Governmental or Regulatory Activity
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
FDA Advisory Panel Rejects PD-1 Inhibitors for Gastric and Esophageal Cancers with Low PD-L1 Expression
FDA, PD-1 inhibitors, gastric cancer, esophageal cancer, PD-L1 expression, biomarker, oncology, drug approval
Novo Nordisk’s Ozempic Expected to Face Medicare Price Negotiations in 2025
Ozempic, Medicare, price negotiations, Novo Nordisk, diabetes medication, Inflation Reduction Act
Appeals Court Revives PhRMA’s Challenge to IRA’s Medicare Drug Price Negotiation Program
PhRMA, Inflation Reduction Act, Medicare Drug Price Negotiation Program, Fifth Circuit Court of Appeals, drug pricing, healthcare litigation
FDA Cancels Advisory Committee Meeting for Applied Therapeutics’ Govorestat, Stock Surges 65%
Applied Therapeutics, FDA, Advisory Committee, Govorestat, Galactosemia, Stock Surge
FDA Advisory Committee Votes Against Ocaliva for Primary Biliary Cholangitis Due to Safety Concerns
Ocaliva, FDA, Primary Biliary Cholangitis, Liver Disease, Safety Concerns, Advisory Committee Vote
FDA Flags Concerns Over Intercept’s Ocaliva Approval in Advisory Committee Briefing
Ocaliva, Intercept Pharmaceuticals, FDA, Advisory Committee, Primary Biliary Cholangitis, Liver Disease
BIOSECURE Act Clears House Hurdle, Heads to Senate for Vote on Restricting Chinese Biotech Ties
BIOSECURE Act, House of Representatives, Senate Vote, Chinese Biotech Companies, National Security Risks, U.S. Pharmaceutical Industry, Biotechnology Innovation, Drug Supply Chain