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 |  BC Extra  |  Financial News

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...
21:12 , Feb 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I diabetes....
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
13:49 , Jan 3, 2019 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Acute myelogenous leukemia (AML) In vitro , cell culture, mouse and rat studies identified an inhibitor of internal tandem duplication (ITD)-mutant FLT3 that could help treat AML. Chemical synthesis and cell-based binding assays of...
04:20 , Dec 21, 2018 |  BC Innovations  |  Product R&D

Cell therapies seek solid ground

To make cell therapies work in solid tumors, drug companies will have to either master combination therapies or figure out how to make their treatments trigger broad immune responses that extend beyond the antigen specificity...
22:07 , Dec 3, 2018 |  BC Extra  |  Company News

NIH may give ElevateBio exclusive CAR T license

NIH's National Cancer Institute is considering granting ElevateBio LLC (Cambridge, Mass.) an exclusive license to develop an undisclosed CAR T therapy targeting FMS-like tyrosine kinase 3 (FLT3; CD135). In a Federal Registry notice , NIH...