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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

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

US Judge enforces settlement deal between Mylan and Endo over generic Frova

US Judge enforces settlement deal between Mylan and Endo over generic Frova

11-04-2014

US generic major Mylan today confirmed that a federal district court has granted its request to enforce…

Endo Health SolutionsEndo PharmaceuticalsFrovaGenericsLegalMylan LaboratoriesNeurologicalNorth AmericaPatentsUSA

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

Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

11-04-2014

The US Food and Drug Administration’s recent approval of Johnson & Johnson subsidiary Janssen’s Topamax…

JanssenJohnson & JohnsonMarkets & MarketingNeurologicalPharmaceuticalRegulationTopamax

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

09-04-2014

US biotech firm Alkermes saw its shares spike on Tuesday, after it announced positive top-line results…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyLundbeckNeurologicalOtsukaRegulationResearch

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

Sunovion’s once-daily epilepsy drug Aptiom debuts in USA

08-04-2014

USA-based Sunovion Pharmaceuticals, a subsidiary of Japanese drug major Dainippon Sumitomo, has launched…

AptiomDainippon Sumitomo PharmaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalSunovionUSA

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

Safinamide marketing application submitted to Swissmedic

07-04-2014

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

Markets & MarketingNeurologicalNewron PharmaNorthern EuropePharmaceuticalRegulationsafinamideZambon

Abilify Maintena cuts hospitalization rates for patients with schizophrenia vs oral antipsychotics

07-04-2014

Danish CNS drug specialist Lundbeck and partner Japanese drugmaker Otsuka Pharmaceutical today announced…

Abilify MaintenaLundbeckNeurologicalOtsukaPharmaceuticalResearch

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

Ph III data shows Pacira’ Exparel good as femoral nerve block in knee arthroplasty

06-04-2014

US drugmaker Pacira Pharmaceuticals has released additional Phase III data supporting the efficacy and…

ExparelNeurologicalPacira PharmaceuticalsPharmaceuticalResearch

UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada

04-04-2014

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…

BiotechnologyGenzymeLemtradaNeurologicalNorthern EuropeRegulationSanofiUK

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

Lundbeck to enter a partnership with Lieber Institute

Lundbeck to enter a partnership with Lieber Institute

01-04-2014

Danish CNS specialist Lundbeck, together with a number of other companies, is now entering into a collaboration…

LundbeckNeurologicalPharmaceuticalResearch

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

Convergence Pharma and Evotec collaborate on chronic pain drugs

Convergence Pharma and Evotec collaborate on chronic pain drugs

31-03-2014

Independent UK biotech firm Convergence Pharmaceuticals has entered into a research alliance with Germany’s…

BiotechnologyConvergence PharmaceuticalsEvotecNeurologicalResearch

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

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