Interview 3 Mar 2023
Interview: how has the first gene therapy for hemophilia B transformed research?
Hemophilia B, a rare disease that affects more than 230,000 people worldwide is caused by the lack of or defective…
European Commission
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News and Trends 28 Feb 2023
European Commission approves first gene therapy for hemophilia B
The European Commission has approved the first gene therapy for the treatment of hemophilia B developed by biotech company CSL…
In Depth 20 Dec 2022
Ebvallo approval ushers in off-the-shelf T-cell immunotherapies
Patient-derived CAR-T immunotherapies have dominated the cancer immunotherapy space over the last decade. The EU approval of Atara Biotherapeutics' Ebvallo…
News and Trends 20 Dec 2022
iOnctura raises €17.5M for pancreatic cancer therapy
iOnctura BV, a clinical-stage biotech developing novel cancer therapies, has been granted €17.5 million ($18.6 million) funding from the European…
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In Depth 15 Dec 2022
To avoid stagnation, the EU must refine its ATMP regulation
Over the decades, the EU has spearheaded the adoption of advanced therapy medicinal products (ATMPs) such as cell and gene…
News and Trends 15 Dec 2022
European Commission approves Dupixent as first and only targeted prurigo nodularis medicine
The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with…
News and Trends 24 Nov 2022
BC Platforms partners on AI-driven EU cancer data project
BC Platforms (BCP), a provider of healthcare data management and analytics, has been chosen as a key partner in a…
News and Trends 21 Nov 2022
Genomic Data Infrastructure Ireland project to support discovery of genetic causes of disease
RCSI University of Medicine and Health Sciences and FutureNeuro are co-leading, with University College Dublin, the Irish element of a…
News and Trends 18 Nov 2022
Sanofi’s Enjaymo for hemolytic anemia given marketing authorization by EC
Sanofi’s treatment, Enjaymo, for hemolytic anemia in adult patients with cold agglutinin disease (CAD), has been granted marketing authorization by…
News and Trends 17 Nov 2022
New EU project looks to unlock the potential of genomics
The European Genomic Data Infrastructure (GDI) project kicked off today in Brussels, Belgium. The new €40 million ($41.4 million) GDI…
More News! 4 Nov 2022
Sanofi and AstraZeneca drug, Beyfortus, for RSV in babies and children approved
A drug being developed jointly by Sanofi and AstraZeneca for the prevention of respiratory syncytial virus (RSV) lower respiratory tract…
News and Trends 2 Nov 2022
Authorization given to BeiGene’s chemo-free treatment option for lymphoma
Marketing authorization has been granted to a drug to treat relapsed/refractory (R/R) marginal zone lymphoma (MZL) without chemotherapy, it was…
News and Trends 3 Oct 2022
Oncopeptides starts European commercialization of myeloma drug in Germany
Swedish biotech company Oncopeptides AB has initiated the commercial launch of Pepaxti (melphalan flufenamide) in Germany. It marks the first…
News and Trends 28 Sep 2022
Project to tackle biodiversity crisis using the power of DNA data and genomics launched
A project to tackle the biodiversity crisis using DNA data, genomic science that will fundamentally change conservation science and policy…
News and Trends 27 Sep 2022
EU Agriculture Ministers meet in Prague to discuss sustainability and food security
At an informal gathering of EU Agriculture Ministers, food security and the role of European agriculture and sustainable global food…
In Depth 20 Sep 2022
Looming challenges for Europe’s cell and gene therapy space
The double whammy of Brexit and the COVID-19 pandemic have posed major logistical challenges for the development of cell and…
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News and Trends 20 Sep 2022
First treatment of rare kidney disease launched in Germany by STADA Arzneimittel
The first and only approved treatment for primary immunoglobin A (IgA) nephropathy, a rare, progressive disease of the kidneys, has…
News and Trends 29 Aug 2022
Marketing authorization granted for treatment of serious retinal diseases
The European Commission has granted marketing authorization to Ranivisio, a treatment for several serious retinal diseases. Polpharma Biologics Group BV,…
News and Trends 26 Aug 2022
First gene therapy for adults with severe hemophilia approved by EC
The European Commission (EC) has granted conditional marketing authorization for a gene therapy to treat severe hemophilia A in adults…
News and Trends 28 Jun 2022
Breast cancer drug recommended for approval
A cancer drug from AstraZeneca and Daiichi Sankyo called Enhertu, that reduces the risk of disease progression or even death…
