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Shire finally accepts AbbVie’s takeover offer

Shire finally accepts AbbVie’s takeover offer

18-07-2014

After a protracted and at times hostile courtship, Ireland-headquartered drugmaker Shire has finally…

AbbVieHumiraMergers & AcquisitionsNeurologicalPharmaceuticalRare diseasesShireUSA

US court preliminary order to prevent Actavis launch of generic Gralise

US court preliminary order to prevent Actavis launch of generic Gralise

18-07-2014

Judge Joel Pisano of the US District Court for the District of New Jersey has entered an order preliminarily…

ActavisActavis Elizabeth LLCAnticonvulsantsDepomedGenericsGraliseHealth Medical PharmaLaw CrimeLegalNeurologicalPatentsPfizerUSA

Mylan wins motion to enjoin GSK from providing paroxetine CR to Apotex

Mylan wins motion to enjoin GSK from providing paroxetine CR to Apotex

17-07-2014

US generics drug major Mylan says that the US District Court for the District of New Jersey granted its…

ApotexGenericsGlaxoSmithKlineLegalMylanNeurologicalparoxetinePaxil-CRUSA

Targacept trial does not show superiority of TC-1734 over donepezil

Targacept trial does not show superiority of TC-1734 over donepezil

15-07-2014

US-based clinical-stage biopharma company Targacept has announced results from a Phase IIb monotherapy…

Alzheimer's diseaseDonepezilNeurologicalPharmaceuticalResearchTargaceptTC-1734USA

Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia

Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia

15-07-2014

US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a supplemental…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationSchizophreniaUSA

Novartis collaborates with Banner Alzheimer's Inst on AD prevention study

Novartis collaborates with Banner Alzheimer's Inst on AD prevention study

15-07-2014

Swiss pharma major Novartis has set up a collaboration with US not-for-profit group the Banner Alzheimer's…

Active immunotherapyAlzheimer's diseaseEuropeNeurologicalNovartisNovartis PharmaceuticalsPharmaceuticalResearchUSA

Lundbeck and Otsuka file for US approval of brexpiprazole

Lundbeck and Otsuka file for US approval of brexpiprazole

14-07-2014

Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka have submitted a New Drug Application…

brexpiprazoleLundbeckMarkets & MarketingNeurologicalOtsukaPharmaceuticalPiperidinesRegulationUSA

Shire confirms it has entered into talks with AbbVie

Shire confirms it has entered into talks with AbbVie

12-07-2014

Following reports by the Bloomberg news service, on Friday Ireland-based drugmaker Shire confirmed that…

AbbVieIrelandMergers & AcquisitionsNeurologicalPharmaceuticalRare diseasesShireUSA

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

10-07-2014

Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention…

Kenneth MandlNeurologicalPharmaceuticalPharmacologyPharmacovigilanceRegulationRitalinUSA

Varenicline combined with nicotine patch improves smoking cessation rates

Varenicline combined with nicotine patch improves smoking cessation rates

09-07-2014

Combining the smoking cessation medication varenicline with nicotine replacement therapy was more effective…

ChantixNeurologicalNicotinePfizerPharmaceuticalResearchSmoking cessationUSAVarenicline

Acorda fights Actavis on generic of its multiple sclerosis drug Ampyra

Acorda fights Actavis on generic of its multiple sclerosis drug Ampyra

09-07-2014

Ireland-headquartered generics major Actavis has confirmed filing an Abbreviated New Drug Application…

Acorda TherapeuticsActavisAmpyradalfampridineGenericsLegalNeurologicalUSA

Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity

03-07-2014

Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

03-07-2014

US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

US FDA delays Allergan’s Semprana decision, approves Ozurdex

US FDA delays Allergan’s Semprana decision, approves Ozurdex

01-07-2014

US drugmaker Allergan, the subject of a hostile $53 billion takeover pursuit by Canada’s Valeant Pharmaceuticals…

AllerganBimatoprost Ophthalmic Solution 0.03% for GlaLevadexNeurologicalOphthalmicsOzurdexPharmaceuticalRegulationResearchSempranaUSA

US psychiatrists’ views on prescribing Otsuka/Lundbeck’s brexpiprazole

26-06-2014

Surveyed US psychiatrists are receptive to novel adjunctive therapies to antidepressants for treatment-resistant…

brexpiprazoleBrintellixLundbeckMarkets & MarketingNeurologicalOtsukaPharmaceuticalUSA

US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy

US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy

25-06-2014

US specialty pharma firm Insys Therapeutics says that the US Food and Drug Administration has granted…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

Rilutek patent expiry to cause negative growth in ALS treatment market by 2018

Rilutek patent expiry to cause negative growth in ALS treatment market by 2018

25-06-2014

The amyotrophic lateral sclerosis (ALS) treatment market value will decline from $64 million in 2013…

EuropeJapanMarkets & MarketingNeurologicalPatentsPharmaceuticalRilutekSanofiUSA

Shire gets positive ruling on Vyvanse patents from US district court

25-06-2014

Ireland-headquartered drugmaker Shire, which is defending itself from a $46 billion unsolicited bid from…

ActavisAmneal PharmaLegalMylanNeurologicalPatentsPharmaceuticalRoxaneSandozShireUSAVyvanse

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

12-06-2014

Ireland-headquartered drugmaker Shire says it has agreed to a written request by the US Food and Drug…

NeurologicalPharmaceuticalRegulationResearchShireUSAVyvanse

US FDA approves sNDAs for Imbruvica and Azilect

US FDA approves sNDAs for Imbruvica and Azilect

09-06-2014

USA-based Pharmacyclics says that the US Food and Drug Administration has accepted for filing its supplemental…

AzilectImbruvicaNeurologicalOncologyPharmaceuticalPharmacyclicsRegulationTeva Pharmaceutical IndustriesUSA

Top 5% of opioid prescribers write 40% of US narcotic prescriptions

Top 5% of opioid prescribers write 40% of US narcotic prescriptions

09-06-2014

In the USA, 40% of narcotic prescriptions in 2011-2012 were written by only 5% of opioid prescribers,…

Markets & MarketingNeurologicalPharmaceuticalUSA

GlaxoSmithKline in $105 million settlement for mis-selling with 44 US states

GlaxoSmithKline in $105 million settlement for mis-selling with 44 US states

05-06-2014

UK pharma giant GlaxoSmithKline has agreed to a $105 million settlement with 44 US states and the District…

AdvairFinancialGlaxoSmithKlineLegalMarkets & MarketingNeurologicalPaxilPharmaceuticalRespiratory and PulmonaryUSAWellbutrin

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