News

18 Sep 2017

EBE-EFPIA Set Out Policy Positions in Their Personalised Medicines Manifesto

The EBE-EFPIA Personalised Medicine Working Group have developed a Manifesto that aims to highlight policy elements that are considered essential to ensure that personalised medicines and their paired diagnostic tests, also called companion diagnostics, successfully reach patients....

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13 Jun 2017

EBE Webinar: IP and its crucial role in bringing innovative medicines to patients

20 June 2017 from 16H30 - 17H30 CET Europe has good science and sound Intellectual Property (IP) policies in place. These IP policies and other incentive offered by legislation when medicines are developed play a critical role in companies corporate and product development strategies....

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30 May 2017

Final Call ATMP Survey: Help improve product development and regulation

Response deadline: 30 June 2017 Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Marketing Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle....

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10 May 2017

What pricing and reimbursement policies to use for off-patent biologicals? – Results from the second EBE biological medicines policy survey

Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off-patent biologicals. ...

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28 Apr 2017

Podcast: EBE Plots Path from “Flawed Underfunded Biotech System”

During DIA’s first DIA BioVenture Day, Ms Freischem delivered a presentation titled Europe’s Flawed and Underfunded Biotech System, which she explores in this exclusive Global Forum podcast....

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05 Apr 2017

Podcast: How To Support Advanced Therapies and Breakthrough Medicines in Europe

On the occasion of  the first DIA BioVenture day on 28 March 2017 in Glasgow, Menno Aarnout, Wolfgang Stoiber and EBE's Barbara Freischem discussed options for solutions to support the development and funding of Advanced Therapies and Breakthrough Medicines in Europe....

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31 Mar 2017

Open Call to all ATMP developers

Invitation for ATMP-developers to help improve product development and its regulation  Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character, frequently addressing disease with high unmet medical need. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Market Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle....

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23 Feb 2017

New project: success and failure in the development and commercialisation of ATMP products

With recent developments in innovative technologies, new opportunities arise to address demands of an aging population, as well as for diseases with high unmet medical needs. ...

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01 Feb 2017

Event report from the 5th annual regulatory conference on ATMPs organised by EBE in collaboration with the EMA

The 5th annual regulatory conference on ATMPs, organised by EBE with the support of the European Medicines Agency (EMA) took place on 16 December 2016, in London, UK. The event saw a packed house - the greatest participation so far....

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23 Jan 2017

Podcasts from the 5th annual regulatory conference on ATMPs, organised by EBE in collaboration with the EMA

On the occasion of the  5th annual conference on the regulation of ATMPs on 16 December 2016 in London, some presenters spoke to us on their work and their thoughts on how to improve access for patients to these potentially curative medicines....

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