FDA moves and virtual meetings as March draws to a close

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

Here is the medical news to watch for March 22-28, 2021.

Arthritis: The FDA’s Arthritis Advisory Committee will met jointly March 24-25 with the Drug Safety and Risk Management Advisory Committee to consider a non-opioid painkiller – a nerve growth factor (NGF) inhibitor (Pfizer and Lilly’s tanezumab) – for relieving the signs and symptoms of moderate-to-severe osteoarthritis in adults for whom use of other analgesics is ineffective or not appropriate. This virtual meeting is unusual in that it will last 1.5 days. Remember, trials of tanezumab were halted in 2010 due to an excess need for joint replacements in tanezumab patients.

Cardiology: The Cardiovascular Research Technologies (CRT) virtual meeting has been taking place every weekend since February 13. On Friday, March 26, the topic of the day will focus on shock care and research. The next day will include live cases and a discussion of vulnerable plaque.

Covid-19: The European Medicines Agency (EMA) is having another virtual public meeting on March 26 on Covid-19 vaccines to update the public about their assessment, approval, and safety. The safety of the AstraZeneca-Oxford vaccine, which the EMA is still recommending be used, is likely to be a hot topic.

Dermatology: The FDA’s General and Plastic Surgery Devices Advisory Committee will meet virtually March 23 to consider the risks and benefits of dermal fillers.


  • The FDA is expected to make a decision by March 27 on dasiglucagon HypoPal (Zealand Pharma), a rescue medication in a pen for treating hypoglycemia in diabetic patients.
  • The Endocrine Society’s annual meeting, ENDO 2021, is continuing virtually through March 23.

Nephrology: A report by the Institute for Clinical and Economic Review (ICER) on the comparative clinical effectiveness and value of two drugs to treat lupus nephritis — Aurinia Pharmaceuticals’ Lupkynis (voclosporin) and GlaxoSmithKline’s Benlysta (belimumab) — will be discussed at the March 26 virtual public meeting of the New England Comparative Effectiveness Public Advisory Council (NE-CEPAC).


  • The European Lung Cancer Congress (ELCC) will take place virtually March 25-27. Topics will include lung cancer screening, immunotherapy for mesothelioma, new treatments for thymic malignancies, immunotherapy combinations, use of liquid biopsies, resistance to checkpoint inhibitors, Covid-19, and much more.
  • The FDA is expected to make a decision by March 27 on an anti-BCMA CAR T therapy for relapsed/refractory multiple myeloma – Bristol-Myers Squibb and bluebird bio’s idecabtagene vicleucel (ide-cel, bb2121).

Pain: The FDA is expected to make a decision by March 22 on expanding use of Pacira BioSciences’ Exparel (liposomal bupivacaine) to include post-surgical analgesia for pediatric patients.

Rare diseases: Data on 16 treatment-naïve or C5 inhibitor inadequate responders with paroxysmal nocturnal hemoglobinuria (PNH) enrolled in a dose-ranging trial of BioCryst Pharmaceuticals’ BCX-9930, an oral Factor D inhibitor, are expected to be released on March 22 at the company’s R&D day.

Regulatory: The FDA will hold a virtual public workshop on March 23 on a Roadmap to 2030 for new drug evaluations in older adults. The discussion will focus on increasing the inclusion of seniors in clinical trials and strategies to ensure safe and effective use of prescription drugs by seniors.

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

Cat ID: 914

Topic ID: 74,914,393,408,914,105,12,533,935,190,127,725,68,925