03:21 , Nov 17, 2018 |  BioCentury  |  Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...
03:17 , Nov 17, 2018 |  BioCentury  |  Product Development

Rethinking RECIST for immunotherapies

Momentum is growing for new tumor response criteria that better reflect the benefits of cancer immunotherapies, with FNIH, companies and FDA all pushing for validation of these criteria. At a Nov. 9 workshop co-hosted by...
00:10 , Nov 17, 2018 |  BC Extra  |  Company News

Adcetris gets speedy label expansion under FDA real-time pilot

FDA approved a label expansion for Adcetris brentuximab vedotin less than two weeks after Seattle Genetics Inc. (NASDAQ:SGEN) submitted the sBLA. The agency said Adcetris is the first U.S.-approved treatment for newly diagnosed peripheral T-cell...
00:06 , Nov 17, 2018 |  BC Extra  |  Company News

Novartis joins call asking FDA to stop biosimilar trash-talkers

Novartis AG (NYSE:NVS; SIX:NOVN) joined Pfizer Inc. (NYSE:PFE) in asking FDA to stop campaigns from branded drugmakers that the pharmas say are misleading the public about the safety of biosimilars. Novartis submitted its comments in...
18:56 , Nov 16, 2018 |  BC Week In Review  |  Company News

ICER: asthma mAbs should be 50% cheaper for cost effectiveness

The Institute for Clinical and Economic Review (ICER) said the costs of five asthma mAbs would need to decrease by at least 50% to be cost effective in a final evidence report . ICER said...
17:10 , Nov 16, 2018 |  BC Week In Review  |  Company News

NICE backs Novartis' Kymriah in acute lymphoblastic leukemia

U.K.'s NICE recommended in final guidance on Nov. 15 that CAR T therapy Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN) for use through the Cancer Drug Fund in patients under 25 with relapsed or refractory...
15:55 , Nov 16, 2018 |  BC Week In Review  |  Financial News

Neurology company Cadent emerges with $40M series B

Cadent Therapeutics Inc. (Cambridge, Mass.) emerged from stealth with news of a $40 million tranched series B round to bring its lead compound through Phase II trials to treat essential tremor and spinocerebellar ataxia (SCA)....
00:01 , Nov 16, 2018 |  BC Extra  |  Company News

NICE backs Novartis' Kymriah in acute lymphoblastic leukemia

U.K.'s NICE recommended in final guidance CAR T therapy Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN) for use through the Cancer Drug Fund in patients under 25 with relapsed or refractory B cell acute lymphoblastic...
11:00 , Nov 15, 2018 |  BC Extra  |  Financial News

Neurology company Cadent emerges with $40M series B

Cadent Therapeutics Inc. (Cambridge, Mass.) emerged from stealth with news of a $40 million tranched series B round to bring its lead compound through Phase II trials to treat essential tremor and spinocerebellar ataxia (SCA)....
22:50 , Nov 13, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: B cell lymphoma Cell and mouse studies suggest promoting PMAIP1 expression or inhibiting MCL1 could enhance the efficacy of BCL-2 inhibitors to treat diffuse large B cell lymphoma (DLBCL). In a DLBCL cell line,...