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FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

13-11-2014

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationUSA

Sarepta will rebound strongly from eteplirsen US delay, says analyst

06-11-2014

US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationSarepta TherapeuticsUSA

CNS drugs development takes longer than other drugs, says Tufts CSDD

05-11-2014

Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are…

NeurologicalPharmaceuticalRegulationResearchUSA

US FDA reveals discussions with Sarepta over eteplirsen

US FDA reveals discussions with Sarepta over eteplirsen

31-10-2014

In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationResearchSarepta TherapeuticsUSA

Pfizer to finally drop Remoxy development

27-10-2014

Shares of Durect Corp plunged 42.9% to $0.79 after it revealed that pharma giant Pfizer has decided to…

DurectLicensingNeurologicalPain TherapeuticsPfizerPharmaceuticalPosidurRemoxyUSA

FDA requests CMC data on Lundbeck’s Carbella application

25-10-2014

Danish CNS drug specialist Lundbeck says that it has received a Complete Response Letter (CRL) from the…

CarbamazepineCarbellaLigand PharmaceuticalsLundbeckNeurologicalPharmaceuticalRegulationUSA

Scientists say USA’s national Alzheimer's plan milestones must be strengthened to meet goal by 2025

20-10-2014

The US government has initiated a major effort to prevent and effectively treat Alzheimer's disease by…

FinancialNeurologicalPharmaceuticalResearchUSA

US FDA backs abuse deterrent labeling for Pfizer’s Embeda ER

19-10-2014

The US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s Embeda…

AvinzaEmbedaNeurologicalPfizerPharmaceuticalRegulationUSA

Rheumatologists welcome novel biologics for systemic lupus erythematosus, survey finds

Rheumatologists welcome novel biologics for systemic lupus erythematosus, survey finds

16-10-2014

Rheumatologists would welcome novel biologics for the treatment of systemic lupus erythematosus (SLE),…

BenlystaBiosimilarsGlaxoSmithKlineHealthcareNeurologicalPharmaceuticalResearchUSA

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

15-10-2014

There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted…

BanzelEisailenvatinibNeurologicalOncologyPharmaceuticalRegulationRufinamide TabletsUSA

Perrigo sells some preclinical assets to Imago

Perrigo sells some preclinical assets to Imago

29-09-2014

US heath care firm Perrigo says it has transferred a portfolio of preclinical research assets, which…

Imago PharmaceuticalsMergers & AcquisitionsNeurologicalPerrigoPharmaceuticalUSA

NovaDel sells ZolpiMist NDA, license and IP to Amherst Pharma

23-09-2014

NovaDel Pharma has sold its insomnia drug ZolpiMist (zolpidem oral spray) New Drug Application to fellow…

Amherst PharmaceuticalsMergers & AcquisitionsNeurologicalNovaDel PharmaPharmaceuticalUSAZolpiMist

Biogen and AbbVie report reduced disease activity with MS drug Zinbryta

Biogen and AbbVie report reduced disease activity with MS drug Zinbryta

18-09-2014

US biotech company Biogen Idec and US pharma giant AbbVie have announced the full results from the Phase…

AbbVieAvonexBiogen IdecImmune systemMultiple sclerosisNeurologicalPharmaceuticalResearchUSAZinbryta

Lilly to pay up to $500 million for AstraZeneca Alzheimer’s candidate

Lilly to pay up to $500 million for AstraZeneca Alzheimer’s candidate

16-09-2014

Anglo-Swedish pharma major AstraZeneca and US peer Eli Lilly have entered an agreement to jointly develop…

AstraZenecaAZD3293Eli LillyLicensingNeurologicalPharmaceuticalResearchUKUSA

Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise

Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise

07-09-2014

US specialty drugmaker Depomed says that Judge Kentaji Brown Jackson of the federal district court for…

DepomedGraliseLegalNeurologicalPharmaceuticalRare diseasesUSA

Lundbeck launches Northera in USA

Lundbeck launches Northera in USA

02-09-2014

Danish CNS specialist Lundbeck said today that Northera (droxidopa) capsules for oral use are now available…

Chelsea TherapeuticsLundbeckMarkets & MarketingNeurologicalNortheraPharmaceuticalUSA

FDA backs added use for UCB’s Vimpat

01-09-2014

Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a…

NeurologicalPharmaceuticalRegulationUCBUSAVimpat

ADHD treatment market set to reach $9.9 billion by 2020

ADHD treatment market set to reach $9.9 billion by 2020

22-08-2014

The attention-deficit hyperactivity disorder (ADHD) therapeutics market value will rise from $6.9 billion…

ADHDEuropeJapanNeurologicalPharmaceuticalPsychiatryUSA

US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

21-08-2014

A judge in US federal court has issued a temporary restraining order following the US Food & Drug Administration’s…

Food and Drug AdministrationHospiraMylanNeurologicalPharmaceuticalPrecedexUSA

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