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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

Japan’s Eisai joins forces with UK researchers on tropical disease research

Japan’s Eisai joins forces with UK researchers on tropical disease research

20-03-2014

Japanese drug major Eisai has entered a collaboration with the UK’s Liverpool School of Tropical Medicine…

EisaiPharmaceuticalResearchTropical diseases

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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