Drugs

Biogen Pulls European Submission on Alzheimer’s Drug

Biogen has withdrawn a European marketing authorization application for its troubled Alzheimer’s drug aducanumab. This is the latest chapter for the therapy, which gained FDA accelerated approval 6/7/21 that ignited a firestorm of criticism and the resignation of several advisory committee members. In the aftermath, then-acting commissioner Janet Woodcock said the process could have been better handled and called for an HHS Office of Inspector General review.

Earlier this month, CMS issued its long-awaited National Coverage Determination (NCD) on Medicare coverage of only FDA traditionally approved monoclonal antibodies that target amyloid (or plaque) for treating Alzheimer’s disease, a significant blow to Biogen’s aducanumab. Additionally, CMS says that as part of its NCD it will provide “enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries.”

With the European submission, the company says it withdrew the application following interactions with EMA’s Committee for Medicinal Products for Human Use “indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of aducanumab by EMA.” Biogen’s submission had been under review in response to the company’s request for a re-examination of a negative opinion by regulators in December.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome