Meitheal Pharmaceuticals Expands Specialty Biopharmaceuticals Portfolio with Acquisition of CONTEPO™ (Fosfomycin for Injection) from Nabriva Therapeutics
Enforcement Report - Week of February 28, 2024
Enforcement Report - Week of September 13, 2023
Having spent the past few months combing through the data from a Phase III trial that it stopped for futility, ContraFect concluded that it still hasn’t gotten to the bottom of whether its antibiotic works in a type of staph infection.
Cipla's Generic Fosfomycin Tromethamine Receives Approval in U.S.
Alkem`s GenericFosfomycin Tromethamine Receives Approval in US
FDA declines to approve Nabriva`s antibiotic for urinary tract infections
Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company's investigational product candidate, ZOLYD™ (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS™ clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). ZOLYD is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action and broad spectrum of activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant (MDR) pathogens
ANVISA published on Monday (21/12) two records of unpublished generic for the Brazilian market. With that the year 2015 was one in which ANVISA approved more unpublished generic since 2006. From January to December this year, 35 were unpublished recorded by the Agency. The number is an important reference for improving access to medicines in Brazil. That's because the arrival of generic unprecedented creates real competition in segments where before there was market dispute. In addition, the generic enters the market with a price 35% less than the value of the reference product, pulling prices down.
Zavante Therapeutics, Inc., a privately-held, late stage clinical biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for a clinical study under the Company's Investigational New Drug application for its lead product ZTI-01 (fosfomycin for injection) to proceed. Specifically, the FDA has endorsed a clinical development plan that includes a single pivotal trial in complicated urinary tract infections (cUTI). In addition, the FDA granted four Qualified Infectious Disease Product (QIDP) designations and granted Fast Track designations for four ZTI-01 indications including cUTI. The Company also reported that it closed a financing of more than $10 million. Zavante expects to begin the pivotal clinical trial in the first quarter of 2016.