Biogen Inc.
Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021
CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021.
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The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021
CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer s disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021.
As part of the ongoing review, Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time for review.
Thursday, January 28, 2021
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.
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Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations.
With President Joe Biden sworn in as the 46th US president, attention has turned to what actions he will take in his first 100 days in office, and beyond. While much of the president’s focus will initially be on the COVID-19 pandemic, increasing vaccination numbers, and economic relief, the pharmaceutical and biotechnology industries, which have been at the forefront of the executive branch’s attention since the start of COVID-19, will likely continue to garner significant policy focus. Specifically, over the next four years, we expect to see more Food and Drug Administration (FDA) independence, transparency, and funding; the application of new strategies to facilitate pharmaceutical product developm
FDA grant priority review to a supplemental biologics license application for nivolumab (Opdivo) for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction cancer.