BioCentury | Feb 3, 2017
Clinical News

Avycaz regulatory update

...double-blind RECAPTURE trial in 1,020 patients hospitalized with cUTI showed that Avycaz was non-inferior to doripenem...
BioCentury | Sep 7, 2015
Clinical News

Avycaz ceftazidime/avibactam: Phase III data

...broad-spectrum beta lactamase (LACTB) inhibitor Indication: Treat complicated urinary tract infections (cUTIs) Endpoint: Non-inferiority to doripenem...
...FDA- and EMA-defined primary endpoints. Avycaz met the FDA-defined co-primary endpoints of non-inferiority to IV doripenem...
...FDA-defined non-inferiority margin was 10%. Avycaz also met the EMA-defined primary endpoint of non-inferiority to doripenem...
BioCentury | Mar 17, 2014
Clinical News

Doribax doripenem regulatory update

...FDA updated the label of Doribax doripenem from Shionogi to include information related to the increased...
...risk of mortality in patients with ventilator-associated bacterial pneumonia (VABP) receiving the broadspectrum carbapenem antibiotic. Doribax...
...BioCentury, Aug. 19, 2013). Shionogi & Co. Ltd. (Tokyo:4507), Osaka, Japan Product: Doribax doripenem ( Finibax...
BioCentury | Aug 19, 2013
Company News

Shionogi, J&J deal

...June. J&J had worldwide rights to Doribax, excluding Japan, where Shionogi markets the product as Finibax...
...in patients treated with Doribax compared with imipenem/cilastatin. FDA also issued a statement noting that Doribax...
BioCentury | Aug 13, 2012
Company News

J&J neurology news

...in April requesting documents relating to the marketing and promotion of Doribax doripenem. J&J markets Doribax...
...carbapenem antibiotic from Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507, Osaka, Japan), which markets it as Finibax...
...which is known as Xeplion in Europe. J&J does not break down sales for Doribax...
BioCentury | Jul 2, 2012
Clinical News

Doribax regulatory update

...EMA's CHMP recommended updating the label for Doribax doripenem to include higher dosage of the antibiotic...
...Doribax from Shionogi, which markets the broad-spectrum carbapenem antibiotic as Finibax in Japan. J&J markets Doribax...
...Osaka:4507), Osaka, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Doribax ( Finibax ) doripenem...
BioCentury | Jun 4, 2012
Clinical News

Finibax regulatory update

...IV Finibax doripenem to include pediatric use, as well as the treatment of purulent meningitis. Finibax...
...Johnson, which has rights from Shionogi, markets the broad-spectrum carbapenem antibiotic in the U.S. as Doribax...
...Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Finibax ( Doribax ) doripenem ( S-4661...
BioCentury | Mar 19, 2012
Regulation

Feasible, perhaps not relevant

...that have exclusion criteria for prior antibiotic use. The Phase III DORI-05 trial for Doribax doripenem...
...32 (5.9%) were enrolled in North America, with the rest in Europe and South America. Doribax...
BioCentury | Jan 16, 2012
Clinical News

Doribax: Phase III halted

...7-day course of Doribax vs. 14.8% for patients receiving a 10-day course of imipenem/cilastatin. Additionally, Doribax...
...tract infections (cUTI). J&J has rights to Doribax from Shionogi, which markets the product as Finibax...
...Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Doribax ( Finibax - Japan) doripenem ( S-4661...
BioCentury | Dec 19, 2011
Regulation

Europe speeds away

...the U.S., after which clinicians will use the drugs off label for pneumonia. "I bet doripenem...
...paid for by Medicare. Why? Because it works," Shlaes said. Johnson & Johnson markets Doribax doripenem...
...has rights to Doribax from Shionogi & Co. Ltd. , which markets the product as Finibax...
Items per page:
1 - 10 of 82