Regulation - Pharmaceutical, Amgen


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Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan


There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan


Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture…

AmgenAsia-PacificDaiichi SankyoOncologyPharmaceuticalPraliaRanmarkRegulation

European Commission OK for Lonquex


Israel-based Teva Pharmaceutical Industries (NYSE: TEVA|), the world's leading generics drugmaker, says…

AmgenEuropeLonquexOncologyPharmaceuticalRegulationTeva Pharmaceutical Industries

Briefs: Elan tender offer; German drug price review; Daiichi Sankyo pays milestone


Ireland-based drugmaker Elan (NYSE: ELN) yesterday reported final results of its modified Dutch auction…

ActemraAmgenAnticalinBayerElanFinancialNovo NordiskPharmaceuticalPradaxaPricingProliaRegulationResearchRocheVictozaXarelto

NICE recommendations on Bayer's Xarelto and Amgen Xgeva's for UK NHS use


Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY:…


Daiichi Sankyo files denosumab in Japan for osteoporosis


Japanese drug major Daiichi Sankyo (TYO: 4568) revealed on Friday that it has filed for approval in Japan…

AmgenAnti-Arthritics/RheumaticsAsia-PacificDaiichi SankyodenosumabPharmaceuticalRegulation

Amgen fails to get FDA advisory backing for extended use of Xgeva


The world’s largest independent biotech firm, Amgen (Nasdaq: AMGN), has failed to convince a Food…

AmgenBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationXgeva

Japanese approval for Regnite and Ranmark


Japanese drug major Astellas Pharma (TYO: 4503) and USA-based XenoPort (Nasdaq: XNPT) revealed yesterday…

AmgenAsia-PacificAstellas PharmaAstraZenecaBiotechnologyDaiichi SankyodenosumabFinancialNeurologicalOncologyPharmaceuticalRanmarkRegniteRegulationXenoPort

Janssen files Xarelto sNDA for ACS; FDA to review Amgen’s Xgeva for CRPC


US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development, has submitted…

AmgenBayerBiotechnologyCardio-vascularJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationXareltoXgeva

FDA eases REMS requirements for Amgen’s Nplate and GSK’s Promacta


The US Food and Drug Administration says that an agency initiated review of the current information has…

AmgenBiotechnologyGlaxoSmithKlineNorth AmericaNplatePharmaceuticalPromactaRare diseasesRegulation

More cancer and HIV drugs added to Australian PBS


More than 160,000 patients will benefit directly from changes to Australia’s Pharmaceutical Benefits…

AmgenAnti-viralsAsia-PacificGilead SciencesOncologyPharmaceuticalPrezistaPricingRegulationXgeva



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