Governmental or Regulatory Activity
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
Teva Pharmaceuticals Agrees to $450M Settlement Over Kickback and Price-Fixing Allegations
Teva Pharmaceuticals, False Claims Act, Anti-Kickback Statute, price-fixing, kickbacks, settlement, generic drugs, Medicare, Copaxone
CMS Unveils Preliminary List of 101 Generic Drugs for Medicare $2 Out-of-Pocket Plan
Medicare $2 Drug List Model, generic drugs, out-of-pocket costs, medication adherence, health outcomes, CMS Innovation Center
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Ahead of Advisory Committee Meeting
FDA, Stealth BioTherapeutics, elamipretide, Barth syndrome, ultra-rare disease, advisory committee meeting, drug approval, efficacy concerns
CMS Prepares for Second Round of Medicare Drug Price Negotiation Program
Medicare Drug Price Negotiation Program, CMS, drug price negotiations, Inflation Reduction Act, Part D drugs, maximum fair prices (MFPs)
Senators Wyden and Brown Urge FTC to Expand Investigation into PBMs’ Anti-Competitive Practices
Pharmacy Benefit Managers (PBMs), Anti-Competitive Practices, FTC Investigation, Co-Manufacturing Agreements, Drug Prices, Healthcare Reform