Governmental or Regulatory Activity – Page 2

US to Stockpile Critical Drug Ingredients Under Latest Trump Executive Order

4 weeks 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

4 weeks 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

4 weeks 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

1 month 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

Two Courts Reject Challenges to Inflation Reduction Act, Marking Major Win for Government

1 month ago talkbio0Tagged administrative law, AstraZeneca, constitutional challenge, Drug Negotiation Program, federal courts, Inflation, Ira (eukaryote), Medicare, Myasthenic Syndromes, Congenital, Third Circuit Court

Inflation Reduction Act; IRA; Medicare Drug Negotiation Program; AstraZeneca; federal courts; constitutional challenge; administrative law; Third Circuit Court; CMS; Medicare

FDA Launches PreCheck Program to Accelerate Domestic Drug Manufacturing

1 month ago talkbio0Tagged alpha 1-antitrypsin, Construction worker, domestic drug manufacturing, Facility (object), National Security, Pharmaceutical Supply Chain, PreCheck, regulatory streamlining, Trump administration, United States Food and Drug Administration

FDA PreCheck; domestic drug manufacturing; pharmaceutical supply chain; API; regulatory streamlining; facility construction; national security; Trump administration

HHS Ends BARDA Funding for Future mRNA Vaccine Development, Citing Efficacy Concerns

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, COVID19 (disease), Effectiveness, Influenza, mRNA Vaccines, project cancellation, public health policy, Robert F. Kennedy, Vaccines

mRNA vaccines; BARDA; Robert F. Kennedy Jr.; vaccine efficacy; HHS; COVID-19; flu; project cancellation; public health policy

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

1 month ago talkbio0Tagged Clinical Trials, Drug Approval, Heterogeneity, IGYNTE, melanoma, Oncolytic Immunotherapy, Rejection, Replimune, RETINITIS PIGMENTOSA 1, scientist protest, United States Food and Drug Administration

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Untangling Sarepta’s Gene Therapy Fallout and Trust Deficit

1 month ago talkbio0Tagged AAVrh74 vector, clinical holds, ELEVIDYS, gene therapy, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Translucent, United States Food and Drug Administration

Sarepta Therapeutics; gene therapy; Elevidys; Duchenne muscular dystrophy; limb-girdle muscular dystrophy; patient deaths; FDA; AAVrh74 vector; regulatory action; clinical holds; transparency

Trump Gives Pharma CEOs 60-Day Ultimatum for ‘Most Favored Nation’ Drug Pricing

1 month ago talkbio0Tagged Drug Industry, Drug Prescriptions, drug price, executive order, Health Policy, Medicaid, nation policy, Transplant Registry Unified Management Program

Trump; pharmaceutical industry; drug pricing; most favored nation policy; executive order; prescription drugs; healthcare policy; Medicaid; tariffs