AHA meeting continues; Headache Symposium convenes; Watch for a regulatory palooza and more

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

Here is the medical news to watch for Nov. 16-22, 2020. A number of medical conferences are wrapping up at the beginning of the week, but FDA events will dominate all week.

Cardiology — The American Heart Association (AHA) virtual meeting is continuing through Nov. 17. Among the keynote topics on the last two days will be:

  • Several late-breaking studies in atrial fibrillation.
  • The FIDELIO cardiovascular outcomes trial of a mineralocorticoid receptor antagonist (MRA), Bayer’s finerenone (BAY-94-8862).
  • The results of the Phase III RHAPSODY trial of an IL-1α/β inhibitor in pericarditis (Kiniksa Pharmaceuticals’ rilonacept). And the results with another SGLT1/2 inhibitor (sotagliflozin, Lexicon Pharmaceuticals’ Zynquista) in Type 2 diabetes patients with worsening heart failure (the SOLOIST-WHF trial) and with chronic kidney disease (the SCORED trial), studies on Covid-19 and cardiovascular patients, and much more.

Hepatology — The last day of the American Association for the Study of Liver Diseases (AASLD) virtual meeting (TLMdX) is Nov. 16, and the news that day will include live sessions (with no replay) on:

  • Research in acute and chronic liver failure.
  • Hepatobiliary cancer.
  • Basic and translational discoveries.
  • Non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD).
  • Eliminating viral hepatitis in the U.S.
  • Late-breaking abstracts.

Neurology – The American Headache Society (AHS)’s Scottsdale Headache Symposium will take place Nov. 21. The meeting promises the practical, clinical, evidence-based information on the diagnosis, management, and treatment of headache patients.

Oncology

  • The FDA is expected to make a decision by Nov. 16 on a CAR T therapy for diffuse large B-cell lymphoma (DLBCL), Bristol-Myers Squibb/Celgene/Juno Therapeutics’ lisocabtagene maraleucel (JCAR-017, liso-cel).
  • The virtual European Cancer Summit will take place Nov. 18-19. Among the topics are: Covid-19 and cancer, implementing quality cancer care in Europe, treatment optimization, disparities in cancer care, taking screening to the next level, the elimination of HPV cancers in Europe, the digital transformation of cancer care, and more.
  • The FDA’s Oncology Center of Excellence will host a webcast on Nov. 19 on Lung Cancer: It Can Happen to Anyone. The focus is on non-smokers who get lung cancer, and up to 20% of lung cancer deaths each year in the U.S. are in people who never smoked or hardly ever smoked. Even healthcare providers often don’t suspect lung cancer in non-smokers, leading to delayed diagnosis and missed opportunities for early treatment. And the prognosis, treatment options, and patient experience may be different for non-smokers who get lung cancer.
  • The ESMO Asia Virtual Congress will take place Nov. 20-22.

Rare diseases – The FDA is expected to make a decision by Nov. 20 on a treatment for progeria and progeroid laminopathies, Eiger BioPharmaceuticals’ Zokinvy (lonafarnib), a farnesyltransferase inhibitor.

Regulatory

  • The FDA’s Center for Veterinary Medicine will hold a virtual public meeting on Nov. 16 to gather information to help the Agency in ranking antimicrobial drugs based on their importance in human medicine.
  • The FDA’s Division of Drug Information will host a webinar for healthcare professionals and students on Nov. 16 to answer questions about how to use the Orange Book, the FDA’s list of drugs that are therapeutically equivalent.
  • The FDA will hold a virtual public meeting on Nov. 17 on the development, content, and format of the Agency’s safety communications about medical devices.
  • On Nov. 18, the FDA will hold another in its series of virtual town halls for developers of SARS-CoV-2 tests to help answer technical questions about development and validation. So far this year, the FDA has approved 288 Covid-19 tests.
  • The FDA’s Office of Women’s Health is holding a virtual Scientific Conference on Nov. 19 to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to CBD and other cannabinoids.
  • The FDA will hold a virtual public meeting on Nov. 19 on reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023-2027. The current legislative authority expires in Sept. 2022, and new legislation will be needed to extend it.

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

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Topic ID: 74,232,730,232,914,111,935,130,295,192,725,925