The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has voted 6-0 in favor of granting full approval to Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. The decision is expected to result in full FDA approval on or before July 6th, as the agency usually follows its advisory committees' recommendations. The FDA released briefing documents that ..
The Biden administration has implemented inflation penalties on 43 Medicare Part B drugs to reduce costs for older Americans, following the imposition of fines on 27 drugs in March. The Inflation Reduction Act (IRA) requires pharmaceutical manufacturers to justify price increases exceeding the inflation rate, with financial penalties imposed if justifications are found insufficient. Under the IR..
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously supported Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. This indicates that the FDA is likely to grant full approval before July 6th, as it usually follows its advisory committee's recommendations. The FDA released briefing documents on Wednesday that showed agency staff be..
The Biden administration is set to impose inflation penalties on 43 Medicare Part B drugs in Q3 of 2023, following the imposition of fines on 27 drugs in March. The Inflation Reduction Act stipulates that pharmaceutical manufacturers must provide justifications for any price increases exceeding the inflation rate, with financial penalties imposed if deemed insufficient. The latest actions are ex..
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously voted in support of Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease, indicating that full approval is likely to be granted on or before July 6. The decision was based on clinical trial results showing consistently favorable outcomes for primary and secondary endpoints, includi..
