FDA Advisers Back Full Approval Of Eisai’s Experimental Alzheimer’s Drug
A panel of expert advisers unanimously recommended Friday that the agency broaden its approval of Leqembi, a treatment for Alzheimer's disease manufactured by Eisai and Biogen. Other pharmaceutical news reports on penalties for drug price hikes, Medicare negotiations, and more.
Stat:
FDA Panel Unanimously Endorses Eisai’s Alzheimer’s Drug Leqembi
Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress. (Feuerstein and Garde, 6/9)
Reuters:
U.S. Government Sets Penalties On 43 Drugs Over Price Hikes
The Biden administration on Friday announced it would impose inflation penalties on 43 drugs for the third quarter of 2023, having fined 27 earlier this year, in a move it said would lower costs for older Americans by as much as $449 per dose. Drugmakers hiked the price of these 43 drugs by more than the rate of inflation and are required to pay the difference of those medicines to Medicare, the federal health program for Americans over age 65. (Wingrove, 6/9)
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Chamber Sues Over Medicare Drug-Price Negotiation
The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts. (Cohrs, 6/10)
Axios:
Drug Patent Reforms Set Off Senate Tug Of War
A fight is heating up over a plan to keep drugmakers from gaming the patent system that would potentially lower drug prices as senators weigh a broader health care package. But the outcome is far from certain, given the range of competing health care interests. (Sullivan, 6/12)
