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Impax Pharma resubmits NDA for Rytary

Impax Pharma resubmits NDA for Rytary

11-04-2014

Impax Laboratories’ branded products division has resubmitted the New Drug Application for Rytary (carbidopa…

Impax LaboratoriesNeurologicalNorth AmericaPharmaceuticalRegulationRytaryUSA

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

JPMA sanctions against Takeda over promotional activities for candesartan in Japan

09-04-2014

Japan’s largest drugmaker Takeda Pharmaceutical says it has received notice of sanctions imposed by…

Asia-PacificBlopressCardio-vascularJapanMarkets & MarketingPharmaceuticalTakeda Pharmaceuticals

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

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

ACC 2014: Bayer presents new data for Xarelto and initiates new Phase III trials

ACC 2014: Bayer presents new data for Xarelto and initiates new Phase III trials

01-04-2014

German drug major Bayer presented new analyses from the pivotal ROCKET AF and EINSTEIN clinical trials…

BayerCardio-vascularJohnson & JohnsonPharmaceuticalResearchXarelto

Novartis halts Ph III LCZ696 trial on strong results

Novartis halts Ph III LCZ696 trial on strong results

31-03-2014

Swiss drug major Novartis says that the Data Monitoring Committee (DMC) unanimously recommended early…

Cardio-vascularLCZ696NovartisPharmaceuticalResearch

ACC 2014: GSK’s darapladib disappoints in Ph III trial

ACC 2014: GSK’s darapladib disappoints in Ph III trial

31-03-2014

UK pharma major GlaxoSmithKline (LSE: GSK) presented disappointing data from its pivotal Phase III STABILITY…

Cardio-vasculardarapladibGlaxoSmithKlinePharmaceuticalResearchUKUSA

ACC 2014: Amgen’s evolocumab reduces cholesterol by up to 66%

ACC 2014: Amgen’s evolocumab reduces cholesterol by up to 66%

31-03-2014

USA-based Amgen announced data at the American College of Cardiology 63rd Annual Scientific Session this…

AmgenBiotechnologyCardio-vascularevolocumabResearchUSA

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

New US guidelines could see 12.8 million more patients prescribed statins

New US guidelines could see 12.8 million more patients prescribed statins

20-03-2014

New US guidelines regarding those patients who are prescribed statins to prevent cardiovascular disease…

Cardio-vascularHealthcarePharmaceuticalResearchUSA

More positive Ph III data for Amgen’s evolocumab

More positive Ph III data for Amgen’s evolocumab

17-03-2014

Leading independent biotech firm Amgen has released more positive clinical trial data with its cholesterol…

AmgenBiotechnologyCardio-vascularevolocumabRare diseasesResearch

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

Ranbaxy recalls Lipitor generic over dose error

Ranbaxy recalls Lipitor generic over dose error

10-03-2014

India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) has recalled more than 64,000 bottles…

Atorvastatin CalciumCardio-vascularIndiaLipitorPharmaceuticalRanbaxy LaboratoriesRegulationUSA

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

Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda files for diabetes drug trelagliptin succinate approval in Japan

09-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese…

Asia-PacificBlopressCardio-vascularDiabetesJapanPharmaceuticalRegulationResearchTakeda Pharmaceuticalstrelagliptin

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

High potency statins linked to better outcome following a heart attack

21-02-2014

A study looking at the data of thousands of patients who suffered heart attacks has suggested treatment…

Cardio-vascularezetimibeMerck & CoPharmaceuticalResearchZetia

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

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