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US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Amarin and Kowa Pharma to co-promote Vascepa in USA

01-04-2014

US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an…

AmarinBiotechnologyCardio-vascularKowa PharmaceuticalsMarkets & MarketingNorth AmericaUSAVascepa

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

Lupin launches generic Niaspan in USA

24-03-2014

Indian drugmaker Lupin says that its US subsidiary has launched its niacin extended-release tablets USP,…

AbbVieCardio-vascularGenericsLupinMarkets & MarketingNiaspanNorth AmericaUSA

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

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

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

Amarin files suit against AstraZeneca over Epanova

Amarin files suit against AstraZeneca over Epanova

05-03-2014

US biotech firm Amarin revealed in a Stock Exchange Commission submission that it has filed a complaint…

AmarinAstraZenecaBiotechnologyCardio-vascularEpanovaLegalNorth AmericaOmthera PharmaceuticalsPatentsUSAVascepa

Actavis challenges Multaq and Colcrys patents

02-03-2014

Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant…

ActavisAnti-Arthritics/RheumaticsCardio-vascularColcrysGenericsLegalMultaqNorth AmericaPatents & Trade marksRegulationSanofiTakeda PharmaceuticalsUSA

Amarin calls on FDA to extend Vascepa exclusivity by five years

28-02-2014

US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLegalLovazaNorth AmericaUSAVascepa

Servier Canada collaborates in two research projects

Servier Canada collaborates in two research projects

17-02-2014

Two major projects in clinical research conducted by Canada’s Montreal Heart Institute (MHI) and the…

CanadaCardio-vascularFinancialNorth AmericaPharmaceuticalResearchServier

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel votes to approve Merck & Co’s vorapaxar

FDA advisory panel votes to approve Merck & Co’s vorapaxar

16-01-2014

There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationUSAvorapaxarZontivity

Surprise FDA advisory panel backing for Chelsea’s Northera

Surprise FDA advisory panel backing for Chelsea’s Northera

15-01-2014

A US Food and Drug Administration advisory panel has voted 16-one to recommend approval of US biotech…

BiotechnologyCardio-vascularChelsea TherapeuticsNorth AmericaNortheraRegulationUSA

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

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

10-01-2014

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

Cardio-vascularCeldara MedicalDaiichi SankyoedoxabanNorth AmericaPharmaceuticalRegulationResearchSavaysaUSAVirtici

Japan to investigate Novartis promotion of Diovan; US allegation over Exjade

Japan to investigate Novartis promotion of Diovan; US allegation over Exjade

10-01-2014

Swiss drug major Novartis faced two problems yesterday, when the Japanese Ministry of Health Labor and…

Asia-PacificCardio-vascularDiovanExjadeHematologyLegalMarkets & MarketingNorth AmericaNovartisPharmaceuticalUSA

Novel oral anticoagulants will continue to drive atrial fibrillation drug market growth

20-12-2013

The atrial fibrillation drug market will experience continued growth through the rest of the decade,…

Asia-PacificBayerBoehringer IngelheimBristol-Myers SquibbCardio-vascularEliquisEuropeMarkets & MarketingNorth AmericaPfizerPharmaceuticalPradaxaXarelto

“Breakthrough Therapy” status for Portola’s andexanet alfa

25-11-2013

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

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

Amgen’s PCSK9 inhibitor evolocumab reduces cholesterol in Phase II study

Amgen’s PCSK9 inhibitor evolocumab reduces cholesterol in Phase II study

20-11-2013

USA-based biotech firm Amgen (Nasdaq: AMGN) has said its investigational PCSK9 inhibitor evolocumab helped…

AmgenBiotechnologyCardio-vascularevolocumabNorth AmericaResearchUSA

FDA says PCSK9 inhibitors may not require outcome studies

FDA says PCSK9 inhibitors may not require outcome studies

18-11-2013

The US Food and Drug Administration has said that pharma companies developing PCSK9 inhibitors will not…

Cardio-vascularNorth AmericaPharmaceuticalRegulationUSA

Actelion receives Health Canada approval of Opsumit for PAH

Actelion receives Health Canada approval of Opsumit for PAH

13-11-2013

Swiss biotech firm Actelion (SIX: ATLN) says that Canada’s regulator Health Canada has approved its…

ActelionCanadaCardio-vascularNorth AmericaOpsumitPharmaceuticalRegulation

New ACC and AHA guidelines could increase sales of statins

New ACC and AHA guidelines could increase sales of statins

13-11-2013

New clinical guidelines have been published for the treatment of cholesterol in people at high risk of…

AbbVieAstraZenecaCardio-vascularCrestorHealthcareLipitorMerck & CoNorth AmericaPfizerPharmaceuticalTricorUSAZetia

Forest Labs settles Bystolic litigation with Actavis

07-11-2013

US drugmaker Forest Laboratories has entered into a settlement agreement with generics drug major Actavis…

ActavisBystolicCardio-vascularForest LaboratoriesGenericsLegalNorth AmericaPatents

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