June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
One year after the US Food and Drug Administration’s accelerated approval of Biogen, Inc.’s Aduhelm (aducanumab-avwa), the Alzheimer’s treatment remains a hot and divisive topic in drug development circles.
Reflecting back on the controversy, it appears the approval and the following pricing and reimbursement decisions could have long-lasting implications,...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
