Regulation or Law

Trump Taps Dr. Oz as Lead Negotiator for ‘Most Favored Nation’ Drug Pricing Policy

2 weeks ago talkbio0Tagged Dr., Drug Costs, drug price, Health Policy, Myasthenic Syndromes, Congenital, Nation, ounce, pharmaceutical negotiations, Transplant Registry Unified Management Program

Trump; Dr. Mehmet Oz; Most Favored Nation; drug pricing; CMS; pharmaceutical negotiations; healthcare policy; drug costs

Roche could rethink $50B US expansion plan if new policies ‘harm’ operations

4 weeks ago talkbio0Tagged expansion, Infantile Neuroaxonal Dystrophy, Investments, Policy, Roche (company), United States

Roche (company), United States, Investments, expansion, Policy, Infantile Neuroaxonal Dystrophy

Accelerating Clinical Trial Excellence: A Seamless IRB & IBC Collaboration

4 weeks ago talkbio0Tagged Biosafety, Clinical Trials, Collaboration, Efficiency, Ethics Committees, Research, Homo sapiens, IBC, multi-institutional research, regulatory, research, streamlined review

Clinical trials, IRB, IBC, collaboration, streamlined review, multi-institutional research, regulatory efficiency, research acceleration, biosafety, human subject protection

Protect Your Trial Data: Endpoint, Imaging, and Safety Review

1 month ago talkbio0Tagged Biomechanical compliance, Clinical Trials, CTMS, Diagnostic Imaging, Encryption, End Point, General Data Protection Regulation, safety review, Security - service

Clinical Trials, Diagnostic Imaging, Security – service, End Point, safety review, General Data Protection Regulation, Biomechanical compliance, CTMS, Encryption

Leaked HHS budget signals $40B in cuts, assumes ACA subsidies expire

2 months ago talkbio0Tagged Administration occupational activities, Agencies, assumes, Budgets, HHS, Leaked, Patient Protection and Affordable Care Act, Programs - Publication Format, proposal - intent, Subsidies

Budgets, HHS, Patient Protection and Affordable Care Act, Subsidies, Agencies, Leaked, Administration occupational activities, proposal – intent, assumes, Programs – Publication Format

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

2 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

Navigating the Biotech Winter: Strategies for Survival and Growth Amid Ongoing Industry Downturn

2 months ago talkbio0Tagged Acquisitions, adaptation, Artificial Intelligence, biotech downturn, growth opportunities, innovation, Landscapes, layoff, Precision Medicine, regulatory, strategic, Survival, trends qualifier

biotech downturn, layoff trends, funding challenges, strategic adaptation, innovation, mergers & acquisitions, workforce planning, precision medicine, artificial intelligence, regulatory landscape, survival strategies, growth opportunities

Biopharma Layoff Trends in Q1 2025 and Outlook for Q2

2 months ago talkbio0Tagged Biopharma, Biopharma layoffs, Changing, Industry, Legal patent, Pharma, pharmaceutical employment, Q1 2025, Q2 layoff, regulatory, restructuring

Biopharma layoffs, Q1 2025 layoffs, biotech job cuts, pharma workforce reductions, restructuring, patent cliffs, regulatory challenges, Q2 layoff forecast, pharmaceutical employment trends, biopharma industry changes.

Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs

2 months ago talkbio0Tagged Biopharma regulatory issues, Budgets, delays, drug review, HHS layoffs, layoffs, Medical Devices, operational, PDUFA, regulatory, RFK Jr., United States Food and Drug Administration, user fee

FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions

Federal Judge Blocks NIH Grant Caps as HHS Appeals Ruling

2 months ago talkbio0Tagged Administration occupational activities, Administrative Procedure Act, appeal, CHARGE Syndrome, federal judge, Health Policy, Indirect, injunction, Legal, Medical Research activity, NIH Mouse, Permanent, research, Transplant Registry Unified Management Program, U.S., United States

NIH, HHS, research funding, grant caps, indirect costs, federal judge, permanent injunction, Trump administration, medical research, Administrative Procedure Act, legal appeal, U.S. healthcare policy.