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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

UK’s NICE backs Lundbeck drug for alcohol dependence

UK’s NICE backs Lundbeck drug for alcohol dependence

10-07-2014

In new draft guidance, the UK drug watchdog the National Institute for Health and Care Excellence (NICE)…

LundbeckNeurologicalPharmaceuticalPricingRegulationSelincroUK

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

AcelRx and Grunenthal file for EU approval of Zalviso

AcelRx and Grunenthal file for EU approval of Zalviso

07-07-2014

USA-based AcelRx Pharmaceuticals revealed this morning that its partner, family-owned German drugmaker…

AcelRxEuropeGrunenthalNeurologicalPharmaceuticalRegulationZalviso

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

Merck Serono to establish production of Rebif in Russia

Merck Serono to establish production of Rebif in Russia

03-07-2014

Merck Serono, the biotech unit of Germany’s Merck KGaA, plans to establish production of its multiple…

BiotechnologyMerck KGaAMerck SeronoNeurologicalPharmstandardProductionRebifRussia

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

Eisai’s Zebinix shown to be effective and well-tolerated

Eisai’s Zebinix shown to be effective and well-tolerated

30-06-2014

Once-daily Zebinix (eslicarbazepine acetate) from Japanese drug major Eisai is effective, retained and…

EisaiEuropeNeurologicalPharmaceuticalResearchZebinix

Lundbeck's desmoteplase misses primary endpoint in Ph III stroke study

28-06-2014

Danish CNS specialist Lundbeck (LUND: CO) released disappointing initial headline conclusions from DIAS-3,…

desmoteplaseLundbeckNeurologicalPharmaceutical

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

Brintellix meets primary efficacy end-point in depression study

Brintellix meets primary efficacy end-point in depression study

26-06-2014

Danish CNS drug specialist Lundbeck has announced results of the SOLUTION trial conducted in Asian patients…

BrintellixDenmarkLundbeckNeurologicalPharmaceuticalResearch

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

Positive Ph III results with Forest Labs’ vilazodone in GAD

24-06-2014

US drugmaker Forest Laboratories has released positive top-line results from three Phase III trials evaluating…

Forest LaboratoriesNeurologicalPharmaceuticalResearchvilazodone

Merck & Co in new accord with Bionomics for CNS research

Merck & Co in new accord with Bionomics for CNS research

24-06-2014

Australian biotech firm Bionomics has entered into a second exclusive research collaboration and license…

BionomicsBiotechnologyBNC375LicensingMerck & CoNeurologicalResearch

Lundbeck to complete Chelsea Thera acquisition today

Lundbeck to complete Chelsea Thera acquisition today

23-06-2014

Danish CNS specialist Lundbeck says that it has completed the tender offer to buy all of the outstanding…

Chelsea TherapeuticsLundbeckMergers & AcquisitionsNeurologicalNortheraPharmaceutical

Roche partners in new company for MS research

Roche partners in new company for MS research

23-06-2014

Swiss drug major Roche has entered into an exclusive partnership with Inception Sciences, a drug discovery…

Inception 5Inception SciencesMergers & AcquisitionsNeurologicalPharmaceuticalResearchRocheVersant Ventures

UK Prime Minister announces drive to discover new dementia drugs in £100 million campaign

UK Prime Minister announces drive to discover new dementia drugs in £100 million campaign

19-06-2014

The UK Prime Minister David Cameron will today pledge a new drive by the UK to discover new drugs and…

DementiaNeurologicalPharmaceuticalResearchUK

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