Governmental or Regulatory Activity
Biopharma Industry Braces for Uncertainty Under Trump’s Second Term: Impact on Vaccines and M&A Deals
Trump’s second term, Biopharma industry, Vaccine regulation, Robert F. Kennedy Jr., M&A deals, FTC policy changes, Healthcare policy uncertainty
FDA Raises Safety Concerns Over AstraZeneca’s Andexxa Ahead of Advisory Committee Meeting
AstraZeneca, Andexxa, FDA, safety concerns, bleeding reversal agent, advisory committee meeting
Dr. Mehmet Oz Nominated to Lead Centers for Medicare and Medicaid Services
Dr. Mehmet Oz, Medicare, Medicaid, Centers for Medicare and Medicaid Services, Trump nomination, healthcare leadership
Pharma’s Future at Stake: Trump’s Victory and Its Implications for Drug Pricing Reform
Donald Trump, Kamala Harris, 2024 Presidential Election, Drug Pricing Reform, Inflation Reduction Act, Medicare Price Negotiations, Pharmaceutical Industry, Biopharma.
FDA Advisory Committee Rejects Lexicon’s Zynquista for Type 1 Diabetes and Chronic Kidney Disease
FDA, Lexicon Pharmaceuticals, Zynquista, sotagliflozin, type 1 diabetes, chronic kidney disease, FDA advisory committee, drug approval
FDA Advisory Committee Votes Against Zynquista for Type 1 Diabetes and Chronic Kidney Disease, Despite Support for Subgroup Benefits
FDA Advisory Committee, Zynquista (sotagliflozin), Type 1 Diabetes (T1D), Chronic Kidney Disease (CKD), Glycemic Control, SGLT1/SGLT2 Inhibitor, Lexicon Pharmaceuticals
Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting
Lexicon Pharmaceuticals, Zynquista, FDA, diabetes drug, advisory committee, regulatory challenges
Federal Court Dismisses Novartis’ Challenge to Inflation Reduction Act, Marking Sixth Win for Government
Inflation Reduction Act, IRA lawsuit, Novartis, Medicare Drug Price Negotiation Program, federal court, pharmaceutical industry, government victory
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
FDA Advisory Committee Supports Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Despite Data Concerns
Stealth BioTherapeutics, elamipretide, Barth syndrome, FDA advisory committee, ultra-rare disease, unmet medical need