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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 […]

June 13, 2023 - 5 minutesmins - By External Contributor

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 […]

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

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 […]

December 15, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 10 Nov 2022

Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Sanofi and GSK’s Covid booster vaccine has been approved in Europe. After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of Covid-19 in adults 18 years of age and older. […]

November 10, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 2 Nov 2022

Meletios Therapeutics wins €5.2M European Commission funding for SARS research

Meletios Therapeutics, a French biotech company, announced today (November 2) that it has been named one of 75 winners of the European Innovation Council (EIC) Accelerator program and will receive €5.2 million ($5.1 million) in funding from the European Commission. The company specializes in the research and development of antiviral treatments and says the funding […]

November 2, 2022 - 3 minutesmins - By Liza Laws

News and Trends 12 Aug 2022

argenx secures European Commission approval for generalized myasthenia gravis treatment

Dutch immunology company argenx says the European Commission (EC) has granted marketing authorization for VYVGART (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The approval is applicable to all 27 European Union (EU) Member States plus Iceland, […]

August 12, 2022 - 3 minutesmins - By Jim Cornall

European Commission bioeconomy header e1573473988265

More News! 12 Oct 2018

European Commission Updates Strategy to Energize Europe’s Bioeconomy

In challenging times of climate change and a scarcity of resources, the European Commission has released a new strategy to boost activity and investment in companies contributing to the bioeconomy. As one of the key economies that signed the Paris Agreement in 2015, the EU aims to cut greenhouse gas emissions by at least 40% […]

October 12, 2018 - 2 minutesmins - By Jonathan Smith

News and Trends 21 Sep 2017

European Commission Approves Merck’s PD-L1 Inhibitor for Aggressive Skin Cancer

Merck and Pfizer’s new immunotherapy, avelumab, has been approved by the European Commission to treat metastatic Merkel cell carcinoma, an aggressive form of skin cancer. The approval is based on data from a Phase II study, JAVELIN Merkel 200, where subjects responded well to treatment for a sustained period of time. Earlier this year, Avelumab was […]

September 21, 2017 - 3 minutesmins - By Alex Dale

News and Trends 18 Mar 2015

Novartis’ Jakavi receives European Commission approval

Novartis received the approval from the European Commission for Jakavi (ruxolitinib) for the treatment of adult patients with Polycythemia Vera (PV) who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. PV is a rare and incurable blood cancer associated with an overproduction […]

March 18, 2015 - 2 minutesmins - By Lourdes Riquelme

News and Trends 19 Oct 2022

Immunethep receives European Innovation Council funding for clinical trials

Immunethep, a Portuguese biotech startup, has been selected by the European Innovation Council (EIC) to receive funding from its EIC Accelerator program. Immunethep will receive initially a €2.5 million ($2.5 million) grant and is eligible for additional equity investment from the EIC Fund for a project with a total investment of €17.5 million ($17.1 million). […]

October 19, 2022 - 3 minutesmins - By Jim Cornall

HealthTech Innovation Days HTID Paris 2022

News and Trends 19 Oct 2022

HealthTech Innovation Days brings European healthtech ecosystem together

The 4th edition of HealthTech Innovation Days (HTID), organized by HealthTech For Care, took place recently in Paris, France. The two-day event had the objective of finding financing and encouraging new industrial partnerships to accelerate the development and market access of new products and treatments for all patients. Around 1,600 formal and informal face-to-face and […]

October 19, 2022 - 3 minutesmins - By Jim Cornall

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

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