Regulation - Research, Neurological

Filter

Current filters:

ResearchNeurological

Popular Filters

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

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

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

07-05-2014

US health care giant Johnson & Johnson subsidiary Janssen Pharmaceuticals has released positive results…

Invega SustennaJanssenJohnson & JohnsonNeurologicalPharmaceuticalRegulationResearch

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

Titan Pharma in general agreement with FDA on pathway for Probuphine

Titan Pharma in general agreement with FDA on pathway for Probuphine

04-03-2014

California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle…

Braeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationResearchTitan PharmaceuticalsUSA

Lilly drops enzastaurin development; Remoxy future viewed by Pfizer and partners

10-05-2013

US drug major Eli Lilly (NYSE: LLY) revealed that Phase III clinical trial results from enzastaurin's…

DurectEli LillyenzastaurinNeurologicalOncologyPain TherapeuticsPfizerPharmaceuticalRegulationRemoxyResearch

FDA guidance on developing Alzheimer's could ease barriers to research

11-02-2013

The US Food and Drug Administration last week issued a proposal designed to assist companies developing…

BiotechnologyNeurologicalNorth AmericaPharmaceuticalRegulationResearch

News briefs from Sanofi, Biogen/SOBI and Novartis

01-11-2012

French drug major Sanofi (Euronext: SAN) and subsidiary Genzyme have reported results from pivotal studies…

AgrippalBiogen IdecBiotechnologyFluadLemtradaNeurologicalNovartisPharmaceuticalRegulationResearchSanofiSwedish Orphan BiovitrumVaccines

EMA expects lower rate of generic applications; Issues guidelines on schizophrenia and MS

11-10-2012

In its mid-year report for 2012, the European Medicines Agency's management board yesterday provided…

BiotechnologyEuropeGenericsNeurologicalPharmaceuticalRegulationResearch

BioDelivery Sciences set to file for Suboxone copy drug 2nd-qtr 2013

17-09-2012

US drugmaker BioDelivery Sciences International (Nasdaq: BDSI) announced a positive outcome of its pivotal…

BioDelivery SciencesBuprenorphine HCl and naloxone HClGenericsNeurologicalReckitt BenckiserRegulationResearchSuboxone

Alzheimer's disease: From setbacks to stepping stones

16-09-2012

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week released two new reports at…

BiotechnologyNeurologicalNorth AmericaPharmaceuticalRegulationResearch

Research news: dolutegravir; TD-1211; and synaptic modulators

11-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and Japanese drugmaker Shionogi (TYO: 4507) have reported…

Anti-viralsdolutegravirGalenea CorpGastro-intestinalsGlaxoSmithKlineLicensingNeurologicalPharmaceuticalRegulationResearchShionogiTD-1211TheravanceZonegran

Lundbeck and Takeda to file for Lu AA21004 approval in USA and Europe on strong Ph III results

15-05-2012

Danish CNS drug specialist Lundbeck A/S (LUND: DC) yesterday announced positive top-line results from…

Lu AA21004LundbeckNeurologicalPharmaceuticalRegulationResearchTakeda Pharmaceuticals

Novartis makes Tekturna label change, updates on Gilenya and stops alisporivir trial

20-04-2012

In a day of mixed news for the Swiss drug major, Novartis (NOVN: VX) said yesterday that it has updated…

alisporivirAnti-viralsCardio-vascularGilenyaNeurologicalNovartisPharmaceuticalRegulationResearchTekturna

Astra Zeneca abandons TC-5214 regulatory filing as Ph III fails

20-03-2012

In what is another pipeline disappointment for the company, Anglo-Swedish drug major AstraZeneca (LSE:…

AstraZenecaNeurologicalPharmaceuticalRegulationResearchTargacept

CNS disease therapies take 35% longer to develop than other drugs, says Tufts CSDD

06-03-2012

Drugs developed to treat central nervous system (CNS) diseases take 35% longer to complete clinical trials…

NeurologicalPharmaceuticalRegulationResearch

Merck & Co confirms NDA filing for suvorexant in 2012

07-02-2012

US drugs giant Merck & Co (NYSE: MRK) yesterday provided an update on the development program for suvorexant,…

Merck & CoNeurologicalNorth AmericaPharmaceuticalRegulationResearchsuvorexant

FDA strengthens warnings on Sanofi’s Multaq; Aubagio disappoints

20-12-2011

The US Food and Drug Administration (FDA) has completed a safety review of French drug major Sanofi’s…

AubagioCardio-vascularMultaqNeurologicalPharmaceuticalRegulationResearchSanofi

New studies on Rx drugs: clinical trials reporting; off-label marketing; and use of antipsychotics

05-12-2011

US federal rules and regulations related to transparency of prescription drug studies and prohibitions…

Markets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulationResearch

Sanofi pays $3 million milestone to ImmunoGen on start of SAR3419 Ph II testing; FDA accepts Aubagio filing

21-10-2011

US biotech firm ImmunoGen (Nasdaq: IMGN) says that SAR3419 has started Phase II testing, which triggers…

AubagioBiotechnologyFinancialGenzymeImmunoGenNeurologicalOncologyPharmaceuticalRegulationResearchSanofi

Back to top