23:02 , Jan 18, 2019 |  BioCentury  |  Finance

Loxo's FOMO

Loxo Oncology Inc. (NASDAQ:LOXO) management held advanced licensing discussions with four potential partners during 2018 for its LOXO-292 program targeting RET, but the company instead chose an uncontested takeout offer from Eli Lilly and Co....
20:27 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

No safety signals with Zafgen's ZGN-1061 in second cohort of diabetes trial

Zafgen Inc. (NASDAQ:ZFGN) said the 1.8 mg subcutaneous dose of ZGN-1061 met primary and secondary endpoints in a second dose cohort from a Phase II trial to treat Type II diabetes. The adverse event profile...
20:26 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

United Neuroscience's vaccine leads to 96% response rate in Chinese Phase IIa for Alzheimer's

United Neuroscience Inc. (Dublin, Ireland) said UB-311 led to a 96% response rate and met the primary endpoints of safety and immunogenicity in a Phase IIa trial to treat mild Alzheimer's disease. Immunogenicity was determined...
20:04 , Jan 18, 2019 |  BC Week In Review  |  Company News

Phoenix, Roche partner to develop TNBC biomarker

Phoenix Molecular Designs (Vancouver, B.C.) and Roche (SIX:ROG; OTCQX:RHHBY) partnered on Jan. 16 to develop a molecular diagnostic to help stratify triple-negative breast cancer patients. Roche will develop an assay to detect activation of RPS6KA3,...
20:04 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

FDA moves up PDUFA for Nabriva's Contepo by two months

Nabriva Therapeutics plc (NASDAQ:NBRV) said FDA accelerated its review timeline for Nabriva's broad-spectrum antibiotic Contepo fosfomycin, moving the NDA's PDUFA date to April 30 from June 30. Nabriva said the accelerated timeline is "due to...
17:31 , Jan 17, 2019 |  BC Week In Review  |  Clinical News

hVIVO reports Phase IIb data of universal flu vaccine

hVIVO plc (LSE:HVO) said a single dose of FLU-v met the primary endpoint of reducing the incidence of mild to moderate influenza disease vs. placebo in the Phase IIb FLU-v 004 trial (p=0.035). The company...
00:53 , Jan 17, 2019 |  BC Extra  |  Company News

Phoenix, Roche partner to develop TNBC biomarker

Phoenix Molecular Designs (Vancouver, B.C.) and Roche (SIX:ROG; OTCQX:RHHBY) partnered on Wednesday to develop a molecular diagnostic to help stratify triple-negative breast cancer patients. Roche will develop an assay to detect activation of RPS6KA3, which...
22:53 , Jan 15, 2019 |  BC Week In Review  |  Clinical News

FDA approves Cabometyx for liver cancer

Exelixis Inc. (NASDAQ:EXEL) said Jan. 14 that FDA approved Cabometyx cabozantinib to treat hepatocellular carcinoma patients previously treated with Nexavar sorafenib. The approval comes two months after Exelixis’ partner Ipsen Group (Euronext:IPN; Pink:IPSEY) received approval...
00:30 , Jan 15, 2019 |  BC Extra  |  Company News

FDA approves Cabometyx for liver cancer

Exelixis Inc. (NASDAQ:EXEL) said Monday FDA approved Cabometyx cabozantinib to treat hepatocellular carcinoma patients previously treated with Nexavar sorafenib. The approval comes two months after Exelixis’ partner Ipsen Group (Euronext:IPN; Pink:IPSEY) received approval from the...
23:23 , Jan 11, 2019 |  BioCentury  |  Politics, Policy & Law

Supreme Court may reset FDA-State power balance

Following oral arguments in Merck v. Albrecht on Jan. 7, the Supreme Court is pondering a decision that could reset the balance of power over drug label warnings between FDA and state courts. The outcome...