BC Innovations | Apr 1, 2019
Emerging Company Profile

Arixa: Breaking resistance with oral beta lactamase inhibitors

Arixa has made an IV antibiotic oral with prodrug chemistry. Arixa Pharmaceuticals Inc. is modifying diazabicyclooctanes, a class of β-lactamase inhibitors that suffer from poor absorption across the GI tract, for use in combination with...
BioCentury | Jun 30, 2018
Regulation

Not a test

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...
BC Week In Review | Jun 29, 2018
Clinical News

FDA approves plazomicin for cUTI, but not blood infections

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...
BC Extra | Jun 26, 2018
Company News

FDA approves plazomicin for cUTI, but not blood infections

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...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  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...
BC Week In Review | Nov 30, 2017
Clinical News

Allergan's Avycaz gets Priority Review

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...
BC Week In Review | Apr 28, 2017
Clinical News

Zavicefta: Additional Ph III REPROVE data

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...
BC Week In Review | Mar 17, 2017
Company News

Zavicefta sales and marketing update

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...
BC Week In Review | Feb 3, 2017
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....
BioCentury | Dec 31, 2016
Finance

Delivering takeouts

  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...
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