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Australian government to undertake review of medicines and medical devices regulation

Australian government to undertake review of medicines and medical devices regulation

24-10-2014

The Australian government is to carry out a review of the regulation of medicines and medical devices.

AustraliaMedicineMedicines AustraliaPharmaceuticalRegulation

European Commission approves Gilead’s Zydelig for blood cancer

European Commission approves Gilead’s Zydelig for blood cancer

19-09-2014

The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig…

BiotechnologyEuropeGilead SciencesLymphomaMedicineOncologyRegulationZydelig

Regado Biosciences announces FDA’s clinical hold of Ph III trial

Regado Biosciences announces FDA’s clinical hold of Ph III trial

10-07-2014

The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences…

Acute coronary syndromeBiotechnologybivalirudinCardio-vascularMedicineRegadoRegulationUSA

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

US health care providers have concerns on proposed FDA generic drug labeling rules

US health care providers have concerns on proposed FDA generic drug labeling rules

19-06-2014

A survey co-released today by the USA’s Generic Pharmaceutical Association (GPhA) and the National…

GenericsHealth Medical PharmaHealthcareMedicinePharmaceutical sciencesPharmacologyPhysicianRegulationUSA

US FDA approves Eisai’s Aloxi for children and extends exclusivity

US FDA approves Eisai’s Aloxi for children and extends exclusivity

29-05-2014

Japanese drug major Eisai announced today that the antiemetic agent Aloxi (palonosetron HCI) has been…

AloxiAntiemeticsEisaiHealth Medical PharmaJapanMedicineOncologyPharmaceuticalRegulationUnited StatesUSAVomiting

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