Lynne Peterson is the Senior Writer for Trends-in-Medicine.
Here is the medical news to watch for June 7-13, 2021.
The FDA’s Vaccines and Related Biological Products Advisory Committee will hold a virtual meeting on June 10 to discuss pediatric emergency use authorizations or full approvals of Covid-19 vaccines. The discussion is expected to focus mainly on vaccine dosing and safety in children age <12.
The European Hematology Association (EHA) virtual meeting is spread out over 9 days, June 9-17. There will be cutting-edge science, new developments in diagnostics and new clinical trial data, including:
- Long-term safety data and pediatric data for Alexion Pharmaceuticals’ Ultomiris (ravulizumab), a complement C5 inhibitor, in paroxysmal nocturnal hemoglobinuria (PNH).
- Updated phase III data on bluebird bio’s LentiGlobin (betibeglogene autotemcel, beti-cel) from the phase III Northstar-2 (HGB-207) and the phase III Northstar-3 (HGB-212) trials in beta thalassemia.
- The results of the phase III ACTIVATE trial of a pyruvate kinase R (PKR) activator – Agios Pharmaceuticals’ mitapivat (AG-348) – in pyruvate kinase deficiency (PKD).
- Phase I/II data on Vertex Pharmaceuticals and CRISPR Therapeutics’ CTX-001, an autologous, ex vivo CRISPR/Cas9 gene-edited therapy, in sickle cell disease and in beta thalassemia.
- Data from the Phase I IMMUNICY-1 trial of a non-gene edited allogeneic CAR T therapy, Celyad Oncology’s CYAD-211, in relapsed/refractory multiple myeloma.
The Federation of Clinical Immunology Societies (FOCiS) meeting is taking place virtually June 8-11. Discover the latest breakthroughs in immune-mediated diseases and more on molecular pathways. And look for Phase Ib/IIa data on Precigen’s AG-019 ActoBiotics in Type 1 diabetes.
The European Renal Association/European Dialysis and Transplant Association (ERA-EDTA) virtual meeting is continuing through June 8. Look for new data on Chinook Therapeutics’ BION-1301, an anti-APRIL, in IgA nephropathy.
The FDA is expected to make a decision by June 7 on Biogen and Eisai’s aducanumab (BIIB-037), an anti-amyloid-beta antibody, to treat Alzheimer’s disease. It’s very controversial. An FDA advisory committee voted overwhelmingly that the data do not support efficacy, and Public Citizen urged the Office of Inspector General (OIG) in the Department of Health and Human Services (HHS) to investigate the “precedented and inappropriate close collaboration” between the FDA and Biogen. But the Alzheimer’s Association supports approval.
- The American Society of Clinical Oncology (ASCO) virtual meeting is continuing through June 8. There are too many key presentations to mention them here.
- The European Association for Cancer Research (EACR) meeting will take place virtually June 9-12, with presentations on basic, preclinical, and translational cancer research across a wide range of topics, from single cell cancer genomics to brain cancer metastases, bioinformatics, and the role of the microbiota in colorectal cancer.
- The FDA is expected to make a decision by June 8 on expanded use of Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor + ivacaftor) to children age 6-11 with cystic fibrosis and at least one F508del mutation.
- The FDA is expected to make a decision by about June 8 on approval of Pfizer’s 20vPnC, a 20-valent pneumococcal conjugate vaccine for people age ≥18.
The Society of Nuclear Medicine and Molecuar Imaging (SNMMI) annual meeting will take place virtually June 11-15, and there is supposed to be four times as much content as last year – education, research, networking that will provide physicians, technologists, pharmacists, laboratory professionals, and scientists with an in-depth view of the latest research and developments in the field as well as insights into practical applications for the clinic.
The Food and Drug Law Institute’s Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies virtual conference will take place June 8-9. There will be sessions on recent breakthroughs, global regulatory collaborations, standardization, regulatory issues, and more.
- The FDA’s Center for Drug Evaluation and Research (CDER) is holding a virtual public workshop on June 7-8 to discuss the current use of morphine milligram equivalents. The workshop will include a review of the science, the underlying data for MME calculations of opioid analgesics, gaps in the data, and future directions.
- The FDA will host a virtual public workshop on June 9 on a review of non-prescription drug labeling. Are the data and information currently available on consumer comprehension of the non-prescription Drug Facts Label (DFL) effective or can it be improved? The FDA wants to know.
- Immunogenicity assessments in drug development will be the focus of a virtual public workshop on June 9 jointly sponsored by the FDA’s Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
- At a virtual meeting on June 9, the FDA’s Pharmacy Compounding Advisory Committee will discuss inclusion of four bulk substances – choline chloride, oxitriptan, melatonin, and methylcobalamin – on the 503A Bulks List.
- The FDA will host a virtual public workshop on June 10 to further public understanding of the FDA’s postmarketing regulation of orthopedic devices.
- On June 11, the FDA will host a webinar to provide an update on the Identification of Medicinal Products (IDMP) standards development and implementation of non-prescription drug labeling.
Sleep 2021, the annual meeting of the Associated Professional Sleep Societies (APSS) will take place virtually June 10-13. Among the topics that will be covered: circadian science, sleep lab emergencies, behavioral treatment of insomnia, and more.
The American Transplant Congress (ATC) is continuing virtually through June 9. Look for data on Eledon Pharmaceuticals’ AT-1501, an anti-CD40L.
Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine
Cat ID: 118
Topic ID: 78,118,118,935,926,127,130,192,195,925,96