Microbiome Therapeutic Beats Placebo for Recurrent C. difficile
Investigational oral live microbiome therapeutic superior to placebo in patients with three or more episodes of C. difficile infection
Gastroenterology
Microbial Contamination Prompts Recall of Senna Syrup
The recalled lot of Senna Syrup 8.8mg/5mL; NDC # 50268-731-24; Lot AM1115S; Expiration Date 01/2023, was distributed to the wholesaler, AvKare.
Immune-Modifying Nanoparticle Therapy Fast Tracked for Primary Biliary Cholangitis
The treatment is expected to reprogram the immune system to induce tolerance to PDC-E2.
HHS Carcinogen Report Updated to Include 8 Substances
The US Department of HHS added 8 new substances to the 15th Report on Carcinogens, bringing the total list to 256 substances.
FDA Denies Approval of Novel Budesonide Formulation for Eosinophilic Esophagitis
The FDA stated that the application could not be approved in its present form and recommended an additional clinical study.
Yusimry, a Humira Biosimilar Product, Gets FDA Approval
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Dartisla ODT Approved to Reduce Symptoms of Peptic Ulcer
Dartisla ODT is an anticholinergic drug that contains 1.7mg of glycopyrrolate in each orally disintegrating tablet.
Maintenance of Clinical Remission Observed With Mirikizumab in UC Trial
LUCENT-2 is a maintenance study evaluating the efficacy and safety of mirikizumab in patients who achieved clinical response in the 12-week LUCENT-1 induction study.
Clinical Remission, Endoscopic Response Seen With Upadacitinib in Crohn Disease Trial
Over 60% of the study participants had previously failed 2 or more biologic therapies.
Prescription Digital Therapeutic Cleared for IBS-Associated Abdominal Pain
Regulora is designed to provide seven 30-minute sessions of remote behavioral therapy based on gut-directed hypnotherapy.
