EMA
EMA issues global recall of heart drugs over cancer risk contamination
July 10, 2018Manufacturing 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 …
CHMP recommends Novartis’ CAR-T therapy Kymriah for EU approval
July 5, 2018Sales 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 …
EMA approves Cimzia for use in treating plaque psoriasis
July 2, 2018Sales 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 …
AB Science will not seek review of masitinib rejection in Europe
May 29, 2018Manufacturing and Production, Sales and Marketing EMA, Europe, ab science, als, masitinib, pharma
AB Science has U-turned on its pursuit of a do-over on its marketing application of masitinib in Europe after the …
ViiV’s two-drug regimen gets EU approval for HIV-1
May 22, 2018Manufacturing and Production, Sales and Marketing EMA, EU, Europe, HIV, Juluca, ViiV Healthcare, pharma
ViiV Healthcare has announced that its HIV therapy Juluca (dolutegravir/rilpivirine) has been awarded marketing authorisation in the EU from the …
EMA review confirms risks of Abbvie and Biogen’s Zinbryta outweigh benefits
May 21, 2018Research and Development, Sales and Marketing EMA, Europe, European Commission, PRAC, multiple sclerosis, pharma, zinbryta
The EMA has judged that the benefits offered by Zinbryta (daclizumab), Abbvie and Biogen’s humanised IgG1 monoclonal antibody for the …
Top Ten most popular articles on Pharmafile.com this week
May 11, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, EMA, GSK, J&J, JJ, Novartis, Shire, Takeda, Valeant, biotech, drugs, pharma, pharmaceutical
It’s been a week in which one of the largest pharmaceutical takeovers in history took place and yet it’s not …
European approval for tablet formulation of Lynparza in ovarian cancer
May 8, 2018Research and Development, Sales and Marketing AstraZeneca, Cancer, EMA, Europe, MSD, lynparza, ovarian cancer, pharma
AstraZeneca and MSD’s poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) has been approved for use in Europe, it has emerged, …
Top Ten most popular articles on Pharmafile.com this week
May 4, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing BMS, EMA, Kymriah, Novartis, Porton Biopharma, Regeneron, Roche, Sandoz, Sanofi, Shire, Takeda, biosimilars, dementia
It’s Friday again and it’s been a week busy with companies’ financials. One company’s in particular were of note due …
CHMP rejects AB Science’s ALS therapy in Europe
April 23, 2018Sales and Marketing AB Sciences, EMA, European Medicines Agency, ab science, als, masitinib, pharma
AB Science has revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …
Top Ten most popular articles on Pharmafile.com this week
April 20, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Amgen, EMA, GW Pharma, J&J, JJ, MHRA, Mylan, Novartis, Sanofi, Shire, Takeda, biotech, drugs, epipen, keytruda, pharma, pharmaceutical
It’s the end of another week and there’s really been one story that has dominated the headlines – Takeda’s potential …
EMA initiates divorce process from the UK’s MHRA
April 19, 2018Medical Communications EMA, UK government, biotech, brexit, drugs, pharma, pharmaceutical
The first stage of separation for the EMA from the UK came with the decision to relocate its headquarters to …
EMA announces second-ever public hearing on high-use antibiotics
April 12, 2018Medical Communications Antibiotics, EMA, biotech, drugs, pharma, pharmaceutical
The EMA has announced, following the first-ever public hearing on valproate, that it would hold a second public hearing regarding …
Six reasons why UK pharma has more to gain, than fear, from Brexit
March 26, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, biotech, brexit, drugs, hard Brexit, pharma, pharmaceutical
There are good reasons to think exiting the EU represents a major opportunity for this dynamic and world-leading industry, argues …
Top Ten most popular articles on Pharmafile.com this week
March 9, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AbbVie, Biogen, Celgene, EMA, Gilead, HIV, Herceptin, Japan, NHS, Ontruzant, Sanofi, opioid crisis, opioids, pharma, real world data, top ten, zinbryta
After a particularly jarring bout of cold weather and snow, we may just have seen off the worst of winter …
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Five Facts about cardiovascular disease
