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European Commission

Showing 15 posts of 91 posts found.

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European Commission warns UK over drug authorisation validity due to Brexit

May 4, 2017
Medical Communications, Sales and Marketing EMA, European Commission, brexit

The European Commission has issued a warning to pharmaceutical firms in the UK over the validity of current and future …

News
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Janssen scores EU approval for blood cancer drug Darzalex

May 2, 2017
Manufacturing and Production, Sales and Marketing Europe, European Commission, Janssen, darzalex

Janssen has announced that its CD38-directed monoclonal antibody Darzalex (daratumumab) has expanded its indication with a thumbs-up from the European …

News
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AZ’s Tagrisso continues successes with EU approval

April 26, 2017
Research and Development, Sales and Marketing AstraZeneca, EU, European Commission, NSCLC, Tagrisso

More good news for AstraZeneca’s Tagrisso (osimertinib), as the company announces that the European Commission has granted the drug full …

News
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MSD’s drug given European approval for first-line treatment in NSCLC

February 1, 2017
Sales and Marketing European Commission, MSD, Merck

The good news keeps coming for MSD, known as Merck in North America, and Keytruda, with a further label expansion …

News
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GSK applies for EU approval for shingles vaccine

November 28, 2016
Sales and Marketing European Commission, GSK, GlaxoSmithKline, Shingrix, shingles

After filing for FDA approval in October, GlaxoSmithKline has now applied for approval from the European Commission (EC) for its …

News
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Celgene says its Revlimid gets European approval to treat rare non-Hodgkin’s lymphoma

July 15, 2016
Medical Communications, Research and Development, Sales and Marketing Celgene, European Commission, Revlimid, drug approval, drug trial, oncology

Celgene (Nasdaq: CELG) said the European Commission (EC) has approved Revlimid (lenalidomide) to treat a rare form of non-Hodgkin’s lymphoma. 

News
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Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition

July 7, 2016
Research and Development, Sales and Marketing European Commission, Revestive, Shire, market authorisation, short bowel syndrome

UK drugmaker Shire (LSE: SHP) said the European Commission has granted extension of Market Authorization for Revestive (teduglutide) to treat …

News
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Takeda says its cancer drug Adcetris gets European backing in for hodgkin lymphoma

July 6, 2016
Research and Development European Commission, Takeda, drug trial, lymphoma

Takeda Pharmaceutical (TSE: 4502) said the European Commission has extended the marketing authorization for its Adcetris (brentuximab vedotin) to treat …

News
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Amgen says its blood cancer drug gets European backing for extended indication

July 4, 2016
Research and Development, Sales and Marketing Amgen, European Commission, Kyprolis, blood cancer, drug trial

Amgen (Nasdaq: AMGN) said the European Commission (EC) has approved a variation to the marketing authorization for its Kyprolis (carfilzomib) to include use …

News
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AstraZeneca’s new antibiotic Zavicefta gets European approval for serious bacterial infections

June 29, 2016
Research and Development, Sales and Marketing AstraZeneca, European Commission, Zavicefta, bacterial infections, regulation

UK drug firm AstraZeneca (LSE: AZN) said the European Commission has granted marketing authorisation for its Zavicefta (ceftazidime-avibactam), a new combination …

News

Roche says combination therapy with its Avastin and Tarceva gets European backing for lung cancer treatment

June 8, 2016
Research and Development, Sales and Marketing European Commission, NSCL, RegulationC, Roche, Tarceva, avastin, drug trial, lung cancer

Cancer drugmaker Roche (SIX: ROG) on Wednesday said the European Commission has approved its Avastin (bevacizumab) in combination with Tarceva …

News

Novartis’ Afinitor gets EU approval to treat cancerous gastrointestinal or lung tumors

June 2, 2016
Research and Development, Sales and Marketing Afinitor, Cancer, European Commission, Novartis, regulation

Swiss drugmaker Novartis (VTX: NOVN) on Thursday said the European Commission has approved its Afinitor (everolimus) to treat cancerous gastrointestinal …

News
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Janssen says its Trevicta gets European regulatory approval as maintenance therapy for Schizophrenia

June 2, 2016
Medical Communications, Research and Development European Commission, Janssen, Trevicta, schizophrenia

Janssen said the European Commission has approved its Trevicta (paliperidone palmitate, a 3‑monthly injection) as maintenance treatment of schizophrenia.  Trevicta …

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GSK’s gene therapy Strimvelis gets European regulatory nod

June 1, 2016
Research and Development, Sales and Marketing EU, European Commission, GlaxoSmithKline, Strimvelis, gene therapy, regulation

UK drugmaker GlaxoSmithKline (LSE: GSK) said its gene therapy Strimvelis has secured backing from the European regulators. The 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) …

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