00:01 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

Avycaz regulatory update

FDA approved an sNDA from Allergan for Avycaz ceftazidime/avibactam to include data from the Phase III RECAPTURE and REPRISE trials of the drug to treat complicated urinary tract infections (cUTIs) caused by susceptible Gram-negative bacteria....
07:00 , Sep 7, 2015 |  BC Week In Review  |  Clinical News

Avycaz ceftazidime/avibactam: Phase III data

Avycaz is marketed in the U.S. to treat cUTI and complicated intra-abdominal infections (cIAI). By year end, Allergan plans to submit an sNDA to FDA to include data from RECAPTURE 1 and RECAPTURE 2 in...
07:00 , Mar 17, 2014 |  BC Week In Review  |  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 is approved in...
07:00 , Aug 19, 2013 |  BC Week In Review  |  Company News

Shionogi, J&J deal

Shionogi disclosed in its first quarter earnings for the period ended June 30, that Johnson & Johnson returned worldwide rights to Doribax doripenem in June. J&J had worldwide rights to Doribax, excluding Japan, where Shionogi...
07:00 , Aug 13, 2012 |  BC Week In Review  |  Company News

J&J neurology news

Johnson & Johnson said in its 2Q12 earnings that it has reached an agreement in principle with the U.S. Department of Justice to settle three civil False Claims Act matters pending in district court. If...
07:00 , Jul 2, 2012 |  BC Week In Review  |  Clinical News

Doribax regulatory update

EMA's CHMP recommended updating the label for Doribax doripenem to include higher dosage of the antibiotic in patients with nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Specifically, CHMP recommended physicians double the dose to 1 g...
07:00 , Jun 4, 2012 |  BC Week In Review  |  Clinical News

Finibax regulatory update

Shionogi said it received Japanese approval to extend the indication for IV Finibax doripenem to include pediatric use, as well as the treatment of purulent meningitis. Finibax is already approved in Japan to treat serious...
07:00 , Mar 19, 2012 |  BioCentury  |  Regulation

Feasible, perhaps not relevant

Two companies developing drugs to treat complicated urinary tract infections say it is feasible to conduct trials according to recommendations in FDA 's new draft guidance. But clinicians are concerned the results of such studies...
08:00 , Jan 16, 2012 |  BC Week In Review  |  Clinical News

Doribax: Phase III halted

Johnson & Johnson said in a Dear Healthcare Professional letter that it terminated a double-blind, international Phase III trial after an interim analysis showed a numerically higher mortality and a numerically poorer clinical cure rate...
08:00 , Dec 19, 2011 |  BioCentury  |  Regulation

Europe speeds away

The European Commission's new action plan to combat antimicrobial resistance could further widen the regulatory gap between the U.S. and Europe, which is already at the point where some physicians worry companies will no longer...