Orphazyme Teeters On The Brink As Arimoclomol EU Filing Is Pulled
Executive Summary
Danish biotech Orphazyme has withdrawn the EU marketing application for its Niemann-Pick disease type C therapy arimoclomol and all hopes for the drug’s survival now rest on a meeting with the US Food and Drug Administration.
You may also be interested in...
Marketing Firsts Due As Amryt’s Filsuvez And Roche’s Lunsumio Win EU Nod
Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.
Janssen’s Multiple Myeloma Gene Therapy On Track For EU-Wide Approval
The European Medicines Agency’s human medicines committee has recommended five new drugs for use in the EU at its latest monthly meeting.
Janssen’s BCMA-Targeting CAR-T, AstraZeneca’s Evusheld Among EU Verdict Hopefuls
The EMA is poised to say whether or not six new drugs are on track for pan-EU approval, including Janssen’s first cell therapy and an antibody combination to prevent COVID-19 in people with poor immune response.