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FDA adds warning to Tecfidera label after patient death

FDA adds warning to Tecfidera label after patient death

26-11-2014

The US Food and Drug Administration has issued a warning that a patient with multiple sclerosis who was…

Biogen IdecCNS DiseasesPharmaceuticalRegulationTecfideraUSA

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

26-11-2014

The chief executive of Medicines Australia has called for a strengthening of Australia’s intellectual…

AustraliaBiotechnologyLegalMedicines AustraliaRegulationResearch

Eisai opens £8 million packaging facility in UK

Eisai opens £8 million packaging facility in UK

26-11-2014

Japanese drug major Eisai has opened a new facility at its EMEA Knowledge Center in Hatfield, UK, to…

EisailenvatinibPharmaceuticalProductionUK

NICE updated guidance backs Novartis’ Glivec for GIST

26-11-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued final…

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

UK's NICE recommends Selincro to help reduce alcohol dependence

UK's NICE recommends Selincro to help reduce alcohol dependence

26-11-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Selincro (nalmefene)…

LundbeckNeurologicalPharmaceuticalRegulationSelincroUK

Merck & Co submits first regulatory filing for omarigliptin, in Japan

Merck & Co submits first regulatory filing for omarigliptin, in Japan

25-11-2014

US pharma giant Merck & Co has submitted a new drug application for omarigliptin, its investigational…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulation

Janssen submits NDA for Yondelis in soft tissue sarcoma

Janssen submits NDA for Yondelis in soft tissue sarcoma

25-11-2014

US health care giant Johnson & Johnson’s subsidiary Janssen Research & Development has submitted a…

Janssen Research and DevelopmentOncologyPharmaceuticalRegulationUSAYondelis

Predictive biomarkers could help costly cancer drugs secure market access

25-11-2014

Biomarker driven prescribing is likely to positively influence perceptions of oncology drugs for both…

EuropeMarkets & MarketingOncologyPharmaceuticalPricing

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