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European Commission

Showing 15 posts of 78 posts found.

EC approves Menarini Group’s Orserdu for breast cancer treatment

September 21, 2023
Medical Communications European Commission, Oncology, Orserdu, breast cancer

The Menarini Group and its subsidiary Stemline Therapeutics have announced that the European Commission (EC) has approved Orserdu (elacestrant) as …

News

EC approves Roche’s Evrysdi for babies under two months with SMA

August 30, 2023
Research and Development European Commission, Evrysdi, Musculo-skeletal disorder, Roche, spinal muscular atrophy

Roche has announced that the European Commission (EC) has approved the extension of Evrysdi’s marketing authorisation in the EU to …

News

EC approves Kaftrio as combination treatment for cystic fibrosis

April 29, 2021
EU, European Commission, cystic fibrosis

Vertex Pharmaceuticals has been granted European Commission approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with …

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EU building with flags outside it

European Commission sues AstraZeneca over COVID-19 jab supplies

April 27, 2021
Manufacturing and Production AstraZeneca, AstraZeneca vaccine, COVID-19, EU, European Commission, covid 19 news, covid-19 news, european union, pharma, pharma news

The European Commission (EC) announced yesterday that it was suing AstraZeneca for failing to respect its contract to supply COVID-19 …

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Sanofi multiple myeloma drug approved for second indication by EC

April 19, 2021
Sales and Marketing European Commission, Sanofi, Sarclisa, pharma, pharma news

The European Commission (EC) has approved a second indication of Sanofi’s Sarclisa drug for the treatment of adult patients with …

News

Novartis MS therapy gains MHRA and EC approval

April 8, 2021
European Commission, MHRA, Novartis, pharma, pharma news

The MHRA and European Commission have both granted marketing authorisation to Novartis for its Kesimpta therapy, for the treatment of …

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Roche building

Roche’s SMA treatment Evrysdi approved by European Commission

March 30, 2021
Manufacturing and Production EMA, European Commission, PTC Therapeutics, Roche, sma, spinal muscular atrophy

The European Commission has granted marketing authorisation to Roche and PTC Therapeutics’ Evrysdi, for the treatment of patients aged 2 …

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european_commission_web

European Commission approves EU’s first peanut allergy treatment

December 21, 2020
Sales and Marketing Aimmune, European Commission, allergy

Aimmune Therapeutics today announced that the European Commission (EC) has approved PALFORZIA as the EU’s first-ever treatment of peanut allergy. …

News

Venclyxto combo scores European approval for previously untreated chronic lymphocytic leukaemia

March 13, 2020
Medical Communications, Sales and Marketing AbbVie, European Commission, Roche, Venclyxto, pharma

The European Commission has moved to authorise AbbVie and Roche’s B-cell lymphoma-2 (BCL-2) inhibitor Venclyxto (venetoclax) when used in combination …

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Top Ten most popular articles on Pharmafile.com this week

January 17, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Big Pharma, European Commission, FDA, Pakistan, Sanofi, Teva

Pakistan is cracking down on corruption and has registered cases against 200 pharmaceutical companies, while in the US the FDA …

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47028496254_21a33b62df_b

NICE rules against the use of Akcea’s Waylivra in the NHS

January 3, 2020
Medical Communications Akcea, European Commission, FCS, NHS, NICE

NICE has not recommended Akcea’s drug Waylivra (volanesorsen) to be used for the treatment of Familial Chylomicronaemia Syndrome (FCS) in …

News

Roche’s Tecentriq combo scoops up European approval in first-line metastatic lung cancer

March 8, 2019
Medical Communications, Sales and Marketing Cancer, Europe, European Commission, NSCLC, Roche, lung cancer, pharma

Roche has announced the approval of the European Commission for its PD-L1 inhibitor Tecentriq (atezolizumab) when used in combination with …

News
amgen_hq

Amgen’s Blincyto secures expanded indication in Europe for acute lymphoblastic leukaemia

January 23, 2019
Research and Development, Sales and Marketing Ammgen, Cancer, Europe, European Commission, blincyto, leukaemia, pharma

The European Commission has chosen to expand the authorised indication for Amgen’s Blincyto (blinatumomab) in the region, it has emerged, …

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gilead-sciences

European Commission greenlights Gilead’s Biktarvy for HIV-1

June 25, 2018
Sales and Marketing Biktarvy, EU, Europe, European Commission, HIV, HIV-1, pharma

Good news for Gilead and HIV patients across the European Union today as the prominent pharma firm announced that its …

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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 …

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