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MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Janssen files new NDA for combination HIV drug containing darunavir

Janssen files new NDA for combination HIV drug containing darunavir

01-04-2014

US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a New Drug Application…

Anti-viralsDarunavirJanssenPharmaceuticalPrezistaRegulationUSA

US FTC releases 2013 highlights, including action against Actavis and Mylan

US FTC releases 2013 highlights, including action against Actavis and Mylan

01-04-2014

The US Federal Trade Commission chairwoman Edith Ramirez has released the agency’s 2013 Annual Highlights,…

ActavisMylan LaboratoriesPharmaceuticalRegulationUSA

Bayer’s Adempas gains EU clearance for two forms of PAH

Bayer’s Adempas gains EU clearance for two forms of PAH

31-03-2014

Following a previous positive opinion from the European Medicines Agency’s advisory committee, the…

AdempasBayerEuropePharmaceuticalRegulationRespiratory and Pulmonary

Novartis halts Ph III LCZ696 trial on strong results

Novartis halts Ph III LCZ696 trial on strong results

31-03-2014

Swiss drug major Novartis says that the Data Monitoring Committee (DMC) unanimously recommended early…

Cardio-vascularLCZ696NovartisPharmaceuticalResearch

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

31-03-2014

UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a…

GlaxoSmithKlineOncologyPharmaceuticalRegulationUKVotrientWomen's Health

Lansen Pharma acquires China rights to Novartis’ Sicorten Plus

Lansen Pharma acquires China rights to Novartis’ Sicorten Plus

31-03-2014

Hong Kong-listed Lansen Pharmaceutical has acquired the pharmaceutical product, marketed and sold in…

Asia-PacificChinaDermatologicalsLansen PharmaceuticalMergers & AcquisitionsNovartisPharmaceuticalSicorten

EU approval for Dainippon Sumitomo and Takeda’s Latuda

EU approval for Dainippon Sumitomo and Takeda’s Latuda

28-03-2014

Japanese drug majors Dainippon Sumitomo Pharma and Takeda Pharmaceutical have received European Commission…

Dainippon Sumitomo PharmaEuropeLatudaNeurologicalPharmaceuticalRegulationSunovionTakeda Pharmaceuticals

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

Alimera resubmits NDA for Iluvien

Alimera resubmits NDA for Iluvien

27-03-2014

US ophthalmic pharma specialist Alimera Sciences has resubmitted its New Drug Application for Iluvien…

AlimeraAlimera SciencesIluvienOphthalmicsPharmaceuticalRegulationUSA

Insmed’s mixed results from Ph II trial for treatment resistant NTM lung infections

27-03-2014

US-based Insmed has reported mixed results from its Phase II clinical trial of Arikayce, for the treatment…

Inflammatory diseasesInsmedPharmaceuticalRegulationRespiratory and PulmonaryUSA

Novartis’ ceritinib improves survival in patients with non-small cell lung cancer

Novartis’ ceritinib improves survival in patients with non-small cell lung cancer

27-03-2014

Swiss drug major Novartis has published clinical trial results showing the investigational compound LDK378…

LDK378Northern EuropeNovartisOncologyPharmaceuticalResearch

GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

27-03-2014

UK pharma giant GlaxoSmithKline released a couple of news items yesterday, one slightly negative regarding…

DiabetesEperzanEuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulationTafinlar

UK’s NICE opens consultation on drug assessments and recommendations

UK’s NICE opens consultation on drug assessments and recommendations

27-03-2014

The UK’s National Institute for Health and Care Excellence (NICE) is beginning a formal consultation…

PharmaceuticalRegulationUK

UK regulator keeps IMS pharmaceutical data undertakings in place

UK regulator keeps IMS pharmaceutical data undertakings in place

26-03-2014

The UK Competition Commission (CC) has decided against varying or removing undertakings which restrict…

IMS HealthNorthern EuropePharmaceuticalRegulationUK

US FDA approves NDA from Actavis and Valeant

US FDA approves NDA from Actavis and Valeant

26-03-2014

US generics major Actavis and Canada’s Valeant Pharmaceuticals said that the US Food and Drug Administration…

ActavisCanadaGenericsMetronidazolePharmaceuticalRegulationUSAValeant PharmaceuticalsWomen's Health

EU approval for Cometriq in medullary thyroid carcinoma

EU approval for Cometriq in medullary thyroid carcinoma

25-03-2014

The European Commission has approved Cometriq (cabozantinib), a drug for the treatment of adult patients…

BiotechnologyCometriqEuropeExelixisOncologyRegulationSwedish Orphan Biovitrum

NICE final guidance again rejects Sanofi’s Zaltrap for colorectal cancer

25-03-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE), today issued final guidance…

Northern EuropeOncologyPharmaceuticalPricingRegulationSanofiUKZaltrap

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

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