Review and approval of first directly administered gene therapy targeting a disease caused by genetic mutations embodies 'spirit' of agency's forthcoming series of guidance documents on gene therapies, FDA Commissioner Gottlieb says; documents are likely to encourage development of the kind of novel and clinically meaningful endpoint that Spark used in its clinical program.
The US FDA's early approval of Spark Therapeutics Inc.'s Luxturna (voretigene neparvovec-rzyl) for inherited vision loss – the third gene therapy licensed in 2017 – created an opening for Commissioner Scott Gottlieb to highlight the agency's plans in the coming year to further align its policy framework with the burgeoning scientific field.
On Dec. 19, FDA licensed Luxturna, an adeno-associated virus vector-based gene therapy, for treatment of patients with confirmed biallelic RPE65...
<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>
