Regulation - Cardio-vascular

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Sanofi and Regeneron’s Praluent BLA gains priority review from US FDA

26-01-2015

The US Food and Drug Administration has accepted for priority review the Biologics License Application…

alirocumabAmgenBiotechnologyCardio-vascularevolocumabPraluentRegeneron PharmaceuticalsRegulationSanofiUSA

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

23-01-2015

The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England,…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

Bayer's Xarelto gets label update in Europe

Bayer's Xarelto gets label update in Europe

20-01-2015

German drug major Bayer has updated the label for its Xarelto (rivaroxaban) in Europe.

BayerCardio-vascularGermanyPharmaceuticalRegulationXarelto

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

12-01-2015

French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines…

alirocumabBiotechnologyCardio-vascularEuropeRegeneronRegulationSanofi

FDA approves Daiichi Sankyo’s anti-clotting drug Savaysa

09-01-2015

The US Food and Drug Administration late yesterday approved Japanese drug major Daiichi Sankyo’s anti-clotting…

Cardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulationSavaysaUSA

FDA backs Actavis’ Namzaric, but issues CRL on nebivolol/valsartan combo

FDA backs Actavis’ Namzaric, but issues CRL on nebivolol/valsartan combo

26-12-2014

The US Food and Drug Administration has approved the New Drug Application for Namzaric (formerly known…

ActavisAdamas PharmaceuticalsCardio-vasculardonepezilMemantine HCLNamzaricnebivololNeurologicalPharmaceuticalRegulationUSAvalsartan

Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

Actelion submits New Drug Application to the FDA for pulmonary arterial hypertension drug Uptravi

23-12-2014

Swiss biotech company Actelion has submitted a New Drug Application to the US Food and Drug Administration…

ActelionCardio-vascularPharmaceuticalRegulationselexipagSwitzerland

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

Mylan confirms first-to-file patent challenge relating to Brevibloc

25-11-2014

US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker…

Baxter InternationalBreviblocCardio-vascularGenericsLegalMylanPatentsRegulationUSA

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

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

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