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Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

24-07-2014

US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable…

Biogen IdecCytokinesMultiple sclerosisNeurologicalPharmaceuticalPlegridyRegulationUSA

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

Canadian approval for Sunovion’s Aptiom

Canadian approval for Sunovion’s Aptiom

14-07-2014

USA-based drugmaker Sunovion Pharmaceuticals, a subsidiary of Japan’s Dainippon Sumitomo, has received…

AptiomBIA-2093-301CanadaDainippon Sumitomo PharmaEpilepsyNeurologicalPharmaceuticalRegulationSunovion Pharmaceuticals

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

NICE issues positive draft FAD guidance on Tecfidera

NICE issues positive draft FAD guidance on Tecfidera

11-07-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

Biogen IdecBiotechnologyMultiple sclerosisNeurologicalPricingRegulationTecfideraUK

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In new draft guidance, the UK drug watchdog the National Institute for Health and Care Excellence (NICE)…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

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

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 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

Review of ibuprofen medicines started by EMA Pharmacovigilance unit

Review of ibuprofen medicines started by EMA Pharmacovigilance unit

16-06-2014

At its June 2014 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee…

EuropeibuprofenInflammatory diseasesNeurologicalPharmaceuticalRegulation

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

Wider use of Novartis’ Gilenya approved in Europe

Wider use of Novartis’ Gilenya approved in Europe

09-06-2014

The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP)…

EuropeGilenyaNeurologicalNovartisPharmaceuticalRegulation

Newron and Zambon file safinamide NDA with FDA

Newron and Zambon file safinamide NDA with FDA

30-05-2014

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

NeurologicalNewron PharmaPharmaceuticalRegulationsafinamideUSAZambon

US FDA accepts resubmission of Lemtrada sBLA by Genzyme

US FDA accepts resubmission of Lemtrada sBLA by Genzyme

30-05-2014

French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme said today that the US Food and Drug…

BiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

Genzyme gains UK NICE backing for second MS drug Lemtrada

Genzyme gains UK NICE backing for second MS drug Lemtrada

28-05-2014

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance…

AubagioBiotechnologyGenzymeLemtradaNeurologicalPricingRegulationSanofiUK

Further FDA setback for QRxPharma’s MoxDuo

27-05-2014

In yet another setback for Australia-based QRxPharma, the US Food and Drug Administration has issued…

MoxDuoNeurologicalPharmaceuticalQRxPharmaRegulationUSA

Positive CHMP opinion for Biogen Idec MS drug Plegridy

25-05-2014

US biotech firm Biogen Idec said on Friday that it had received a positive recommendation from the European…

Biogen IdecBiotechnologyEuropeNeurologicalPlegridyRegulation

Teva and Active Biotech will continue with Nerventra development despite negative CHMP decision

25-05-2014

Teva Pharmaceutical Industries, the world’s largest generic drugs firm, and Swedish partner Active…

Active BiotechEuropeNerventraNeurologicalPharmaceuticalRegulationTeva Pharmaceutical Industries

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