03:20 , Feb 16, 2019 |  BioCentury  |  Product Development

ADCs’ inflection point

Industry is writing a new rule book for antibody-drug conjugates that could take the modality beyond the one-size-fits-all approach that has limited its success. By 2Q20, late-stage data from at least four ADCs testing new...
19:42 , Feb 15, 2019 |  BC Week In Review  |  Clinical News

Priority Review for Keytruda in RCC, head and neck cancer

FDA accepted and granted Priority Review to two sBLAs for anti-PD-1 mAb Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK). The agency assigned a June 10 PDUFA date to an sBLA for Keytruda as a...
15:05 , Feb 15, 2019 |  BC Extra  |  Company News

Keytruda-Inlyta combo under Priority Review for first-line RCC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to its sBLA for Keytruda pembrolizumab plus Inlyta axitinib as a first-line treatment for renal cell carcinoma. Its PDUFA date is June 20....
23:20 , Feb 13, 2019 |  BC Week In Review  |  Financial News

HaiHe raises $147M in series B to advance cancer candidates

Shanghai HaiHe Biopharma Co. Ltd. (Shanghai, China) raised $146.6 million on Feb. 11 to advance its oncology focused pipeline in a series B round led by Huagai Capital. Also participating were Yingke PE, CSPC Pharmaceutical...
22:08 , Feb 11, 2019 |  BC Extra  |  Financial News

HaiHe raises $147M in series B to advance cancer candidates

Shanghai HaiHe Biopharma Co. Ltd. (Shanghai, China) raised $146.6 million to advance its oncology focused pipeline in a series B round led by Huagai Capital. Also participating were Yingke PE, CSPC Pharmaceutical Group Ltd., Hillhouse...
00:41 , Feb 9, 2019 |  BioCentury  |  Product Development

Genentech takes the wheel

Roche has good cause to call on Genentech to prevent it from losing its long-standing dominance in cancer. While the pharma is late to the party in immuno-oncology, its former biotech unit is behind at...
00:14 , Feb 9, 2019 |  BioCentury  |  Product Development

Merck KGaA's large-scale partnering

Merck KGaA's deal with GlaxoSmithKline plc to develop cancer therapy M7824 enables Merck to pursue a more ambitious development plan than it could have done by going it alone, and provides a template for how...
20:46 , Feb 8, 2019 |  BC Week In Review  |  Clinical News

Hua starts U.S. Phase I trial of diabetes candidate

Hua Medicine Ltd. (HKEX:2552) began a Phase I trial of its dorzagliatin (sinogliatin, HMS5552, RO5305552) in combination with Januvia sitagliptin in patients with Type II diabetes. The open-label, U.S. trial will evaluate the pharmacokinetic and...
05:39 , Feb 8, 2019 |  BC Week In Review  |  Clinical News

Preliminary ORR 24% for Oncosec's Tavo plus Keytruda in Phase II for melanoma

OncoSec Medical Inc. (NASDAQ:ONCS) reported preliminary data from 21 evaluable metastatic/recurrent melanoma patients in the Phase IIb KEYNOTE-695 trial showing that Tavo tavokinogene telseplasmid/IL-12 plus Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) led to...
01:53 , Feb 8, 2019 |  BC Week In Review  |  Company News

Via Merck KGaA Deal, GSK adds to growing immuno-oncology pipeline

Two months after announcing it would pay $5.1 billion for Tesaro Inc., GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has partnered with Merck KGaA (Xetra:MRK) in another deal to bolster its immuno-oncology pipeline. GSK is paying the German...