23:16 , Jun 21, 2019 |  BC Extra  |  Company News

June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib  Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...
22:28 , Jun 18, 2019 |  BC Extra  |  Company News

Japanese approvals include a global first for Roche's tissue-agnostic cancer drug

Among the four Japanese drug approvals announced on Tuesday was the global first for tissue-agnostic cancer therapy Rozlytrek entrectinib from Roche. Japan's Ministry of Health, Labour and Welfare (MHLW) approved the inhibitor of ROS1, TrkA,...
14:09 , Jun 3, 2019 |  BC Extra  |  Clinical News

Astellas, Seattle Genetics ADC could provide new option for checkpoint non-responders in bladder cancer

Data presented at ASCO on Monday for Astellas and Seattle Genetics' enfortumab vedotin showed that metastatic bladder cancer patients who don't respond or relapse after PD-1/PD-L1 therapy could soon have a new treatment option. In...
02:43 , Jun 1, 2019 |  BioCentury  |  Product Development

ASCO 2019 abstracts show solid tumor race heating up among bispecifics and CAR Ts

While strong progress in CAR T therapies will again feature at this year’s ASCO meeting, bispecific antibodies are having a moment -- making more inroads into solid tumors than CAR Ts and branching out via...
22:37 , May 30, 2019 |  BC Extra  |  Company News

May 30 Company Quick Takes: Unity in-licenses protein for cognitive decline, plus Astellas, Organovo, Iovance

Unity in-licenses UCSF protein for cognitive improvement  Unity Biotechnology Inc. (NASDAQ:UBX) licensed from the University of California San Francisco exclusive, worldwide rights to IP relating to KLA, including its use to reverse or prevent cognitive...
21:58 , May 24, 2019 |  BioCentury  |  Product Development

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

FDA's ODAC may have given the thumbs down to Daiichi’s quizartinib, but a stocked pipeline and another ongoing trial of the candidate suggest it’s more of a hiccup than a hurdle in the Japanese pharma’s...
23:26 , May 14, 2019 |  BC Extra  |  Clinical News

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

Missing data and lingering safety questions dogged a pair of Daiichi Sankyo oncology agents that came before ODAC on Tuesday, but a lack of available treatment options for tenosynovial giant cell tumor and a clear...
23:30 , May 13, 2019 |  BioCentury  |  Finance

How ElevateBio plans to create portfolio of cell, gene therapy newcos with $150M MPM, F2-led round

With $150 million in series A funding and an executive team led by Alexion and bluebird veterans, ElevateBio emerged from stealth on Monday with plans to accelerate cell and gene therapy discovery and development by...
18:59 , Apr 12, 2019 |  BC Week In Review  |  Company News

ODAC to discuss Daiichi Sankyo's pexidartinib, quizartinib NDAs

FDA’s Oncologic Drugs Advisory Committee will meet on May 14 to discuss two NDAs from Daiichi Sankyo, one for pexidartinib to treat symptomatic tenosynovial giant cell tumors and the other for quizartinib to treat relapsed...
01:49 , Feb 8, 2019 |  BC Week In Review  |  Clinical News

CTI withdraws MAA for myleofibrosis therapy

CTI BioPharma Corp. (NASDAQ:CTIC) withdrew its MAA for pacritinib to treat myelofibrosis following interactions with EMA's CHMP suggesting the committee was likely to issue a negative opinion. CTI said CHMP indicated the risk-benefit profile of...