EMA
57% of cancer drugs uses approved by EMA show no benefit
October 5, 2017Sales and Marketing EMA, biotech, drugs, oncology, pharma, pharmaceutical
A new study conducted by King’s College London and LSE has found that of 48 treatments approved between 2009 and …
Top Ten most popular articles on Pharmafile.com this week
September 29, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Allergan, EMA, FDA, HIV, J&J, JJ, Kevzara, Mylan, NICE, Sanofi, nash, top ten
It’s Friday, and it’s time for another round up of the most popular articles on pharmafile.com over the last seven …
Roche’s Tecentriq scores approvals in metastatic lung and bladder cancer
September 27, 2017Research and Development, Sales and Marketing Cancer, EMA, EU, European Commission, Roche, bladder cancer, immunotherapy, lung cancer, pharma, tecentriq
It’s good news for Roche as the company’s immunotherapy drug Tecentriq secures approval from the European Commission to be used …
EMA relocation will cause drug approval delays even in best case scenario, agency says
September 27, 2017Research and Development EMA, brexit, pharma, pharmaceuticals
As a direct result of the UK’s referendum vote to leave the EU last year, the headquarters of the EMA, …
The October 2017 issue of Pharmafocus is now live!
September 26, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, EMA, Pharmafocus
The October edition of Pharmafocus is now live! You can read it here.
Standing together: Supercharging the clinical trial in Europe
September 18, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, biotech, clinical trials, drugs, pharma, pharmaceutical
The European Medicines Agency is on the cusp of rolling out one of the most ground-breaking digital platforms for facilitating …
‘Trade secret information’ to be shared between EMA and FDA
August 25, 2017Manufacturing and Production, Medical Communications EMA, FDA, biotech, drugs, pharma, pharmaceutical
As part of the on-going harmonisation of manufacturing standards across the Atlantic, the EMA and FDA have announced that they …
EMA reveals ‘business continuity plan’ for Brexit, cuts resources from non-essential areas
August 2, 2017Medical Communications, Research and Development EMA, brexit, drugs, life sciences, medicines, pharma, pharmaceutical
The uncertainty caused by Brexit has been and continues to be far-reaching, and perhaps most impactful for business, organisations and …
EMA reveals new clinical trial guidelines to reduce patient risk
July 28, 2017Medical Communications, Research and Development EMA, biotech, clinical trials, drugs, pharma, pharmaceutical
The EMA has announced its intention to introduce revised guidelines concerning the use of medicines in first in-human clinical trials …
European pharma pulls together to ensure ‘minimal disruption’ from Brexit
July 10, 2017Research and Development, Sales and Marketing EMA, Europe, UK
As a consequence of the triggering of Article 50 and the UK’s exit from the EU, the EMA – currently …
EMA and FDA harmonise over development of Gaucher drugs
July 5, 2017Medical Communications, Research and Development, Sales and Marketing EMA, FDA, Gaucher disease
The EMA and the FDA have announced that they have developed a joint proposal to promote more efficient means of …
Ministers move to clarify drug regulation Post-Brexit
July 4, 2017Manufacturing and Production, Medical Communications EMA, Jeremy Hunt, MHRA, NHS, NICE
Jeremy Hunt, Health Secretary, and Greg Clark, Business Secretary, have made a bold move to suggest that the UK will …
Novartis gains first-line approval for Zykadia in lung cancer
June 29, 2017Research and Development EMA, European Commission, NSCLC, Novartis
The European Commission has followed the EMA’s CHMP positive opinion by approving Novartis’ Zykadia for first-line treatment of patients with …
Novo Nordisk’s diabetes drug recommended for expanded indication in Europe
June 27, 2017Research and Development, Sales and Marketing CHMP, EMA, EU, Novo Nordisk, Victoza
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to expand the indication of Novo …
Humira set to face new European biosimilar rival
June 26, 2017Sales and Marketing CHMP, EMA, Samsung Bioepis
A position opinion from the EMA for Samsung Bioepis’ biosimilar of Humira looks set to unleash a second rival to …
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