Regulation - Merck & Co


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Merck & Co submits ragweed AIT BLA to the FDA


US pharma giant Merck & Co (NYSE: MRK) has submitted a Biologics License Application (BLA) to the US…

ALK AbelloFinancialImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

New Zealand considers listing Merck & Co's Bridion


New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list the…

Asia-PacificBridionFinancialMerck & CoNeurologicalPharmaceuticalRegulation

EMA Pharmacovigilance committee calls for Tredaptive suspension; contraceptives update


At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee…

Cardio-vascularEuropeMerck & CoNeurologicalPharmaceuticalRegulationReproductivetetrazepamTredaptive

EMA starts review of Merck & Co's cholesterol drug Tredaptive


The European Medicines Agency said on December 21 that it has started a review of the safety and efficacy…

anacetrapibCardio-vascularEli LillyEuropeevacetrapibMerck & CoPharmaceuticalRegulationTredaptive

Merck & Co to drop Tredaptive development in USA


US drug giant Merck & Co (NYSE: MRK) said yesterday that, following disappointing clinical trial results…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationResearchTredaptive

Merck & Co pulls EU marketing application for ridaforolimus


US drug giant Merck & Co (NYSE: MRK) says it has formally notified the European Medicines Agency of its…

EuropeMerck & CoOncologyPharmaceuticalRegulationridaforolimus

FDA accepts Merck & Co's suvorexant; panel backs Novo's Tresiba and Ryzodeg


US drug giant Merck & Co (NYSE: MRK) says that the New Drug Application for suvorexant, the company's…

DegludecDiabetesMerck & CoNeurologicalNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegsuvorexantTresiba

Merck & Co to file for approval of two heart drugs next year


US drugs giant Merck & Co (NYSE: MRK) says that, following a review of the clinical trial data and discussions…

anacetrapibCardio-vascularEuropeMerck & CoNorth AmericaPharmaceuticalRegulationResearchTredaptivevorapaxar

Merck & Co closes odanacatib trial early on good results in osteoporosis


US drug giant Merck & Co (NYSE: MRK) says it is halting a Phase III trial of its investigational osteoporosis…

Anti-Arthritics/RheumaticsMerck & CoodanacatibPharmaceuticalRegulationResearch

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

Batch of mixed opinions from FDA advisory panels


Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of…

carfilzomibKyprolisMerck & CoNorth AmericaOncologyOnyx PharmaceuticalsPfizerPharmaceuticalPneumovaxPrevnarRegulationSanofisemuloparinVaccines

FDA calls for more trials on Merck & Co and Ariad's sarcoma drug ridaforolimus


US drug giant Merck & Co (NYSE: MRK) has received a complete response letter from the US Food and Drug…

Ariad PharmaceuticalsMerck & CoNorth AmericaOncologyPharmaceuticalRegulationridaforolimusTaltorvic

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

Thumbs down for Merck & Co and Ariad sarcoma drug Taltorvic from FDA advisory


The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) yesterday voted by 13 to…

Ariad PharmaceuticalsMerck & CoNorth AmericaOncologyPharmaceuticalRegulationridaforolimusTaltorvic

NICE backs Merck & Co hep C drug Victrelis


UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has today (March 9)…

Anti-viralsEuropeMerck & CoPharmaceuticalPricingRegulationVictrelis

FDA calls for more data on Merck combo drug; Good results with allergy drug


The US Food and Drug Administration (FDA) has issued a Complete Response Letter to drug giant Merck &…

ALK AbelloatorvastatinCardio-vascularezetimibeImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulationResearch

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