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Biocad’s AcellBia is first MAb biosimilar approved by Russia’s Ministry of Health

15-05-2014

A biosimilar of Swiss drug major Roche’s MabThera (rituximab), to be marketed under the trade name…

AcellBiaBiocadBiosimilarsGenericsMabTheraOncologyRegulationRocheRussia

Mylan debuts generic Zyprexa Zydis in USA; Actavis Exalgo copy approved

Mylan debuts generic Zyprexa Zydis in USA; Actavis Exalgo copy approved

14-05-2014

US generic drugmaker Mylan says it has launched Olanzapine Orally Disintegrating tablets (ODT), 5mg,…

ActavisEli LillyExalgoGenericsMallinckrodtMarkets & MarketingMylanNeurologicalRegulationUSAZyprexa

Significant decline in 1st-qtr US FDA drug approvals

Significant decline in 1st-qtr US FDA drug approvals

14-05-2014

Warning signs of a decline in pharma R&D activity and successes has come in the form of a new analysis…

PharmaceuticalRegulationResearchUSA

Negative NICE draft guidance on Janssen’s Zytiga for prostate cancer

Negative NICE draft guidance on Janssen’s Zytiga for prostate cancer

14-05-2014

In draft guidance published this morning, the UK drugs watchdog the National Institute for Health and…

JanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationUKZytiga

FDA approves new indication for Bayer's Kogenate

12-05-2014

The US Food and Drug Administration has approved a new indication for German drug major Bayer's Kogenate…

BayerHematologyKogenate FSPharmaceuticalRegulationUSA

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

12-05-2014

Japanese drug major Eisai has exercised its option to jointly develop and commercialize its clinical…

Biogen IdecEisaiFycompaGermanyItalyLicensingNeurologicalPharmaceuticalPricingRegulationZebinix

Vivus says Actavis has filed ANDA for generic Qsymia

Vivus says Actavis has filed ANDA for generic Qsymia

10-05-2014

US drug developer Vivus disclosed on Friday that the company had received notice from generics major…

ActavisGenericsMetabolicsPatentsQsymiaRegulationUSAVivus

GPs lack awareness of NICE guidelines on HMB, survey shows

GPs lack awareness of NICE guidelines on HMB, survey shows

09-05-2014

Less than 5% of UK general practitioners (GPs) prescribe in line with guidelines from the National Institute…

BayerHealth Medical PharmaHealth Medical PharmaMilitary scienceNavigationPharmaceuticalRegulationSocial IssuesUKWomen's Health

FDA approves Merck & Co’s new blood thinner Zontivity

FDA approves Merck & Co’s new blood thinner Zontivity

09-05-2014

The US Food and Drug Administration yesterday approved US pharma giant Merck & Co’s Zontivity (vorapaxar)…

Cardio-vascularMerck & CoPharmaceuticalRegulationUSAZontivity

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

GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

09-05-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline and partner…

Anoro ElliptaEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance

NICE issues positive recommendation for Astellas' Xtandi

NICE issues positive recommendation for Astellas' Xtandi

09-05-2014

In an about turn, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

Astellas PharmaOncologyPharmaceuticalPricingRegulationUKXtandi

AbbVie files for EU marketing approval for its all-oral, interferon-free hepatitis C therapy

AbbVie files for EU marketing approval for its all-oral, interferon-free hepatitis C therapy

08-05-2014

US drugmaker AbbVie has submitted marketing authorization applications to the European Medicines Agency…

AbbVieAnti-viralsPharmaceuticalRegulationUSA

Janssen submits sNDA for Olysio in combination with sofosbuvir

Janssen submits sNDA for Olysio in combination with sofosbuvir

08-05-2014

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson, has submitted…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioRegulationSovaldiUSA

Roche may lose $240 million contract in Russia to Biocad biosimilar

Roche may lose $240 million contract in Russia to Biocad biosimilar

07-05-2014

Swiss drug major Roche may lose an important $240 million contract in Russia for the supply of its anti-cancer…

AcellBiaBiocadBiosimilarsBiotechnologyMabTheraMarkets & MarketingOncologyRegulationrituximabRoche

Merck & Co updates on near-term opportunities and strategy

Merck & Co updates on near-term opportunities and strategy

07-05-2014

US pharma giant Merck & Co, which has just sold its consumer health care business to Bayer for $14.2…

Merck & CoPharmaceuticalRegulationResearch

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

07-05-2014

US health care giant Johnson & Johnson subsidiary Janssen Pharmaceuticals has released positive results…

Invega SustennaJanssenJohnson & JohnsonNeurologicalPharmaceuticalRegulationResearch

US priority review for Astellas and Medivation’s sNDA for prostate cancer

US priority review for Astellas and Medivation’s sNDA for prostate cancer

06-05-2014

Japanese drug major Astellas' US subsidiary and Medivation revealed that the US Food and Drug Administration…

Astellas PharmaBiotechnologyMedivationOncologyRegulationUSAXtandi

US FDA approval for AstraZeneca’s Epanova

US FDA approval for AstraZeneca’s Epanova

06-05-2014

There was good news today for Anglo-Swedish drug major AstraZeneca, as the US Food and Drug Administration…

AstraZenecaCardio-vascularEpanovaLovazaPharmaceuticalRegulationUSAVascepa

Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma

Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma

06-05-2014

French drugmaker Pierre Fabre Dermatologie Laboratories has obtained European Commission authorization…

DermatologicalsEuropeHemangeolHemangiolPharmaceuticalPierre FabreRegulation

FDA issues CRL over Acorda's Plumiaz marketing application

FDA issues CRL over Acorda's Plumiaz marketing application

02-05-2014

There was disappointment for US biotech firm Acorda Therapeutics, which says it has received a complete…

Acorda TherapeuticsBiotechnologyNeurologicalPlumiazRegulationUSA

EMA advisory committee backs addition for Eliquis SmPC

EMA advisory committee backs addition for Eliquis SmPC

02-05-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

Bristol-Myers SquibbCardio-vascularEliquisPfizerPharmaceuticalRegulation

FDA calls for more info on The Medicines Company’s cangrelor

FDA calls for more info on The Medicines Company’s cangrelor

01-05-2014

The US Food and Drug Administration has issued a Complete Response Letter for The Medicines Company’s…

cangrelorCardio-vascularPharmaceuticalRegulationThe Medicines Company

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

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