Governmental or Regulatory Activity
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
Key Democrat to Oppose Biosecure Act, Citing Concerns Over Legislation’s Design and Impact on U.S.-China Biotech Relations
Biosecure Act, U.S.-China relations, biotech restrictions, national security, WuXi Biologics, BGI, Congressional opposition
FDA Raises Concerns Over Inappropriate Use of Iterum’s Antibiotic Ahead of Advisory Committee Meeting
Iterum Therapeutics, FDA, antibiotic resistance, sulopenem etzadroxil/probenecid, uncomplicated urinary tract infections (uUTIs), advisory committee meeting
FDA to Reassess Checkpoint Inhibitors for Stomach Cancer Based on PD-L1 Expression
FDA, checkpoint inhibitors, stomach cancer, PD-L1 expression, Oncologic Drugs Advisory Committee
Embracing Agility: Critical for the Role of QARA Professional
QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.