07:00 , Apr 28, 2014 |  BC Week In Review  |  Clinical News

Ceftolozane/tazobactam regulatory update

Cubist submitted an NDA to FDA for ceftolozane/tazobactam to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). The company plans to submit an MAA to EMA next half. Cubist is also planning...
08:00 , Dec 23, 2013 |  BC Week In Review  |  Clinical News

Ceftolozane/tazobactam: Phase III data

Last month, Cubist reported that IV ceftolozane/tazobactam met the FDA- and EMA-defined primary endpoints of non-inferiority to IV levofloxacin in a pair of identical Phase III trials to treat complicated urinary tract infection (cUTI) (see...
08:00 , Dec 9, 2013 |  BC Week In Review  |  Clinical News

Ceftolozane/tazobactam: Phase III data

Cubist expects to report top-line data late this month from a pair of Phase III trials evaluating ceftolozane/tazobactam to treat complicated intra-abdominal infections (cIAI). Cubist plans to submit an NDA to FDA in 1H14 and...
07:00 , Jul 22, 2013 |  BC Week In Review  |  Clinical News

Ceftolozane/tazobactam: Phase III started

Cubist began the open-label, U.S. and Australian Phase III VECTOR trial comparing 3,000 mg IV ceftolozane/tazobactam every 8 hours vs. 4,500 mg piperacillin/tazobactam every 6 hours in about 300 patients. The product is in Phase...
07:00 , May 13, 2013 |  BC Week In Review  |  Clinical News

Ceftolozane/tazobactam regulatory update

FDA granted Fast Track designation to ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) and complicated urinary tract infection (cUTI). The product already has Fast Track designation to treat complicated intra-abdominal infections...
07:00 , Mar 18, 2013 |  BC Week In Review  |  Company News

Cubist, Astellas deal

Cubist acquired rights to the cephalosporin antibiotic ceftolozane in undisclosed Asia-Pacific and Middle East territories from Astellas. The pharma will receive $25 million up front and sales of ceftolozane/tazobactam ( CXA-201 ) in the newly...
07:00 , Mar 18, 2013 |  BioCentury  |  Finance

Entering new Domains

Entering new Domains One year after setting up shop in Russia, Domain Associates unveiled plans to do so in China through a deal with consulting firm Beijing Elite Management Consulting Ltd. Domain Elite Holdings Ltd.,...
07:00 , Sep 10, 2012 |  BioCentury  |  Finance

Antibiotic replay

Antibiotic replay Frazier Healthcare Ventures is betting the team at Kalidex Pharmaceuticals Inc. can build a third successful antibiotic company. Kalidex, which emerged from stealth mode last week, quietly raised $45 million in a series...
01:14 , Sep 5, 2012 |  BC Extra  |  Company News

Kalidex debuts

Kalidex Pharmaceuticals Inc. (Menlo Park, Calif.) made its public debut on Tuesday and said it raised $45 million in a series A round in February 2011. Frazier Healthcare Ventures; Domain Associates; Canaan Partners; New Leaf...
08:00 , Feb 6, 2012 |  BioCentury  |  Finance

Frazier's bumper crop

The exits achieved by portfolio companies of Frazier Healthcare in 2011 are another indication that things could be looking up for the venture community and the LPs that fund it. The firm recently reported a...