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

Here is the medical news to watch for November 1-7, 2021. It will be an even busier than usual week, with 12 medical conferences and a very active FDA.

Allergy/asthma: The hybrid American College of Allergy, Asthma, and Immunology (ACAAI) meeting will take place in New Orleans and virtually November 4-8. Interested in the most up-to-date allergy and asthma news? You’ll find it here. The theme this year is “Promoting Innovation and Diversity.”

Cardiology

  • The FDA’s Circulatory System Devices Advisory Committee will meet virtually on:
    • November 2 on the risk of Type III endoleaks with Endologix’s AFX, an endovascular graft system.
    • November 3 on the safety and effectiveness of endovascular stent grafts more generally.
  • The hybrid Transcatheter Cardiovascular Therapeutics (TCT) meeting will take place in Orlando and virtually November 4-6. There will be 24 live cases from 10 sites in the U.S., Ireland, the Netherlands, Germany, and Italy. Among the many trials to be presented are:
    • FAME-3 trial of FFR-guided stenting vs. coronary artery bypass grafts (CABG).
    • FAVOR-III CHINA, an investigator-initiated trial comparing QFR-guided and angio-guided percutaneous coronary intervention (PCI).
    • PARTNER-3 two-year economic outcomes of transcatheter aortic valve replacement (TAVR) vs. surgical valves in low-risk patients.
    • CHOICE-CLOSURE trial of plug-based vs. suture-based large-bore vascular closure.
    • OPT-PEACE trial of the gastrointestinal effect of different antiplatelet regimens.

Covid-19: The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will meet virtually November 2-3, and topics on the agenda are expected to include Covid-19 vaccination of children age 5-11 with Pfizer and BioNTech’s Comirnaty. An FDA advisory committee recommended the vaccine for children that young, and the FDA is expected to issue an emergency use authorization prior to the ACIP meeting, which will then put it on its agenda.

Dermatology: The New York Academy of Medicine’s hybrid 4th Inflammatory Skin Disease Summit will take place in New York City and virtually November 3-6. There will be a review of novel therapies to treat inflammatory skin diseases affecting adults and children—from psoriasis to vitiligo, urticaria, alopecia areata, atopic dermatitis, and more. Among the data to watch: More phase Ib data on RAPT Therapeutics’ RPT-193, an oral CCR4 antagonist, in atopic dermatitis.

Gene therapy: The Gene Therapy for Rare Disorders Europe meeting will take place virtually November 2-4. The focus will be on scalable and robust manufacturing, engaging patients in trials, and demonstrating value to regulators, payors, and governmental bodies.

Hematology: The FDA’s Blood Products Advisory Committee will meet virtually November 4 to review research projects at three FDA departments—the Plasma Derivatives Branch, the Laboratory of Cellular Hematology, and the Laboratory of Emerging Pathogens.

Nephrology: The American Society of Nephrology: Kidney Week will take place virtually November 4-7. Among the data to watch:

  • Interim safety results from the phase Ib EQUALISE trial of Biocon’s Alzumab (itolizumab, EQ-001), an anti-CD6, in systemic lupus erythematosus and lupus nephritis.
  • Initial phase I/II results with Aduro Biotech’s BION-1301, an anti-APRIL IgG4 antibody, in IgA nephropathy.
  • Phase IIa results from the JANUS trial of Vera Therapeutics’ atacicept, a recombinant fusion protein, in IgA nephropathy.
  • Phase II results from the REDUX trial of DiaMedica Therapeutics’ DM-199, a recombinant human KLK1, in chronic kidney disease (CKD).
  • Phase II results from the pivotal PHYOX2 trial of Dicerna Pharmaceuticals’ nedosiran, an RNAi therapy, for primary hyperoxaluria type 1.

Neurology

  • The American Academy of Neurology (AAN) Fall Meeting will take place virtually November 5-7. For neurologists, there will be updates on the hottest topics in neurology, real-world issues in practice management, and innovative science. However, no press coverage is allowed.
  • The FDA is expected to make a decision by November 6 on Eton Pharmaceuticals’ oral topiramate, an anticonvulsant, for treating seizures. The FDA had been expected to make a decision by August 6, but that was delayed by three months after the company submitted additional data.

Obesity: ObesityWeek will take place virtually November 1-5, with a discussion of everything related to obesity, from evidence-based obesity science to cutting-edge basic and clinical research, state-of-the-art treatments, prevention, advocacy, and public policy.

Oncology

  • The Chemotherapy Foundation Symposium (CFS): Innovative Cancer Therapy for Tomorrow will take place November 3-5 in New York City and virtually. It’s an opportunity to learn how innovative approaches fit into existing treatment paradigms and get in-depth updates on hematologic malignancies, and review the latest practice-changing trial results.
  • The Advanced Breast Cancer Sixth International Consensus Conference (ABC6) will take place virtually November 4-6. This is a forum for sharing best clinical practices, getting scientific updates, and advancing the goal of improving outcomes in advanced breast cancer.

Plastic surgery: The hybrid American Society of Plastic Surgeons meeting will wind up on November 1.

Psychiatry: The FDA’s Psychopharmacologic Drugs Advisory Committee will meet virtually November 4 on Levo Therapeutics’ carbetocin nasal spray to treat hyperphagia, anxiety, and distress behaviors associated with Prader-Willi syndrome.

Pulmonology

  • The North American Cystic Fibrosis Conference (NACFC) will take place virtually November 2-5. There is supposed to be twice as much content this year as last year, with symposia, workshops, plenary sessions, live interactive sessions, on-demand sessions, a poster gallery, and live poster sessions. Selected sessions will also offer simultaneous Spanish interpretation. Among the data to watch: The phase Ib results for Calithera Biosciences’ CB-280, an oral arginase inhibitor, in cystic fibrosis patients with a pseudomonas aeruginosa infection.
  • The FDA is expected to make a decision by November 7 on Liquidia’s LIQ-861, an inhaled dry powder formulation of treprostinil, to treat pulmonary arterial hypertension (PAH). In November 2020, the FDA rejected the drug, issuing a complete response letter saying that the application was incomplete. Then, in May 2021, the company submitted new information on chemistry, manufacturing, and controls (CMC) and on device biocompatibility.

Regulatory

  • Ethics: The Pharmaceutical and Medical Device Ethics and Compliance Congress will take place virtually November 2-5.
  • Oncology: The FDA is hosting a virtual public workshop on November 3 on clinical trial endpoint development in locally-advanced head and neck squamous cell cancer.
  • Orthopedics: The FDA is holding a virtual public meeting on November 4 to review the Orthopedic Strategically Coordinated Registry Network (Ortho-CRN), which is aimed at facilitating information exchange among doctors, academic centers, and device manufacturers interested in developing a national patient-centered orthopedic medical device evaluation and surveillance system.

Rheumatology: The American College of Rheumatology (ACR) Convergence will take place virtually November 3-10. Among the data to watch:

  • Phase III results for Tonix Pharmaceuticals’ Tonmya (TNX-102 SL), a very low dose cyclobenzaprine, in fibromyalgia.
  • Results of the phase III AURORA-2 trial of Aurinia Pharmaceuticals’ Lupkynis (voclosporin) in lupus nephritis.

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

Cat ID: 100

Topic ID: 80,100,497,730,223,914,105,795,118,935,31,100,328,99,127,541,131,192,146,725,195,234,934,167,222,233,327