Clinical trial randomisation is the process of assigning patients by chance to groups that receive different treatments
Biogen has agreed to pay USD 900 million to resolve allegations that it violated federal law by paying kickbacks to doctors to persuade them to prescribe its multiple sclerosis drugs, federal prosecutors said. The agreement announced on Monday settles a whistleblower lawsuit brought by former Biogen employee Michael Bawduniak, according to a statement from the office of US attorney for Massachusetts, Rachael Rollins. Under the terms of the settlement, Biogen will pay more than USD 843 million to the federal government and more than USD 56 million to 15 states for overbilling Medicare and Medicaid insurance programs. Bawduniak will receive a portion of the federal recovery. The Cambridge, Massachusetts-based pharmaceutical company in a statement said it settled so it can focus on our patients and strategic priorities" and said the settlement does not include an admission of liability. Biogen believes its intent and conduct was at all times lawful and appropriate and Biogen denies a
The FDA approved the drug in June despite its committee of outside experts voting in November 2020 that the drug should not be approved.
Biogen said that it will cut the wholesale acquisition cost of the drug by about 50 per cent next month
Biogen Inc said the approval of its Alzheimer's disease drug was based on extensive data as it seeks to quell concerns about the drug's effectiveness
By Deena BeasleyBiogen's drug had been hailed by patient advocates and some neurologists eager to have an effective option for patients with the lethal disease.
A panel of outside advisers to the US FDA voted that a potential Alzheimer's treatment from Biogen has not been proven to slow the progression of the disease
The number of people in the United States living with Alzheimer's, the most common form of dementia, is expected to triple to nearly 14 million by 2050 without effective treatments
The US Food and Drug Administration granted priority review for risdiplam, an oral medicine for those with the potentially deadly muscle-wasting disorder
Shares dropped as much as 29 percent in heavy trading, knocking about $18 billion out of the company's market value and marking its biggest intraday stock drop since 2008