Lynne Peterson is the Senior Writer for Trends-in-Medicine.
Here is the medical news to watch for Nov. 9-15, 2020.
Asthma/Allergy: The American College of Allergy, Asthma, and Immunology (ACAAI) will meet virtually Nov. 13-15. Among the key topics this year are the diagnosis and treatment of cough, the utilization and cost-effectiveness of biologics for various allergic conditions, payment systems, diagnostics and testing, implementing clinical guidelines, vaping and e-cigarettes, peanut immunotherapy options, management of nasal polyps, and more.
Cardiology: The American Heart Association (AHA) meeting will take place virtually Nov. 13-17. Among the keynote topics will be Covid-19, blood pressure and the brain, the science of racism and cardiovascular health, and accelerating breakthroughs and improving cardiovascular health. Among the many hot topics are: a paradigm shift in the management of atrial fibrillation, CT versus stress testing, and much, much more. Watch for the results of the phase III GALACTIC-HF trial of Amgen, Cytokinetics, and Servier’s omecamtiv mecarbil (CK-1827452), a cardiac myosin activator, in heart failure with reduced ejection fraction (HFrEF).
Dermatology: The virtual Dermatology Drug Development Summit will take place Nov. 10-12. Among the topics to be discussed: regulatory issues, clinical development and research, patient-centricity, reimbursement, translational research, rare skin diseases, and topical drug development.
Hepatology: The American Association for the Study of Liver Diseases (AASLD) virtual meeting (dubbed TLMdX this year) will take place Nov. 13-16. The key topics this year will be non-alcoholic steatohepatitis (NASH), hepatitis B, hepatocellular carcinoma, liver transplant, and more. Among a raft of other data, look for:
- Phase Ib data on Metacrine’s MET-409, an oral farnesoid X receptor (FXR) agonist, in NASH.
- 52-week data from the open-label Phase III MAESTRO-NAFLD-1 trial of Madrigal Pharmaceuticals’ resmetirom (MGL-3196), a selective THR-β agonist, in non-alcoholic fatty liver disease (NAFLD).
- Phase II results of Can-Fite BioPharma’s namodenoson (CF-102) in NASH.
- Phase III PEDFIC-1 trial of Albireo Pharma’s odevixibat, a non-systemic ileal bile acid transport inhibitor (IBATi), in progressive familial intrahepatic cholestasis (PFIC).
Oncology: The Society for Immunotherapy of Cancer (SITC) conference will take place virtually Nov. 9-14. As usual, there will be a long list of new data, largely early-stage data, presented.
The American Academy of Ophthalmology (AAO) virtual meeting will take place Nov. 13-15. Among the data to be presented are:
- Phase II results of Aldeyra Therapeutics’ reproxalap in allergic conjunctivitis.
- Phase I/II 12-month data from MeiraGTx on AAV-RPGR, a gene therapy for X-linked retinitis pigmentosa.
- Updated phase I/IIa data on Lineage Cell Therapeutics’ OpRegen for dry age-related macular degeneration.
The FDA’s Ophthalmic Devices Advisory Committee will meet virtually on Nov. 9 to review Refocus Group’s VisAbility Micro Insert for presbyopia.
Opioids: The FDA is expected to make a decision by Nov. 15 on a new formulation of naloxone – Adamis Pharmaceuticals and US WorldMeds’ ZIMHI (APC-6000, naloxone injection) – for treating opioid overdoses. The FDA rejected this drug in Nov. 2019, issuing a complete response letter that mostly cited issues with chemistry, manufacturing, and controls (CMC) that Adamis believes are now resolved.
Orthopedics: The FDA is hosting a virtual public workshop on Nov. 13 on orthopedic device-related infections. The goal is to improve public understanding of infections related to orthopedic devices and appropriate mitigation measures but also to explore potential strategies to reduce these infections.
- The virtual Neuropsychiatric Drug Development Summit will take place Nov. 10-12, with an emphasis on depressive disorders, schizophrenia, addiction, and post-traumatic stress disorder (PTSD).
- The FDA is expected to make a decision by November 15 on Alkermes’ ALKS-3831 (olanzapine + samidorphan) for bipolar I disorder and schizophrenia. Last month, an FDA advisory committee recommended approval, voting 16-1 that the drug meaningfully mitigates olanzapine-associated weight gain and 13-3 that the safety is adequately characterized.
Rare diseases: The FDA is expected to make a decision by Nov. 13 on a complement C1 inhibitor for treating cold agglutinin disease (Sanofi’s sutimlimab).
- The FDA is holding its second virtual Digital Health Center of Excellence Listening Session on Nov. 12.
- An FDA webcast on Nov. 12 will consider how well facial coverings flatten the curve during the Covid-19 pandemic.
- The FDA is hosting a webinar on Nov. 13 on promoting safe and effective prescription drug use in geriatric patients.
Rheumatology: The virtual American College of Rheumatology (ACR) Convergence meeting will finish up on Nov. 9. On the last day, there will be:
- Phase IIb data on Navidea Biopharmaceuticals’ NAV3-31 (Tc99m tilmanocept), a radiopharmaceutical agent for rheumatoid arthritis.
- The detailed results of a phase II trial of Kiniksa Pharmaceuticals’ mavrilimumab, an anti-GM-CSF receptor antibody, in giant cell arteritis.
Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine
Cat ID: 146
Topic ID: 87,146,393,730,232,105,935,100,328,146,57,150,725,158,234,925,240