logo
Plus   Neg
Share
Email

Biogen Plans To Submit BLA For Aducanumab In Alzheimer's Disease; Shares Jump

Biogen Inc. (BIIB) and Eisai, Co. Ltd. said, after consulting with the U.S. FDA, Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease. The decision is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019.

Biogen plans to file a Biologics License Application in early 2020. The company said it will continue dialogue with regulatory authorities including those in Europe and Japan.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Eisai Co., Ltd. is a global research and development-based pharmaceutical company headquartered in Japan.

Shares of Biogen Inc. were up more than 25% in pre-market trade on Tuesday.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The European Commission said Friday that it has signed a deal with Sanofi and GlaxoSmithKline to secure up to 300 million doses of their potential COVID-19 vaccine. Acella Pharmaceuticals recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency, the U.S. Food and Drug Administration said in a statement. The company is recalling one lot of 15mg and one lot of 120mg of NP Thyroid that are packaged in 100 count bottles in strengths of 15 mg, and 120 mg, with expiration dates between October 2020 and November 2020. Walmart announced its decision to raise wages for around 165,000 hourly associates across all its U.S. stores starting October, and introduce a team-based operating model in Supercenters. In a tweet, the retail giant said, "Today we're introducing new leadership roles and cross-training opportunities, giving our associates more ways to grow their careers."
Follow RTT