23:35 , Nov 20, 2018 |  BC Extra  |  Company News

Merck KGaA, Palantir team up to drive cancer research data sharing and integration

Merck KGaA (Xetra:MRK) and big data company Palantir Technologies (Palo Alto, Calif.) plan to create a JV under the name Syntropy to help facilitate collaboration among cancer researchers. Syntropy will offer a data integration software...
22:05 , Nov 20, 2018 |  BC Extra  |  Company News

Ascletis adds marketed HBV drug from Roche to Chinese portfolio

With one marketed HCV therapy in China and another under review, Ascletis Pharma Inc. (HKSE:1672) extended its commercial viral hepatitis footprint in the country on Tuesday with exclusive rights to marketed HBV drug Pegasys peginterferon...
23:44 , Nov 19, 2018 |  BC Extra  |  Company News

Management tracks: Brickell, Genevant

Dermatology company Brickell Biotech Inc. (Boulder, Colo.) hired Robert Brown as CEO, effective Jan. 1. He will replace co-founder and CEO Reginald Hardy, who will remain on the board and serve as special adviser to...
23:15 , Nov 19, 2018 |  BC Extra  |  Company News

Immunocore, Genentech team up to bring soluble TCR therapy into clinic

Despite losing at least five key executives this year, Immunocore Ltd. (Abingdon, U.K.) has teamed up with Genentech Inc. to advance the first soluble TCR-based therapy from their existing deal into clinical testing for solid...
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...
02:00 , Nov 17, 2018 |  BioCentury  |  Emerging Company Profile

Sepset’s sepsis signature

Sepset Biosciences Inc.’s gene expression test detects an "endotoxin tolerance" signature that can diagnose sepsis as soon as patients appear in an emergency room, earlier than approved assays and thereby providing more time for antibiotics...
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...
22:19 , Nov 16, 2018 |  BC Extra  |  Company News

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup. The agency backed...
20:42 , Nov 16, 2018 |  BC Extra  |  Clinical News

Imfinzi fails again in MYSTIC trial for first-line NSCLC

In another strike against tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the co-primary endpoint of improving overall survival (OS) in the Phase III MYSTIC trial...