Ex vivo genome editing webcast, upcoming FDA decisions, virtual medical conferences and more

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

Here is the medical news to watch for June 1-7, 2020. Be careful and be safe. Don’t take chances.

Cell therapies: The FDA is hosting a 1-hour webcast on ex vivo genome editing in cell therapies on June 2. The lecture will discuss generating data to assess best methods for identifying and assessing potential off-target effects.

Covid-19: The FDA’s Center for Devices and Radiological Health (CDRH) is hosting a virtual town hall on June 3 on new guidance that went into immediate effect on development and validation of coronavirus diagnostic tests.

Dermatology: The FDA is expected to make a decision by June 2 on a minocycline foam (Menlo Therapeutics/Foamix Pharmaceuticals’ FMX-103) to treat moderate-to-severe papulopustular rosacea.

Gynecology: The FDA is expected to make a decision by about June 4 on expanded use of a gonadotropin-releasing hormone antagonist to include management of heavy menstrual bleeding associated with uterine fibroids (AbbVie and Neurocrine Biosciences’ Orilissa, elagolix).

Infectious diseases: The FDA is expected to make a decision by June 4 on expanding approval of an antibiotic – Merck MSD’s Recarbrio (imipenem + cilastatin + relebactam) – to include treating hospital-acquired Gram-negative bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Regulatory: The FDA is holding a virtual conference on June 4 and 5 on Pan American stakeholder experiences with the International Council for Harmonisation (ICH) Good Clinical Practice guidelines (ICH E6).

Upcoming Virtual Medical Conferences:

  • June 3-6: European League Against Rheumatism (EULAR), with posters available starting June 4.
  • June 6-8: European Academy of Allergy and Clinical Immunology (EAACI).
  • June 6-9: European Society of Human Genetics (ESHG).
  • June 6-9: European Renal Association/European Dialysis and Transplant Association (ERA-EDTA).

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

Cat ID: 151

Topic ID: 88,151,105,124,190,133,151,725,527