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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

Australia to review program for life-saving drugs access

Australia to review program for life-saving drugs access

10-04-2014

The Australian government says that it will review the Life Saving Drugs Program (LSDP) - a move aimed…

Asia-PacificAustraliaFinancialHealthcarePharmaceuticalRare diseases

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

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

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

EMA and Australia’s TGA collaborate in the area of orphan medicines

EMA and Australia’s TGA collaborate in the area of orphan medicines

07-04-2014

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi,…

AustraliaEuropePharmaceuticalRare diseasesRegulation

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

New funding program to support Australian biopharmaceutical manufacturing development

04-04-2014

The first round of a new pilot funding program opens this week in Queensland, Australia, with at least…

Asia-PacificAustraliaBiotechnologyDSM Biologics

Price cuts mean PBS can afford new medicines, says Medicines Australia

Price cuts mean PBS can afford new medicines, says Medicines Australia

01-04-2014

As of today in Australia, price cuts come into effect for 121 medicines, and trade group Medicines Australia…

Asia-PacificAustraliaHealthcarePharmaceuticalPricing

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

Australian government plans no action on Pharmaceutical Patent Review

Australian government plans no action on Pharmaceutical Patent Review

27-03-2014

The Australian federal government last week released a statement on the Pharmaceutical Patent Review…

Asia-PacificAustraliaBiotechnologyPatentsResearch

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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