20:22 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

FDA approves Paratek antibiotics

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) received a pair of FDA approvals Oct. 2 for Nuzyra omadacycline and Seysara sarecycline. The agency approved Nuzyra to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure...
23:45 , Oct 2, 2018 |  BC Extra  |  Company News

FDA approves Paratek antibiotics

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) received a pair of FDA approvals Tuesday for Nuzyra omadacycline and Seysara sarecycline. The agency approved Nuzyra to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections...
18:10 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

TB Alliance starts pivotal trial of four-drug regimen

The Global Alliance for TB Drug Development (TB Alliance) began the pivotal Phase IIc SimpliciTB trial evaluating an oral four-drug regimen called BPaMZ to treat tuberculosis. SimpliciTB will compare BPaMZ, which comprises a once-daily combination...
20:43 , Aug 28, 2018 |  BC Extra  |  Clinical News

TB Alliance starts pivotal trial of four-drug regimen

The Global Alliance for TB Drug Development (TB Alliance) began the pivotal Phase IIc SimpliciTB trial evaluating an oral four-drug regimen called BPaMZ to treat tuberculosis. SimpliciTB will compare BPaMZ, which comprises a once-daily combination...
23:48 , Aug 8, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Pneumonia; bacterial infection Cell culture and mouse studies identified a methoxyquinolone-based compound that could help treat bacterial pneumonia. Structure-based design, chemical synthesis and testing in bacterial cultures of methoxyquinolone analogs yielded a compound that...
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...