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FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

16-09-2014

US biotech firm Regeneron Pharmaceuticals says that the US Food and Drug Administration has granted Eylea…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

15-09-2014

Ireland-headquartered drugmaker Shire has received acceptance for its filing with priority review for…

AbbVieIrelandNeurologicalPharmaceuticalRegulationShireVyvanse

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

PharmaceuticalPharmacologyRegulationResearchUSA

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

15-09-2014

The pan-European medicines verification system that the European Federation of Pharmaceutical Industries…

EuropeLegitimate supply chainMarkets & MarketingPharmaceuticalRegulation

FDA approves Baxter/Halozyme’s HyQvia

FDA approves Baxter/Halozyme’s HyQvia

14-09-2014

The US Food and Drug Administration on Friday approved Baxter International’s and Halozyme Therapeutics’…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUSA

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

14-09-2014

Shares of US biotech firm Amarin Corp tanked 23.7% to $1.38 on Friday in heavy trading, when the company…

AmarinCardio-vascularGlaxoSmithKlineLovazaPharmaceuticalRegulationVascepa

EMA’s PRAC concludes review of Valdoxan/Thymanax

EMA’s PRAC concludes review of Valdoxan/Thymanax

14-09-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded its regular…

EuropeNeurologicalPharmaceuticalRegulationServierThymanaxValdoxan

Further guidance on adaptive licensing pilot project available from EMA

12-09-2014

Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines…

EuropePharmaceuticalRegulation

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

ABPI and Department of Health announce second PPRS payment

ABPI and Department of Health announce second PPRS payment

12-09-2014

The Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health have announced…

Association of the British Pharmaceutical IndustryNHS EnglandPharmaceuticalRegulationUK

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

12-09-2014

There was good news for Danish diabetes care giant Novo Nordisk yesterday, when the US Food and drug…

liraglutideMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

FDA at last approves weight-management drug Contrave

FDA at last approves weight-management drug Contrave

11-09-2014

After considerable delay, the US Food and Drug Administration late yesterday finally granted approval…

Arena PharmaceuticalsBelviqContraveMetabolicsOrexigen TherapeuticsPharmaceuticalQnexaRegulationTakeda PharmaceuticalsUSAVivus

Indian clinical trial rules counter-productive, says ASSOCHAM

Indian clinical trial rules counter-productive, says ASSOCHAM

10-09-2014

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback…

IndiaPharmaceuticalPoliticsRegulationResearch

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

10-09-2014

The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyEuropeInsulinLantusPharmaceuticalRegulationSanofi

FDA Advisory votes against approving Actavis nebivolol/valsartan combo

FDA Advisory votes against approving Actavis nebivolol/valsartan combo

10-09-2014

Ireland-based generic drug major Actavis yesterday confirmed that the US Food and Drug Administration's…

ActavisCardio-vascularnebivololPharmaceuticalRegulationUSAvalsartan

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

09-09-2014

The US Food and Drug Administration has published briefing documents on Danish insulin giant Novo Nordisk’s…

Anti-diabetic drugsDiabetesliraglutideNovo NordiskPharmaceuticalRegulationTreatment of obesityUSA

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

09-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft…

AbraxaneBiotechnologyCelgene Corp.OncologyPaclitaxelPricingRegulationUK

Roche’s RoActemra gains EU approval for use in early RA

Roche’s RoActemra gains EU approval for use in early RA

08-09-2014

The European Commission has approved Swiss pharma major Roche’s RoActemra (tocilizumab) for use in…

ActemraAnti-Arthritics/RheumaticsEuropeInterleukin 6PharmaceuticalRegulationRoActemraRoche

Astellas' isavuconazole NDA accepted by US FDA

Astellas' isavuconazole NDA accepted by US FDA

08-09-2014

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major…

Astellas PharmaFungal diseasesInvasive aspergillosisInvasive mucormycosisisavuconazoleOncologyPharmaceuticalRegulationUSA

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