Europe

The European Commission has granted conditional marketing authorisation for CSL’s Hemgenix (etranacogene dezaparvovec), the first one-time gene therapy for severe and moderately severe haemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors.   In an ongoing clinical trial, the drug reduced the rate of annual bleeds with a single infusion […]

Vésale Bioscience, a company in the research and development of solutions and treatments using phage therapy for multi-resistant infections, has received €1.8 million in grants from the European Innovation Council (EIC) Accelerator Fund for its PhageDiag project.  The project is a phagogram using artificial intelligence (AI) that enables decentralised diagnostics and personalised treatment. According to […]

Janssen has submitted a marketing authorisation application (MAA) seeking approval of talquetamab in Europe for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).   Talquetamab is an investigational, off-the-shelf, bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and CD3 […]

A new drug based on the active ingredient Lutetium-177 PSMA-617 has been approved by the European Commission for the treatment of metastatic prostate cancer carrying the surface molecule PSMA (prostate specific membrane antigen).   The drug was developed under the leadership of the German Cancer Research Center (DKFZ) in collaboration with Heidelberg University Hospital and Heidelberg […]

UCB’s Fintepla (fenfluramine) oral solution has been recommended for marketing authorisation in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare, severe form of epilepsy.  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on safety and efficacy data […]

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).  The CHMP has recommended conditional marketing authorisation of CSL’s etranacogene dezaparvovec, a one-time gene therapy for the treatment of appropriate adults with the disease.  The therapy […]

The ‘Rare Disease Moonshot’, a new initiative to boost research and development into rare and paediatric diseases, has launched at the European Health Summit.  The initiative is a commitment and collaboration between seven organisations to break down the barriers to finding new treatments and cures for the world’s rarest and severe conditions. It aims to […]

Irish biotech company OmniSpirant and French biotech EVerZom have joined other partners to launch INSPIRE, a €12.8 million lung cancer project funded by Horizon Europe.   The project gathers European partners spanning across biotechnology, medical devices, cancer research, academia and patient advocacy. Over the next three years, the consortium will progress the development of a regenerative gene […]

As we start to look beyond the pandemic, which areas of Europe’s drug discovery community should we take note of? Lu Rahman highlights some of the key players.  The European drug discovery sector is buoyant. Valued at $14.8 billion in 2020, the sector is expected to grow by 8.3% until 2030. This growth is due […]