ORG – Page 27 – Talk Bio

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

2 months 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 months 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 months 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 months 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

Scancell’s Cancer Vaccine Supercharges Melanoma Immunotherapy in Recent Trials

2 months ago talkbio0Tagged Cancer Vaccines, checkpoint inhibitors, Clinical Trials, Immunotherapy, iSCIB1 +, melanoma, Melanoma TRP2 CTL Epitope Vaccine SCIB1, Scancell, SCOPE trial

Scancell; SCIB1; iSCIB1+; melanoma; cancer vaccine; immunotherapy; checkpoint inhibitors; clinical trial; SCOPE trial

Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys

2 months ago talkbio0Tagged ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Pauses, Safety, shipment, United States Food and Drug Administration

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

GSK to Lay Off 150 Employees in Cambridge, Massachusetts Amid Vaccine Manufacturing Shift

2 months ago talkbio0Tagged biotech employment, Cambridge Massachusetts, Drug Industry, layoffs, Marietta Pennsylvania, site transfer, SmithKline Beecham, Vaccines

GSK; layoffs; Cambridge Massachusetts; vaccine manufacturing; site transfer; Marietta Pennsylvania; pharmaceutical industry; biotech employment

AstraZeneca Highlights Survival Benefit for Tagrisso Combo Amid Competition in Lung Cancer

2 months ago talkbio0Tagged AstraZeneca, Benefit, Combined, EGFR-mutated, FLAURA2 trial, Johnson & Johnson, life-extension, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, Overall Survival, Pharmacotherapy, Tagrisso

AstraZeneca; Tagrisso; lung cancer; Johnson & Johnson; EGFR-mutated NSCLC; overall survival; chemotherapy combination; FLAURA2 trial; life-extension benefit

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

2 months ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings

Sanofi Tightens Grip on RSV with $1.15B Upfront Acquisition of Vicebio, Diversifying Beyond mRNA Vaccines

2 months ago talkbio0Tagged Acquisition, Homo sapiens, Metapneumovirus, Molecular Clamp Technology, non-mRNA vaccine, Respiratory syncytial virus, respiratory vaccines, RSV, sanofi, vaccine pipeline, Vaccines, Combined, Vicebio

Sanofi; Vicebio; acquisition; RSV; human metapneumovirus; combination vaccine; Molecular Clamp technology; non-mRNA vaccine; vaccine pipeline; respiratory vaccines