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EC
This page shows the latest EC news and features for those working in and with pharma, biotech and healthcare.
Another day, another Brexit delay – so what happens now?
EC president Donald Tusk confirms Brexit delay. It looks like EU27 leaders favoured a short technical extension, to allow Prime Minister Boris Johnson (pictured below, right) more time to win support
Latest news
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Aspen to pay millions to NHS following drug pricing investigation
The EC was concerned that Aspen may have used the tactic of withdrawing or threatening to withdraw the medicines – chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan – from sale in some EU member
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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,
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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
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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
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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
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Latest Intelligence
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Strengthening business competition and reducing anti-competitive practices
This appears to be a global trend, not least (from a European perspective) since the European Commission (EC) published its final report in its pharmaceutical sector inquiry in July 2009. ... Settling the score. While the level of financial penalties
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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
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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
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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.
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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.
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Latest appointments
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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
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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
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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.
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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).
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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
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Fake News is Bad for your Health
Viral misinformation. Nature, 16 October 2018. http://www.nature.com/articles/d41586-018-07034-4?
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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.
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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.
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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”.
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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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