Governmental or Regulatory Activity
Understanding the Second Round of Medicare Drug Price Negotiations: What Trump’s CMS Can and Can’t Change
Medicare drug price negotiation, Trump administration, CMS, Inflation Reduction Act, drug prices, negotiation process
Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug
FDA, Vanda Pharmaceuticals, Fast Track Designation, Gastroparesis, Drug Approval Process
FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025
FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development
FDA Advisory Panels: Activity Levels Normalize After 2023 Surge
FDA advisory panels, adcomms, regulatory changes, advisory committee meetings
Healthcare Sector Winners and Losers in the 2024 Government Funding Bill
Healthcare funding, government shutdown, telehealth, Medicare payments, Medicaid DSH, hospital-at-home programs, physician pay cuts, healthcare legislation.
Congress Passes Slimmed-Down Continuing Resolution, Extends Telehealth Flexibilities and Includes PBM Reform
Continuing Resolution, Telehealth Flexibilities, PBM Reform, Healthcare Package, Medicare, Medicaid
Moderna’s RSV Vaccines Face Safety Concerns Over Severe Infections in Infants
Moderna, RSV vaccines, safety concerns, severe infections, infants, mRNA vaccines, FDA, advisory committee
BIOSECURE Act Excluded from US Defense Bill, Offering Reprieve to Chinese Biotechs
BIOSECURE Act, Chinese biotechs, US defense bill, biotechnology supply chains, national security concerns
Healthcare M&A and IRA Price Negotiations: Key Trends to Watch Amidst Political Shifts
Healthcare M&A, IRA Price Negotiations, Medicare Drug Price Negotiation Program, Inflation Reduction Act, Pharmaceutical Industry Trends, Mergers and Acquisitions Outlook 2024
Biden Administration Proposes Expanded Coverage of Anti-Obesity Medications for Medicare and Medicaid Enrollees
Biden Administration, Obesity Drug Coverage, Medicare, Medicaid, Prescription Drug Costs, Healthcare Reform