Lynne Peterson is the Senior Writer for Trends-in-Medicine.
Here is the medical news to watch for July 19-25, 2021.
Cardiology: The Transcatheter Valve Therapies (TVT) conference will take place July 20-22, with limited in-person attendance in Miami Beach and a full virtual schedule. TVT will focus on the evaluation and management of patients, imaging modalities, current and future therapeutic options, and skills needed to perform transcatheter aortic valve replacement (TAVR), left atrial appendage (LAA) closure, and patent foramen ovale (PFO) closure.
Gastroenterology: The FDA is holding a two-day virtual public workshop on endpoints in gastroenterology trials. On July 21, the focus will be eosinophilic gastrointestinal (GI) disorders beyond eosinophilic esophagitis, and on July 22 the topic will be celiac disease.
Hematology: The International Society on Thrombosis and Haemostasis (ISTH) is continuing virtually through July 21.
Hepatology: The FDA is expected to make a decision by July 20 on a treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) – Albireo Pharma’s Bylvay (odevixibat, A-4250), an IBAT inhibitor.
- A pooled analysis of 192-week data from open-label extension periods of two Phase III trials of Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) in treatment-naïve adults.
- 72-week safety and switching data in Blacks/African Americans from the BRAAVE trial.
- New data on lenacapavir, a capsid inhibitor.
- Data from a Phase 1b trial of vesatolimod, a toll-like receptor 7 (TLR7) agonist
Neurology: The Gene Therapy for Neurological Disorders Europe meeting will take place virtually July 19-21, focusing on the industry’s challenges in developing and delivering gene therapy to the central nervous system. Among the speakers will be experts from UCB, Lysogene, uniQure, and AskBio.
- The FDA is hosting two half-day virtual public workshops July 21 and July 23 on clinical outcome assessment in cancer trials, particularly the use of patient-reported outcome (PRO) measures in those trials.
- The FDA is expected to make a decision by July 25 on Incyte’s retifanlimab, an anti-PD-1 for locally advanced/metastatic squamous cell carcinoma of the anal canal. Remember, in June the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 13-4 to recommend the FDA defer approval until there are more data.
Urology: The FDA is expected to make a decision by July 25 on Iterum Therapeutics’ sulopenem etzadroxil/probenecid, an oral broad-spectrum penem β-lactam antibiotic, for uncomplicated urinary tract infections. However, the outlook is more uncertain than usual because the FDA found “deficiencies” in the marketing application.
Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine
Cat ID: 914
Topic ID: 74,914,730,914,111,188,118,935,202,130,192,725,241,201