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EMA

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European Medicines Agency: Staying consistent in a turbulent time

June 12, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, European Medicines Agency, brexit

With Brexit looming, the future of the EMA headquarters in London has been cast in doubt. Pharmafocus spoke to Marie-Agnes …

Feature
european_commission_web

New biosimilar guidelines launched in the EU

June 1, 2017
Medical Communications, Research and Development, Sales and Marketing EMA, biosimilars

A joint effort by the EMA and the European Commission has seen the publication of a biosimilar information guide for …

News
european_commission_web

European Commission warns UK over drug authorisation validity due to Brexit

May 4, 2017
Medical Communications, Sales and Marketing EMA, European Commission, brexit

The European Commission has issued a warning to pharmaceutical firms in the UK over the validity of current and future …

News
uk_location_in_the_eu_2016

Pharma industry calls for EMA relocation by June in open EFPIA letter

April 25, 2017
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EFPIA, EMA

Heads of research from 19 of the biggest players in the industry have called for a decision to be made …

News
eu_and_fda

EU-US reach landmark deal on mutual recognition of manufacturing inspection

March 3, 2017
Medical Communications EMA, EU, FDA, US

The European Union and the US has announced that an agreement has been made to mutually recognise inspection of drug …

News
astrazeneca-sign

AstraZeneca’s hyperkalaemia treatment rebounds with European recommendation

February 24, 2017
Sales and Marketing AstraZeneca, EMA

AstraZeneca have received some positive news on its hyperkalaemia drug, ZS-9, as it received a recommendation from the Committee for …

News

FDA Priority Review for Pfizer investigational leukaemia drug

February 22, 2017
Research and Development, Sales and Marketing EMA, FDA, Inotuzumab ozogamicin, Pfizer, priority review

Pfizer has announced that its leukaemia treatment inotuzumab ozogamicin has been accepted for Priority Review by the US Food and …

News
social_media

Socially vigilant: Does pharmacovigilance need secondary data & social media?

February 6, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, MHRA, pharmacovigilance

As the world’s drug consumption continues to rise alongside advancements in the medical and pharmaceutical industries, so too do new …

Feature
abbvie_0

EMA Accelerated Assessment for AbbVie’s hepatitis C regimen

January 24, 2017
Manufacturing and Production, Research and Development AbbVie, EMA, hepatitis C

AbbVie has announced that its investigational, pan-genotypic regimen of Glecaprevir/Pibrentasvir has been awarded Accelerated Assessment by the European Medicines Agency …

News
bristol

Opdivo first PD-1 inhibitor given European approval for haematological cancer

November 25, 2016
Medical Communications, Sales and Marketing BMS, Bristol-Myers Squibb, EMA, PD1-Inhibitor, bristol myers-squibb

Bristol-Myers Squibb announced that it has received the first and only European approval for a PD1 inhibitor in the treatment …

News

Pfizer’s breast cancer drug gets EU approval

November 10, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, Novartis, Pfizer, ibrance

Pfizer is celebrating the approval by the European Union of its breast cancer drug Ibrance, following a positive recommendation from …

News

EMA has validated Merck and Pfizer’s MAA for avelumab

November 1, 2016
Manufacturing and Production, Sales and Marketing EMA, Merck KGaA, Pfizer, avelumab

The European Medicines Agency has validated the Marketing Authorisation Application for avelumab for the proposed indication of metastatic Merkel cell …

News
ema_inside

EMA opens clinical trial data to public

October 25, 2016
Manufacturing and Production Amgen, AstraZeneca, EMA, EU, Kyprolis, clinical reports, clinical trials

The European Medicine Agency has begun to release to the public data on clinical trial via their own website. The …

News
ema_building_face_web

EMA grants conditional approval for biliary cholangitis treatment

October 17, 2016
Sales and Marketing EMA, intercept, ocaliva, primary biliary cholangitis

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voiced its approval of Intercept’s Ocaliva …

News
biogen_austria_238

Biogen closes in on bringing muscular atrophy preventing drug to market

September 26, 2016
Manufacturing and Production, Research and Development Biogen, EMA, FDA, Nusinersen

Biogen has applied for Priority Review, which, if granted, would shorten the review period necessary for nusinersen. They also plan …

News
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