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EMA, GSK blast BMJ’s ‘flawed’ Pandemrix safety report fiercepharma
December 11, 2018
European drug regulatory bodies and GlaxoSmithKline have quickly rallied their rebuttals to a BMJ report that questioned the safety profile of GSK’s now-unavailable pandemic flu vaccine Pandemrix...
Five more countries to join EMA-FDA mutual recognition europeanpharmaceuticalreview
December 07, 2018
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)…
ICR report shows lag in UK patient access to new cancer drugs pharmaceutical-technology
December 05, 2018
A new report by The Institute of Cancer Research, London (ICR) has revealed an increase of nearly one year in delay between clinical trials, regulatory approvals and patient access to new cancer medications....
First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee pharmafile
November 21, 2018
Sanofi’s fexinidazole, the first all-oral therapy for the treatment of human African trypanosomiasis (HAT), or sleeping sickness, has secured a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHM
GW Pharma's Epidiolex becomes first cannabis-based medicine to be made available in United States pharmafile
November 19, 2018
GW Pharma’s Epidiolex has become the first plant-derived, cannabis-based medicine to be made available on prescription in all 50 US states. The medication consists of highly-purified
First all-oral treatment for sleeping sickness leads positive recommendations from CHMP's November meeting firstwordpharma
November 19, 2018
At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended four drugs for approval
Concerns over Brexit cause Recardio to cease clinical trials in the UK pharmaceutical
November 19, 2018
California-based clinical stage pharmaceutical company Recardio has halted its UK activities due to concerns over Brexit and how it will impact the approval of medicines.
Hansa Medical Receives Positive Opinion for Orphan Drug Designation in the EU for Imlifidase for Anti-GBM Disease firstwordpharma
October 25, 2018
Hansa Medical Receives Positive Opinion for Orphan Drug Designation in the EU for Imlifidase for Anti-GBM Disease
Pace of cancer drug reimbursement varies wildly across Europe pharmaceutical-technology
October 22, 2018
Researchers have found that some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions about reimbursing cancer drugs following European Medicines Agency (EMA) approval.
Rigel Receives EMA Validation for Fostamatinib americanpharmaceuticalreview
October 12, 2018
Rigel Pharmaceuticals announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for fostamatinib in adult chronic immune thrombocytopenia.

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