22:38 , Sep 14, 2018 |  BC Extra  |  Company News

ACS’s Brawley disappointed in Baselga resignation

American Cancer Society Chief Medical and Scientific Officer Otis Brawley said he was disappointed that José Baselga resigned from Memorial Sloan Kettering Cancer Center after failing to disclose financial ties to industry. Baselga, who was...
15:37 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

resTORbio forging ahead with anti-infective after Phase IIb readout

Data from Part 2 of a Phase IIb trial evaluating RTB101 from resTORbio Inc. (NASDAQ:TORC) to prevent respiratory tract infections showed that all three dose regimens of the candidate missed the study's primary endpoint vs....
20:57 , Jul 25, 2018 |  BC Extra  |  Clinical News

resTORbio forging ahead with anti-infective after Phase IIb readout

Data from Part 2 of a Phase IIb trial evaluating RTB101 from resTORbio Inc. (NASDAQ:TORC) to prevent respiratory tract infections showed that all three dose regimens of the candidate missed the study's primary endpoint vs....
19:08 , May 18, 2018 |  BC Week In Review  |  Company News

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
13:30 , May 17, 2018 |  BC Extra  |  Politics & Policy

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
00:24 , Feb 17, 2018 |  BioCentury  |  Product Development

This year’s model

Companies are answering FDA’s push for model-informed dose optimization in cancer by modeling how tumors grow and how tumor kinetics relate to outcomes. The models can support dosing decisions and help companies make faster, better...
20:13 , Feb 2, 2018 |  BC Week In Review  |  Financial News

resTORbio raises $97.8M IPO

resTORbio Inc. (NASDAQ:TORC) raised $97.8 million through the sale of 6.5 million shares at $15 in an IPO underwritten by BofA Merill Lynch, Leerink Partners, Evercore ISI and Wedbush PacGrow. The figures includes an 850,000-share...
22:40 , Jan 26, 2018 |  BC Extra  |  Financial News

resTORbio raises $85M IPO

resTORbio Inc. (NASDAQ:TORC) gained $1.88 (13%) to $16.88 in its first day of trading Friday after raising $85 million through the sale of 5.7 million shares at $15 in an IPO underwritten by BofA Merill...
19:08 , Jan 26, 2018 |  BC Extra  |  Company News

FDA approves Novartis' Lutathera for GEP-NETs

FDA approved Lutathera (177-Lu-Dotatate) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, including foregut, midgut, and hindgut neuroendocrine tumors. Novartis gained the drug when it acquired Advanced Accelerator...
22:14 , Jan 5, 2018 |  BC Week In Review  |  Clinical News

Eisai's Lenvima gets Priority Review for HCC in China

Eisai Co. Ltd. (Tokyo:4523) said China FDA granted Priority Review to an NDA for Lenvima lenvatinib mesylate (Kisplyx - EU, E7080) to treat hepatocellular carcinoma (HCC). The company submitted the NDA in October 2017. The...