July 28, 2025 – Talk Bio

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

4 weeks 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

GSK Strengthens COPD Offering via $12 Billion Multi-Program Deal with China’s Hengrui Pharma

4 weeks ago talkbio0Tagged biobucks, COPD, Hengrui Pharma, HRS-9821, Immunology, Licensing, Neoplasms, Nucala, PDE3/4 inhibitor, SmithKline Beecham

GSK; Hengrui Pharma; COPD; biobucks; PDE3/4 inhibitor; HRS-9821; Nucala; immunology; oncology; licensing deal

RFK Jr. Reportedly Weighs Preventive Services Panel Revamp, Raising Risks for HIV PrEP Drugmakers

4 weeks ago talkbio0Tagged Advisory Committees, drugmakers, health disparity, HIV Prevention, Insurance, PREP gene, preventive services panel, public health policy, revamp, RFK Jr., USPSTF

RFK Jr.; preventive services panel; USPSTF; PrEP; HIV prevention; insurance coverage; public health policy; drugmakers; health disparities; revamp; task force

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

4 weeks 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

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

4 weeks 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

Rethinking Clinical Trial Data in the Era of Decentralization: Key Trends and Challenges (2025)

4 weeks ago talkbio0Tagged Aortic Valve Insufficiency, Clinical Trials, Data Integration, Data Quality, DCT gene, decentralized, Diversity, Preventive monitoring, regulatory guidance, Remote, risk-based oversight, trials

decentralized clinical trials; DCT; data quality; patient diversity; remote monitoring; AI in trials; data integration; risk-based oversight; clinical trial data; regulatory guidance

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

4 weeks 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