BioCentury | Nov 19, 2020
Finance

VCs back Celleron spinout with €37M to develop former Roche asset for rare joint disorder

...La Thangue said it will likely be placebo-controlled.There is one FDA-approved therapy for TGCT: Turalio pexidartinib...
BioCentury | Jun 26, 2020
Regulation

Data Bytes: CHMP’s June opinions

...with transfusion-dependent anemia. Elizabeth S. Eaton, Staff Writer Veklury, remdesivir (GS-5734) Reblozyl, luspatercept-aamt (ACE-536) IdeS, imlifidase Trikafta, elexacaftor/tezacaftor/ivacaftor (VX-445/VX-661/VX-770) Turalio, pexidartinib (PLX3397) Xiidra...
BioCentury | Aug 2, 2019
Company News

Aug. 2 Company Quick Takes: Daiichi's cancer drug gets U.S. approval, plus BioMarin, Acorda, Stemline and more

...FDA approves Daiichi's pexidartinib FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat...
...colony-stimulating factor 1 receptor (C-FMS) Consensus estimates provided by FactSet. BioCentury Staff Elzonris (tagraxofusp-erzs, SL-401) Inbrija (CVT-301) pexidartinib (PLX3397) Vimizim...
BioCentury | May 24, 2019
Product Development

Why quizartinib hiccup at ODAC shouldn’t derail Daiichi’s 2025 cancer drug goals

...split. The efficacy and lack of available treatments swayed the panel to support approval of pexidartinib...
...second trial of the AML candidate (see "Daiichi Gets ODAC Split, with FDA Panel Backing Pexidartinib...
...HER3 (ERBB3;EGFR3) - Erb-b2 receptor tyrosine kinase 3 TOP1 - Topoisomerase I Erin McCallister, Senior Editor pexidartinib (PLX3397) quizartinib...
BioCentury | May 14, 2019
Clinical News

Daiichi gets ODAC split, with FDA panel backing pexidartinib for rare cancer

...options for tenosynovial giant cell tumor and a clear win on the primary endpoint for pexidartinib...
...as well, with the Oncologic Drugs Advisory Committee snubbing the compound with a 3-8 vote. Pexidartinib...
...tyrosine kinase (c-Kit; KIT; CD117); CSF1R - colony-stimulating factor 1 receptor (C-FMS) Erin McCallister, Senior Editor pexidartinib (PLX3397) quizartinib...
BioCentury | May 10, 2019
Company News

May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

...FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib Despite both pexidartinib and quizartinib meeting the primary...
...documents posted ahead of a May 14 meeting of FDA’s Oncologic Drugs Advisory Committee. For pexidartinib...
...Staff Writer, and Erin McCallister, Senior Editor Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy (Other) pexidartinib (PLX3397) quizartinib...
BioCentury | Apr 12, 2019
Company News

ODAC to discuss Daiichi Sankyo's pexidartinib, quizartinib NDAs

...Committee will meet on May 14 to discuss two NDAs from Daiichi Sankyo, one for pexidartinib...
...quizartinib to treat relapsed or refractory FLT3-internal tandem duplication (ITD) mutation-positive acute myelogenous leukemia (AML). Pexidartinib...
...“Daiichi’s AML Candidate Leads to Median OS of 6.2 Months” ; “Daiichi Planning NDA for Pexidartinib...
BioCentury | Jun 8, 2018
Clinical News

Daiichi planning NDA for pexidartinib on Phase III TGCT data

...tenosynovial giant cell tumors (TGCT) in the Phase III ENLIVEN trial showing that oral pexidartinib (PLX3397...
...an NDA to FDA for pexidartinib in the indication, but declined to disclose a timeline. Pexidartinib...
...U.S. and EU to treat TGCT. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Pexidartinib (PLX3397...
BioCentury | Feb 9, 2018
Emerging Company Profile

Fast boat to China

...inhibitors in the clinic for cancer. The most advanced is Daiichi Sankyo Co. Ltd.’s pexidartinib (PLX3397...
...a greater reduction in tumor volume in a syngeneic mouse model of breast cancer than pexidartinib...
BioCentury | Nov 3, 2017
Clinical News

Daiichi's pexidartinib passes Phase III test in TGCT

...Daiichi Sankyo Co. Ltd. (Tokyo:4568) said oral pexidartinib (PLX3397) met the primary endpoint of reducing tumor...
...of response. Daiichi said an ongoing comprehensive benefit-risk evaluation for the indication based on its pexidartinib...
...Phase II testing to treat glioblastoma. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Pexidartinib (PLX3397...
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