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

Here is the medical news to watch for October 25-31, 2021.

Covid-19: The FDA’s Vaccines and Related Biological Products Advisory Committee will meet virtually on October 26 to consider an emergency use authorization (EUA) for Pfizer and BioNTech’s Comirnaty, a Covid-19 vaccine, for children age 5-11.

Gastroenterology: The hybrid American College of Gastroenterology (ACG) meeting is continuing through October 27 in Las Vegas and virtually. Look for data from the phase II VIBRANT trial of 9 Meters Biopharma’s vurolenatide (NM-002, formerly NB-1001), a long-acting GLP-1 agonist to treat short bowel syndrome by slowing gastric transit.

Neurology

  • The hybrid Consortium of Multiple Sclerosis Centers (CMSC) meeting will take place in Orlando and virtually October 25-28. MS healthcare professionals will find leading research and great education at the meeting.
  • The FDA is expected to make a decision by October 29 on a resubmitted supplemental new drug application for ANI Pharmaceuticals’ Cortrophin Gel (repository corticotropin injection) to treat multiple sclerosis and other inflammatory conditions. Remember, in 2020 the FDA initially issued a Refusal to File letter over chemistry, manufacturing, and controls issues, which the company believes are now resolved.
  • The hybrid Neurocritical Care Society (NCS) will meet in Chicago and virtually October 26-29, and you will find cutting-edge education, including sessions on critical care ultrasound, neuromonitoring, advances in traumatic brain injury, and more.

Oncology

  • The FDA’s Center for Drug Evaluation and Research (CDER)–as part of its Small Business and Industry Assistance (SBIA) program–is holding a two-day virtual symposium on October 26-27 on the latest developments in pharmaceutical quality. Speakers will highlight the ways in which innovations have been embraced, share lessons learned from the Covid-19 pandemic, describe recent regulatory innovates related to pharmaceutical quality, and more.
  • The FDA’s Oncologic Drugs Advisory Committee will meet virtually on October 28 to consider Oncopeptides’ Pepaxto (melphalan flufenamide) for ≥5-line relapsed/refractory multiple myeloma.
  • The Oncolytic Virotherapy Summit will take place in Boston (not virtually) October 26-28. All three days are filled with in-depth, cutting-edge case studies and industry discussions about the challenges and opportunities for oncolytic viruses, including how viral backbone modification can allow IV delivery, how payloads can be harnessed to achieve systemic effects, how to scale production for commercialization, and much more.

Ophthalmology

  • The FDA is expected to make a decision by October 28 on Eyenovia’s MydCombi (tropicamide + phenylephrine) for pupil dilation administered with a delivery system, Optejet.
  • The FDA is expected to make a decision by October 30 on Bausch Health’s Xipere (suprachoroidal triamcinolone injectable), administered with Clearside Biomedical’s SCS Microinjector, to treat macular edema associated with uveitis. Remember, the FDA rejected Xipere in 2019, issuing a complete response letter.

Plastic surgery: The hybrid American Society of Plastic Surgeons (PSTM) meeting will take place in Atlanta and virtually October 29-November 1. There will be separate tracks for aesthetic, craniomaxillofacial, breast, reconstructive, hand/upper extremities, and practice management.

Radiology: The hybrid American Society for Radiation Oncology (ASTRO) meeting is continuing through October 27 in Chicago or virtually with two options: Digital XP, which is close to a live virtual meeting, and onDemand, a recorded option. Expect phase II/III data on Nanobiotix’s NBTXR3, a radioenhancer made out of functionalized crystalline hafnium oxide (HfO2) nanoparticles for use in both soft tissue sarcoma and head and neck cancer.

Regulatory

  • The virtual DIA Japan meeting is continuing through October 26, with a focus on lessons from the Covid-19 pandemic.
  • The FDA’s Allergenic Products Advisory Committee will meet virtually October 28 to review the research programs in the FDA’s Laboratory of Immunobiochemistry.

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

Cat ID: 725

Topic ID: 88,725,730,316,935,190,192,725,925,240,547,162