Regulation - Pharmaceutical, Cardio-vascular

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FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

18-12-2014

US pharma company Pozen has received a second complete response letter from the US Food and Drug Administration…

Cardio-vascularPharmaceuticalPozenRegulationUSAYosprala 325/40Yosprala 81/40

NICE backs Pradaxa for treating and preventing potentially fatal blood clots

NICE backs Pradaxa for treating and preventing potentially fatal blood clots

17-12-2014

In final guidance published today, UK health cost watchdog the National Institute for Health and Care…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulationUK

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

08-12-2014

The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured…

AdempasBayerCardio-vascularGazyvaroOncologyPharmaceuticalRegulationRoche

Mixed findings from IQWiG on added benefit for Eliquis

05-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier on Eliquis…

Bristol-Myers SquibbCardio-vascularEliquisGermanyPfizerPharmaceuticalPricingRegulation

Actelion submits selexipag for EMA marketing authorization in PAH

Actelion submits selexipag for EMA marketing authorization in PAH

03-12-2014

Swiss biotech firm Actelion has submitted a centralized Marketing Authorization Application to the European…

ActelionCardio-vascularEuropePharmaceuticalRegulationselexipag

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

28-11-2014

Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products…

Cardio-vascularEuropeLCZ696NovartisPharmaceuticalRegulation

EMA makes recommendation for reducing heart attack risk of Servier's Corlentor/Procoralan

EMA makes recommendation for reducing heart attack risk of Servier's Corlentor/Procoralan

21-11-2014

The European Medicines Agency has reviewed angina medication Corlentor/Procoralan (ivibradine), manufactured…

Cardio-vascularEuropePharmaceuticalProcoralanRegulationServier

EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine

09-11-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a…

AmgenCardio-vascularEuropeivabradinePharmaceuticalProcoralanRegulationServier

US FDA advisory panel backs Daiichi Sankyo’s Savaysa for stroke risk and SEE

03-11-2014

A US Food and Drug advisory panel has voted in favor of the use of Japanese pharma major Daiichi Sankyo’s…

Cardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulationSavaysaUSA

NICE recommends Pradaxa for DVT and PE

NICE recommends Pradaxa for DVT and PE

31-10-2014

In draft guidance published today, the UK health costs watchdog the National Institute for Health and…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulationUK

UK’s NICE backs another use for Bayer’s Xarelto

UK’s NICE backs another use for Bayer’s Xarelto

23-10-2014

In draft guidance published today for consultation, the UK’s health costs watchdog the National Institute…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

06-10-2014

Anglo-Swedish pharma major AstraZeneca today confirmed that the American Heart Association (AHA) and…

AstraZenecaBrilintaCardio-vascularClopidogrelDaiichi SankyoEli LillyPharmaceuticalprasugrelRegulationSanofiticagrelorUSA

Positive results with Portola’s anti-clotting agent andexanet alfa and Eliquis

Positive results with Portola’s anti-clotting agent andexanet alfa and Eliquis

01-10-2014

Portola Pharmaceuticals says that its first Phase III study of andexanet alfa, a potential universal…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularedoxabanEliquisJanssenPfizerPharmaceuticalPortola PharmaceuticalsRegulationResearchUSAXarelto

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

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

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

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