European Commission Archives

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 project, coordinated by ELIXIR, is jointly funded by the European Commission under the Digital Europe Programme and through co-funding from participating Member States. In the area of health, the Digital Europe Programme aims to support […]

November 17, 2022 - 3 minutesmins - By Jim Cornall

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 disease in newborns and infants was approved today (November 4). The European Commission has approved Beyfortus which is so far the first and only broadly protective option against the virus. Thomas Triomphe, executive vice president, […]

November 4, 2022 - 2 minutesmins - By Liza Laws

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 announced today (November 2). The European Commission (EC) gave the authorization to biotech company, BeiGene, for Brukinsa (zanubrutinib), which treats adults with the condition who have received at least one prior anti-CD20-based therapy. The approval […]

November 2, 2022 - 3 minutesmins - By Liza Laws

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 market in Europe where the drug is being launched. On August 18, the European Commission granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, for […]

October 3, 2022 - 2 minutesmins - By Jim Cornall

Biodiversity Genomic Europe project will tackle biodiversity crisis

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 has been launched by European experts. The new pan-European Biodiversity Genomic Europe (BGE) consortium was made public day (September 28) is leading the way with this large-scale application of genomic science. Impacts are predicted to […]

September 28, 2022 - 4 minutesmins - By Liza Laws

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 production were the main discussion points. At the meeting held in Prague, the EU agriculture ministers also agreed that the time is now to act in a coordinated way to maximize sustainable increases in agricultural […]

September 27, 2022 - 5 minutesmins - By Liza Laws

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 gene therapies (CGTs) in the last two years. In spite of these obstacles, Europe’s CGT market is catching up to that of the U.S. The CGT space experienced a shot in the arm in the […]

September 20, 2022 - 7 minutesmins - By Jonathan Smith

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 been launched in Germany. European commercial partner of Calliditas Therapeutics AB, STADA Arzneimittel AG, says the treatment will launch in additional European countries later. The disease, also known as Berger’s disease, occurs when immunoglobin builds […]

September 20, 2022 - 3 minutesmins - By Liza Laws

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, Formycon AG and their Swiss joint venture, Bioeq AG, announced the news today (August 29) that the authorization was granted to Ranivisio, which is a biosimilar to Lucentis, a ranibizumab injection. Positive opinion: CHMP The […]

August 29, 2022 - 3 minutesmins - By Liza Laws

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 it was announced yesterday (August 25). BioMarin Pharmaceutical Inc.’s Roctavian (valoctocogene roxaparvovec) treats the congenital factor 8 deficiency in adults patients without a history of factor VIII inhibitors without detectable antibodies to adeno-associated virus serotype […]

August 26, 2022 - 3 minutesmins - By Liza Laws

Kintor Pharmaceutical drug gets positive results for breast cancer

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 by 72%, has been recommended for approval in the European Union (EU). The drug containing trastuzumab deruxtecan is specifically engineered for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer treated with […]

June 28, 2022 - 3 minutesmins - By Liza Laws

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