January 2023 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in January 2023 for investigational products in development.
Diagnosis & Disease Information
CDC Investigating Artificial Tears Product Linked to Drug-Resistant Infections
The Centers for Disease Control and Prevention (CDC) is urging health care providers and patients to immediately discontinue use of EzriCare Artificial Tears as the Agency is currently investigating its link to multiple different infection types, including eye infections. From May 17, 2022 to January 19, 2023, the CDC, alongside state and local health departments,…
Algorithm Predicts Urinary Tract Infection Without Microscopy
Authors say the new algorithm could be used to safely withhold antibiotics in low-risk patients in the primary care setting
December 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in December 2022 for investigational products in development.
FDA to Review 20-Valent Pneumococcal Conjugate Vaccine for Pediatric Use
The 20vPnC vaccine consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13, along with 7 additional serotypes that cause invasive pneumococcal disease.
FDA to Review BLA for Pentavalent Meningococcal Vaccine
The BLA is supported by data from a clinical trial which included 2341 healthy individuals 10 through 25 years of age.
Accord Recalls One Lot of Daptomycin for Injection
A product complaint report stated that vials labeled as “Daptomycin for Injection 500mg/vial” were found in cartons labeled as “Daptomycin for Injection 350mg/vial”.
MPR Weekly Dose Podcast #139
FDA pulls bebtelovimab EUA; compounding guidance issued in light of the amoxicillin shortage; the first fecal microbiota treatment is approved; a treatment for Alzheimer disease agitation shows promise; and a gene therapy for Duchenne muscular dystrophy is accepted for Priority Review.
Sulbactam-Durlobactam Gets Priority Review for Acinetobacter Infections
The investigational intravenous product is a combination of sulbactam, a β-lactam antibiotic, and durlobactam, a broad-spectrum β-lactamase inhibitor.
