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EMA

Showing 15 posts of 400 posts found.

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
ema_building_face_web

AB Science will not seek review of masitinib rejection in Europe

May 29, 2018
Manufacturing 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 …

News
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ViiV’s two-drug regimen gets EU approval for HIV-1

May 22, 2018
Manufacturing 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 …

News
european_commission_web

EMA review confirms risks of Abbvie and Biogen’s Zinbryta outweigh benefits

May 21, 2018
Research 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 …

News
top_ten

Top Ten most popular articles on Pharmafile.com this week

May 11, 2018
Business 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 …

News
credit_-_daniel_leal-olivas-afp

European approval for tablet formulation of Lynparza in ovarian cancer

May 8, 2018
Research 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, …

News
top_ten

Top Ten most popular articles on Pharmafile.com this week

May 4, 2018
Business 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 …

News
credit_-_daniel_leal-olivas-afp

CHMP rejects AB Science’s ALS therapy in Europe

April 23, 2018
Sales 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 …

News
top_ten

Top Ten most popular articles on Pharmafile.com this week

April 20, 2018
Business 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 …

News
brexit_flag_0

EMA initiates divorce process from the UK’s MHRA

April 19, 2018
Medical 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 …

News
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EMA announces second-ever public hearing on high-use antibiotics

April 12, 2018
Medical 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 …

News
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Six reasons why UK pharma has more to gain, than fear, from Brexit

March 26, 2018
Business 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 …

Feature
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Top Ten most popular articles on Pharmafile.com this week

March 9, 2018
Business 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 …

News

Abbvie and Biogen pull MS drug Zinbryta following urgent EMA safety review

March 5, 2018
Sales and Marketing AQbbvie, Biogen, EMA, Europe, mulyiple sclerosis, pharma, zinbryta

Biogen and Abbvie have announced their intention to voluntarily withdraw their multiple sclerosis therapy Zinbryta (daclizumab) from all global markets …

News
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