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Top Ten most popular articles on Pharmafile.com this week

September 29, 2017
Business 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 …

News
roche

Roche’s Tecentriq scores approvals in metastatic lung and bladder cancer

September 27, 2017
Research 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 …

News
brexit_flag

EMA relocation will cause drug approval delays even in best case scenario, agency says

September 27, 2017
Research 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, …

News
pharmafocus_october__cover_2017

The October 2017 issue of Pharmafocus is now live!

September 26, 2017
Business 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.

News
computer_and_doctor

Standing together: Supercharging the clinical trial in Europe

September 18, 2017
Business 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 …

Feature
manufacturing_image_1

‘Trade secret information’ to be shared between EMA and FDA

August 25, 2017
Manufacturing 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 …

News
ema_inside

EMA reveals ‘business continuity plan’ for Brexit, cuts resources from non-essential areas

August 2, 2017
Medical 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 …

News
shutterstock_243110086

EMA reveals new clinical trial guidelines to reduce patient risk

July 28, 2017
Medical 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 …

News
brexit_flag

European pharma pulls together to ensure ‘minimal disruption’ from Brexit

July 10, 2017
Research 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 …

News
eu_and_fda

EMA and FDA harmonise over development of Gaucher drugs

July 5, 2017
Medical 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 …

News
brexit_flag_0

Ministers move to clarify drug regulation Post-Brexit

July 4, 2017
Manufacturing 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 …

News
novartis_headquarters

Novartis gains first-line approval for Zykadia in lung cancer

June 29, 2017
Research 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 …

News

Novo Nordisk’s diabetes drug recommended for expanded indication in Europe

June 27, 2017
Research 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 …

News

Humira set to face new European biosimilar rival

June 26, 2017
Sales 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 …

News
pharma_pill_manufacturing

EMA lags behind FDA on continuous manufacturing regulation

June 15, 2017
Manufacturing 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 …

News
The Gateway to Local Adoption Series

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