ESC readies packed program, FDA decisions pending, WIP to hold in-person conference

Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Cardiology: The European Society of Cardiology (ESC) meeting has gone virtual and will take place Aug. 29-Sept. 1. The theme this year is “The Cutting Edge of Cardiology.” It is a busy program, with more than 70 late-breaking science studies, four new guidelines (sports cardiology, atrial fibrillation, adult congenital heart disease, and non-ST-segment elevation acute coronary syndromes). Among the key trials to be presented are:

  • EMPEROR-Reduced — an SGLT2 inhibitor outcomes study.
  • EXPLORER-HCM — in symptomatic obstructive hypertrophic cardiomyopathy.
  • PARALLAX — Sacubitril/valsartan (Novartis’ Entresto) versus individualized RAAS blockade in patients with heart failure with preserved ejection fraction (HFpEF).
  • BRACE-CORONA — continuing versus suspending ACE inhibitors and ARBs in Covid-19 patients.

Dermatology: The FDA is expected to make a decision by Aug. 27 on a topical androgen receptor inhibitor for acne — Cassiopea’s Winlevi, clascoterone cream 1%.

Endocrinology: The FDA is expected to make a decision by Aug. 28 on an oral testosterone undecanoate (Lipocine’s Tlando) for hypogonadism. The FDA rejected Tlando last year, saying there were efficacy questions. The data were reanalyzed, and the drug was resubmitted to the FDA.

Hepatology: The European Association for the Study of the Liver (EASL) will host a digital (virtual) International Liver Congress (ILC) Aug. 27-29. The program includes sessions on liver tumors, acute liver failure, cirrhosis, non-alcoholic fatty liver disease (NAFLD), viral hepatitis, and more.

Pain: The World Institute of Pain (WIP) – the only in-person medical conference since the pandemic began — is scheduled to take place at the Rome Marriott Park Hotel in Rome, Italy, Aug. 26-29, if anyone shows up. There will also be a virtual meeting, but details are scarce.

Rare diseases: The World Orphan Drug Congress will take place virtually Aug. 24-27. It will bring together leading industry, government, and regulatory officials as well as patient advocacy groups, and payors to brainstorm and discuss ways to advance orphan drug development and improve access to therapies for rare diseases. There will be sessions on clinical development, commercialization, patient advocacy, pricing and reimbursement, advanced therapies, and more.

Regulatory

  • On Aug. 26 the FDA is also hosting yet another virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2, the virus that causes Covid-19.
  • The FDA will hold a webinar on Aug. 28 on the Center for Drug Evaluation and Research (CDER)’s standard core clinical outcome assessments (COAs) and endpoints pilot grant program.

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 151

Topic ID: 88,151,393,730,204,3,914,105,187,111,192,151,725