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UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a…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

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

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

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

28-03-2014

Final draft guidance from the UK health care costs watchdog the National Institute for Health and Care…

Anti-Arthritics/RheumaticsJanssenJohnson & JohnsonNorthern EuropePharmaceuticalPricingRegulationStelara InjectionUK

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

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

Solid financials from Stada but outlook sends stock down

Solid financials from Stada but outlook sends stock down

25-03-2014

German generic and branded drugmaker Stada Arzneimittel posted a solid set of financial results for 2013,…

FinancialGenericsSTADA Arzneimittel

64 to 88 of 3393 results

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