trials to Enhance Study Efficiency

9 months ago talkbio0Tagged adaptive trial designs, Bundled, Clinical Trials, Diversity, Efficiency, Endpoints, Medidata, Patient-Centered, Solutions, trials, Vaccines

Medidata, Oncology Trials, Vaccine Trials, Bundled Solutions, Clinical Trial Efficiency, Patient-Centered Endpoints, Adaptive Trial Designs, Trial Diversity

FDA Places Clinical Hold on Novavax’s COVID-19-Influenza Combination and Standalone Influenza Vaccine Trials

9 months ago talkbio0Tagged COVID19 (disease), Novavax, Peripheral motor neuropathy, Study on Hold, trials, United States Food and Drug Administration, Vaccines

Novavax, FDA, Clinical Hold, COVID-19, Influenza, Vaccine Trials, Motor Neuropathy

Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Eyes 2025 Launch for HIV Prevention

10 months ago talkbio0Tagged HIV prevention, Injection of therapeutic agent, launch, Lenacapavir, PREP gene, regulatory, trials, twice-yearly

Lenacapavir, HIV Prevention, Twice-Yearly Injection, Gilead Sciences, PrEP, PURPOSE 1 and 2 Trials, Regulatory Filings, 2025 Launch

Otsuka Discontinues Alzheimer’s Agitation Drug Development Following Second Unsuccessful Trial

1 year ago talkbio0Tagged Agitation, Alzheimer 's disease, Clinical Trials, Discontinuation (procedure), Drug Development, Failed, Otsuka, trials

Otsuka, Alzheimer’s disease, agitation, drug development, clinical trials, failed trials, discontinuation

Lilly’s Weekly Insulin Therapy Excels in Two Major Clinical Trials, Narrowing Gap with Novo Nordisk

1 year ago talkbio0Tagged Administration occupational activities, Clinical Trials, Diabetes, Drug Industry, Eli Lilly, Insulin, insulin therapy, Nordisk, Primary Endpoint, trials, Weekly

Lilly, Novo Nordisk, weekly insulin, primary endpoint, pivotal trials, diabetes management, insulin therapy, clinical trials, diabetes treatment, pharmaceutical industry.