Evaluation – Talk Bio

Trump’s Pharmaceutical Tariffs Materialize in New US-EU Trade Deal

3 weeks ago talkbio0Tagged 15%, European (ethnic group), Evaluation, pharmaceutical tariffs, Sectioning technique, tariff, trade agreement, Transplant Registry Unified Management Program, U.S., Union, US-EU

Trump; pharmaceutical tariffs; US-EU trade deal; 15% tariff; Section 232 investigation; European Union exports; trade agreement

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

2 months ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

OpenAI Debuts HealthBench Dataset to Evaluate AI Models in Real-World Medical Scenarios

3 months ago talkbio0Tagged AI safety, Aortic Valve Insufficiency, Evaluation, HealthBench, healthcare benchmark, language models, medical AI, open-source dataset, OpenAI, Physicians, realistic medical scenarios, rubrics

OpenAI; HealthBench; AI healthcare benchmark; large language models; medical AI evaluation; physician rubrics; realistic medical scenarios; AI safety; open-source dataset

Citing tariffs, Illumina slashes guidance, confirms SEC’s Grail investigation is closed

4 months ago talkbio0Tagged Acquisition (action), Divestiture, Evaluation, Grail, Illumina, SEC

Illumina, SEC, Acquisition (action), Evaluation, divestiture, Grail

FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth

4 months ago talkbio0Tagged Cytokinetics, Deferred, Evaluation, Extension, Hypertrophic obstructive cardiomyopathy, Mitigation Strategy, oHCM, PDUFA, Regulatory Setback, REMS, Risk, United States Food and Drug Administration

Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback

Pfizer CEO Bourla suggests pharma tariffs will focus on US adversaries, not allies

4 months ago talkbio0Tagged Administration occupational activities, Albert, Bourla, chain concerns, Evaluation, Investments, Manufacturing, National Security, pharmaceutical tariffs, Policy, Sectioning technique, TNFRSF19 gene, Transplant Registry Unified Management Program

Pharmaceutical tariffs, Section 232 investigation, Albert Bourla, national security, trade policy, manufacturing investments, Trump administration, supply chain concerns

U.S. Biotechs Reveal Tariff Exposure as Trade Inquiry Signals Imminent Pharmaceutical Tariffs

4 months ago talkbio0Tagged Evaluation, global supply chain, Impact food supplement, Import, Manufacturing, pharmaceutical ingredients, pharmaceutical tariffs, Policy, regulatory, reshoring, Sectioning technique, supply chain exposure, TNFRSF19 gene, United States

U.S. biotech, pharmaceutical tariffs, Section 232 investigation, supply chain exposure, trade policy, import costs, reshoring manufacturing, drug pricing, global supply chain, pharmaceutical ingredients, regulatory impact