Latest Uploads

19 Oct 2018 - News

EBE-EFPIA Position Paper on Next Generation Sequencing (NGS)

Next generation sequencing (NGS), also known as high-throughput sequencing, is a DNA and RNA sequencing technology which has revolutionized genomic research. Today, an entire human genome can b...

Read more
19 Oct 2018 - Position Paper

EBE-EFPIA Position Paper on Next Generation Sequencing (NGS)

Next generation sequencing (NGS), also known as high-throughput sequencing, is a DNA and RNA sequencing technology which has revolutionized genomic research. Today, an entire human genome can b...

Read more
06 Sep 2018 - News

Joint EBE-EFPIA Position on CE Marking

A Topic Group of the joint Personalised Medicine Working Group has been developing a slide deck highlighting the position of the pharmaceutical industry on the need to consider a risk-based a...

Read more
23 Jul 2018 - Position Paper

EBE-EFPIA Reflection Paper: An Industry Perspective on Article 117 of the EU Medical Devices Regulation and the Impact on how Medicines are Assessed

With the publication of the new Regulation on Medical Devices (MDR, Regulation (EU) 2017/745) comes an important amendment to the medicines legislation, in Article 117. As part of the marketing author...

Read more
10 Jul 2018 - News, Press Release

New EBE-EFPIA study demonstrates benefits of personalised medicine for patients, society and healthcare systems and makes recommendations for equitable access for patients in Europe

The European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) released today the outcome of the evidence-based analysis on personal...

Read more
02 Jul 2018 - News, Press Release

EBE announces its 2018-2020 Board of Directors

Brussels, 2 July 2018 – The European Biopharmaceutical Enterprises (EBE), is pleased to announce its Board of Directors for 2018-2020, following the decisions taken at the EBE Annual Meeting on 26 J...

Read more
20 Jun 2018 - News

Incentives, IP and Smaller Companies - the story of uniQure

Download the Case Story in PDF format here uniQure, based in Amsterdam in the Netherlands  and Lexington, Massachusetts, USA, is developing curative gene therapies for patients with severe genetic...

Read more
07 Jun 2018 - Publication

KPMG Report: Site Selection for Life Sciences Companies in Europe 2018

EBE supports the 2018 version of the KPMG report on site selection for life science companies in Europe, developed in collaboration with Venture Valuation. Each company seeking to establish European...

Read more
07 Jun 2018 - News

KPMG Report: Site Selection for Life Sciences Companies in Europe 2018

EBE supports the 2018 version of the KPMG report on site selection for life science companies in Europe, developed in collaboration with Venture Valuation. Each company seeking to establish European...

Read more
28 May 2018 - News, Press Release

EBE statement on the European Commission’s proposal to introduce an SPC manufacturing waiver, which puts patient care at risk

Brussels – After the European Commission released its proposal to introduce a Supplementary Protection Certificates (SPCs) manufacturing waiver today, the European Biopharmaceutical Enterprises (EBE...

Read more
23 Mar 2018 - News

Statement in response to the EU Council ratifying the Brexit transition deal

The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today respond...

Read more
23 Mar 2018 - Press Release

Statement in response to the EU Council ratifying the Brexit transition deal

The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today respond...

Read more
14 Mar 2018 - Publication

European Investment Bank Report: "Financing the next wave of medical breakthroughs - What works and what needs fixing?"

EBE was proud to support the launch of the European Investment Bank's report "Access-to-finance conditions for Life Sciences R&D" at BioEurope Spring. This reports identifies a number of necessary...

Read more
13 Mar 2018 - News

European Investment Bank report: "Financing the next wave of medical breakthroughs - What works and what needs fixing?"

EBE was proud to support the launch of the European Investment Bank's report "Access-to-finance conditions for Life Sciences R&D" at BioEurope Spring. This reports identifies a number of neces...

Read more
26 Feb 2018 - News

EBE at Bio Europe Spring 2018 - "Funding gaps in the European Life Science Sector"

14 March 2018 from 9h00 - 10h00 CET at RAI Amsterdam Convention Center, Room E107, Europa plein, NL 1078 GZ Amsterdam, The Netherlands The European Investment Bank (EIB) and the European Commission...

Read more
15 Jan 2018 - Position Paper

EBE reflection paper on "Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment"

Within the European Biopharmaceutical Enterprises (EBE), a working group focused on EU specific topics relating to those integral combination products, which are regulated as medicinal products but wh...

Read more
19 Dec 2017 - News

EFPIA-EBE White Paper: Expedited CMC Development- Accelerated Access for Medicines of Unmet Medical Need

Since 2012 there has been a focus on faster translation of scientific breakthroughs to new, high quality medicines meeting unmet medical need through a programme initially referred to as Medicines Ada...

Read more
15 Dec 2017 - News

Incentives for Innovation. Incentivising Research in Areas of High Unmet Medical Need: Lilly’s Alzheimer’s Quest

With over 7,000 medicines in development, new treatments will continue to change patients’ lives, slowing disease progression, avoiding illness and reducing overall costs for healthcare systems....

Read more
14 Dec 2017 - Position Paper

The associations representing the European and British life science industry have today launched a joint policy document on the potential impact of the United Kingdom’s exit the European Union

The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launche...

