Coronavirus vaccine committee review tops news for coming week

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

Here is the medical news to watch for December 7-13, 2020. It’s a busy week, so you probably won’t get much Christmas shopping done.

Covid-19

  • On December 10, the FDA’s Vaccines and Related Biological Products Advisory Committee will consider whether the FDA should issue an emergency use authorization (EUA) for Pfizer and BioNTech’s BNT-162b2, a two-dose mRNA Covid-19 vaccine. The panel meeting will be webcast by the FDA and will be available on YouTube and Twitter.
  • On December 11, the European Medicines Agency (EMA) is hosting a virtual public meeting on development and authorization of Covid-19 vaccines in the European Union.

Neurology: The virtual American Epilepsy Society (AES) meeting is continuing through December 8. There will be clinically-oriented presentations, reviews of common issues in epilepsy, the latest science, and special interest sessions.

Oncology

  • The American Society of Hematology (ASH) virtual meeting is continuing through December 8. Among the data to watch on the last two days:
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    • The Phase III results of the UNITY-CLL trial of TG Therapeutics’ ublituximab (TG-1101) and umbralisib (TGR-1202) in chronic lymphocytic leukemia (CLL).
    • The details of the failed Phase III RESET trial of Pfizer and GlycoMimetics’ rivipansel (GMI-1070) in prevention of vaso-occlusive crises in sickle cell disease patients.
    • The Phase III results of the HOPE-B trial of a gene therapy, uniQure’s etranacogene dezaparvovec (AMT-061), in hemophilia B.
  • The virtual San Antonio Breast Cancer Symposium (SABCS) will take place December 8-11. Among the things to watch are the results of the Phase III CONTESSA trial of Genta’s tesetaxel, an oral taxane, in metastatic breast cancer, increased use of molecular testing, advances in triple-negative breast cancer, and more.
  • The ESMO Immuno-Oncology Virtual Congress will take place December 9-12. The program will include immunotherapy basics, the latest research, different treatment options, management of toxicities, and interpretation of new data.
  • The International Symposium on Pediatric Neuro-Oncology (ISPNO) will start December 13 in Karuizawa, Japan. Yes, an on-site medical conference! It will be a hybrid meeting, with virtual content as well. It is hard to believe there will be many international attendees at this meeting since all other medical conferences for many months — and continuing well into 2021 — have gone totally virtual. The meeting will include sessions on all aspects of pediatric neuro-oncology, including diagnosis, clinical trials, novel treatments, basic and translational research, neuroradiology, psychology, quality of life, nursing, and patient care. Advances in molecular genetics, translational research, and where future research is headed will all be discussed.

Opioids: The FDA is hosting a virtual public workshop on December 11 to evaluate the risk evaluation and mitigation strategy (REMS) for opioids, looking at prescribing behaviors and patient outcomes. The meeting has three objectives: discussing specific, measurable outcomes which might demonstrate that the REMS is effective in educating healthcare providers, discussing the feasibility of a study to evaluate REMS-compliant continuing education, and discuss alternatives to a study.

Regulatory

  • The FDA is hosting another webcast on December 8 in its series on respirators and other personal protection equipment (PPE) for healthcare personnel during Covid-19.
  • The FDA is holding a two-day virtual public meeting on December 8-9 on its drug supply chain security act pilot project and enhanced drug distribution security.

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

Cat ID: 31

Topic ID: 79,31,393,730,238,332,697,31,926,842,192,927,725,928,925,934,237,331,696,841