Antibiotics developers shouldn’t read too much into FDA’s rejection of the first drug to be reviewed under a new limited-use pathway that is supposed to make it easier to develop treatments for rare and resistant...
Achaogen Inc. (NASDAQ:AKAO) said FDA approved Zemdri plazomicin to treat complicated urinary tract infections (cUTIs), but issued a complete response letter for the same candidate to treat bloodstream infections. The mixed decision is in line...
Achaogen Inc. (NASDAQ:AKAO) said FDA approved Zemdri plazomicin to treat complicated urinary tract infections (cUTIs), but issued a complete response letter for the same candidate to treat bloodstream infections. The mixed decision is in line...
The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
In October, FDA accepted and granted Priority Review to an sNDA from Allergan plc (NYSE:AGN) for Avycaz ceftazidime/avibactam (CAZ-104) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in adults. FDA's decision is...
Additional data from the double-blind, double-dummy, international Phase III REPROVE trial in 879 patients with HAP, including VAP, showed that 2,000 mg/500 mg IV Zavicefta ceftazidime/avibactam as a 2-hour infusion every 8 hours led to...
Pfizer launched Zavicefta ceftazidime/ avibactam in the U.K. and Germany to treat complicated infections caused by Gram-negative bacteria. Pfizer said the cost of Zavicefta is £857 ($1,047) for 10 vials. Zavicefta is indicated to treat...
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....
BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are...
Pfizer will acquire AstraZeneca’s small molecule anti-infectives business. The unit includes approved drugs Zavicefta ceftazidime/ avibactam , Zinforo ceftaroline fosamil and Merrem /Meronem meropenam, as well as Phase II candidates, ATM-AVI and CXL . AZ...