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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

Boehringer’s Pradaxa gains added indication in Europe

Boehringer’s Pradaxa gains added indication in Europe

06-06-2014

German family-owned pharma major Boehringer Ingelheim said today that its blood thinner Pradaxa (dabigatran…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaRegulation

Daiichi Sankyo launches blood thinner Efient in Japan

27-05-2014

Daiichi Sankyo said this morning that it has launched its anti-blood clotting drug Efient (prasugrel…

Cardio-vascularDaiichi SankyoEfientJapanMarkets & MarketingPharmaceuticalRegulation

EMA/CHMP again rejects Novartis’ serelaxin for AHF

26-05-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has for a second…

Cardio-vascularEuropeNovartisPharmaceuticalReasanzRegulationserelaxin

FDA finds favorable risk:benefit balance for Boehringer’s Pradaxa

18-05-2014

As part of its ongoing review, the US Food and Drug Administration last week released latest findings…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaRegulationUSA

US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

16-05-2014

The US Food and Drug Administration has issued a Complete Response Letter regarding the Biologics License…

Cardio-vascularNovartisPharmaceuticalReasanzRegulationserelaxinUSA

FDA approves Merck & Co’s new blood thinner Zontivity

FDA approves Merck & Co’s new blood thinner Zontivity

09-05-2014

The US Food and Drug Administration yesterday approved US pharma giant Merck & Co’s Zontivity (vorapaxar)…

Cardio-vascularMerck & CoPharmaceuticalRegulationUSAZontivity

US FDA approval for AstraZeneca’s Epanova

US FDA approval for AstraZeneca’s Epanova

06-05-2014

There was good news today for Anglo-Swedish drug major AstraZeneca, as the US Food and Drug Administration…

AstraZenecaCardio-vascularEpanovaLovazaPharmaceuticalRegulationUSAVascepa

EMA advisory committee backs addition for Eliquis SmPC

EMA advisory committee backs addition for Eliquis SmPC

02-05-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

Bristol-Myers SquibbCardio-vascularEliquisPfizerPharmaceuticalRegulation

FDA calls for more info on The Medicines Company’s cangrelor

FDA calls for more info on The Medicines Company’s cangrelor

01-05-2014

The US Food and Drug Administration has issued a Complete Response Letter for The Medicines Company’s…

cangrelorCardio-vascularPharmaceuticalRegulationThe Medicines Company

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