Biologically Active Substance – Page 11

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

5 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Boundless Bio Lays Off 33% of Staff Following Stumble of Lead Program

6 months ago talkbio0Tagged BBI-355, BBI-825, Bio, Boundless, CHEK1 protein, human, Clinical Trials, Combined Modality Therapy, Inhibitor, layoffs, pipeline restructuring, ribonucleoside-diphosphate reductase activity, Solid Neoplasm

Boundless Bio; layoffs; biotech; clinical trial; BBI-355; BBI-825; RNR inhibitor; CHK1 inhibitor; combination therapy; solid tumors; pipeline restructuring

About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds

6 months ago talkbio0Tagged Biological Factors, CBER, CDER, Drug Approval Process, drug review, layoffs, Staff, Trump administration, United States Food and Drug Administration

FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process

Sanofi Acquires Vigil Neuroscience for $470 Million, Bolstering Alzheimer’s Drug Pipeline

6 months ago talkbio0Tagged Acquisition, Agonist, Alzheimer 's disease, Microglia, Neurodegenerative Disorders, Phase 2 Trials, sanofi, TREM2, VG-3927, Vigil Neuroscience

Sanofi; Vigil Neuroscience; acquisition; Alzheimer’s disease; TREM2 agonist; VG-3927; microglia; neurodegenerative disease; Phase 2 trials; biotech deals

FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

6 months ago talkbio0Tagged Advisory Committees, enzalutamide, expansion, Inhibitor, Labels (device), Malignant neoplasm of prostate, mCRPC, PARP1 gene, Pfizer, talazoparib, Talzenna, unanimous vote, United States Food and Drug Administration

FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

6 months ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy

GSK Acquires Phase III-Ready Liver Drug Efimosfermin for Up to $2B to Enter MASH Arena

6 months ago talkbio0Tagged Analog, Boston Pharmaceuticals, drug acquisition, efimosfermin alfa, fibroblast growth factor 21, Liver diseases, MASH, Phase III, SLC17A5 gene, SmithKline Beecham

GSK; Boston Pharmaceuticals; efimosfermin alfa; Phase III; liver disease; MASH; SLD; drug acquisition; FGF21 analog

Lilly says further head-to-head trial data back Zepbound over Novos Wegovy

6 months ago talkbio0Tagged Comparative Efficacy, Obesity, semaglutide, SURMOUNT-5 Trial, tirzepatide, Weight Loss

Tirzepatide, Semaglutide, Weight Loss, Obesity Treatment, SURMOUNT-5 Trial, Comparative Efficacy

Lilly backs $65M raise for biotech plumbing the ‘dark genome’ with AI

6 months ago talkbio0Tagged Artificial Intelligence, Dark color, Eli, Eli Lilly, Genome, Haya, Long Intergenic Non-Protein Coding RNA, Obesity

Haya, Eli Lilly, Genome, Long Intergenic Non-Protein Coding RNA, Obesity, Aortic Valve Insufficiency, Eli, Dark color

Teva plots thousands of job cuts as restructuring drive enters ‘acceleration’ phase

6 months ago talkbio0Tagged 8, Biological Factors, Financial cost, Financial savings, generics, Investments, Operational streamlining, Pivot Device, R&D, Strategic Overhaul, Workforce reduction

Workforce reduction (8%), $700 million cost savings, Strategic overhaul, Generics to biopharmaceuticals pivot, Operational streamlining, R&D investment