Regulation - Research, Cardio-vascular


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FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab


French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda files for diabetes drug trelagliptin succinate approval in Japan


Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese…

Asia-PacificBlopressCardio-vascularDiabetesJapanPharmaceuticalRegulationResearchTakeda Pharmaceuticalstrelagliptin

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical


Japanese drug major Daiichi Sankyo has filed a New Drug Application for its investigational, oral, once-daily…

Cardio-vascularCeldara MedicalDaiichi SankyoedoxabanNorth AmericaPharmaceuticalRegulationResearchSavaysaUSAVirtici

“Breakthrough Therapy” status for Portola’s andexanet alfa


USA-based Portola Pharmaceuticals has been granted “Breakthrough Therapy” designation by the US Food…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates


The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

Japanese lawmakers are stepping in to Diovan investigation


Members of Japan’s Diet (Congressmen) have formed a bipartisan study group to examine Swiss drug major…


RedHill Biopharma views regulatory pathway for RHB-101 in CHF and hypertension


Emerging Israeli biopharma company RedHill Biopharma (TASE: RDHL) says that it recently concluded a positive…

BiotechnologyCardio-vascularCarvedilolLicensingPharmaceuticalRedHill BiopharmaRegulationResearchRHB-101

Daiichi Sankyo updates on PRASFIT-Elective study, NDA filing


Japanese drug major Daiichi Sankyo (TYO: 4568) says that the follow-up period for the Phase III PRASFIT-Elective…

Asia-PacificAspirinCardio-vascularDaiichi SankyoEffientPharmaceuticalprasugrelRegulationResearch

Merck & Co gets all clear to continue Vytorin study; FDA warns on Pfizer's Zithromax


US pharma giant Merck & Co said yesterday that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT…

Antibiotics and Infectious diseasesCardio-vascularMerck & CoNorth AmericaPfizerPharmaceuticalRegulationResearchVytorinZithromax

Plans for Armetheon's anticoagulant tecarfarin for patients with prosthetic heart valves or chronic renal dysfunction


Privately-held US drug developer Armetheon revealed on Friday that it plans to develop its novel oral…

ArmetheonCardio-vascularEuropeNorth AmericaPharmaceuticalRegulationResearchtecarfarin

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

Serious bleeding risk with Boehringer's Pradaxa no worse than warfarin, says FDA


In a follow up to a 2011 safety communication, the US Food and Drug Administration has evaluated new…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationResearch

Daiichi Sankyo to file prasugrel in Japan next year, following strong results


Japanese drug major Daiichi Sankyo (TYO: 4568) has announced data from the PRASFIT-ACS study, a double-blind…

Asia-PacificCardio-vascularDaiichi SankyoPharmaceuticalprasugrelRegulationResearch

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

EU Ombudsman wants more transparency concerning medicines for children


European Union Ombudsman Nikiforos Diamandouros has called on the European Medicines Agency to increase…

AstraZenecaCandesartan CilexetilCardio-vascularEuropePharmaceuticalRegulationResearchTakeda Pharmaceuticals

Novartis makes Tekturna label change, updates on Gilenya and stops alisporivir trial


In a day of mixed news for the Swiss drug major, Novartis (NOVN: VX) said yesterday that it has updated…


Strong results for Bayer's Xarelto in treating pulmonary blood clots


German drugs and crops sciences group Bayer (BAY: DE), and partner Janssen, part of US health care major…

BayerCardio-vascularJanssenJohnson & JohnsonPharmaceuticalRegulationResearchRespiratory and PulmonaryXarelto

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

Bayer and Algeta’s Alpharadin efficacy confirmed; Almirall to market Xarelto in Spain


German drug major Bayer (BAY: DE) and Norwegian partner Algeta (OSE: ALGETA) announced that the survival…

AlgetaAlmirallAlpharadinBayerCardio-vascularEuropeMarkets & MarketingOncologyPharmaceuticalRegulationResearchXarelto

Bayer’s Xarelto OKed in Japan; promising regorafenib data


Bayer Healthcare, a unit of Germany’s Bayer AG (BAY: DE), had a couple of good news item to report…

BayerCardio-vascularOncologyOnyx PharmaceuticalsPharmaceuticalregorafenibRegulationResearchXarelto

FDA strengthens warnings on Sanofi’s Multaq; Aubagio disappoints


The US Food and Drug Administration (FDA) has completed a safety review of French drug major Sanofi’s…


Isis sees Kynamro delay; adds new drugs to pipeline


California, USA-based Isis Pharmaceuticals (Nasdaq: ISIS) announced yesterday that there will be a slight…

Cardio-vascularGenzymeIsis PharmaceuticalsKynamromipomersenNephrology and HepatologyPharmaceuticalRegulationResearchSanofi

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