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Novartis’ meningitis B vaccine Bexsero approved by US FDA

Novartis’ meningitis B vaccine Bexsero approved by US FDA

24-01-2015

On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’…

BexseroNovartisPharmaceuticalRegulationUSAVaccines

US FDA approves NPS Pharma’s Natpara

US FDA approves NPS Pharma’s Natpara

24-01-2015

The US Food and Drug Administration on Friday approved NPS Pharmaceuticals’ Natpara (parathyroid hormone)…

BiotechnologyNatparaNPS PharmaceuticalsRare diseasesRegulationShireUSA

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

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

22-01-2015

French drug major Sanofi and its subsidiary Genzyme have been granted marketing authorization by the…

BiotechnologyCerdelgaGeneticsGenzymeRegulationSanofi

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

Latest approval for Novartis’ Cosentyx, from US FDA

Latest approval for Novartis’ Cosentyx, from US FDA

22-01-2015

Adding to recent marketing clearances in Japan and the European Union, the US Food and Drug Administration…

BiotechnologyCosentyxDermatologicalsNovartisRegulationUSA

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

Naming conventions for biosimilars in Australia

Naming conventions for biosimilars in Australia

21-01-2015

Following recent international developments in the area of biosimilar naming, Australian regulator the…

AustraliaBiosimilarsBiotechnologyRegulationTherapeutic Goods Administration

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

New phase of MAb biosimilars opportunities in Japan

New phase of MAb biosimilars opportunities in Japan

21-01-2015

The launch of Remicade (infliximab, from Johnson & Johnson) biosimilar in December 2014 in the Japan…

BiosimilarserythropoietinGenericsJapanMarkets & MarketingRegulationRemicade

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

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