An FDA Covid-19 Town Hall, ASCO’s virtual meeting, upcoming drug approvals, and more

Here is the medical news to watch for May 25-31, 2020. Be careful and be safe. Don’t take chances.

Covid-19: A second FDA virtual Town Hall on May 27 will discuss diagnostic tests for Covid-19 with clinical laboratories and commercial manufacturers.

Dermatology: The FDA is expected to make a decision by May 26 on expanded approval for use of dupilumab (Sanofi and Regeneron Pharmaceuticals’ Dupixent), an anti-IL-4 /13, for children age 6-11 with moderate-to-severe atopic dermatitis.

Neurology

  • The European Academy of Neurology (EAN) virtual meeting is continuing through May 26.
  • The Consortium of Multiple Sclerosis Centers (CMSC) virtual meeting will take place May 26-June 4. Educational sessions will be available May 26-29, a patient session on May 30, and posters and product theaters on June 1-4.

Obstetrics and gynecology: The FDA is expected to make a decision by May 25 on a vaginal contraceptive gel [Evofem Biosciences’ Amphora (L-lactic acid + citric acid + potassium bitartrate)]. The FDA rejected this therapy in 2016, issuing a complete response letter (CRL) which requested additional data. The resubmission is based on a new Phase III trial which showed an 86% efficacy rate with typical use and a pregnancy rate of 1.3% over 7 cycles (a 98.7% efficacy rate).

Oncology: The American Society of Clinical Oncology (ASCO) virtual meeting is taking place May 29-31. See our ASCO preview for details on the many, many studies being presented.

Psychiatry: The virtual meeting of the American Society of Clinical Psychopharmacology (ASCP) — formerly NCDEU — will take place May 29-30, 2020. ASCP also is offering an online continuing education course May 26-29. Watch for:

  • Phase II data on a treatment for acute psychosis in schizophrenics (Karuna Therapeutics’ KarXT), an oral co-formulation of xanomeline (a muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist).
  • The implications of difficult-to-treat depression for research and practice.
  • Public-private partnerships for schizophrenia drug development.
  • Clinical updates in psychopharmacology.
  • Anger and irritability as a guide to novel therapeutics for depression.
  • The impact of stimulants on function outcomes in attention-deficit/hyperactivity disorder (ADHD).

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

Cat ID: 172

Topic ID: 98,172,449,122,190,764,191,53,55,57,172,763