ORG – Page 25 – Talk Bio

DTC vs. DTP: Regulatory Uncertainty & Access Challenges Drive New Go-to-Market Models (2025 Update)

2 months ago talkbio0Tagged Access, Aortic Valve Insufficiency, Artificial Intelligence, Diphtheria-Tetanus-Pertussis Vaccine, Direct-to-Consumer, direct-to-patient, Ditiocarb, DTP, formulary restrictions, go-to-market models, OOP costs, pharmaceutical marketing, regulatory uncertainty, Rx abandonment, Telemedicine, United States Food and Drug Administration

DTC (Direct-to-Consumer); DTP (Direct-to-Patient); regulatory uncertainty; access challenges; pharmaceutical marketing; go-to-market models; FDA; Rx abandonment; formulary restrictions; OOP costs; telehealth; AI in marketing

Atai’s Schizophrenia Drug Fails to Improve Cognition in Phase 2 Study

2 months ago talkbio0Tagged Atai Life Sciences, CIAS, clinical endpoints, Clinical trial failure, Cognition, Impaired cognition, inidascamine, Recognify Life Sciences, Schizophrenia

Atai Life Sciences; Recognify Life Sciences; inidascamine; schizophrenia; cognitive impairment; Phase 2b trial; clinical trial failure; cognition; CIAS; clinical endpoints

FDA Investigates Elevidys Death; Sarepta and Roche Deny Link to Gene Therapy

2 months ago talkbio0Tagged Brazil, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Patient Death, Roche (company), Safety, Suspensions, United States Food and Drug Administration

FDA; Elevidys; Sarepta Therapeutics; Roche; gene therapy; Duchenne muscular dystrophy; patient death; Brazil; market suspension; safety concerns

Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab

2 months ago talkbio0Tagged Alzheimer 's disease, amyloid-lowering drug, Biological Markers, Brainshuttle, Drug Development, Interventional procedure, Phase 3 Clinical Trials, Roche (company), TRONTIER, Trontinemab

Roche; Alzheimer’s disease; trontinemab; amyloid-lowering drug; Brainshuttle; Phase III trial; TRONTIER studies; drug development; biomarkers; early intervention

CHMP Recommends Against Approval of Elevidys Gene Therapy in Europe, Dealing Blow to Sarepta and Roche

2 months ago talkbio0Tagged CHMP, ELEVIDYS, EMBARK trial, Europe, gene therapy, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Muscular Dystrophy, Duchenne, negative opinion, Roche (company)

CHMP; Elevidys; Sarepta; Roche; gene therapy; Duchenne muscular dystrophy; EMA; negative opinion; Europe; EMBARK trial

Trinity Biotech Repositions for AI-Driven Growth with CGM+ Biosensor Platform

2 months ago talkbio0Tagged AI-powered healthcare, biotech, CGM, chronic disease management, continuous glucose monitor, digital health, multi-sensor, Precision Medicine, Predictive analytics, Trinity (ethnic group), wearable biosensor

Trinity Biotech; CGM+; AI-powered healthcare; digital health; continuous glucose monitor; wearable biosensor; multi-sensor data; predictive analytics; personalized medicine; chronic disease management

Novartis Bets on Covalent Chemistry in $1B Matchpoint Therapeutics Deal

2 months ago talkbio0Tagged Advanced phase, biotechnology partnerships, covalent chemistry, Covalent Interaction, Drug Development, Inflammatory disorder, License, Matchpoint Therapeutics, Novartis, oral inhibitors

Novartis; Matchpoint Therapeutics; covalent chemistry; exclusive option and license agreement; inflammatory diseases; oral inhibitors; Advanced Covalent Exploration platform; drug development; biotechnology partnerships

Rocket Pharmaceuticals Cuts 30% of Staff, Refocuses on Heart Gene Therapies

2 months ago talkbio0Tagged 30%, Anemia, BAG3-associated, cardiovascular gene therapy, Deficiency of pyruvate kinase, Dependovirus, Financial cost, Glycogen Storage Disease Type IIb, Kresladi, layoffs, PKP2-associated cardiomyopathy, restructuring, Rocket

Rocket Pharmaceuticals; layoffs; restructuring; 30% workforce reduction; cardiovascular gene therapy; adeno-associated virus (AAV); Danon disease; PKP2-associated cardiomyopathy; BAG3-associated dilated cardiomyopathy; operating cost reduction; Fanconi Anemia; Pyruvate Kinase Deficiency; KRESLADI

Galapagos Considers Sale of Cell Therapy Unit in Ongoing Strategic Overhaul

2 months ago talkbio0Tagged Business Development, Cell Therapy, Galapagos, Gilead Sciences, GLPG5101, Mantle cell lymphoma, pipeline, Sales - occupational activity, strategic alternatives

Galapagos; cell therapy; sale; strategic alternatives; pipeline pruning; biotech; spinout; Gilead Sciences; GLPG5101; mantle cell lymphoma; business development

FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys

2 months ago talkbio0Tagged approval status, CBER, concerns, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, Pauses, Safety, Scientific Study, shipment, United States Food and Drug Administration

Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status