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Astellas settles with US DoJ over Mycamine marketing

Astellas settles with US DoJ over Mycamine marketing

17-04-2014

The US subsidiary of Japanese drug major Astellas Pharma will pay $7.3 million to resolve allegations…

Antibiotics and Infectious diseasesAstellas PharmaLegalMarkets & MarketingMycamineNorth AmericaPharmaceuticalUSA

Depomed settlements with two Gralise ANDA filers

15-04-2014

US specialty drugmaker Depomed has entered into settlement agreements with two of the three defendants…

DepomedGenericsGraliseIncepta PharmaceuticalsLegalNeurologicalNorth AmericaPatentsUSAZydus Cadila

GSK faces bribery allegations in Poland

GSK faces bribery allegations in Poland

14-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribing doctors in Poland, according to the…

BBCGlaxoSmithKlineGSK regional managerLegalMajorMedicinePharmaceuticalPolandPulmonologyRespiratory and PulmonarySeretideUK

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

Takeda ordered to pay $6 billion damages in Actos trial

Takeda ordered to pay $6 billion damages in Actos trial

08-04-2014

Japan’s largest drugmaker Takeda Pharmaceutical has been ordered to pay $6 billion in punitive damages…

ActosDiabetesEli Lilly and CompanyJapanJudgeLegalMajorPharmaceuticalPyridinesTakeda NycomedThiazolidinedionesUSA

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

EMA confirms AbbVie’s withdrawal of court cases on access to clinical-trial data

04-04-2014

The European Medicines Agency confirms that US drugmaker AbbVie has withdrawn both its court cases brought…

AbbVieEuropeLegalPharmaceuticalResearch

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

Lilly's Alimta patent upheld through 2022

Lilly's Alimta patent upheld through 2022

01-04-2014

US pharma major Eli Lilly says that the US District Court for the Southern District of Indiana has ruled…

AlimtaEli LillyLegalNorth AmericaOncologyPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

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

US Supreme Court agrees to hear Teva’s Copaxone patent appeal

US Supreme Court agrees to hear Teva’s Copaxone patent appeal

01-04-2014

Israel’s Teva Pharmaceutical Industries, the world largest generic drugmaker, says that the US Supreme…

CopaxoneLegalNeurologicalNorth AmericaPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

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

Actavis prevails in Lialda patent dispute in USA

Actavis prevails in Lialda patent dispute in USA

31-03-2014

US generics major Actavis says that the US Court of Appeals for the Federal Circuit has reversed a lower…

ActavisGastro-intestinalsGenericsLegalLialdaNorth AmericaPatentsShireUSA

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

Mylan prevails in breach of contract case against GlaxoSmithKline

Mylan prevails in breach of contract case against GlaxoSmithKline

27-03-2014

US generics major Mylan reveals that, after a trial in the US District Court for the District of New…

GenericsGlaxoSmithKlineLegalMylan LaboratoriesNeurologicalparoxetinePaxil-CR

Proposed new bill would create new patent term extension for certain biologics patents in USA

Proposed new bill would create new patent term extension for certain biologics patents in USA

26-03-2014

Earlier this week in the USA, legislation was introduced allowing new sponsors to gain intellectual property…

BiotechnologyLegalNorth AmericaPatentsPoliticsUSA

1 to 25 of 922 results

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