Enforcement Report - Week of May 24, 2023
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.
Global drug giant Pfizer is warning physicians and clinicians in India to immediately stop using four of its antibiotics due to manufacturing issues at a contract producer.
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
Enforcement Report - Week of February 22, 2023
Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)
Piramal Critical Care Launches First to Market Generic Zinc Sulfate Injection in the U.S.
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...