Archive for September 2022

Biogen has agreed to pay $900 million to resolve a federal whistleblower lawsuit charging that the company bribed doctors with kickbacks to prescribe its multiple sclerosis drugs, resulting in the submission of false claims to Medicare and Medicaid. Source: Drug Industry Daily

The version of user fee legislation that’s slated to be attached to a continuing resolution (CR) later this week — just days before the end of the fiscal year — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Source: Drug Industry Daily

The FDA reprimanded Jerome Stevens Pharmaceuticals in a Form 483 for inadequate validation studies and other deficiencies observed during an inspection of its Bohemia, N.Y., plant from May 25 to June 15. Source: Drug Industry Daily

Sally Choe, director of the FDA’s Office of Generic Drugs (OGD), will be stepping down from the agency on Oct. 8, and Susan Rosencrance, director of the Office of Lifecycle Products within the Office of Pharmaceutical Quality, has been tapped to replace her as acting OGD head. Source: Drug Industry Daily

Six EU countries have successfully turned up the heat on sponsors who haven’t shared the findings of their clinical trials, a new analysis finds. But some member states still appear to be making little to no effort on trial transparency, threatening current efforts within the 27-nation trade bloc. Source: Drug Industry Daily

FDA leaders in oncology want sponsors seeking accelerated approval (AA) for cancer drugs to use new trial designs that will make the whole process more efficient and ultimately safer for patients. Source: Drug Industry Daily

Repeated problems with aseptic areas landed India’s global pharmaceutical company Cipla Limited a Form 483, in addition to new quality and computer control issues. Source: Drug Industry Daily

The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Source: Drug Industry Daily

Biogen’s investigational drug for SOD1 amyotrophic lateral sclerosis (ALS), tofersen, has delivered more promising results in an extension study published in the New England Journal of Medicine. Source: Drug Industry Daily

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted down cancer drugs Copiktra and Pepaxto at its meeting late last week. Source: Drug Industry Daily