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...
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...
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...
17:33 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Venclexta/Gazyva combo meets PFS endpoint in Phase III for first-line CLL

Genentech Inc. and AbbVie Inc. (NYSE:ABBV) said first-line treatment with Venclexta venetoclax plus Gazyva obinutuzumab met the primary endpoint of improving investigator-assessed progression-free survival (PFS) compared with Gazyva plus chlorambucil in the Phase III CLL14...
01:14 , Nov 16, 2018 |  BC Innovations  |  Emerging Company Profile

Virion: Harnessing viral defects

Virion Biotherapeutics Ltd. has capitalized on a naturally occurring viral mutation to develop broad-spectrum antivirals with lower potential for resistance than marketed products. Its lead compound, VH244, is in preclinical development to treat respiratory infections...
00:30 , Nov 15, 2018 |  BC Extra  |  Company News

Management tracks: Ascletis, Agenus

Antiviral company Ascletis Pharma Inc. (HKSE:1672) hired Lindi Tan as CFO. She was a global healthcare analyst at SeaTown Holdings International. Ascletis was the first biotech to go public on the Hong Kong stock exchange's...