15:30 , May 25, 2018 |  BC Week In Review  |  Clinical News

Nabriva's lefamulin meets in Phase III LEAP 2 trial for CABP

Nabriva Therapeutics plc (NASDAQ:NBRV) reported a higher incidence of GI adverse events in patients who received oral lefamulin (BC-3781) in the Phase III LEAP 2 trial to treat moderate community-acquired bacterial pneumonia (CABP). While the...
22:45 , May 21, 2018 |  BC Extra  |  Clinical News

Nabriva falls on GI safety in second Phase III for CABP

Nabriva Therapeutics plc (NASDAQ:NBRV) lost $0.90 (17%) to $4.53 on Monday after reporting a higher incidence of GI adverse events in patients who received oral lefamulin (BC-3781) in the Phase III LEAP 2 trial to...
20:36 , Feb 2, 2018 |  BC Week In Review  |  Clinical News

Da Volterra's DAV132 meets in Phase I for antibiotic-induced dysbiosis

Da Volterra (Paris, France) reported data from the open-label, French Phase I DAV132-CL-1002 trial in 44 healthy volunteers showing that DAV132 met the primary endpoint by effectively capturing residual moxifloxacin in the colon. Specifically, co-administration...
20:11 , Sep 22, 2017 |  BC Week In Review  |  Clinical News

Nabriva's lefamulin meets in Phase III LEAP 1 trial for CABP

Nabriva Therapeutics plc (NASDAQ:NBRV) reported that IV-to-oral lefamulin (BC-3781) met the FDA- and EMA-defined primary endpoints in the double-blind, international Phase III LEAP 1 trial to treat moderate to severe community-acquired bacterial pneumonia (CABP). Top-line...
20:24 , Sep 18, 2017 |  BC Extra  |  Clinical News

Nabriva rises on Phase III CABP success

Nabriva Therapeutics plc (NASDAQ:NBRV) jumped $2.01 (29%) to $8.87 on Monday after reporting that IV-to-oral lefamulin (BC-3781) met the FDA- and EMA-defined primary endpoints in the Phase III LEAP 1 trial to treat moderate to...
23:13 , Apr 13, 2017 |  BC Week In Review  |  Clinical News

Lefamulin: Completed Ph III enrollment

Nabriva completed enrollment of 550 patients in the double-blind, international Phase III LEAP 1 trial comparing IV and oral lefamulin vs. IV and oral moxifloxacin with or without Zyvox linezolid for 7 or 10 days....
19:18 , Apr 7, 2017 |  BC Week In Review  |  Clinical News

Omadacycline: Ph III OPTIC data

Top-line data from 774 patients with CABP in the ITT population of the double-blind, international Phase III OPTIC trial showed that once-daily IV-to-oral omadacycline for 7-14 days met the FDA-defined primary endpoint of non-inferiority to...
22:38 , Apr 3, 2017 |  BC Extra  |  Clinical News

Paratek's omadacycline meets second Phase III endpoint

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) surged $5.85 (31%) to $24.45 in early after-hours trading on Monday after it said omadacycline (formerly PTK 0796) met FDA and EMA-specified primary endpoints in the Phase III OPTIC study to...
20:22 , Feb 16, 2017 |  BC Week In Review  |  Clinical News

Quinolones/fluoroquinolones regulatory update

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began a review of systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects primarily affecting muscles, joints and the nervous system. Germany’s Federal...
17:33 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

Lefamulin: Ph III LEAP 1 ongoing

An independent committee recommended continuation of the double-blind, international Phase III LEAP 1 trial comparing IV and oral lefamulin vs. IV and oral moxifloxacin with or without Zyvox linezolid for 7 or 10 days. The...