Read more
12 Dec 2017 - Publication

Presentations and Conference Report from the 6th EBE Annual Conference on ATMPs - 5 December 2017, London

UPDATE 12 February 2018: Conference Report now available here The remarkable opportunities that cell and gene therapies can offer, but also the seemingly increasing number of obstacles to their wi...

Read more
08 Dec 2017 - News

Incentives, IP and smaller companies: the story of Lysogene

How Lysogene contributes to improving health outcomes Founded in France in 2009, and employing 18 staff at the end of 2017, Lysogene specialises in gene therapy targeting rare, neurod...

Read more
05 Dec 2017 - News, Press Release

Escher Study Identifies Hurdles to ATMP Development in Europe

First results of a study into factors associated with successful development of Advanced Therapy Medicinal Products (ATMPs) were reported today by Utrecht University at European Biopharmaceuti...

Read more
01 Dec 2017 - Publication

Incentives for Innovation: the story of Gilenya by Novartis

With over 7,000 medicines in development, new treatments will continue to change patients’ lives, slowing disease progression, avoiding illness and reducing overall costs for healthcar...

Read more
30 Nov 2017 - Position Paper

EBE Concept Paper: Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products

Effective management and control of raw materials (RM) used in the manufacture of biological medicinal products requires an appropriate framework to identify and focus on critical aspects that must be...

Read more
24 Nov 2017 - Publication

Incentives, IP and smaller companies - the story of Transgene

Download the Case Story in PDF format here How Transgene wants to change patients’ lives by improving health outcomes Transgene S.A., founded in December 1979, and part of the Fr...

Read more
17 Nov 2017 - News

Incentives, IP and smaller companies - the story of Vaxeal

Vaxeal Holding SA is headquartered in Vevey, Switzerland, with operations in Evry and Paris, France. The company was created in 2009. It develops therapeutic vaccines in combination with immune ch...

Read more
10 Nov 2017 - Publication

Incentives, IP and smaller companies - the story of Chiesi and Holostem

Download the Case Story in PDF format here Chiesi and Holostem Terapie Avanzate have jointly developed Holoclar, the first stem-cell-based product to be approved in Europe. Chiesi lice...

Read more
02 Nov 2017 - Publication

Incentives, IP and smaller companies - the story of TiGenix

Download the Case Story in PDF format here How TiGenix wants to change patients’ lives by improving health outcomes TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced Belgian...

Read more
24 Oct 2017 - Publication

Incentives, IP and smaller companies – the story of ProAxsis

Download the Case Story in PDF format here How ProAxsis helps to change patients’ lives by improving diagnostics ProAxsis Limited is a spin out from Queen’s University of Belf...

Read more
18 Oct 2017 - Publication

Incentives, IP and smaller companies - the story of CureVac

Download the Case Story in PDF format here How CureVac helps to change patients’ lives CureVac, a biopharmaceutical company headquartered in Tübingen, Germany, has grown from three orig...

Read more
10 Oct 2017 - Position Paper

EBE and EFPIA call on the EU Commission and Member States to improve transparency on Hospital Exemptions for Advanced Therapies

“Therapies for the future - Exploring solutions for innovative treatments in Europe” will take place at the European Parliament  on 11 October 2017. In advance of this significant discussion...

Read more
27 Sep 2017 - Position Paper

ARM, EBE, EFPIA and EuropaBio jointly publish a series of proposals to streamline requirements and accelerate approvals of clinical trials with new therapies that consist of or contain Genetically Modified Organisms (GMOs) in Europe

The Alliance for Regenerative Medicine (ARM), the European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EuropaBio jointly...

Read more
18 Sep 2017 - News

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

In 2017, the EBE-EFPIA Personalised Medicine Working Group developed a Manifesto setting out policy elements considered essential to ensure t...

Read more
18 Sep 2017 - Position Paper

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...

Read more
29 Jun 2017 - Press Release

EFPIA, EBE and Vaccines Europe Back EU Leadership in Sustainable, Collaborative Fight Against AMR

The launch of the European Commission’s Action Plan on Antimicrobial Resistance (AMR) confirms the EU’s determination to take a leading role in combatting thi...

Read more
13 Jun 2017 - News

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 d...

Read more
30 May 2017 - News

Final Call ATMP Survey: Help improve product development and regulation

End of March 2017 Lygature, a Dutch public-private collaboration catalysing new medical solutions, the European Biopharmaceutical Enterprises (EBE), together with EFPIA (European Federation of Pharm...

Read more
10 May 2017 - News

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

Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a re...

Read more
28 Apr 2017 - News

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

During DIA’s first DIA BioVenture Day, Ms Barbara Freischem, EBE Executive Director, delivered a presentation titled Europe’s Flawed and Underfunded Biotech System, which she explores in this ex...

Read more
26 Apr 2017 - Press Release

Intellectual Property: the key to innovation and survival for small and medium-sized biopharma companies

Today is World Intellectual Property day, an opportunity to reflect on the relevance of intellectual property rights to society where invention and innovation is valued for the greater benefit of all....

Read more
25 Apr 2017 -

United Action for Allergy and Asthma – a European Political Call to Action

April 25th 2017, marked the launch of the political Call to Action - ‘United Action for Allergy and Asthma' at the European Parliament in Brussels. This campaign has been initiated by the Europ...

Read more