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...
03:50 , Dec 1, 2018 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first...
20:35 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves Astellas’ Xospata in FLT3-positive AML

FDA approved Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) to treat relapsed or refractory acute myelogenous leukemia in patients with an FMS-like tyrosine kinase 3 (FLT3; CD135) mutation. The company said Xospata is the first...
18:25 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves two drugs for first-line AML

FDA approved on Nov. 28 two drugs for first-line treatment of acute myelogenous leukemia, setting off a race in a setting that's been void of new approvals for patients who do not harbor an FMS-like...