European Commission

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Boehringer Ingelheim’s Giotrif gets Europan regulatory backing in another lung cancer indication

April 7, 2016
Business Services, Research and Development, Sales and Marketing Boehringer Ingelheim, European Commission, giotrif, lung cancer

German drugmaker Boehringer Ingelheim on Thursday said European regulators have granted marketing rights for its non-small cell lung cancer (NSCLC) …

AZ sign

AstraZeneca’s Tagrisso gets EU lung cancer sign-off

February 4, 2016
Sales and Marketing AstraZeneca, European Commission, NSCLC, Tagrisso, non-small cell lung cancer, osimertinib

The European Commission (EC) has granted conditional marketing authorisation to AstraZeneca’s Tagrisso to treat locally advanced or metastatic non-small cell …

Imlygic

European approval for Amgen cancer drug Imlygic

December 18, 2015
Sales and Marketing Amgen, European Commission, Imlygic, melanoma, skin cancer, t-vec, talimogene laherparepvec

The European Commission has approved the use of Amgen’s Imlygic for adults with advanced melanoma, making it the first drug …

Gilead image

EU approval for Gilead’s HIV combo Genvoya

December 1, 2015
Manufacturing and Production, Sales and Marketing European Commission, Genvoya, Gilead, Gilead Sciences, HIV, TDF, World Aids Day, european union, taf

Gilead Sciences has won marketing authorisation from the European Commission (EC) for the once-daily single tablet regimen Genvoya as an …

EU flag

Novartis and Amgen drugs signed-off by European Commission

November 24, 2015
Manufacturing and Production Amgen, Entresto, European Commission, Novartis, blincyto

The European governing body, the European Commission, has approved the Novartis drug Entresto for heart failure and Amgen’s Blincyto for …

Europe Member State flags

EU plans export waiver for pharma manufacturing

November 3, 2015
Manufacturing and Production EGA, European Commission, biologics, biosimilars, generics, manufacturing, supplementary protection certificates

The European Commission plans to bring in an export waiver for supplementary protection certificates, in order to boost pharma industry …

EU flag

European Commission funds €23m project to develop HIV vaccine

November 2, 2015
Research and Development, Sales and Marketing BioNTech, European Commission, HIV, R&D, horizon 2020

The European Commission has kicked-off a new €23 million research program to bring together researchers to work on a potential …

Vidaza product image

Celgene’s Vidaza earns wider approval

November 2, 2015
Sales and Marketing Celgene, European Commission, Vidaza, acute myeloid leukaemia, azacitidine, leukaemia

Swiss firm Celgene has been given approval by the European Commission to extend its marketing authorisation for the cancer treatment …

Praluent

Sanofi and Regeneron given European nod for Praluent

September 28, 2015
Sales and Marketing European Commission, Regeneron, Sanofi, alirocumab, high cholesterol, marketing authorisation, praluent

The European Commission (EC) has approved the marketing authorisation of Sanofi and Regeneron’s cholesterol drug Praluent.  The heart drug is …

Farydak

Novartis blood cancer drug Farydak receives EU approval

September 4, 2015
Sales and Marketing Cancer, European Commission, Farydak, Novartis, multiple myeloma, myeloma, panobinostat

The European Commission has approved Novartis’s Farydak, in combination with Velcade and dexamethasone, for the treatment of adult patients with …

CEP report

Pharma ‘spends €40m to sway EU politicians’

September 2, 2015
Medical Communications EU, European Commission, TTIP, drug policy, lobbying, transparency

The pharma industry has excessive power over EU decision-makers and spends €40 million a year to influence EU drug policy, …

Alexion sign

Alexion scores double EU approval

September 1, 2015
Manufacturing and Production, Sales and Marketing Alexion, EC, European Commission, Kanuma, Strensiq, asfotase alfa, sebelipase alfa, ultra rare disease, ultra-rare disease

Two treatments developed by ultra-rare disease specialists Alexion Pharmaceuticals are now approved for use in Europe. The European Commission approved …

Opdivo

BMS halts Opdivo kidney cancer trial early

July 22, 2015
Research and Development BMS, Bristol-Myers Squibb, European Commission, Kidney cancer, opdivo, renal cell carcinoma

Bristol-Myers Squibb has stopped its Phase III study of its immunotherapy drug Opdivo in people with kidney cancer early after …

Amgen’s Repatha wins PCSK9 heart drug race

July 21, 2015
Sales and Marketing Amgen, European Commission, PCKS9, Repatha, evolocumab, high cholesterol

The European Commission has signed off on Amgen’s Repatha, making it the first in a new class of cholesterol-lowering drugs …

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European Imbruvica approval for Janssen

July 20, 2015
Medical Communications, Sales and Marketing B-cell lymphoma, EC, European Commission, Janssen, Waldenström’s Macroglobulinemia, imbruvica, rare cancer

Janssen has received final European sign-off for its oncology treatment Imbruvica (ibrutinib) as a treatment option for adult patients with …

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