Governmental or Regulatory Activity – Page 4

Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel

2 months ago talkbio0Tagged Advisory Committees, CHARGE Syndrome, Paul Offit, Policy, removal technique, RFK Jr., United States Food and Drug Administration, vaccine panel, Vaccines, VRBPAC

Paul Offit; FDA; vaccine panel; RFK Jr.; removal; vaccine policy; VRBPAC; advisory committee; HHS

FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

2 months ago talkbio0Tagged Adverse event, Cessation of life, chikungunya vaccine, Encephalitis, Hospitalization, Ixchiq, license suspension, Safety, United States Food and Drug Administration, Valneva

FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths

Tariffs and MFN Policy Power a Broad, Confusing Pharma War

2 months ago talkbio0Tagged Drug Industry, drug manufacturing, Drug Prescriptions, Medicaid, MFN, Nation, onshoring, pharma innovation, Policy, Trump administration

tariffs; Most Favored Nation (MFN) policy; prescription drug pricing; pharmaceutical industry; Trump administration; drug manufacturing; onshoring; Medicaid; pharma innovation

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

2 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, access program, Drug Approval, Elamipretide, Infrequent, resubmission, Stealth BioTherapeutics, United States Food and Drug Administration

Stealth BioTherapeutics; FDA resubmission; rare disease; Barth syndrome; elamipretide; drug approval; expanded access program

Conflicts of Interest Among Federal Vaccine Advisors at Historic Lows Through 2024

2 months ago talkbio0Tagged ACIP, Advisory Committees, Centers for Disease Control and Prevention (U.S.), JAMA study, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccines, VRBPAC

conflicts of interest; vaccine advisory committees; ACIP; VRBPAC; CDC; FDA; transparency; Robert F. Kennedy Jr.; JAMA study

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

2 months ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

US to Stockpile Critical Drug Ingredients Under Latest Trump Executive Order

3 months ago talkbio0Tagged ASPR, domestic manufacturing, drug ingredients, essential medicines, executive order, National Security, Pharmaceutical Ingredients Reserve, Pharmaceutical Supply Chain, strategic, Transplant Registry Unified Management Program

Trump; Executive Order; drug ingredients; pharmaceutical supply chain; Strategic Active Pharmaceutical Ingredients Reserve; ASPR; domestic manufacturing; national security; essential medicines

Uncertainty Clouds Finances for Payers and Health Systems in Q2 2025

3 months ago talkbio0Tagged Budgets, Changing, Consumer, federal, health systems, healthcare financial performance, Hospital admission, Medicaid, Medicare, payers, Policy, Q2 2025, Uncertainty

Q2 2025; healthcare financial performance; payers; health systems; uncertainty; Medicaid; Medicare; admissions; policy changes; federal budget; consumer confidence

Obesity Leaders Dig Manufacturing Moats To Defend Injectable GLP-1 Empires

3 months ago talkbio0Tagged Bariatric Surgery, biosimilars/generics, Capital Expenditures, China, competition, constraints, eli lilly, GLP-1 pipeline, Glucagon-Like Peptide 1, manufacturing capacity, Market, Medicare, Nordisk, Obesity, Policy, Risk, Wegovy, Zepbound

GLP-1; manufacturing capacity; Eli Lilly; Novo Nordisk; obesity drugs; Wegovy; Zepbound; capital expenditures; supply constraints; market competition; Medicare coverage; policy risk; biosimilars/generics; China GLP-1 pipeline; bariatric surgery

GSK set to receive over $500M from mRNA patent settlement tied to BioNTech–CureVac–Pfizer deal

3 months ago talkbio0Tagged BioNTech, BioNTech acquisition, COVID19 (disease), CureVac, global framework, Influenza virus vaccine, Licensing, Litigation, Pfizer, RNA, Messenger, royalties, settlement, SmithKline Beecham, U.S., upfront payment, Vaccines, Vaccines, Combined

GSK; CureVac; BioNTech; Pfizer; mRNA patents; settlement; royalties; COVID-19 vaccine; influenza vaccine; combination vaccines; licensing; upfront payment; US litigation; global framework; BioNTech acquisition of CureVac