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US FDA approves Stallergenes’ allergy tablet Oralair

US FDA approves Stallergenes’ allergy tablet Oralair

02-04-2014

The US Food and Drug Administration has approved Oralair immunotherapy tablet from French allergen specialist…

ImmunologicalsOralairPharmaceuticalRegulationStallergenesUSA

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

Actavis forks out $100 million for Thai generics firm

Actavis forks out $100 million for Thai generics firm

02-04-2014

Ireland-headquartered US generic major Actavis has acquired Silom Medical Company, a privately held generic…

Asia-PacificAurobindo PharmaGenericsMergers & AcquisitionsSilom Medical CompanyTeva Pharmaceutical Industries

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

Prasco to market the authorized generic of Lilly’s Evista in USA

01-04-2014

Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsMarkets & MarketingNorth AmericaPrasco LaboratoriesUSA

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

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

Actavis prevails in Lialda patent dispute in USA

Actavis prevails in Lialda patent dispute in USA

31-03-2014

US generics major Actavis says that the US Court of Appeals for the Federal Circuit has reversed a lower…

ActavisGastro-intestinalsGenericsLegalLialdaNorth AmericaPatentsShireUSA

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

Study produces map of pharma industry and API production in Brazil

Study produces map of pharma industry and API production in Brazil

28-03-2014

Brazil is failing to produce the number of active pharmaceutical ingredients in order to produce the…

BrazilGenericsMarkets & MarketingProductionSouth America

Philippine government increasing financial support for health care spending

28-03-2014

The size of the Philippine pharmaceutical market, now worth around $3.2 billion, is expected to expand…

Asia-PacificFinancialGenericsMarkets & MarketingPharmaceutical

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

New HIV/AIDS drug will be offered through Brazil’s SUS

New HIV/AIDS drug will be offered through Brazil’s SUS

27-03-2014

A medicine that combines tenofovir (Gilead’s Viread) and lamivudine (GlaxoSmithKline’s Combivir)…

Anti-viralsBlanver FarmoquimicaBrazilGenericsLamivudineProductionSouth AmericaTenofovir Disoproxil Fumarate

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

Mylan prevails in breach of contract case against GlaxoSmithKline

Mylan prevails in breach of contract case against GlaxoSmithKline

27-03-2014

US generics major Mylan reveals that, after a trial in the US District Court for the District of New…

GenericsGlaxoSmithKlineLegalMylan LaboratoriesNeurologicalparoxetinePaxil-CR

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

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

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