Regulation - Cardio-vascular

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Added indication for Daiichi Sankyo’s Lixiana in Japan

Added indication for Daiichi Sankyo’s Lixiana in Japan

29-09-2014

The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi…

Cardio-vascularDaiichi SankyoJapanLixianaPharmaceuticalRegulation

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

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

Vifor reports positive results from Ferinject study for chronic heart failure

Vifor reports positive results from Ferinject study for chronic heart failure

01-09-2014

Switzerland-based iron specialist Vifor Pharma says its Ferinject (ferric carboxymaltose) has met its…

Cardio-vascularChronic heart failureFerinjectPharmaceuticalRegulationSwitzerlandVifor Pharma

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

31-08-2014

Swiss drug major Novartis on Saturday presented striking new data for its LZC696 heart drug at the European…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationResearch

Amgen files for US approval of cholesterol drug evolocumab

28-08-2014

USA-based Amgen, the world's leading independent biotech firm, has filed a Biologics License Application…

AmgenBiotechnologyCardio-vascularChemistryevolocumabFamilial hypercholesterolemiaHealth Medical PharmaHigh cholesterolPCSK9RegulationUSA

FDA priority review for Amgen’s ivabradine in CHF

FDA priority review for Amgen’s ivabradine in CHF

27-08-2014

The US Food and Drug Administration has granted priority review designation for US biotech giant Amgen’s…

AmgenBiotechnologyCardio-vascularivabradineRegulationServierUSA

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

30-07-2014

The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban)…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

23-07-2014

The National Institute for Health and Care Excellence (NICE), the UK’s health care guidance body, has…

Acute coronary syndromesCardio-vascularEfientEli LillyPharmaceuticalprasugrelRegulationUK

Regado Biosciences announces FDA’s clinical hold of Ph III trial

Regado Biosciences announces FDA’s clinical hold of Ph III trial

10-07-2014

The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences…

Acute coronary syndromeBiotechnologybivalirudinCardio-vascularMedicineRegadoRegulationUSA

Proveca reaches agreement with EMA over heart failure drug for children

Proveca reaches agreement with EMA over heart failure drug for children

10-07-2014

UK pharmaceutical company Proveca has reached its fourth key agreement with the European Medicines Agency…

CaptoprilCardio-vascularPharmaceuticalRegulationUK

Mylan launches generic Micardis in USA

Mylan launches generic Micardis in USA

08-07-2014

US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version…

Boehringer IngelheimCardio-vascularGenericsMarkets & MarketingMicardisMylanRegulationTelmisartanUSA

Pozen re-files for US approval of PA8140/PA32540

Pozen re-files for US approval of PA8140/PA32540

02-07-2014

US drug firm Pozen has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole)…

AspirinCardio-vascularOmeprazolePA8140/PA32540PharmaceuticalPozenRegulationUSA

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

26-06-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an…

Boehringer IngelheimCardio-vascularidarucizumabPharmaceuticalPradaxaRegulationResearchUSA

FDA review of CV risks for diabetics taking olmesartan not conclusive

FDA review of CV risks for diabetics taking olmesartan not conclusive

25-06-2014

The US Food and Drug Administration has completed its safety review and has found no clear evidence of…

BenicarCardio-vascularDaiichi SankyoDiabetesolmesartanPharmaceuticalRegulationUSA

Ivabradine and CV events in angina patients under review in Australia

Ivabradine and CV events in angina patients under review in Australia

23-06-2014

Australian pharma regulator the Therapeutic Goods Administration (TGA) is reviewing new information regarding…

AustraliaCardio-vascularCoralanivabradinePharmaceuticalRegulationServier

UK’s NICE draft guidance recommends Lilly’s Efient

UK’s NICE draft guidance recommends Lilly’s Efient

20-06-2014

UK health care watchdog the National Institute for Health and Care Excellence (NICE) has today published…

Cardio-vascularEfientEli LillyPharmaceuticalPricingRegulationUK

New NICE guidance on cardiovascular treatments

New NICE guidance on cardiovascular treatments

18-06-2014

Thousands of people with atrial fibrillation could be saved from strokes, disability or death because…

Cardio-vascularPharmaceuticalRegulationUKWarfarin Sodium

Orexigen stock falls after FDA extends review of obesity drug

Orexigen stock falls after FDA extends review of obesity drug

11-06-2014

Obesity-focused US biopharmaceutical company Orexigen Therapeutics says that the US Food and Drug Administration…

AnorecticsBiopharmaceuticalCardio-vascularContraveHealth Medical PharmaNB32Orexigen TherapeuticsPharmaceuticalPharmacologyRegulationUSA

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