Congress Leaves Town with Major Drug-Related Bills on Hold
Pandemic preparedness and curbing PBMs among the pending legislation that will have to wait until after summer recess.
FDA Inspections Face Overhaul
The agency proposes significant revisions to oversight programs for drugs and medical products.
Industry Slams Medicare Price Negotiation Scheme
Recent lawsuits are challenging the constitutionality of provisions in the Inflation Reduction Act.
Medicare Still Won’t Pay for Alzheimer’s Drugs Without Confirmatory Data
Indicates that reimbursement for new slate of Alzheimer’s treatments will occur only with the completion of studies to support full approval.
Pharma-PBM Battle Escalates on Capitol Hill
Amid drug pricing blame game, Congress advancing a range of reform efforts to manage and curb pharmacy benefit manager practices.
Feds to Review March-In Authority on Drug Patents
Amid continued tussling over drug costs, a new working group will review the government’s authority to revoke licenses for medical products.
Congress Probes PBM Link to Higher Drug Prices
Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.
Ukraine Invasion Challenges Biopharma Research and Operations
From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.
No slowing of approval train at FDA
Pandemic notwithstanding, the agency maintained a steady pace in 2021 in clearing important new therapies, including new vaccines and drugs for Covid
Drug costs central issue in budget battles
Biden touts provisions administration believes can curb spending on pharmaceuticals
Califf nominated to head FDA
White House announces official endorsement, paving way for Senate confirmation process
Generic drugmakers also fight price controls
It’s not just innovator pharma companies concerned with the proposed compromise to Medicare price negotiations and inflation-based rebates
Biosimilars gain traction with regulators, manufacturers
Recent FDA actions may finally usher in access boost to follow-on biologics in the US
Biden highlights drug pricing reforms to advance legislative agenda
Plan aims to offset costs associated with proposed social and health initiatives
Pharma prices and patents under attack
The drive for “vaccine equity” around the world is strengthening efforts to limit patent protections on innovative drugs and vaccines to combat Covid
White House seeks funding boost for medical research, disease tracking
Proposal also points to need for further resource investment to “enhance” FDA operations