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

Here is the medical news to watch for Sept. 20-26.

Dermatology

  • The hybrid World Congress of Paediatric Dermatology (WCPD) on Sept. 22-25 has been converted to a completely virtual meeting. Topics will include atopic dermatitis, congenital ichthyosis, itch, adolescent dermatology, genodermatoses, psoriasis, and more. Among the data to watch are the quality of life and anxiety/depression results of the LIBERTY AD PEDS trial of dupilumab (Sanofi and Regeneron Pharmaceuticals’ Dupixent) in children age 6-11.
  • The FDA is expected to make a decision by Sept. 21 on a topical JAK inhibitor, Incyte’s ruxolitinib, to treat atopic dermatitis. The FDA previously extended the PDUFA date from June 21. Given the FDA’s recent addition of a boxed warning on JAK inhibitors for arthritis, the outlook for this agent is definitely uncertain.
  • The FDA is expected to make a decision by Sept. 23 on what could become the first topical treatment for molluscum contagiosum – Verrica Pharmaceuticals’ VP-102, a drug-device combination containing a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator. Remember, the FDA rejected VP-102 in July 2020, issuing a complete response letter, but the new drug application was resubmitted, and the PDUFA date was already extended by 3 months.

Endocrinology: The European Society for Paediatric Endocrinology (ESPE) meeting will take place virtually Sept. 22-26. This is an opportunity to get updated on the latest treatments, clinical best practice, and cutting edge research in pediatric endocrinology. The theme this year is Lifelong endocrine care through collaboration, discovery, and innovation.

Hematology: The FDA is expected to make a decision by Sept. 22 on a JAK inhibitor to treat chronic graft-versus-host disease, Incyte’s Jakafi (ruxolitinib).

Neurology

  • The International Parkinson and Movement Disorder Society virtual meeting is continuing through Sept. 22.
  • The World Muscle Society (WMS) virtual meeting will take place Sept. 20-24. There is a wider range of topics this year than usual, including Duchenne muscular dystrophy (DMD), amyotrophic lateral sclerosis (ALS), autoimmune and inflammatory neuropathies, myasthenia gravis, next-generation diagnostics, Pompe disease – everything neuromuscular. Among the interesting debates: pre-conception genetic testing, the need for large-animal models, and whether humans or machines should evaluate patients in clinical trials. Among the data to watch are the final results of the Phase II HOPE-2 trial of Capricor Therapeutics’ CAP-1002, a cardiac cell therapy, in DMD. This meeting is not open for press coverage.

Oncology

  • The virtual International Workshop on CLL (chronic lymphocytic leukemia) biennial conference will wind up on Sept. 20.
  • The European Society for Medical Oncology (ESMO) virtual conference is continuing through Sept. 21.
  • The RAS-Targeted Drug Development conference will take place virtually Sept. 21-23. It’s an opportunity to hear from industry leaders working in this field, from a deep dive into emerging modalities to combination strategies and much more. Among the data to be presented are the results of a Phase I/IIa trial of a PLK1 inhibitor (Onconova Therapeutics’ rigosertib) plus a PD-1 inhibitor (Bristol-Myers Squibb’s Opdivo, nivolumab) in KRAS-positive non-small cell lung cancer (NSCLC).
  • The Global Summit on Precision Diagnosis and Treatment of Prostate Cancer will take place virtually Sept. 23-25. Watch for safety data from the Phase II ULYSSES trial of Candel Therapeutics’ aglatimagene besadenovec (CAN-2409), an oncolytic viral immunotherapy.
  • The European Association of Neuro-Oncology (EANO) meeting will take place virtually Sept. 25-26. Among the data to watch is a Phase I biomarker trial of Candel Therapeutics’ CAN-3110, an engineered oncolytic virus, in glioma.

Regulatory

  • The FDA’s Center for Drug Evaluation and Research (CDER) and Duke-Margolis will hold a joint virtual workshop on Sept. 20-21 on pharmacodynamic biomarkers for development and approval of biosimilars.
  • The FDA is hosting a virtual public workshop on Sept. 21 on clinical trial challenges and design considerations for developing therapeutics to treat progressive multifocal leukoencephalopathy (PML).
  • The FDA and the University of Georgia College of Pharmacy’s Institute of International Biomedical Regulatory Sciences will jointly hold a virtual Medical Device Regulations Conference on Sept. 21-22 for the medical device industry and those who interact with them. This is an opportunity to learn about critical issues and current thinking in medical device regulations.
  • The FDA will hold a virtual public workshop on Sept. 21-22 on generic drug development, assessment, and approval.
  • On Sept. 22, the FDA and the Nuclear Regulatory Commission (NRC) will hold a virtual public workshop on targeted alpha emitting radiopharmaceuticals, especially Actinium-225 (Ac-225).
  • On Sept. 22-23, the FDA will host its annual Scientific Computing Days symposium virtually on the latest advances in scientific computing technologies. This year’s theme is “Advancing One Health Using Science, Technology, and Innovation.” The goal is to help FDA improve the application of technology and scientific computing.
  • The FDA and Project DS are jointly holding a virtual symposium on Sept. 23 on data sharing in oncology with a focus on use of patient-level data to accelerate cancer research.

Lynne Peterson, Senior Writer for Trends-in-Medicine

Cat ID: 192

Topic ID: 86,192,730,105,187,118,935,192,725,925

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