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Showing 15 posts of 383 posts found.

7359dba7-e1da-4eb4-8765-58da6178899b

Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy

September 24, 2018
Research and Development, Sales and Marketing CHMP, Duchenne Muscular Dystophy, EMA, Europe, Exondys 51, pharma, sarepta

Sarepta Therapeutics has been rocked by a hurdle in its pursuit of regulatory approval in Europe, as the company revealed …

News
drug_safety

Drug safety: UK and EU post-Brexit

September 10, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, Europe, MHRA, UK, brexit, drug safety, pharmacovigilance

What does Brexit mean for drug safety in Europe and the United Kingdom? Louis Goss looks into Britain’s exit from …

Feature
top_10_image

Top Ten most popular articles on Pharmafile.com this week

September 7, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, MHRA, Trump, brexit, research, scandal, top 10

Brexit took the top two spots this week after it was revealed that the EMA has awarded Britain’s MHRA just …

News
28246711066_52e38bc591_z

MHRA loses EMA contracts in wake of Brexit

September 3, 2018
Sales and Marketing EMA, MHRA, UK, brexit, contracts, politics, regulation

The EMA has awarded Britain’s regulatory body the MHRA just two contracts this year, as the European agency suggested that …

News
top_10_image

Top Ten most popular articles on Pharmafile.com this week

August 3, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, GSK, Sanofi, brexit, pharmafile, top 10

While average temperatures dropped to a comfortable 22 degrees, the past week has put the EMA in a sticky position …

News
ema_logo

EMA to cut activities as it forecasts loss of 30% of staff

August 2, 2018
Medical Communications, Research and Development EMA, London, UK, amsterdam, brexit, disruption, staff

The European Medicines Agency is set to enact temporary cuts in activities as it prepares for significant disruption in the …

News

Pfizer notches two EU approvals, including Herceptin biosimilar

August 1, 2018
Research and Development, Sales and Marketing Cancer, EMA, EU, Genetech, Herceptin, Pfizer, Trazimera, Xeljanz, biosimilar, breast cancer, pharma

Pfizer is patting itself on the back after securing two new approvals in Europe within 24 hours: Xeljanz (tofacitinib citrate) …

News
White blood cells

CHMP recommend white blood cell growth stimulator biosimilar to EMA

July 30, 2018
Sales and Marketing Amgen, CHMP, EMA, Neulasta, biosimilar, chemotherapy, pegfilgrastim

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of two separate …

News
Canary Wharf European Medicines Agency

Landlord demands EMA pay £500m for Canary Wharf lease

July 27, 2018
Medical Communications Canary Wharf, EMA, Litigation, London, amsterdam, court

A British landlord is taking the European Medicines Agency (EMA) to court over a £500 million bill for unpaid rent. …

News
28246711066_52e38bc591_z

MPs vote to stay in EMA after Brexit

July 19, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, UK, brexit, parliament, vote

British MPs have voted for the UK’s continued participation in the regulatory network operated by the European Medicines Agency (EMA) …

News
top_10_image

Top Ten most popular articles on Pharmafile.com this week

July 12, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Pfizer, Sanofi, Trump, top 10

In the week leading up to Donald Trump’s visit to the United Kingdom, the news has been dominated by the …

News
28246711066_52e38bc591_z

EMA survey identifies gaps in pharma industry’s preparedness for Brexit

July 11, 2018
Research and Development CAPS, EEA, EMA, brexit, preparedness

An EMA survey has identified gaps in the pharmaceutical industry’s preparedness for Brexit, finding that only 58% of market authorisation …

News
shutterstock_2

EMA issues global recall of heart drugs over cancer risk contamination

July 10, 2018
Manufacturing and Production EMA, Europe, heart disease, pharma, valsartan

Several drugs designed for the treatment of high blood pressure and heart conditions have been recalled across Europe over fears …

News
kymriah

CHMP recommends Novartis’ CAR-T therapy Kymriah for EU approval

July 5, 2018
Sales and Marketing CAR-T, CHMP, EMA, EU, Kymriah, Novartis, pharma

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T …

News

EMA approves Cimzia for use in treating plaque psoriasis

July 2, 2018
Sales and Marketing Cimzia, EMA, UCB, indication, pharmaceutical

The Brussels-based pharmaceutical company UCB has announced that the European Medicines Agency (EMA) has approved a label extension for Cimzia …

News

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