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 inhibitor...
23:23 , Dec 1, 2017 |  BC Extra  |  Clinical News

Bayer reports mortality signal with Xofigo in early CRPC

Bayer AG (Xetra:BAYN) said an IDMC observed more fractures and deaths among patients treated with Xofigo radium-223 dichloride vs. placebo in the Phase III ERA223 trial to treat metastatic castration-resistant prostate cancer. Bayer said it...
21:55 , Dec 1, 2017 |  BC Week In Review  |  Financial News

resTORbio raises $40M series B

resTORbio Inc. (Boston, Mass.) raised $40 million in an oversubscribed series B round led by OrbiMed Advisors with participation from Fidelity, Rock Springs Capital, Quan Capital and Nest Bio. The aging-related disease company has raised...
20:40 , Nov 30, 2017 |  BC Extra  |  Financial News

resTORbio raises $40M

resTORbio Inc. (Boston, Mass.) raised $40 million in an oversubscribed series B round led by OrbiMed Advisors with participation from Fidelity, Rock Springs Capital, Quan Capital and Nest Bio. The aging-related disease company has raised...