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Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

02-03-2015

Taiho Pharma Europe, a subsidiary of Japanese pharma company Otsuka (TYO: 4768), has submitted a marketing…

EuropeOncologyPharmaceuticalRegulationTaiho PharmaceuticalsTAS-102

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

28-02-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

AvastinBiotechnologyEuropeOncologyRegulationRoche

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

28-02-2015

US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line…

AlprolixBiogen IdecBiotechnologyEuropeHematologyRegulationResearchSobiSwedish Orphan Biovitrum

Three new drugs recommended for approval by EMA/CHMP

Three new drugs recommended for approval by EMA/CHMP

27-02-2015

Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines…

AmgenEuropeJinarcNephrology and HepatologyNovartisOncologyOtsuka PharmaceuticalPharmaceuticalRegulationRistempaVectibixZykadia

EC approves Zambon and Newron’s Xadago for late-stage PD patients

EC approves Zambon and Newron’s Xadago for late-stage PD patients

27-02-2015

Zambon and its partner, fellow Italy-based Newron Pharmaceuticals, have received approval from the European…

EuropeNeurologicalNewron PharmaceuticalsPharmaceuticalRegulationXadagoZambon

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

27-02-2015

The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib)…

AmgenEuropeKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Eli Lilly delays US and Europe filings for new diabetes agent peglispro

23-02-2015

US pharma major Eli Lilly says it is delaying the submission of its basal insulin peglispro (BIL) to…

DiabetesEli LillyEuropepeglisproPharmaceuticalRegulationUSA

Holoclar, the first stem cell-based medicinal product approved in Europe

Holoclar, the first stem cell-based medicinal product approved in Europe

22-02-2015

The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004,…

BiotechnologyChiesi FarmaceuticiEuropeHoloclarHolostem Terapie AvanzateOphthalmicsRegulation

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