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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

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

EGA president seeks partnership with Italian government on generics and biosimilars

09-04-2014

The president of the European Generic Medicines Association (EGA), Nick Haggar, attended the Stati Generali…

BiosimilarsEuropeGenericsItalyMarkets & MarketingPolitics

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

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

07-04-2014

Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to…

BiosimilarsEuropeFilgrastimInterviewsMarkets & MarketingRegulationSandoz

EGA Biosimilars: European monitoring and global business opportunities

EGA Biosimilars: European monitoring and global business opportunities

07-04-2014

The spotlight was on the European uptake of biosimilars at the European Generic medicines Association’s…

BiosimilarsEuropeGlobalInterviewsMarkets & Marketing

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

EGA Biosimilars: Call for regulatory authorities to improve awareness of biosimilars

EGA Biosimilars: Call for regulatory authorities to improve awareness of biosimilars

04-04-2014

Clear and unbiased information on biosimilars is needed to increase uptake of the medicines across Europe,…

BiosimilarsEurope

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

Fast growth forecast for South Korean pharma market

Fast growth forecast for South Korean pharma market

02-04-2014

South Korea's pharmaceuticals market was valued at $20 billion in 2012, growing from $14.5 billion in…

Asia-PacificBiosimilarsBiotechnologyMarkets & MarketingPricingResearch

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

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

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

EU approval for Dainippon Sumitomo and Takeda’s Latuda

EU approval for Dainippon Sumitomo and Takeda’s Latuda

28-03-2014

Japanese drug majors Dainippon Sumitomo Pharma and Takeda Pharmaceutical have received European Commission…

Dainippon Sumitomo PharmaEuropeLatudaNeurologicalPharmaceuticalRegulationSunovionTakeda Pharmaceuticals

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

Biotie to regain global rights to tozadenant from UCB

Biotie to regain global rights to tozadenant from UCB

26-03-2014

Finland-based Biotie Therapies says that partner Belgium-based drugmaker, following a portfolio review,…

BiotechnologyBiotie TherapiesLicensingNeurologicaltozadenantUCB

Xenon and Genentech establish new pain discovery collaboration

26-03-2014

Privately-held US biotech firm Xenon Pharmaceuticals has established a new collaboration with Swiss drug…

BiotechnologyGenentechLicensingNeurologicalResearchRocheXenon Pharmaceuticals

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