WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that the U.S. Food and Drug Administration (FDA) approved XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.
WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA) focused on delivering innovative therapies in critical care and infectious disease, today announced that The Lancet Infectious Diseases published detailed results from the pivotal Phase 3 ATTACK trial of sulbactam-durlobactam, the first pathogen-targeted therapy being studied for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.
April 17 (Reuters) - A panel of U.S. Food and Drug Administration advisers on Monday unanimously voted in favor of Innoviva Inc's (INVA.O) experimental antibiotic in the treatment of serious bacterial infections, typically associated with hospitalizations, the company said.
Sulbactam-Durlobactam Unanimously Recommended for Approval by FDA Advisory Committee
Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)
WALTHAM, Mass., June 09, 2022 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (Nasdaq: ETTX), a late-stage clinical biopharmaceutical company focused on the discovery and development of novel...
A new antibiotic by Entasis Therapeutics has bested an existing therapy against a pathogen deemed by the Centers for Disease Control and Prevention (CDC) to be an urgent threat during a phase 3 clinical trial.nThe Zai Lab-partnered drug, called SUL-DUR, will now be headed for an initial FDA filing in mid-2022, Entasis said in a Monday statement.