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Public Citizen sues FDA for failing to ban dangerous dose of Aricept


The Food and Drug Administration has dragged its feet for too long on a petition calling on the agency…

AriceptEisaiLegalNeurologicalNorth AmericaPfizerPharmaceuticalRegulation

Eisai gets South Korean approval for breast cancer drug Halaven


The South Korean sales subsidiary of Japanese drug major Eisai (TYO: 4523) has received approval from…


Positive final pivotal Ph III results for Eisai's Fycompa


Results from the final pivotal Phase III study and long term Phase III extension study of Japanese drug…


EU approval for Eisai's epilepsy drug Fycompa and Vertex' Kalydeco


Japanese drug major Eisai (TYO: 4523) says that the European Commission has approved for marketing its…

EisaiEuropeFycompaKalydecoNeurologicalPharmaceuticalRare diseasesRegulationVertex

Eisai's Fycompa improves seizure control, pivotal Ph III study shows


Japanese drug major Eisai (TYO: 4523) announced results from a pivotal Phase III clinical trial (Study…


Swissmedic clears Eisai's Inovelon for rare form of epilepsy


Japanese drug major Eisai's (TYO: 45230) European subsidiary says that the regulatory agency Swissmedic…


Eisai's Halaven gains French reimbursement; disappointing new research


Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin), a novel treatment for patients with locally…


News briefs: Priority review for ocriplasmin; Zonegran monotherapy in EU


Belgium-based biopharma firm ThromboGenics (Euronext Brussels: THR) says that the US Food and Drug Administration…

EisaiEuropeNeurologicalNorth AmericaocriplasminOphthalmicsPharmaceuticalRegulationThromboGenicsZonegran

Eureka moment: US FDA approves first new obesity drug in 13 years


After several years of investigation, and a rejection by the US regulator, the Food and Drug Administration…

Arena PharmaceuticalsBelviqEisailorcaserinMetabolicsNorth AmericaPharmaceuticalRegulation

Zonegran Russian approval prompts Eisai's expansion in that market


Eisai (TYO: 4523), a leading Japanese drugmaker, says it plans to expand its operations into Russia,…

EisaiEuropeFycompaHalavenMarkets & MarketingNeurologicalPharmaceuticalRegulationZonegran

Eisai launches Lunesta in Japan, debuts Zebinix in France; opens Dubai office


Japanese drug major Eisai (TYO: 4523) says it launched the insomnia treatment Lunesta (eszopiclone) in…

Asia-PacificEisaiEuropeLunestaMarkets & MarketingNeurologicalPharmaceuticalRest of the WorldZebinix

Eisai enters deals with Valeant and Minophagen


The European subsidiary of Japanese drug major Eisai (TYO: 4523) and PharmaSwiss, a division of Canada-based…

bexaroteneEisaiHalavenLicensingMarkets & MarketingMinophagenOncologyPharmaceuticalValeant Pharmaceuticals

Eisai breast cancer drug still viewed as not cost effective by NICE


In a third rejection, the UK drug watchdog the National Institute for Health and clinical Excellence…


Arena Pharma updates on lorcaserin filings in EU and USA


San Diego, USA-based Arena Pharmaceuticals (Nasdaq: ARNA) revealed yesterday that the European Medicines…

Arena PharmaceuticalsEisaiEuropelorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulation

US FDA delays Eisai's Dacogen for AML; accepts perampanel NDA


The US Food and Drug Administration has issued a Complete Response Letter to Japanese drug major Eisai…

Astex PharmaceuticalsDacogenEisaiNeurologicalNorth AmericaOncologyperampanelPharmaceuticalRegulation

Added benefit of Eisai’s Halaven not proven, says Germany’s IQWiG


In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…


Actavis to debut generic Aricept in EU markets as patents expire


Icelandic generics firm Actavis yesterday announced the launch of donepezil, a generic copy of Eisai…

ActavisAriceptdonepezilEisaiEuropeGenericsMarkets & MarketingNeurologicalPfizer

FDA wants more info on Menveo; advisory negative on Dacogen


Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter…

Astex PharmaceuticalsDacogenEisaiMenveoNorth AmericaNovartisOncologyPharmaceuticalRegulationVaccines

Eisai gets Lunesta approval in Japan, launches Fostoin


Japanese drug major Eisai (TYO: 4523) this week received approval from Japan's Ministry of Health, Labor…

Asia-PacificEisaiFostoinLunestaMarkets & MarketingNeurologicalNobelpharmaPharmaceuticalRegulation

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