Pembrolizumab Combos Miss Primary Endpoints in Liver, Prostate Cancer Trials
The LEAP-002 study evaluated pembrolizumab plus lenvatinib in patients with uHCC; the KEYNOTE-921 study evaluated pembrolizumab plus docetaxel in patients with mCRPC.
Gastroenterology
AbbVie Seeks Crohn Disease Indication for Upadacitinib
The application is supported by data from the two phase 3 induction studies, U-EXCEED and U-EXCEL, and one phase 3 maintenance study, U-ENDURE.
OTC Laxative Recall Expanded; Vi-Jon Investigating 3 Reports of Adverse Events
Immunocompromised individuals may be at an increased risk for invasive infections if a contaminated product is consumed.
Glycopyrrolate Injection 0.6mg/3mL Now Available in Ready-to-Administer Prefilled Syringe
The Simplist ready-to-administer prefilled syringes minimize preparation steps for clinicians.
Dupilumab Demonstrates Benefit in Pediatric Eosinophilic Esophagitis Trial
The phase 3 EoE KIDS study included 102 children with active eosinophilic esophagitis based on histologic improvement meeting validated histologic criteria.
IBS-C Treatment Zelnorm Withdrawn From the Market Again
The decision to remove Zelnorm from the market was strictly a business decision.
OTC Laxative Recalled Due to Microbial Contamination
At this time, there have been no reports of adverse events related to this recall.
Skyrizi Approved for Moderately to Severely Active Crohn Disease
The approval was based on data from two phase 3 induction studies, and one phase 3 maintenance study.
Amvuttra Approved for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
Amvuttra is a subcutaneously-administered RNAi therapeutic designed to block the production of wild-type and mutant transthyretin protein.
Safety, Efficacy of Oral Microbiome Therapeutic Confirmed in Recurrent CDI Study
Confirmatory results were announced from a phase 3 study investigating the oral microbiome therapeutic SER-109 for the treatment of recurrent Clostridioides difficile infection (CDI). SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors. The open-label ECOSPOR IV study (ClinicalTrials.gov Identifier: NCT03183141) included a total of 263 adults with recurrent…
