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Nuvo Pharmaceuticals Inc. d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, announced Health Canada has issued a Notice of Compliance (NOC) in relation to the Company’s Supplement to New Drug Submission for the pediatric use of Blexten.
CSL Behring, a global biotherapeutics leader has received FDA) approval for its supplemental request (submitted Aug. 30, 2020) for co-packaging of a convenience administration kit along with its product Berinert, indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients.
ALK Abello announced that the FDA approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the treatment of short ragweed pollen-induced allergic rhinitis in persons ages five through 65.
A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy.
This guideline covers assessment and referral for anaphylaxis. It aims to improve the quality of care for people with suspected anaphylaxis by detailing the assessments that are needed and recommending referral to specialist allergy services.
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What is immunology?
Immunology is a branch of medicine and biology that investigates immunity, the immune system and immune cells in both healthy people and in immune-mediated diseases. There are several branches within immunology, including clinical immunology, diagnostic immunology and nutritional immunology. The immune system is the body’s natural defence against foreign substances on the skin, in body tissues and in bodily fluids1.
What are the components of the immune system?
The immune system is made up of the innate immune system and adaptive immune system. The innate immune system is the first-line, non-specific response to pathogens, such as bacteria and viruses. In the innate immune response, inflammatory cells, such as phagocytes and natural killer cells, destroy the pathogen. The adaptive immune system produces a slower response that targets the pathogen specifically using antibodies and cells like T lymphocytes and B lymphocytes. There are many different types of immune system disorders that can affect all the major body systems, including hypersensitivities and allergies, immune deficiencies and autoimmune diseases1.
What is immune hypersensitivity?
Hypersensitivities and allergies are responses that occur when the body responds inappropriately to antigens that are usually non-pathogenic, called allergens. Local atopic responses include asthma, contact dermatitis, urticaria and rhinitis. Other types of hypersensitivities include drug allergies and food allergies. A food allergy can occur in response to any of the 14 major allergens, including peanuts, milk and eggs. Severe food allergies can lead to anaphylaxis, a life-threatening condition. Immune cells involved in these hypersensitive immune responses are primarily leukocytes, such as T cells, monocytes, macrophages, eosinophils, basophils and mast cells2,3.
What are immunosuppressive disorders?
Immunosuppression, or immunodeficiency, is temporary or permanent weakening or suppression of the immune system. Immune suppression can arise from a variety of sources, including inherited or congenital diseases, also known as primary immunodeficiency disorder (PID), or primary immune deficiency diseases (PIDDs)4,5. Immunosuppression can also arise from acquired and/or chronic medical health conditions, such as heart disease, lung disease, diabetes, cancer and human immunodeficiency virus (HIV)6. Finally, immunosuppression can be caused by certain treatments such as chemotherapy, pregnancy, and short-lived infections like influenza. Immunocompromised patients are more likely to pick up opportunistic infections, like Covid-19, than people who are not immunocompromised7.
What are autoimmune disorders?
Autoimmune diseases, or autoimmunity, occur when adaptive immune cells that recognise host cells are unchecked, so the immune system attacks healthy host cells. Autoimmune diseases include psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, crohn’s disease, systemic lupus erythematosus (lupus) and thyroid diseases. Autoimmune disorders are often associated with an inflammatory response which can cause acute inflammation or chronic inflammation8.
What is immunotherapy?
Immunotherapy is used to treat diseases by modulating the immune system, either by activation or suppression of the immune system. There has been much focus on immunotherapy for cancer treatment (cancer immunotherapy, or immuno-oncology) in recent years. Cancer immunotherapies include immune checkpoint inhibitors, T-cell transfer therapy, monoclonal antibodies (mAbs), treatment vaccines and immune system modulators9.
- Institute for Quality and Efficiency in Health Care (IQWiG) (2017). Abdominal aortic aneurysm: Overview. In: InformedHealth.Org [Internet]. Available at: https://www.ncbi.nlm.nih.gov/books/NBK441574/?report=reader - !po=10.0000 (Accessed May 2021).
- Valenta R, Hochwallner H, Linhart B, Pahr S. Food Allergies: The Basics. Gastroenterology. 2015;148:1120–1131.
- Mak TW, Saunders ME, Jett BD (2014). Immune Hypersensitivity. In: Primer to the Immune Response (Second Edition) [Internet]. Available at: https://www.sciencedirect.com/science/article/pii/B9780123852458000182 (Accessed May 2021).
- National Institute of Allergy and Infectious Diseases, 2014. Available at: https://www.niaid.nih.gov/research/immune-system-disorders (Accessed May 2021).
- McCusker C, Upton J, Warrington R. Primary immunodeficiency. 2018;14 (Suppl 2):141–152
- Alberta Health Services (2017). Available at: https://www.albertahealthservices.ca/assets/healthinfo/ipc/hi-ipc-immunocompromised-patients.pdf (Accessed May 2021).
- Centres for Disease Control and Prevention (2021). Available at: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html (Accessed May 2021).
- Wang L, Wang F-S, Gershwin ME. Human autoimmune diseases: a comprehensive update. Intern. Med. 2015;278:369–395.
- National Cancer Institute (2019). Available at: https://www.cancer.gov/about-cancer/treatment/types/immunotherapy (Accessed May 2021).