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EC

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

MSD’s Keytruda catches up in kidney cancer

Combination therapy approved in EU for all risk groups. MSD’s Keytruda in combination with Inlyta (axitinib) has won European Commission (EC) approval in the first-line treatment of the most ... The EC approval is based on the phase 3 KEYNOTE-426 trial,

Latest news

Imbruvica gains expanded use in Europe

Rival Calquence receives accelerated review in US. AbbVie and Janssen’s Imbruvica (ibrutinib) has received approval from the European Commission (EC) for two expanded variations to broaden the use of the ... drug. . The EC has approved the use of
Ursula von der Leyen nominated for EU President role

Von der Leyen has been an outspoken critic of Brexit, describing it as a "burst bubble of hollow promises." However whoever is named as the new EC president role won't
A first for Bluebird and Europe as gene therapy Zynteglo approved

EC authorisation of Zynteglo brings a new treatment option, in the form of the first one-time gene therapy for a subset of TDT patients one step closer to being available
European approval for Skyrizi, hot on the heels of US

The drug received EC approval based on four pivotal phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2, 000 patients with moderate to severe plaque
Shire’s bleeding disorder drug approved in Europe

Veyvondi for patients with rare disease von Willebrand disease. The European Commission (EC) has given the green light to Shire’s haemostatic disorder treatment Veyvondi, which is now set to prevent

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Latest Intelligence

A new EU in the making, what lies ahead for pharma?

Margrethe Vestager was being tipped as a possible EC President. She has taken a very tough line on competition and IP, which are obviously big issues for pharma, and has taken
Tackling a formidable foe

A year ago the company won EC approval for MAVENCLAD, a course of just 20 tablets that tames the body’s immune response system and can be taken on ten consecutive
The sound of silence puts the squeeze on generics and biosimilars

EFPIA issued a statement on its position, stating: “The SPC regime is part of the current EC review of incentives.
European CTR implementation advances ethical assessment of clinical trials

well as a clear process of selection of a Central ‘EC’ that will be dealing with a trial. ... who would deal with a selection of the appropriate EC, timelines and financial aspects.
Europe vs the US: New drug product approvals

pending approval by the European Commission (EC) in January 2017 (compared to no biosimilars gaining EU approval in 2015).

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Latest appointments

CureVac’s CEO appointed to EC High Level Group

Dr Hoerr joins a panel of 15 group members who will advise the EC on how to strengthen support for breakthrough, market-creating innovation in the Horizon 2020 project as well
New EC health director general takes office

Prats Monné's appointment was part of a reshuffle of the Commission's senior management by president Jean-Claude Juncker and, in a statement, the EC said the changes were a
IMI appoints new chair of scientific committee

Portugal’s Maria Beatriz da Silva Lima to join EC’s collaborative research group. ... the EC and the industry to improve health innovation in Europe.
Jonathan Dickinson joins Ariad from BMS

He joins at an important time for Ariad in Europe as it prepares to launch its chronic myeloid leukaemia treatment Iclusig (ponatinib), pending approval from the European Commission (EC).
Tonio Borg nominated to replace John Dalli as EC Health Commissioner

Candidacy of the Maltese deputy prime minister and minister of foreign affairs accepted by Barroso

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Latest from PMHub

Fake News is Bad for your Health

Viral misinformation. Nature, 16 October 2018. http://www.nature.com/articles/d41586-018-07034-4?
Rare Disease Day 2019: A patient perspective on primary sclerosing cholangitis

Goode EC, Clark AB, Mells GM et al. Factors associated with outcomes of patients with primary sclerosing cholangitis and development and validation of a risk scoring system.
Ensuring quality in medical translation when working ‘blind’

There is also often the need for a review by an Ethics Committee (EC), which can remove some errors, but can introduce spelling or grammar errors too. ... Any EC or client changes should be sent back to the original translators to be checked again.
Can rare diseases be a viable option for the pharma industry?

EU has enacted similar legislation, Regulation (EC) No 141/2000, in which pharmaceuticals developed to treat rare diseases are referred to as “orphan medicinal products”.
What we learnt from taking a mobile app through MHRA compliance

We launched an app that conforms to the EU Medical Device Directive 2007/47 EC for Rosemont Pharmaceuticals who are now registered as a Class 1 device manufacturer.

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