Tag Archive for: Biogen

Europe’s medicines regulator on Friday recommended granting a marketing authorization to Biogen’s drug for the deadly and progressive neurodegenerative disease known as amyotrophic lateral sclerosis (ALS).

Biogen has disclosed in a Wednesday Securities and Exchange Commission filing that it has been served a subpoena by the U.S. Department of Justice, which is seeking more information regarding the company’s overseas operations.

Biogen misses Q4 revenue estimates on Aduhelm costs, lower MS drug sales Published: Feb 13, 2024 By Tyler Patchen BioSpace Biogen’s fourth-quarter financial results were weighed down by declining multiple […]

The European Commission on Monday approved Biogen’s Skyclarys (omaveloxolone) for the treatment of the rare genetic disorder Friedrich’s ataxia in patients aged 16 years and above.

During yesterday’s third-quarter fiscal year 2023 earnings report, Eisai revealed that the launch of its Biogen-partnered Alzheimer’s disease treatment Leqembi (lecanemab) has not been going according to plan, making the company’s goal of treating 10,000 patients by the end of March 2024 appear out of reach.

Today Biogen said it would terminate a post-approval study of its Alzheimer’s drug, Aduhelm, after failing to find a partner or external financing for the controversial treatment.

Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.

The two companies are preparing to launch the drug in the second quarter of Eisai’s 2024/25 business year starting in April.

The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.

While the patent for Biogen’s drug has expired in the United States, it had scored a win in Europe in March.