EMA
Novartis withdraw marketing application for heart drug
December 17, 2018Sales and Marketing CHMP, EMA, MI, Novartis, pharma
Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events …
First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee
November 20, 2018Manufacturing and Production, Sales and Marketing CHMP, EMA, Europe, Sanofi, fexinidazole, pharma, sleeping sickness
Sanofi’s fexinidazole, the first all-oral therapy for the treatment of human African trypanosomiasis (HAT), or sleeping sickness, has secured a …
EMA says pharma industry now more prepared for Brexit
September 27, 2018Manufacturing and Production, Medical Communications EMA, EU, brexit, products, qppv
In July of this year the European Medicines Agency (EMA) identified significant gaps in the pharmaceutical industry’s preparedness for Brexit. …
Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy
September 24, 2018Research 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 …
Drug safety: UK and EU post-Brexit
September 10, 2018Business 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 …
Top Ten most popular articles on Pharmafile.com this week
September 7, 2018Business 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 …
MHRA loses EMA contracts in wake of Brexit
September 3, 2018Sales 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 …
Top Ten most popular articles on Pharmafile.com this week
August 3, 2018Business 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 …
EMA to cut activities as it forecasts loss of 30% of staff
August 2, 2018Medical 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 …
Pfizer notches two EU approvals, including Herceptin biosimilar
August 1, 2018Research 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) …
CHMP recommend white blood cell growth stimulator biosimilar to EMA
July 30, 2018Sales 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 …
Landlord demands EMA pay £500m for Canary Wharf lease
July 27, 2018Medical 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. …
MPs vote to stay in EMA after Brexit
July 19, 2018Business 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) …
Top Ten most popular articles on Pharmafile.com this week
July 12, 2018Business 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 …
EMA survey identifies gaps in pharma industry’s preparedness for Brexit
July 11, 2018Research 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 …
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