56 documents

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00:59 , Jun 30, 2018 |  BioCentury  |  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...
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15:03 , Jun 29, 2018 |  BC Week In Review  |  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...
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15:30 , Jun 26, 2018 |  BC Extra  |  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...
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00:38 , Jan 6, 2018 |  BioCentury  |  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...
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23:20 , Nov 30, 2017 |  BC Week In Review  |  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...
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14:36 , Apr 28, 2017 |  BC Week In Review  |  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...
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19:14 , Mar 17, 2017 |  BC Week In Review  |  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...
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00:01 , Feb 3, 2017 |  BC Week In Review  |  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....
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00:53 , Dec 31, 2016 |  BioCentury  |  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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07:00 , Sep 5, 2016 |  BC Week In Review  |  Company News

AstraZeneca, Pfizer deal

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...
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