Lynne Peterson is the Senior Editor for Trends-in-Medicine.
Here is the medical news to watch for December 13-19, 2021.
- The FDA is hosting a webinar on December 15 to explain its latest order on the marketing of over-the-counter sunscreen products and its proposed changes to that order.
- The FDA is expected to make a decision by December 19 on expanded approval for Amgen’s Otezla (apremilast), an oral PDE4 inhibitor, to include treatment of mild-to-moderate plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
The FDA is expected to make a decision by December 15 on Calliditas Therapeutics’ Nefecon (oral budesonide) for IgA nephropathy. This is the first time the FDA is considering accelerated approval in IgA nephropathy on the basis of proteinuria as a surrogate endpoint.
- The FDA is expected to make a decision by December 17 on Argenx’s efgartigimod, an anti-FcRn antibody fragment, for myasthenia gravis.
- The FDA is expected to make a decision by December 17 on expanded approval for Intra-Cellular Therapies’ CAPLYTA (lumateperone) to include treatment of depressive episodes associated with bipolar depression.
The hybrid American Society of Hematology (ASH) meeting is continuing in Atlanta and virtually through December 14.
Rare diseases – The first Neurodevelopmental Drug Development Summit is taking place virtually December 14-15. It is an industry meeting focused on treatments for rare neurodevelopmental disorders—including (but not limited to) Angelman syndrome, Dravet syndrome, Fragile X, and Rett syndrome—as well as anti-epileptic therapeutics. There will be discussions of trial designs, outcome measures, case studies, pipelines, and much more.
- On December 13, the FDA is hosting another webcast in its series of Conversations on Cancer. The topic this week is “50 Years and Counting: Engaging the Generations on Future Cancer Equity Opportunities.”
- The FDA is hosting a webinar on December 16 on its draft guidance on recommended documentation sponsors should include in premarket submissions for device software functions for both software in a medical device (SiMD) and software as a medical device (SaMD).
The FDA is expected to make a decision by December 17 on Coherus BioSciences’ CHS-1420, a biosimilar of AbbVie’s Humira (adalimumab) for all the Humira indications.
Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine
Cat ID: 925
Topic ID: 915,925,730,105,127,130,192,925
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