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EMA recommends suspending medicines over flawed studies at GVK Biosciences

EMA recommends suspending medicines over flawed studies at GVK Biosciences

23-01-2015

A number of medicines for which authorization in the European Union was primarily based on clinical studies…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

FDA's anti-infective committee recommends Astellas' Cresemba

FDA's anti-infective committee recommends Astellas' Cresemba

23-01-2015

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

Antibiotics and Infectious diseasesAstellasCresembaPharmaceuticalRegulationUSA

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

23-01-2015

The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese…

EisaiGermanyHalavenOncologyPharmaceuticalRegulation

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

23-01-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive…

PfizerPharmaceuticalPrevenarRegulationRespiratory and Pulmonary

Novo Nordisk gets positive opinion for Saxenda from EMA’s CHMP

Novo Nordisk gets positive opinion for Saxenda from EMA’s CHMP

23-01-2015

Danish diabetes care giant Novo Nordisk revealed yesterday that the European Medicines Agency’s Committee…

DiabetesEuropeMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

23-01-2015

The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England,…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

NICE set to recommend Boehringer’s type 2 diabetes drug Jardiance

NICE set to recommend Boehringer’s type 2 diabetes drug Jardiance

22-01-2015

England’s health care costs watchdog the National Institute for Health and Care Excellence (NICE) has…

Boehringer IngelheimDiabetesJardiancePharmaceuticalPricingRegulationUK

EMA publishes guide for pharma companies to support new medicines monitoring standard

EMA publishes guide for pharma companies to support new medicines monitoring standard

22-01-2015

The European Medicines Agency has published its guide to support the implementation of a new international…

EMAEuropeEuropean Medicines AgencyPharmaceuticalRegulation

AstraZeneca files marketing authorization application with EMA for lesinurad

AstraZeneca files marketing authorization application with EMA for lesinurad

22-01-2015

The European Medicines Agency has accepted the marketing authorization application by AstraZeneca for…

AstraZenecaGastro-intestinalslesinuradPharmaceuticalRegulation

IQWiG reports negative views on Provenge, Velphoro and Zydelig

IQWiG reports negative views on Provenge, Velphoro and Zydelig

22-01-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers…

DendreonGermanyGilead SciencesNephrology and HepatologyOncologyPharmaceuticalPricingProvengeRegulationVelphoroVifor PharmaZydelig

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

21-01-2015

Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European…

BRIVARACETAMEuropeNeurologicalPharmaceuticalRegulationUCBUSA

EMA launches public consultation on clinical trial transparency proposals

EMA launches public consultation on clinical trial transparency proposals

21-01-2015

The European Medicines Agency has launched a public consultation on how the transparency rules of the…

Clinical researchEuropeEuropean UnionPharmaceuticalRegulation

US FTC approves final order preserving in nicotine patches market competition

US FTC approves final order preserving in nicotine patches market competition

21-01-2015

Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling…

GlaxoSmithKlineHabitrolMergers & AcquisitionsNeurologicalNovartisPharmaceuticalRegulationUSA

EFPIA and EGA among bodies announcing strategies to limit supply issues in Europe

EFPIA and EGA among bodies announcing strategies to limit supply issues in Europe

21-01-2015

European pharma bodies including the European Federation of Pharmaceutical Industries and Associations…

EuropeEuropean Federation of Pharmaceutical Industries and AssociationsPharmaceuticalProductionRegulation

Novo Nordisk's Victoza granted label extension in the UK

Novo Nordisk's Victoza granted label extension in the UK

20-01-2015

A license extension has been granted in the UK for Victoza (liraglutide) from Danish insulin giant Novo…

Nephrology and HepatologyNovo NordiskPharmaceuticalRegulationUKVictoza

Ariad gets positive final EC decision on Iclusig

20-01-2015

USA-based Ariad Pharmaceuticals today revealed that the European Commission has endorsed the final opinion…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalRegulation

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

20-01-2015

Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group, has received approval from the US…

FreseniusFresenius Kabineostigmine methylsulfateNeurologicalPharmaceuticalRegulationUSA

Bayer's Xarelto gets label update in Europe

Bayer's Xarelto gets label update in Europe

20-01-2015

German drug major Bayer has updated the label for its Xarelto (rivaroxaban) in Europe.

BayerCardio-vascularGermanyPharmaceuticalRegulationXarelto

Boehringer’s Ofev approved in EU for the treatment of IPF

19-01-2015

German family-owned pharma major Boehringer Ingelheim revealed today that the European Commission has…

Boehringer IngelheimEuropeOfevPharmaceuticalRegulationRespiratory and Pulmonary

The first Sabin IPV approved by China FDA

19-01-2015

The China Food and Drug Administration (CFDA) on January 14 approved the production of the first inactivated…

ChinaPharmaceuticalProductionRegulationVaccines

EC approves AbbVie’s Viekirax + Exviera for hepatitis C

EC approves AbbVie’s Viekirax + Exviera for hepatitis C

16-01-2015

The European Commission has granted marketing authorizations for US drugmaker AbbVie’s all-oral, short-course,…

AbbVieAnti-viralsEuropeExvieraPharmaceuticalRegulationViekirax

FDA committee votes to not recommend Ferring’s desmopressin

FDA committee votes to not recommend Ferring’s desmopressin

15-01-2015

The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has…

desmopressinFerring PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

FDA launches Office of Pharmaceutical Quality

FDA launches Office of Pharmaceutical Quality

14-01-2015

The US Food and Drug Administration has launched an Office of Pharmaceutical Quality in a bid to clamp…

Office of Pharmaceutical QualityPharmaceuticalPharmaceutical industryRegulationUSA

US FDA approves AbbVie’s Duopa for Parkinson’s disease

US FDA approves AbbVie’s Duopa for Parkinson’s disease

13-01-2015

The US Food and Drug Administration has approved US drugmaker AbbVie’s Duopa (carbidopa and levodopa)…

AbbVieCarbidopa-LevodopaNeurologicalPharmaceuticalRegulationUSA

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