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FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
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Eisai
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Life-extending breast cancer drug approved by NICE
3 November 2016 | By Niamh Louise Marriott, Digital Content Producer
NICE has said eribulin, which is also called Halaven and made by Eisai, should be an option for people with locally advanced or metastatic breast cancer...
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ESMO 2016: New data from Eisai’s oncology portfolio for halaven (eribulin), lenvima (lenvatinib) and kisplyx (lenvatinib)
4 October 2016 | By Niamh Louise Marriott, Digital Content Producer
European Pharmaceutical Review will of course keep you up to date with all the latest pharma news from the conference. Here's a preview snippet...
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Eisai bewildered as IQWIG fails to recognise OS benefit of liposarcoma drug
5 September 2016 | By Niamh Louise Marriott, Digital Content Producer
n study 309, the pivotal phase III trial on which the indication approval was based, eribulin demonstrated a significant survival advantage in advanced liposarcoma; patients treated with eribulin compared to those treated with dacarbazine, a longstanding, established and internationally accepted treatment option, benefited from a median 7.2 month increase in…
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Eisai calls for immediate solution to CDF black hole
8 July 2016 | By Victoria White, Digital Content Producer
Eisai has expressed concern that patients in England and Wales will have to wait three years to access Lenvatinib due to a ‘black hole’ in the CDF process...
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The vascular remodelling effects of eribulin in advanced breast cancer
12 May 2016 | By Victoria White, Digital Content Producer
Newly published data validate the distinct vascular remodelling activity of Halaven (eribulin) compared to bevacizumab in breast tumour tissue...
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EC approves eribulin for the treatment of advanced liposarcoma
5 May 2016 | By Victoria White, Digital Content Producer
Eribulin is approved for those patients who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease...
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CHMP adopts positive opinion for eribulin in advanced liposarcoma
5 April 2016 | By Victoria White
The European Medicines Agency’s CHMP has adopted a positive opinion for a licence extension for Eisai’s Halaven (eribulin)...
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Lenvatinib approved in Israel for patients with advanced thyroid cancer
9 March 2016 | By Victoria White
From today, people in Israel with radioactive iodine refractory differentiated thyroid cancer will have access to Eisai’s Lenvima (lenvatinib)...
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Eisai criticises NHSE for further delaying access to cancer treatments
26 February 2016 | By Victoria White
New licensed drugs that have been denied access since May 2015 will have to wait until at least July 2016 before they can be considered for the new Cancer Drug Fund...
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New study to investigate PQR309 and eribulin in triple-negative breast cancer
17 February 2016 | By Victoria White
Eisai and PIQUR Therapeutics are to collaborate to conduct the Phase I/IIb clinical study of PIQUR’s PQR309 in combination with Eisai’s eribulin...
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Results from eribulin study in liposarcomas and leiomyosarcomas published
11 February 2016 | By Victoria White
Eisai's Halaven (eribulin) is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action...
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FDA approves Eisai’s Halaven in liposarcoma
29 January 2016 | By Victoria White
Halaven is the first and only single agent to demonstrate an overall survival benefit in a Phase III trial in patients with leiomyosarcoma or liposarcoma...
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Eisai’s lenvatinib receives FDA priority review
18 January 2016 | By Victoria White
The FDA has accepted for Priority Review Eisai’s supplemental New Drug Application for lenvatinib for the potential treatment of patients with renal cell carcinoma...
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Eisai submits MAA for lenvatinib in renal cell carcinoma
12 January 2016 | By Victoria White
Eisai has submitted the MAA to the EMA for the use of lenvatinib in combination with everolimus to treat people with unresectable advanced or metastatic renal cell carcinoma who have received one prior vascular endothelial growth factor targeted therapy...
