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Eisai files first marketing application for lenvatinib in Japan

Eisai files first marketing application for lenvatinib in Japan

26-06-2014

Japanese pharma major Eisai said today that it has submitted its first marketing authorization application…

EisaiJapanlenvatinibOncologyPharmaceuticalRegulation

US FDA approves Eisai’s Aloxi for children and extends exclusivity

US FDA approves Eisai’s Aloxi for children and extends exclusivity

29-05-2014

Japanese drug major Eisai announced today that the antiemetic agent Aloxi (palonosetron HCI) has been…

AloxiAntiemeticsEisaiHealth Medical PharmaJapanMedicineOncologyPharmaceuticalRegulationUnited StatesUSAVomiting

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

12-05-2014

Japanese drug major Eisai has exercised its option to jointly develop and commercialize its clinical…

Biogen IdecEisaiFycompaGermanyItalyLicensingNeurologicalPharmaceuticalPricingRegulationZebinix

Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

22-01-2014

The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted…

amatuximabEisaiEuropePharmaceuticalRare diseasesRegulation

Ranbaxy cleared to market branded generic of Aricept in Canada

Ranbaxy cleared to market branded generic of Aricept in Canada

08-01-2014

The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil…

AriceptCanadaDaiichi SankyoEisaiGenericsNeurologicalNorth AmericaRAN-DonepezilRanbaxy LaboratoriesRegulation

Eisai seeks expanded Japanese indication for Aricept

Eisai seeks expanded Japanese indication for Aricept

01-11-2013

Japanese drug major Eisai says it has filed an application for its already marketed anti-Alzheimer's…

AriceptAsia-PacificEisaiNeurologicalPharmaceuticalRegulation

FDA clears Eisai Zonegran facility in UK for US exports

FDA clears Eisai Zonegran facility in UK for US exports

15-10-2013

Eisai says the US Food and Drug Administration has approved the US supply of the epilepsy drug Zonegran…

EisaiEuropeNeurologicalNorth AmericaPharmaceuticalProductionRegulationZonegran

Eisai launches legal action after "unreasonable" delay for its epilepsy drug

20-08-2013

Japanese drug major Eisai (TYO: 4523) has taken legal action in the USA over the delay of the recommendation…

EisaiFycompaNeurologicalNorth AmericaPharmaceuticalRegulation

Eisai gains Swiss approval for Zonegran and Canadian OK for Fycompa

11-07-2013

Japanese drug major Eisai (TYO: 4205) says that Zonegran (zonisamide) has been approved by Switzerland's…

EisaiEuropeFycompaNeurologicalNorth AmericaPharmaceuticalRegulationZonegran

Eisai temporarily suspend Fycompa in Germany, following negative G-BA decision

25-06-2013

Japanese drug major Eisai (TYO: 4523) said today (June 25) that, "with regret," it will suspend temporarily…

EisaiEuropeFycompaMarkets & MarketingNeurologicalPharmaceuticalPricingRegulation

It's official: "obesity is a disease," says AMA

20-06-2013

The American Medical Association at its annual meeting this week adopted a policy that recognizes obesity…

Arena PharmaceuticalsBelviqEisaiMarkets & MarketingMetabolicsNorth AmericaPharmaceuticalQsymiaRegulationVivus

Arena and Eisai finally get DEA scheduling for obesity drug Belviq

08-05-2013

The long wait to get obesity drug Belviq (lorcaserin) to the US market, where it was approved by the…

Arena PharmaceuticalsBelviqEisaiMetabolicsNorth AmericaPharmaceuticalRegulation

Eisai files for new Halaven indication; gets orphan status for lenvatinib in EU

08-05-2013

Japanese drug major Eisai (TYO: 4523) has filed a Type II Variation application with the European Medicines…

EisaiEuropeHalavenlenvatinibOncologyPharmaceuticalRegulation

Arena Pharma pulls EU application for Belviq; posts 1st-qtr results

06-05-2013

As part of an update on its activities and first-quarter financial results report, USA-based Arena Pharmaceutical…

Arena PharmaceuticalsBelviqEisaiEuropeFinancialMetabolicsPharmaceuticalRegulation

FDA approves Eisai's Aciphex Sprinkle for GERD in children; Inovelon OKed in Japan

28-03-2013

Japanese drug major Eisai (TYO: 4523) says that the US Food and Drug Administration has approved Aciphex…

AciphexAsia-PacificEisaiGastro-intestinalsInovelonNeurologicalNorth AmericaPharmaceuticalRegulation

Eisai slams German decision on Fycompa; Takeda files vedolizumab with EMA

08-03-2013

The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system…

EisaiEuropeFycompaGastro-intestinalsNeurologicalPharmaceuticalRegulationTakeda Pharmaceuticalsvedolizumab

Eisai expands in South Africa, filing for approval of Halaven and Fycompa

30-01-2013

Japanese drug major Eisai (TYO: 4523) says it is expanding its operations into South Africa, with the…

EisaiFycompaHalavenMarkets & MarketingNeurologicalOncologyPharmaceuticalRegulationRest of the World

Eisai disagrees with Germany's IQWiG report on epilepsy drug Fycompa

19-12-2012

In the assessment report by the German Institute for Quality and Efficiency in Health Care (IQWiG) on…

EisaiEuropeFycompaNeurologicalPharmaceuticalPricingRegulation

Scottish Medicines Consortium approves Eisai's Fycompa and Novartis' Lucentis for DME

11-12-2012

Japanese drug major Eisai's (TYO: 4523) Fycompa (perampanel), a treatment for partial epilepsy, is now…

EisaiEuropeFycompaLucentisNeurologicalNovartisPharmaceuticalPricingRegulation

FDA approves Eisai's Fycompa to treat epileptic seizures and Supernus' Oxtellar XR

23-10-2012

The US Food and Drug Administration yesterday approved Japanese drug major Eisai's (TYO: 4523) Fycompa…

EisaiFycompaNeurologicalNorth AmericaOxtellar XRPharmaceuticalRegulationSupernus Pharmaceuticals

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

07-09-2012

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

04-09-2012

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

Asia-PacificEisaiHalavenOncologyPharmaceuticalRegulation

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