00:35 , Feb 1, 2019 |  BC Innovations  |  Tools & Techniques

TMB needs company

Tumor mutation burden is looking less like a magic bullet and more like just one of at least three variables that could jointly predict responses to checkpoint inhibitors. Combining TMB measurements with markers of T...
00:40 , Jan 25, 2019 |  BC Week In Review  |  Clinical News

Lartruvo fails confirmatory study; Lilly suspending promotion

Eli Lilly and Co. (NYSE:LLY) said on Jan. 18 that it will suspend promotion of Lartruvo olaratumab after it missed the primary endpoints of the Phase III ANNOUNCE trial to treat advanced or metastatic soft...
13:43 , Jan 18, 2019 |  BC Extra  |  Clinical News

Lartruvo fails confirmatory study; Lilly suspending promotion

Eli Lilly and Co. (NYSE:LLY) said it will suspend promotion of Lartruvo olaratumab after it missed the primary endpoints of the Phase III ANNOUNCE study to treat advanced or metastatic soft tissue sarcoma. The trial...
19:39 , Jan 9, 2019 |  BC Extra  |  Politics & Policy

FDA to expand Sentinel in five-year plan

FDA announced Wednesday a five-year plan to expand the analysis capabilities of its Sentinel safety monitoring platform and leverage the platform to accelerate the use of real-world evidence. Sentinel allows FDA to run queries that...
20:30 , Jan 4, 2019 |  BC Extra  |  Company News

Immunocore taps MedImmune's Jallal as CEO

TCR company Immunocore Ltd. (Abingdon, U.K.) hired Bahija Jallal as CEO. She was EVP of AstraZeneca plc (LSE:AZN; NYSE:AZN) and president of its MedImmune LLC subsidiary. Jallal, who joined MedImmune in 2006, oversaw the development...
19:27 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Revlimid combo improves PFS by 25.3 months in Phase III for indolent lymphoma

Celgene Corp. (NASDAQ:CELG) reported additional data from the Phase III AUGMENT trial to treat relapsed or refractory follicular and marginal zone lymphoma showing that Revlimid lenalidomide plus Rituxan rituximab significantly improved median progression-free survival (PFS)...
18:33 , Dec 14, 2018 |  BC Week In Review  |  Company News

Millendo, OvaScience merge, raise $50M

Emerging from the reverse-merger of private endocrine company Millendo Therapeutics Inc. and former public fertility company OvaScience Inc., Millendo Therapeutics Inc. (NASDAQ:MLND) raised $49.5 million in a financing Friday. The combined company will begin trading...
17:50 , Dec 7, 2018 |  BC Extra  |  Company News

Millendo, OvaScience merge, raise $50M

Emerging from the reverse-merger of private endocrine company Millendo Therapeutics Inc. and former public fertility company OvaScience Inc., Millendo Therapeutics Inc. (NASDAQ:MLND) raised $49.5 million in a financing Friday. The combined company will begin trading...
19:03 , Dec 6, 2018 |  BC Extra  |  Politics & Policy

FDA releases real-world evidence framework

FDA is creating a roadmap that will facilitate the integration of real-world evidence into drug development. FDA’s framework for real-world evidence envisions using data from electronic health records (EHRs), observational and pragmatic studies, and mobile...
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...