Europe

The EU has historically been a leader in vaccine research, development and manufacturing, but is now seeing a decline in vaccine research, according to data published by Vaccines Europe (VE). The EU has hosted approximately 20% of global vaccine clinical trials over the past two decades, as well as research facilities affiliated with the world’s […]

Specialist pharmaceutical company Norgine has appointed Saulo Martiniano as its new Chief Operating Officer (COO).  Martiniano previously worked at L’Oréal and was responsible for leading Global Manufacturing Excellence across 38 plants that included more than 10,000 employees.  Martiniano will now be based in the UK and takes on the responsibility of overseeing Norgine’s global operations […]

As negotiations continue between the UK and EU over Horizon Europe, the largest collaborative research programme in the world, the scientific research community has urged the Prime Minister to secure the UK’s membership as soon as possible.  Figures reported in The Guardian from the European Commission emphasise the importance of the programme to UK research. […]

Vesalius Biocapital, a life sciences venture capital investor, has closed its fourth fund, Vesalius Biocapital IV, securing over €95 million of commitments. The company plans to invest in first and best-in-class European life science companies in drug development and digital health. The goal is to build a portfolio of 10-15 companies, providing capital and the […]

Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH). The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for the long-term treatment of pulmonary arterial hypertension (PAH, World […]

The proposed joint clinical assessment methodology would have rejected nearly 90% of the ATMPs currently authorised in the EU, claims the Alliance for Regenerative Medicine (ARM). According to ARM, all seven gene therapies for rare genetic diseases would have been rejected under the baseline methodologies proposed for the EU joint clinical assessment (JCA) starting in […]

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Exact Sciences, Guardant Health, Illumina, MSD and Novartis have come together to launch the European Coalition for Access to Comprehensive Genomic Profiling (ECGP). It is hoped that the Coalition will improve cancer care through increased routine clinical access and reimbursement of Comprehensive Genomic Profiling (CGP) in Europe. CGP […]

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a series of reports about the availability of new medicines throughout Europe. EFPIA’s 2022 Patient WAIT Indicator tracks the availability of new medicines and length of time it takes patients to get them in 37 countries in the EU and EEA. Figures show that, […]

SLAS Europe 2023 will take place 22-26 May in Brussels, Belgium, where attendees will embrace the theme Science Set in Motion. DDW’s Multimedia Editor Megan Thomas explores what to expect from the event. Scientific tracks SLAS Europe 2023 will feature four tracks focused on life sciences and their global impact: Biology Unveiled, Frontiers in Technology, […]

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 […]