EMA
EMA lags behind FDA on continuous manufacturing regulation
June 15, 2017Manufacturing and Production EMA, FDA, continuous manufacturing
Continuous manufacturing is increasingly an area of fixation within the pharma industry for the benefits it can bring to the …
European Medicines Agency: Staying consistent in a turbulent time
June 12, 2017Business 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 …
New biosimilar guidelines launched in the EU
June 1, 2017Medical 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 …
European Commission warns UK over drug authorisation validity due to Brexit
May 4, 2017Medical 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 …
Pharma industry calls for EMA relocation by June in open EFPIA letter
April 25, 2017Manufacturing 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 …
EU-US reach landmark deal on mutual recognition of manufacturing inspection
March 3, 2017Medical 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 …
AstraZeneca’s hyperkalaemia treatment rebounds with European recommendation
February 24, 2017Sales 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 …
FDA Priority Review for Pfizer investigational leukaemia drug
February 22, 2017Research 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 …
Socially vigilant: Does pharmacovigilance need secondary data & social media?
February 6, 2017Business 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 …
EMA Accelerated Assessment for AbbVie’s hepatitis C regimen
January 24, 2017Manufacturing 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 …
Opdivo first PD-1 inhibitor given European approval for haematological cancer
November 25, 2016Medical 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 …
Pfizer’s breast cancer drug gets EU approval
November 10, 2016Business 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 …
EMA has validated Merck and Pfizer’s MAA for avelumab
November 1, 2016Manufacturing 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 …
EMA opens clinical trial data to public
October 25, 2016Manufacturing 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 …
EMA grants conditional approval for biliary cholangitis treatment
October 17, 2016Sales 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 …
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