Regulation - Pharmaceutical, Eisai

Filter

Current filters:

PharmaceuticalEisai

Popular Filters

1 to 25 of 51 results

Eisai's Halaven now available in Russia for advanced breast cancer

Eisai's Halaven now available in Russia for advanced breast cancer

18-12-2014

Halaven (eribulin) manufactured by Japanese drug major Eisai is now available in Russia.

EisaiHalavenOncologyPharmaceuticalRegulationRussia

Eisai “dismayed” by G-BA decision on Fycompa

06-11-2014

Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee…

EisaiFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

IQWIG confirms an additional benefit of Eisai's Halaven

IQWIG confirms an additional benefit of Eisai's Halaven

04-11-2014

Following a benefit:cost re-assessment, the German Institute for Quality and Efficiency in Health Care…

EisaiGermanyHalavenOncologyPharmaceuticalPricingRegulation

Eisai's Fycompa launches in Australia for seizures

Eisai's Fycompa launches in Australia for seizures

03-11-2014

Fycompa (perampanel), manufactured by Japanese drug major Eisai, has been approved for reimbursement…

AustraliaEisaiFycompaNeurologicalPharmaceuticalRegulation

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

20-10-2014

Japanese drug major Eisai has had a supplemental New Drug Application for its in-house-discovered AMPA…

CNS DiseasesEisaiFycompaJapanPharmaceuticalRegulation

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

15-10-2014

There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted…

BanzelEisailenvatinibNeurologicalOncologyPharmaceuticalRegulationRufinamide TabletsUSA

FDA approves Eisai’s Akynzeo for CINV

13-10-2014

The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant…

AkynzeoEisaiHelsinnnetupitantOncologypalonosetronPharmaceuticalRegulationUSA

French Transparency Commission recognizes efficacy of Eisai’s Zonegran monotherapy

French Transparency Commission recognizes efficacy of Eisai’s Zonegran monotherapy

06-10-2014

Transparency advice for Japanese pharma major Eisai’s Zonegran (zonisamide) monotherapy in the treatment…

EisaiFranceNeurologicalPharmaceuticalRegulationZonegran

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

18-08-2014

Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European…

DonepezilEisaiEuropelenvatinibOncologyPharmaceuticalRegulationUSA

IQWiG again turns down Eisai’s epilepsy drug Fycompa

IQWiG again turns down Eisai’s epilepsy drug Fycompa

17-08-2014

The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa…

EisaiEpilepsyFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Eisai's Fycompa launches in Belgium for partial-onset seizures

Eisai's Fycompa launches in Belgium for partial-onset seizures

04-08-2014

Fycompa (perampanel), an epilepsy drug developed by Japanese dug major Eisai, launches today in Belgium.

BelgiumCentral nervous systemEisaiEpilepsyFycompaJapanNeurologicalPharmaceuticalRegulation

EMA approves Eisai's request for accelerated assessment of lenvatinib in thyroid cancer

EMA approves Eisai's request for accelerated assessment of lenvatinib in thyroid cancer

31-07-2014

The European Medicines Agency (EMA) has approved a request by Japanese drug major Eisai for the accelerated…

Cell signalingEisaiEuropeEuropean Medicines AgencylenvatinibOncologyPharmaceuticalRegulationThyroid cancer

Eisai’s breast cancer drug Halaven receives MAA in Europe

Eisai’s breast cancer drug Halaven receives MAA in Europe

03-07-2014

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from…

EisaiEuropeHalavenOncologyPharmaceuticalRegulation

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

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 gains WHO prequalification for DEC; launches high-dose Aricept in Korea

27-08-2013

Japanese drug major Eisai (TYO: 4523) has received prequalification from the World Health Organization…

AriceptAsia-PacificdiethylcarbamazineEisaiMarkets & MarketingNeurologicalPharmaceuticalRegulationTropical diseases

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

1 to 25 of 51 results

Back to top