More than 300 current and former biotech and pharmaceutical executives have signed an open letter criticizing a federal Texas judge over his recent decision to suspend FDA approval of the abortion pill mifepristone. “We cannot stay quiet. We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate…

The Veterans Health Administration (VHA) will provide coverage for Japanese company Eisai Co., Ltd and Biogen’s Alzheimer’s treatment Leqembi to eligible veterans living with early stages of Alzheimer’s disease, the companies announced on March 13. In order to be eligible for the drug, veterans will need to meet certain VHA criteria (pdf), such as having undergone an MRI scan within…

Pharmaceutical giant Biogen has agreed to pay $900 million to settle claims that it paid kickbacks to physicians to encourage them to prescribe its multiple sclerosis drugs, the Department of Justice announced on Monday. The Cambridge, Massachusetts-based company’s settlement resolves a lawsuit filed in 2012 by former Biogen employee turned whistleblower, Michael Bawduniak. Bawduniak sued Biogen under the False…

Analysis Aduhelm is the brand name under which the Alzheimer’s drug Aducanumab is marketed. It is developed by the U.S. company Biogen. The drug is to be administered as an intra-venous infusion every four weeks. The Food and Drug Administration (FDA) approved Aducanumab in June 2021, making it the first Alzheimer’s disease medication approved by the…

Biogen Inc. and Japanese partner Eisai Co. said on Thursday the U.S. Food and Drug Administration (FDA) had granted “fast track” designation to their experimental therapy lecanemab for the treatment of early Alzheimer’s disease. The FDA had granted “breakthrough” therapy designation to the drug earlier this year. The drug works in a similar manner to…

Biogen Inc. on Monday cut the price of its Alzheimer’s drug by about half to $28,200 for an average weight person after facing slower-than-expected U.S. sales on complaints from hospitals that its high cost was not worth its benefits. The U.S. Food and Drug Administration (FDA) approved the drug, Aduhelm, in June to treat the…

As physicians and health policy experts debate the merits of Aduhelm, the first new drug approved for Alzheimer’s disease in 18 years, patients want to know: “Will this medication help me—and how much?” Doctors explaining the pros and cons of Aduhelm won’t have a definitive answer. “On an individual basis, it will be absolutely impossible…

The U.S. Food and Drug Administration could potentially have done more to avoid the current controversies around its accelerated approval of Biogen’s Alzheimer’s drug, Aduhelm, FDA acting Commissioner Janet Woodcock said during a Wednesday summit hosted by Stat. The FDA last week called for an independent federal probe into its representatives’ interactions with Biogen ahead…

Government health official on Monday approved Biogen’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s disease, sending its shares soaring, despite controversy over whether the clinical evidence proves the drug works. Biogen said it has priced the drug, to be sold as Aduhelm, at $56,000 per year. Its shares jumped nearly…