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FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug


The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended


Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development…

DiabetesfasiglifamGastro-intestinalsNorth AmericaPharmaceuticalRegulationResearchTakeda PharmaceuticalsUSAvedolizumab

Positive results with MannKind's type 1 diabetes drug please investors


There was good news for loss-making US drugmaker MannKind (Nasdaq: MNKD), when the company announced…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationResearch

American Diabetes Association calls for independent review of incretin-based therapy


The American Diabetes Association is asking all pharmaceutical companies involved in the development…

DiabetesJanuviaMerck & CoPharmaceuticalRegulationResearch

Zealand Pharma valuation hinged on Lyxi/Lanti "fixflex"


The recent European Medicine Agency advisory committee, CHMP, positive opinion for French drug major…

BiotechnologyDiabetesFinancialLantusLyxumiaNovo NordiskRegulationResearchSanofiTresibaVictozaZealand Pharma

Safety of Novartis' Lucentis in VI-DME confirmed with new data; efficacy in CNV


New data revealed yesterday by Swiss drug major Novartis (NOVN: VX) showed that Lucentis (ranibizumab)…


GlaxoSmithKline readies for filing of diabetes drug albiglutide on positive final data


UK pharma giant GlaxoSmithKline (LSE: GSK) says that positive data from the Phase III Harmony 8 study…

albiglutideDiabetesGlaxoSmithKlineJanuviaMerck & CoPharmaceuticalRegulationResearch

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal


Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Victoza US label update includes superior efficacy over Januvia, says Novo Nordisk


The US Food and Drug Administration has approved an update to the product label for Victoza (liraglutide…

DiabetesJanuviaLevemirMerck & CoNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Drug approval and launch for Novartis in China, where Quintiles expands


Swiss drug major Novartis (NOVN: VX) says it has received regulatory approval in China from the State…

Asia-PacificDiabetesGalvusLucentisMarkets & MarketingNovartisOphthalmicsPharmaceuticalQuintilesRegulationResearch

Novo Nordisk reaches a milestone in stopping animal testing


Danish insulin giant Novo Nordisk (NVO: N) has released a video highlighting that, effective yesterday…

DiabetesNovo NordiskPharmaceuticalRegulationResearch

Merck & Co drops combo diabetes drug Janacti filing in Europe; presents data on discontinued vorapaxar study


The European Medicines Agency says it has been formally notified by Merck Sharp & Dohme (Europe), a subsidiary…

Cardio-vascularDiabetesJanactiMerck & CoPharmaceuticalPioglitazoneRegulationResearchsitagliptinvorapaxar

Merck & Co debuts Nexplanon in USA; gets negative FDA response on Zoely and Saflutan


Merck & Co (NYSE; MRK), the USA’s second largest drugmaker, says that its Nexplanon (etonogestrel…

DiabetesJanuviaMarkets & MarketingMerck & CoNexplanonOphthalmicsPharmaceuticalRegulationReproductiveResearchSaflutanZoely

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