Regulation - Merck & Co

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Merck & Co submits ragweed AIT BLA to the FDA

11-03-2013

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

30-01-2013

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

13-01-2013

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

24-12-2012

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

21-12-2012

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

30-11-2012

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

09-11-2012

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

28-08-2012

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

13-07-2012

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

12-07-2012

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

21-06-2012

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

06-06-2012

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

10-04-2012

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

21-03-2012

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

09-03-2012

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

06-03-2012

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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