Uncategorized – Page 2

Flagship’s Most-Funded Startups, Generate and Tessera, Announce Layoffs in 2025

1 day ago talkbio0Tagged Biomedicines, Flagship, layoffs, Pioneering, startups, Tessera

Flagship Pioneering; startups; Generate:Biomedicines; Tessera; layoffs; biotech; 2025

Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

2 days ago talkbio0Tagged AD109, Apnimed, aroxybutynin, atomoxetine, Clinical Trials, LunAIRo, oral drug, Sleep Apnea, Obstructive, Submission, SynAIRgy, United States Food and Drug Administration

Apnimed; AD109; obstructive sleep apnea; OSA; oral drug; phase 3 trial; LunAIRo; SynAIRgy; FDA submission; clinical trial; aroxybutynin; atomoxetine

Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns

2 days ago talkbio0Tagged concerns, ELEVIDYS, gene therapy, halt, Muscular Dystrophy, Duchenne, patient deaths, Roche (company), Safety, shipment, United States Food and Drug Administration

Roche; Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy; gene therapy; FDA; shipment halt; safety concerns; patient deaths

Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure

2 days ago talkbio0Tagged concerns, DMD, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Safety, shipment, Suspensions, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths

CDMO Pulse Check: Lonza Posts Major Sales Rebound as Samsung Bio Keeps Revenue Growth Rolling

2 days ago talkbio0Tagged capsule (pharmacologic), CDMO, commercial, expansion, Growth, Lonza, Manufacturing, profit margin, Sales - occupational activity, Samsung Bio

Lonza; CDMO; sales growth; Samsung Bio; 2025 outlook; profit margin; Capsules & Health Ingredients; commercial momentum; manufacturing expansion

Dispatch Bio Launches with $216M and CAR-T Pioneer Carl June to Advance Universal Solid Tumor Immunotherapy

2 days ago talkbio0Tagged Arch of foot, Cancer Therapeutic Procedure, CAR-T, Carl June, Dispatch Bio, Flare platform, Funding, Immunotherapy, Parker Institute for Cancer Immunotherapy, Partner in relationship, Series, Solid Neoplasm, venture

Dispatch Bio; solid tumors; immunotherapy; CAR-T; Carl June; Series A funding; Flare platform; Parker Institute for Cancer Immunotherapy; ARCH Venture Partners; universal cancer treatment

Abivax aces pair of phase 3 ulcerative colitis trials as end of cash runway looms

2 days ago talkbio0Tagged Abivax, ABTECT-1, ABTECT-2, cash runway, clinical remission, induction trials, maintenance trial, Obefazimod, Oral cavity, Ulcerative Colitis

Abivax; Obefazimod; ulcerative colitis; Phase 3 trial; clinical remission; ABTECT-1; ABTECT-2; cash runway; induction trials; oral miR-124 enhancer; maintenance trial

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

2 days ago talkbio0Tagged Blood - brain barrier anatomy, CorestemChemon, Drug Discovery, FDA/EMA regulatory pathways, Gene Expression Profiling, heart organoids, Lifetech, liver organoids, lymphocyte immune globulin, anti-thymocyte globulin, Organoids, preclinical CRO, Predictive analytics, Tumorigenicity

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models

Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

2 days ago talkbio0Tagged drug rejection, ELEVIDYS, gene therapy, George Tidmarsh, Liver Failure, Acute, pharmaceutical manufacturing, reshoring, Study on Hold, United States Food and Drug Administration

Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

2 days ago talkbio0Tagged ELEVIDYS, gene therapy, lack of transparency, Market, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration, Withdraw (activity)

Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy