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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…

July 28, 2023 - 7 minutesmins - By External Contributor

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…

June 13, 2023 - 5 minutesmins - By External Contributor

Assessing the EU Pharmaceutical Package – Positives, negatives and the impact on smaller pharma and biotech companies

After several delays, the EU Pharmaceutical Package was published on 26 April 2023. This is the first significant review in over two decades of the foundational legislation which governs the…

May 30, 2023 - 7 minutesmins - By External Contributor

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…

March 3, 2023 - 8 minutesmins - By Roohi Mariam Peter

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…

February 28, 2023 - 3 minutesmins - By Roohi Mariam Peter

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…

September 20, 2022 - 3 minutesmins - By Liza Laws

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…

December 20, 2022 - 6 minutesmins - By Jonathan Smith

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…

December 20, 2022 - 2 minutesmins - By Jim Cornall

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…

December 15, 2022 - 8 minutesmins - By Jonathan Smith

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…

December 15, 2022 - 5 minutesmins - By Jim Cornall

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,…

November 24, 2022 - 2 minutesmins - By Jim Cornall

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…

November 21, 2022 - 3 minutesmins - By Jim Cornall

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