Busy week ahead—ESMO, EASD, ASGCT, FSCDR, plus regulatory decisions

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

Here is the medical news to watch for Sept. 21-27, 2020. The week will be dominated by the ESMO Virtual Congress 2020 and a busy regulatory calendar.

Endocrinology: The European Association for the Study of Diabetes (EASD) virtual meeting will take place Sept. 21-25. Among the data to watch: Additional phase I/II data from the Simplici-T1 trial of vTv Therapeutics’ TTP-399, an oral small molecule glucokinase activator, in type 1 diabetes.

Gene therapy: The American Society of Gene + Cell Therapy (ASGCT) will hold a virtual two and a half day Policy Summit on Sept. 23-25, looking at ethical and regulatory issues in gene and cell therapy. Topics will include transient gene therapies for prophylactic use, non-therapeutic uses of gene editing, the design of gene therapy trials in rare diseases, sickle cell disease, and newborn screening.

Hematology: The Foundation for Sickle Cell Disease Research (FSCDR) annual research and education symposium will take place virtually Sept. 23-25. There are three themes this year: navigating the emerging complexity of reimbursement, addressing the dearth of provider care, and increasing access to care. Among the trials to watch: Biomarker data for the failed phase III RESET trial of a pan-selectin antagonist (GlycoMimetics’ rivipansel, GMI-1070) for vaso-occlusive crisis.

Neurology: The FDA is expected to make a decision by Sept. 27 on a new formulation of an existing drug to treat seizure clusters in epileptics – diazepam buccal film (Aquestive Therapeutics’ Libervant).

Oncology: The European Society for Medical Oncology (ESMO) virtual science session is continuing through Sept. 21. Remember, the education session will be Oct. 16-18.

Regulatory

  • The FDA will host another virtual Town Hall webcast for clinical laboratories and commercial manufacturers on Covid-19 diagnostic tests on Sept. 23.
  • The FDA is hosting a virtual webinar on Sept. 24 on its final guidance on the safety and performance-based pathway criteria for conventional Foley catheters and cutaneous electrodes for recording purposes.
  • The FDA will host a virtual webcast also on Sept. 24 on the Mayo Clinic experience with point-of-care manufacturing.
  • On Sept. 25, the FDA will hold a virtual public workshop on challenges in the development of inhaled antifungal drugs.

Respiratory: The FDA is expected to make a decision by Sept. 26 on an expanded indication for mepolizumab (GlaxoSmithKline’s Nucala) to treat hypereosinophilic syndrome (HES).

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

Cat ID: 725

Topic ID: 88,725,497,187,413,118,697,130,34,192,725,412,696