Organic Chemical – Page 3

AstraZeneca Appeals to Supreme Court in Final Attempt to Challenge Medicare Drug Price Negotiation Program

1 month ago talkbio0Tagged AstraZeneca, drug price, Farxiga, Inflation Reduction Act, Medicare, Myasthenic Syndromes, Congenital, Negotiation Program, Supreme Court

AstraZeneca; Medicare Drug Price Negotiation Program; Supreme Court; Inflation Reduction Act; Third Circuit; due process; pharmaceuticals; CMS; drug pricing; Farxiga

Sparrow Pharmaceuticals Raises $95M Series B for Midstage Diabetes Study

1 month ago talkbio0Tagged Capital Management, clofutriben, Diabetes Mellitus, Non-Insulin-Dependent, Forbion, hydrocortisone, Psychological inhibition, Rheumatoid Arthritis, Series B fundraising, SPAG8 gene, Sparrow Pharmaceuticals, venture

Sparrow Pharmaceuticals; Series B fundraising; Type 2 diabetes; clofutriben; phase 2b trial; HSD-1 inhibition; cortisol; RA Capital Management; Forbion; venture capital

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

1 month 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

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

1 month 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

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

1 month 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

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

1 month 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

FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence

1 month ago talkbio0Tagged brexpiprazole, Clinical Trials, Complete, Drug Approval, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Response Letter, Rexulti, sertraline, sNDA, United States Food and Drug Administration

FDA; Rexulti; Lundbeck; Otsuka; PTSD; brexpiprazole; sertraline; Complete Response Letter; sNDA; clinical trials; drug approval

FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

1 month ago talkbio0Tagged BTK inhibitor, Clinical action, December 2025, drug review, Multiple Sclerosis, nrSPMS, PDUFA, sanofi, Tolebrutinib, United States Food and Drug Administration

FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA

Roche’s Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial

1 month ago talkbio0Tagged advanced breast cancer, Clinical Research, ER-positive, giredestrant, Hormone Therapy, Malignant neoplasm of breast, Oral SERD, Phase 3 Clinical Trials, Progression-Free Survival, Roche (company)

Roche; oral SERD; giredestrant; progression-free survival; pivotal study; breast cancer; ER-positive; endocrine therapy; Phase III trial; advanced breast cancer

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

1 month ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review