2- Tuesday Pharmacy Practice News – 26th October

1 – FDA Advisory Committee Recommends Authorization of Johnson & Johnson COVID-19 Booster Dose

• An FDA advisory committee has voted unanimously to recommend emergency use authorization for a booster dose of the COVID-19 vaccine from Johnson & Johnson.
• The panel recommended that the booster dose be administered at least 2 months after initial immunization with the single-shot vaccine.
• The recommendation is for individuals ages 18 years of age and older.
• The committee’s recommendation is based on data from Johnson & Johnson demonstrating that the protection from the single primary dose remains largely stable over time, although a second dose increased protection.
• Some experts, however, expressed doubt about the vaccine’s efficacy, especially compared to the high rates of efficacy for Moderna and Pfizer’s vaccines

Source: Pharmacy Times

2 – Temelimab: A Novel Disease-Modifying Agent for Diabetes Management

• New disease state-modifying therapies could be on the way for management of type 1 diabetes.
• The autoimmune disease, which affects 1.6 million people in the United States, is characterized by destruction of the insulin-producing β cells, leading to severe metabolic conditions and even death.
• Current therapies for type 1 diabetes are focused on supplementing insulin for glycemic control but does not impact the pathology of β cell destruction.
• GeNeuro is in phase 2 trials for their novel biologic, temelimab (GNbAC1), a monoclonal antibody used to preserve β cell function without impairing the immune system.
• Temelimab is a recombinant humanized IgG4 monoclonal antibody, which blocks human endogenous retrovirus type W (HERV-W) protein.
• HERV-W is associated with the pathology of autoimmune disorders, such as multiple sclerosis (MS) and type 1 diabetes.

Source: Pharmacy Times

3 – FDA Advisory Committee Unanimously Votes to Recommend Emergency Use Authorization of Moderna COVID-19 Booster Vaccine    

• An advisory committee for the FDA voted unanimously in support of an emergency use authorization (EUA) for a booster dose of Moderna’s COVID-19 vaccine for adults 65 years of age and older or younger adults at high risk of contracting COVID-19.
• Although the advisory committee’s recommendation is not binding, the FDA will take their recommendation into consideration when making a final decision on the authorization.
• The CDC Advisory Committee on Immunization Practices will also meet soon to discuss their recommendations for COVID-19 boosters.
• The recommendation is for a 50-µg dose of the vaccine administered at least 6 months after completion of the primary 2-dose series.
• According to a press release from Moderna, if the booster dose were to be officially approved under EUA by the FDA, it could result in up to 1 billion extra doses available for distribution in 2022.

Source: Pharmacy Times

4- Immune Family Members Associated With Lower Risk of COVID-19 Infection for Those Without Immunity

• Individuals without COVID-19 immunity had a significantly lower risk of infection and hospitalization if their family members had immunity from a previous infection or full vaccination, according to a study published by JAMA Internal Medicine.
• The study, conducted by investigators at Umeå University, Sweden, reviewed data from more than 1.8 million individuals throughout Sweden.
• To conduct the study, investigators combined registry data from the Public Health Agency of Sweden, the National Board of Health and Welfare, and Statistics Sweden.
• The investigators found a dose-response association between the number of immune individuals in each of the reviewed families and the risk of infection and hospitalization in family members who were not immune.
• These individuals had between a 45% and 97% lower risk as the number of immune family members increased, according to the results of the study.
• These findings accounted for differences in age, socioeconomic status, clustering within families, and several diagnoses previously identified as risk factors for COVID-19.

Source: Pharmacy Times

5 – Study: Artificial Intelligence Can Predict Risk of Recurrence for Women With Common Breast Cancer

• A study from Gustave Roussy and the startup Owkin shows that deep learning analysis in digitized pathology slides can help classify patients with localized breast cancer between high- and low-risk of metastatic relapse in the next 5 years using artificial intelligence (AI).
• This could help in therapeutic decision making and avoid unnecessary chemotherapy affecting the personal, professional, and social lives for low-risk women, according to the researchers.
• They added that this is one of the first proofs of concept illustrating the power of an AI model for identifying parameters associated with relapse that the human brain could not detect.
• The RACE AI study was conducted among a cohort of 1400 patients managed at Gustave-Roussy between 2005 and 2013 for localized hormone-sensitive (hormone receptor-positive, humean epidermal growth factor receptor 2-negative) breast cancer, and these women were treated with surgery, radiotherapy, hormone therapy, and sometimes chemotherapy to reduce the risk of distant relapse.

Source: Pharmacy Times

6 – Cardiovascular and Kidney Outcomes of Spironolactone or Eplerenone in Combination with ACEI/ARBs in Patients with Diabetic Kidney Disease

• Mineralocorticoid receptor antagonist (MRA) when combined with either angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) may provide additional benefits of cardiovascular and kidney disease risk reduction in patients with diabetic kidney disease (DKD) and hypertension.
• They evaluated the effectiveness of combination therapy (MRAs, either spironolactone or eplerenone, plus ACEI/ARB) compared with monotherapy (ACEI/ARB only) in patients with DKD and hypertension.
• Among patients with DKD and hypertension, the short-term use of MRAs, either spironolactone or eplerenone, in combination with ACEI/ARBs was not associated with lower risk of cardiovascular or kidney outcomes compared with ACEI/ARB monotherapy.
• The risk of hyperkalemia and the short duration of combination therapy may suggest a real-world clinical challenge for MRA with ACEI/ARB combination therapy.

Source: ACCP

• Read more from FADIC Blog, with many articles with evidence based articles.
• Learn More Through FADIC® – Online Programs & Mini-Courses.
• Listen Now to FADIC Podcast focusing on varieties of pharmacist perspectives in specialties.
• Read More Now about FADIC Pharmacy Events to get more Experience.

Course Copyrights:

All Courses is meant for SINGLE user use only.
If more than one person acceced this course, they will be BLOCKED Forever.

Why FADIC 2020 Pharmacotherapy Daily News (FNN) ?

• It helps to keep up with the literature!
• Provide you with the Updated with the latest in your clinical practice. Wherever you are, and Whenever you need!
• Help you to share in the advance in clinical career. In addition to adding an impressive image to the pharmacists all-around!

Subscribe to FADIC 2021 Pharmacy Practice FNN E-News, for publication of:

Read & Download FNN Issue 8 of April 2020 FNN News