Governmental or Regulatory Activity – Page 6

FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

4 months ago talkbio0Tagged Advisory Committees, Ataxia, Spinocerebellar, Biohaven, Deferred, disease drug, Extension, Infrequent, Neurodegenerative Disorders, PDUFA, Troriluzole, United States Food and Drug Administration

Biohaven; FDA delay; troriluzole; spinocerebellar ataxia (SCA); rare disease drug; PDUFA extension; advisory committee; neurodegenerative disease

RFK Jr. Defends HHS Staff Cuts and Reorganization at House and Senate Hearings

4 months ago talkbio0Tagged Budgets, CHARGE Syndrome, Congress (U.S. Legislature), health coverage, HELP Committee, House Appropriations Committee, Medicaid, reorganization, RFK Jr., Senate, Staff

RFK Jr.; HHS; staff cuts; reorganization; Congress; House Appropriations Committee; Senate HELP Committee; budget cuts; Medicaid; health coverage

White House Threatens Most Favored Nation Plan to Lower US Drug Prices, but Many Questions Remain

4 months ago talkbio0Tagged Comparison, Drug Prescriptions, drug price, Favored, global price, Nation, Pharmaceutical Policy, Trump administration, U.S., White House

Most Favored Nation; drug pricing; White House; executive order; prescription drugs; Trump administration; US drug prices; global price comparison; pharmaceutical policy

Trump signs sweeping executive order to cut US drug prices by ‘up to 90%’

4 months ago talkbio0Tagged HHS, Policy, Prices, Transplant Registry Unified Management Program, United States

Prices, HHS, United States, Transplant Registry Unified Management Program, Policy

FDA Vaccine Advisory Committee to Determine 2025-2026 COVID-19 Vaccine Formulation

4 months ago talkbio0Tagged Advisory Committees, COVID19 (disease), Formula - diet, meeting, strain selection, United States Food and Drug Administration, Vaccines, VRBPAC

COVID-19 vaccines, FDA advisory committee, strain selection, 2025-2026 formula, vaccine updates, VRBPAC meeting

From deal to disaster: Drugmakers face a changed Washington as Trump embraces most favored nation prices

4 months ago talkbio0Tagged Disasters, drugmakers, Medicaid, MFN, Nation, Policy, Prices, Transplant Registry Unified Management Program, U.S.

Prices, Transplant Registry Unified Management Program, MFN, Nation, Disasters, Medicaid, Policy, drugmakers, U.S.

‘Now is not the time to retreat’: BMS CEO blasts Trump admin tariffs, health reforms amid $40B US investment pledge

4 months ago talkbio0Tagged Drug Industry, Health Care Reform, Home environment, Manufacturing, Myers, pharmaceutical manufacturing, pharmaceutical tariffs, squibb, Trump tariffs, U.S.

Bristol Myers Squibb, Trump tariffs, pharmaceutical manufacturing, domestic investment, pharmaceutical industry, US manufacturing, healthcare reform, pharmaceutical tariffs

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

5 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

CMS would absorb 340B drug discount program under leaked HHS reorganization proposal

5 months ago talkbio0Tagged 340B, Centers for Medicare and Medicaid Services, Changing, CMS, drug discount program, HHS, Leaked, Policy, Programs - Publication Format, proposal - intent, reorganization, United States Health Resources and Services Administration

340B, Centers for Medicare and Medicaid Services, HHS, reorganization, Programs – Publication Format, proposal – intent, drug discount program, United States Health Resources and Services Administration, CMS, Policy, Leaked, Changing

FDA moves to block biopharma employees from serving on advisory committees

5 months ago talkbio0Tagged Advisory Committees, Industry, Policy, United States Food and Drug Administration, Workers

United States Food and Drug Administration, Workers, Advisory Committees, Industry, Policy