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NICE issues new quality standard to prevent hepatitis B transmission

NICE issues new quality standard to prevent hepatitis B transmission

28-07-2014

On World Hepatitis Day today, the UK’s clinical standards body, the National Institute for Health and…

BaracludeBristol-Myers SquibbGilead SciencesHealthHepatitis BHepatologyMedicineNephrology and HepatologyPharmaceuticalPurinesRegulationUKViread

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

Actavis and Forest to divest four generics to gain FTC OK for merger

01-07-2014

In order for Ireland-headquartered generics major Actavis to complete its previously-announced $25 billion…

ActavisForest LaboratoriesGeneric pharmaceuticalsGenericsHealth Medical PharmaMedicinePharmaceutical industryPharmacologyRegulationUSA

Actavis files for generic version of Acorda’s Ampyra

Actavis files for generic version of Acorda’s Ampyra

27-06-2014

US biotech firm Acorda Therapeutics has been advised that Ireland-headquartered generics major Actavis…

Acorda TherapeuticsActavisAmpyraGenericsHealth Medical PharmaMedicinePharmaceutical sciencesPharmacologyRegulationUS Food and Drug AdministrationUSA

Vertex leaps on positive Ph III results with lumacaftor

Vertex leaps on positive Ph III results with lumacaftor

24-06-2014

US biotech firm Vertex Pharmaceuticals saw its share price rocket nearly 52% to $101.20 in extending…

BiotechnologyBusiness FinanceCystic fibrosisHealth Medical PharmaKalydecolumacaftorMedicinePhenolsRare diseasesRegulationResearchVertex Pharmaceuticals

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

EMA examines warnings of anaphylactic reactions to Rienso

EMA examines warnings of anaphylactic reactions to Rienso

09-05-2014

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started two…

Anaphylactic reactionsEuropeHealthLong-term kidney diseaseMedicinePharmaceuticalPharmacovigilance Risk Assessment CommitteeRegulationRienso

US FDA approves GSK’s Incruse Ellipta for COPD

US FDA approves GSK’s Incruse Ellipta for COPD

01-05-2014

The US Food and Drug Administration has approved UK pharma major GlaxoSmithKline’s Incruse (umeclidinium)…

Chronic lower respiratory diseasesCOPDGlaxoSmithKlineIncruseIncruse ElliptaMajorMedicinePharmaceuticalPulmonologyRegulationRespiratory and PulmonaryUKUSA

NICE draft guidance recommends Ferring’s Firmagon for prostate cancer

NICE draft guidance recommends Ferring’s Firmagon for prostate cancer

15-04-2014

In final draft guidance published today, the UK’s National Institute for Health and Care Excellence…

AnatomyCare ExcellenceFerring PharmaceuticalsFirmagonHealth Medical PharmaMedicineOncologyPharmaceuticalRegulationUKUnited Kingdom

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