19:58 , Nov 4, 2016 |  BC Week In Review  |  Company News

Cempra, Toyama milestone payment

Cempra received a $10 million milestone payment from Toyama under a 2013 deal granting Toyama exclusive rights to develop and commercialize solithromycin in Japan. The payment was triggered by the start of a Japanese Phase...
07:00 , Oct 3, 2016 |  BioCentury  |  Strategy

Combo deals

Allergan plc's two NASH acquisitions give it the second biggest pipeline for the indication and enough mechanisms to develop in-house combinations that could target multiple drivers of the disease pathophysiology. Together, Allergan's Sept. 20 deals...
07:00 , Mar 21, 2016 |  BC Week In Review  |  Company News

Cempra, U.S. Department of Health and Human Services infectious news

HHS’s Biomedical Advanced Research and Development Authority (BARDA) exercised an option under a 2013 contract with Cempra to develop solithromycin ( CEM-101 ) to treat infections in pediatric populations and infections caused by bioterror threat...
08:00 , Jan 18, 2016 |  BC Week In Review  |  Clinical News

Oral solithromycin: Phase II started

Cempra began an open-label, U.S. Phase II trial to evaluate once-daily 400 mg oral solithromycin for 13 weeks in up to 15 patients ages 18-70 with NASH without cirrhosis. Cempra has exclusive rights to solithromycin...
07:00 , Oct 26, 2015 |  BC Week In Review  |  Clinical News

IV solithromycin: Phase III data

The EMA-defined primary endpoint was non-inferiority in the ITT and CE populations of patients with CABP in PORT pneumonia severity risk classes III and IV at the short-term follow-up visit. Solithromycin was non-inferior to moxifloxacin...
07:00 , Aug 24, 2015 |  BC Week In Review  |  Clinical News

Oral solithromycin regulatory update

FDA granted Fast Track designation to IV and oral solithromycin from Cempra to treat community-acquired bacterial pneumonia (CABP). Both formulations of the fluoroketolide/macrolide antibiotic are in Phase III testing for CABP, with an NDA submission...
07:00 , Jul 20, 2015 |  BC Week In Review  |  Clinical News

IV solithromycin: Completed Phase III enrollment

Cempra completed enrollment of 863 patients in the double-blind, international Phase III Solitaire-IV trial comparing once-daily IV solithromycin for 7 days vs. IV moxifloxacin for 7 days. Patients will receive an 800 mg solithromycin loading...
07:00 , May 11, 2015 |  BC Week In Review  |  Clinical News

Oral solithromycin: Additional Phase III data

Data from a predefined subgroup of patients ages >=75 with moderate to severe CABP in the double-blind, international Phase III Solitaire-Oral trial showed that once-daily oral solithromycin for 5 days led to an early clinical...
08:00 , Jan 12, 2015 |  BC Week In Review  |  Clinical News

Oral solithromycin: Phase III data

Cempra is evaluating IV solithromycin in the Phase III Solitaire-IV trial to treat CABP. The company plans to include pooled data from both trials in an NDA to FDA under proposed FDA CABP guidance, which...
08:00 , Jan 12, 2015 |  BC Week In Review  |  Company News

Cempra, U.S. Department of Health and Human Services infectious news

HHS’s Biomedical Advanced Research and Development Authority (BARDA) exercised its first option under a 2013 contract with Cempra to develop solithromycin ( CEM-101 ) to treat infections in pediatric populations and infections caused by bioterror...