Governmental or Regulatory Activity – Page 5

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

3 months 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

3 months 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

3 months 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

3 months 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

3 months ago talkbio0Tagged AAVrh74 vector, clinical holds, ELEVIDYS, gene therapy, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, 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

3 months 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

Moderna Wins UK Appeals Court in Covid-19 Patent Case Against Pfizer/BioNTech

3 months ago talkbio0Tagged appeal, BioNTech, court, COVID19 (disease), EP'949, infringement, Legal patent, legal victory, Moderna, Pfizer, UK, Vaccines

Moderna; Pfizer; BioNTech; UK Court of Appeal; COVID-19 vaccine; patent infringement; EP’949 patent; Comirnaty; legal victory

Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK

3 months ago talkbio0Tagged CEO, competition, Drops - Drug Form, drug market, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Prices, Regulatory Affairs, Shakeup, SmithKline Beecham, United States Food and Drug Administration

Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA

Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy

3 months ago talkbio0Tagged CBER, conservative criticism, departure - ActRelationshipType, Drug Approval, gene therapy, Muscular Dystrophy, Duchenne, Prasad, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vinay

Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration

RFK Jr. Reportedly Weighs Preventive Services Panel Revamp, Raising Risks for HIV PrEP Drugmakers

3 months ago talkbio0Tagged Advisory Committees, drugmakers, health disparity, HIV Prevention, Insurance, PREP gene, preventive services panel, public health policy, revamp, RFK Jr., USPSTF

RFK Jr.; preventive services panel; USPSTF; PrEP; HIV prevention; insurance coverage; public health policy; drugmakers; health disparities; revamp; task force