European Commission
European Commission targets Aspen over 1,500% price hikes
May 16, 2017Manufacturing and Production, Sales and Marketing European Commission, aspen
The European Commission (EC) has opened its first investigation over drug pricing following alleged hiking by pharma company Aspen, which …
European Commission warns UK over drug authorisation validity due to Brexit
May 4, 2017Medical 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 …
Janssen scores EU approval for blood cancer drug Darzalex
May 2, 2017Manufacturing 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 …
AZ’s Tagrisso continues successes with EU approval
April 26, 2017Research 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 …
MSD’s drug given European approval for first-line treatment in NSCLC
February 1, 2017Sales 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 …
GSK applies for EU approval for shingles vaccine
November 28, 2016Sales 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 …
Celgene says its Revlimid gets European approval to treat rare non-Hodgkin’s lymphoma
July 15, 2016Medical 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.
Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition
July 7, 2016Research 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 …
Takeda says its cancer drug Adcetris gets European backing in for hodgkin lymphoma
July 6, 2016Research 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 …
Amgen says its blood cancer drug gets European backing for extended indication
July 4, 2016Research 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 …
AstraZeneca’s new antibiotic Zavicefta gets European approval for serious bacterial infections
June 29, 2016Research 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 …
Roche says combination therapy with its Avastin and Tarceva gets European backing for lung cancer treatment
June 8, 2016Research 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 …
Novartis’ Afinitor gets EU approval to treat cancerous gastrointestinal or lung tumors
June 2, 2016Research 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 …
Janssen says its Trevicta gets European regulatory approval as maintenance therapy for Schizophrenia
June 2, 2016Medical 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 …
GSK’s gene therapy Strimvelis gets European regulatory nod
June 1, 2016Research 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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