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FDA approves new indication for Amgen's Xgeva

FDA approves new indication for Amgen's Xgeva

08-12-2014

USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab),…

AmgenBiotechnologyOncologyRare diseasesRegulationUSAXgeva

GlaxoSmithKline files for added Revolade indication in EU

12-11-2014

UK pharma major GlaxoSmithKline has filed an application with the European Medicines Agency for a variation…

EuropeGlaxoSmithKlineLigand PharmaceuticalsOncologyPharmaceuticalPromactaRare diseasesRegulationRevolade

bluebird bio poised to advance gene therapy pipeline

bluebird bio poised to advance gene therapy pipeline

02-09-2014

US clinical-stage biotech firm bluebird bio is advancing a pipeline focused on gene therapy, a rapidly…

Biotechnologybluebird bioCelgene Corp.OncologyRare diseasesResearch

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

20-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products,…

Federal Joint CommitteeGermanyJakaviMyelofibrosisNovartisOncologyPharmaceuticalPricingRare diseasesRegulation

Oncothyreon acquires Alpine Biosciences

Oncothyreon acquires Alpine Biosciences

12-08-2014

US biotech firm Oncothyreon says that it has acquired Alpine Biosciences, of Seattle, Washington, a privately…

Alpine BiosciencesBiotechnologyBusiness FinanceImmunotherapyMedicineMergers & AcquisitionsOncologyOncothyreonRare diseasesUSA

US and European orphan status for AbbVie’s glioblastoma candidate

US and European orphan status for AbbVie’s glioblastoma candidate

04-08-2014

Both the European Medicines Agency and the US Food and Drug Administration have granted orphan drug designation…

AbbVieABT-414Brain tumorEuropeGlioblastoma multiformeMarkets & MarketingOncologyPharmaceuticalRare diseasesRegulationUS Food and Drug AdministrationUSA

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

17-06-2014

USA-based Mirati Therapeutics has been granted Orphan Drug designation by the US Food and Drug Administration…

BiotechnologyOncologyRare diseasesRegulation

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