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European Commission

This page shows the latest European Commission news and features for those working in and with pharma, biotech and healthcare.

AstraZeneca and MSD’s breast cancer drug Lynparza receives EC approval

AstraZeneca (AZ) and MSD’s – known as Merck &Co in the US and Canada – Lynparza (olaparib) has been approved by the European Commission (EC) for the treatment of patients with germline

Latest news

GSK to supply 85 million doses of pandemic influenza vaccine to EU

GSK has signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses ... Through this agreement for 85 million doses,
FDA grants Novavax’s COVID-19 vaccine emergency use authorisation for adults

In addition to the FDA EUA, the Novavax COVID-19 vaccine has received conditional authorisation for use in individuals aged 18 and over from multiple regulatory agencies worldwide, including the European ... Commission, and an emergency use listing from
Sanofi and Sobi announce positive phase 3 trial results for severe haemophilia A

The European Commission also granted efanesoctocog alfa Orphan drug designation in June 2019.
$Roche’s Lunsumio granted Priority Review by FDA for people with relapsed or refractory follicular lymphoma$ Roche’s Lunsumio granted Priority Review by FDA for people with relapsed or refractory follicular lymphoma

The European Commission issued a conditional marketing authorisation for Lunsumio in June 2022 for patients with R/R follicular lymphoma who have received at least two prior systemic therapies.
NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis

In 2021, the European Commission approved Adtralza for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines &Healthcare products Regulatory Agency

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Latest Intelligence

EU cross-border healthcare

The European Commission’s evaluation of the Directive provides an opportunity to examine the current and future needs of patients in cross- border healthcare with both pathways in mind. ... This would be in keeping with the vision of the European
From if to how: when imagination and regulation work together

As the European Commission explores the reopening of regulations surrounding Orphan Medicinal Products this year, it is clear that we need to ensure our vision for delivering better care is a
The search for effective drug treatments for COVID-19

The European Commission has signed a joint procurement agreement for Gilead’s COVID-19 antiviral treatment remdesivir.
Industry needs an aligned position on the future of the EU OMP Regulation

By Emma Eatwell. In March 2020 the European Commission presented its ‘New Industrial Strategy for Europe’, which proposes to move the European Union towards climate neutrality and digital leadership. ... The potential legislation and initiatives have
Weirdos and misfits

Consider a few examples. On mental health, the European Commission’s State of Health in the EU estimates suggest that one in six people across the EU experienced mental health issues

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Latest appointments

Hanover Health appoints Aleksandra Lugović as an associate director

Lugović joins from GOPA Com. Brussels, where she ran global campaigns for the European Commission across the EU, US, Africa and Asia. ... She also worked in media and events, during which time she organised political conferences hosting European
New hires at EMA, Gilead and BeiGene

European Medicines Agency (EMA). The European Medicines Agency (EMA) management board has nominated Emer Cooke (pictured above) as its new executive director. ... Cooke worked for the pharmaceutical unit of the European Commission from 1998 to 2002, and
CureVac’s CEO appointed to EC High Level Group

Dr Ingmar Hoerr, chief executive officer of clinical-stage mRNA technology specialist CureVac, has been appointed to the European Commission's High Level Group for research and innovation programmes. ... Dr Hoerr said: “It is a tremendous honor to be
New EC health director general takes office

XavierPrats Monné will report to health commissioner Dr Vytenis Andriukaitis. The European Commission's health and food safety directorate has a new director general, with Xavier Prats Monné taking over from ... A Spanish national, he has also served
European Commissioner for health and food safety elected

Juncker said: “In the new European Commission, form follows function. We have to be open to change. ... We have to show that the Commission can change. What I present to you today is a political, dynamic and effective European Commission, geared to

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Latest from PMHub

The future of nanomedicine regulation

Giving the EU a chance to set a precedent. In November 2021, the European Parliament adopted an own-initiative resolution on a pharmaceutical strategy for Europe, guiding the European Commission ahead ... In the adopted text, Members of the European
Rare Disease Day – looking to the future with hope

The DevelopAKUre consortium, a European collaboration involving academia, industry and patient organisations, demonstrated this recently when they partnered to accelerate the development of a treatment for alkaptonuria – a rare disorder caused
Will most electronic consumer goods turn into medical devices after the MDR?

Whilst waiting for more concise guidance from the European Commission, it is left to our own interpretation as to how far the Medical Device Regulation (MDR) will go when it comes ... devices. The solution is simple. Rather than imposing further burdens
Rare Disease Day – why it’s important to show your stripes

The European Commission for Public Health defines rare diseases as life-threatening or chronically debilitating diseases, which are of such a low prevalence that special efforts are needed to address them. ... high, with both NORD and the European
What does the COVID-19 vaccine mean for the future of R&D?

The European Commission and the UK Government Vaccine Taskforce have also been significant contributors to a wide variety of vaccine projects. ... as the European Medicines Agency (EMA) introduced “rolling reviews”, to monitor data as and when it was