News and Trends 11 Sep 2024
Can Europe revive its biopharma innovation leadership?
Find out if the biotech runner-up, Europe, can step up to boost research and revive its innovation leadership.
European Commission
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Expert Advice 28 Jul 2023
What you need to know about the EU HTA regulation before deadline
By Anke van Engen, senior principal, EMEA value & payer evidence, IQVIA, and Dima Samaha, senior principal, EMEA value & payer evidence, IQVIA The European Union (EU) comprises 27 member states (MS) with varying laws, processes and regulatory standards. This variation has led to a complex data landscape for health technologies and drug therapeutics developers, […]
Opinion 13 Jun 2023
How will European Commission proposals on data exclusivity and the bolar exemption affect pharma companies?
By Andrew Sharples, co-head of EIP’s UK litigation team In April, the European Commission published proposed legislation (specifically a new Regulation and a new Directive) aimed at reforming EU legislation in relation to pharmaceuticals. These proposals, if adopted, will affect pharmaceutical regulation in several ways. In relation to IP specifically, they will affect the periods […]
Assessing the EU Pharmaceutical Package – Positives, negatives and the impact on smaller pharma and biotech companies
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 clotting protein factor IX often due to a spontaneous mutation in the F9 gene, leading to excessive bleeding. Until recently, routine prophylactic infusions of factor IX replacement therapy to maintain enough clotting factor to prevent […]
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 Behring. The one-time gene therapy etranacogene dezaparvovec sold under the brand name Hemgenix is manufactured by UniQure Inc. and distributed by CSL Behring. The gene therapy is used to treat severe and moderately severe hemophilia […]
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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 marks the first immunotherapy based on T cells sourced from healthy donors. Since the approvals of Kymriah and Yescarta in 2017, CAR-T immunotherapies have changed the way we treat rare forms of blood cancer. In […]
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 Investment Council’s (EIC) accelerator program to develop IOA-289 for pancreatic cancer. The EIC’s funding consists of a grant of €2.5 million ($2.7 million), and €15 million ($16 million) of equity investment. Earlier this month, iOnctura […]
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 therapies. However, changes are needed to ATMP regulations to keep Europe competitive with the rest of the world. The EU has a rich resource base in terms of biotech innovation. Over the last decades, this […]
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 moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials […]
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 European Commission (EC) project. Under the EC’s Horizon Europe program, Helsinki University Hospital (HUS), has been awarded a contract to lead a €7 million ($7.2 million) consortium project termed ONCOVALUE. BCP will work with HUS […]
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 new EU project to support the integration of genomics into healthcare and advance new treatments for patients. Jointly funded by the European Commission, under the Digital Europe Programme, and the Health Research Board (HRB), Genomic […]
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