September 24, 2025

Acadia Halts Development of Nasal Prader-Willi Drug After Phase 3 Failure

2 weeks ago talkbio0Tagged Acadia, carbetocin, Clinical trial failure, Compass, Hyperphagia, Nasal Spray, Prader-Willi Syndrome

Acadia Pharmaceuticals; carbetocin; Prader-Willi syndrome; Phase 3 trial; COMPASS PWS study; clinical trial failure; nasal spray; hyperphagia

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

2 weeks ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

Sanofi Injects $625M Into Biotech Investment Arm to Accelerate Innovation

2 weeks ago talkbio0Tagged Cash, cell/gene therapy, digital health, expansion, Immunology, Infrequent, Infusion procedures, Investments, Neurology speciality, portfolio, sanofi, Sanofi Ventures, venture capital

Sanofi; Sanofi Ventures; biotech investment; $625M cash infusion; digital health; immunology; rare diseases; neurology; venture capital; cell/gene therapy; portfolio expansion

FDA’s Move to Update GSK’s Leucovorin for Autism Raises Questions on Dose, Supply, and Data

2 weeks ago talkbio0Tagged Autistic Disorder, Clinical Data, Dosage, drug relabeling, leucovorin, Neurodegeneration Due To Cerebral Folate Transport Deficiency, SmithKline Beecham, United States Food and Drug Administration, Wellcovorin

FDA; GSK; leucovorin; Wellcovorin; autism; cerebral folate deficiency; drug relabeling; dose; supply; clinical data

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

2 weeks ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing

Eli Lilly Picks Houston for $6.5 Billion API Manufacturing Facility

2 weeks ago talkbio0Tagged alpha 1-antitrypsin, cardiometabolic, Eli, Eli Lilly, Generation Park, Houston, Immunology, Investments, Manufacturing, Neoplasms, Neuroscience discipline, pharmaceutical manufacturing, small molecule medicines

Eli Lilly; Houston; API manufacturing; $6.5 billion investment; Generation Park; small molecule medicines; pharmaceutical manufacturing; cardiometabolic; oncology; immunology; neuroscience

BMS Breaks Clinical Losing Streak with Positive Phase 3 Myeloma Readout for Iberdomide

2 weeks ago talkbio0Tagged CELMoD, Clinical Trials, EXCALIBER-RRMM, iberdomide, Minimal Residual Disease Negativity, Multiple Myeloma, Myers, Phase 3, Progression-Free Survival, Protein Degradation, Metabolic, Relapsing course, squibb, Unresponsive to Treatment

Bristol Myers Squibb; iberdomide; multiple myeloma; clinical trial; EXCALIBER-RRMM; minimal residual disease negativity; CELMoD; protein degradation; progression-free survival; phase 3; relapsed or refractory

Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial

2 weeks ago talkbio0Tagged Biopharma, cash runway, Clinical Research, Feedback - system communication, layoffs, Microbiome, Microbiome SER-155, Seres, United States Food and Drug Administration

Seres Therapeutics; layoffs; microbiome; FDA feedback; SER-155; phase 2 trial; workforce reduction; biopharma; clinical studies; cash runway