FDA on tap for decisions in Emergency Ed, Oncology, and Sleep Medicine; Also upcoming virtual meetings, webinars.

Here is the medical news to watch for July 20-26, 2020.

Emergency Medicine: The FDA missed making a decision by July 8 on a treatment for exertional heat stroke, Eagle Pharmaceuticals’ Ryanodex (dantrolene sodium for injectable suspension), so there could be a decision this week. Remember, the FDA rejected this muscle relaxant in 2017, issuing a complete response letter that said an additional trial would be needed before approval. Eagle conducted another 41-patient trial and resubmitted dantrolene.

Oncology

  • The FDA is expected to make a decision by about July 21 on an anti-BCMA (Seattle Genetics and GlaxoSmithKline’s belantamab mafodotin) as a monotherapy treatment for fifth-line relapsed/refractory multiple myeloma. On July 14, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-0 that the benefits of the drug outweigh the risks in patients who have already had an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38.
  • The American Association for Cancer Research (AACR) is holding a virtual meeting on July 20-22 on Covid-19 and cancer, with a focus on emerging data in basic, clinical, and epidemiologic research.
  • The virtual International Papillomavirus Conference (IPVC) will take place July 20-24. Researchers, clinicians, and other health professions will share their knowledge and ideas on papillomaviruses and their associated diseases, from basic science to the global health impact.

Ophthalmology: The American Society of Retina Specialists (ASRS) virtual meeting will be held July 24-26. It’s a great source for everything retina.

Regulatory

  • The FDA is holding a virtual public meeting on July 21 on reauthorization of the generic drug user fee amendments (GDUFA) for FY2023-2027.
  • The FDA is holding a virtual public meeting on July 23 on reauthorization of the prescription drug user fee act (PDUFA) for FY2023-2027.
  • The FDA’s Center for Drug Evaluation and Research (CDER), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), is hosting a two-day virtual public workshop on July 23-24 on topical drug development. The meeting, which builds on a prior workshop in 2019, will consider advances in the assessment of dermal absorption, an update on sunscreen and topical antiseptic absorption, and more.

Sleep Medicine: The FDA is expected to make a decision by July 21 on a treatment for cataplexy and excessive daytime sleepiness associated with narcolepsy, Jazz Pharmaceuticals’ JZP-258, an oral oxybate product.

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

Cat ID: 150

Topic ID: 88,150,254,730,935,50,150,725,240