Regulation - Research, Neurological


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US FDA delays Allergan’s Semprana decision, approves Ozurdex

US FDA delays Allergan’s Semprana decision, approves Ozurdex


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


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


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

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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


Merck & Co confirms NDA filing for suvorexant in 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


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


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


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


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


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