CLINICAL ROLE -
Ashley Gallagher is an assistant editor at Pharmacy Times®. She graduated from St. Bonaventure University in 2020 in journalism and mass communications. Previously, she worked as a pharmacy technician for a retail chain.
FDA Approves mRNA-1345 for Protection Against Lower Respiratory Tract Disease Caused by RSV
This is Moderna's second mRNA vaccine approval and the first mRNA vaccine approved for an indication other than COVID-19.
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Quality Improvement Methodology Increases Pneumococcal Vaccination for Patients With Rheumatic Diseases
Pediatric patients with rheumatic disease, such as systemic lupus erythematosus, mixed connective tissue disease, juvenile dermatomyositis, and systemic vasculitis are at an increased risk of serious infection.
Once Weekly Efsitora Shows Non-Inferiority in A1c Reductions Compared With Daily Basal Insulin
Topline results of QWINT-2 and QWINT-4 met the primary end point of change in hemoglobin A1c compared to degludec and glargine, respectively, for those with type 2 diabetes.
FDA Approves Lisocabtagene Maraleucel for Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) is a CD19-directed CAR T-cell therapy that is delivered as a one-time infusion.
FDA Approves Eculizumab-Aeeb as Interchangeable Biosimilar for 2 Rare Diseases
Eculizumab-aeeb (Bkemv; Amgen) is approved for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Semaglutide Shows Sustained Weight Loss Over 4 Years
Added data from the SELECT trial helps to increase confidence in safety and efficacy of semaglutide, a glucagon-like peptide 1 medication.
Study: Third of Individuals With Actinic Keratosis Unaware of Its Cause
Although sun-protective measures have been increasing, the incidence of skin cancer has also increased, suggesting better targeted interventions and patient education are needed.
Study Finds Guidance Is Needed for Health Technology Assessments of Biosimilars
Australia, Québec, and Sweden have defined processes for reimbursements by health technology assessments, but the United States has a low reliance rate.
Counsel Patients on Nutrition and Following a Balanced Diet Complementary to GLP-1s
The GLP-1 market is expected to exceed $100 billion by 2023, according to J.P. Morgan Research, with total users in the United States projected to reach 30 million.
FDA Approves First Biosimilars to Eylea
Aflibercept-jbvf (Yesafili; Biocon Biologics) and aflibercept-yszy (Opuviz; Biogen, Samsung Bioepis) are the first interchangeable biosimilars to aflibercept (Eylea; Regeneron).
FDA Approves Subcutaneous Belimumab for Patients Aged 5 With Systemic Lupus Erythematosus
Belimumab (Benlysta; GSK) is a B-lymphocyte stimulator-specific inhibiting monoclonal antibody.
May Is Hepatitis Awareness Month
Hepatitis Awareness Month is designed to raise awareness of viral hepatitis and promote testing and vaccination while decreasing the stigma against the virus.
Study: Contact With Children Causes Transmission of Pneumococcal Disease Among Older Adults
The prevalence of transmission was higher for those who had contact with children aged less than 5 years and aged 5 to 9 years compared with children aged older than 10.
Pharmacists Need Additional Training to Combat Corticophobia for Patients With Atopic Dermatitis
Corticophobia is defined as a phobia of topical corticosteroids due to negative feelings or beliefs, which can come from misinformation about the long-term effects.
Survey: 1 in 8 Adults Have Utilized a GLP-1 Medication, 6% Currently Are
According to the results, approximately 82% of adults said they have heard at least a little about GLP-1 medications and 32% said they have heard a lot.
AACP Delegation Emphasizes Importance of Learning International Pharmaceutical Systems
The American Association of Colleges of Pharmacy led a pharmacy education seminar in Cuba discussing cultural differences and approaches to medication and care.
Study: Chemotherapy, Pembrolizumab Adjuvant Therapy Did Not Improve Disease-Free Survival for Endometrial Cancer
The study’s co-primary endpoint of overall survival was not formally tested due to DFS not being reached.
Dietary Resistant Starch, RAS Inhibitor Demonstrate Protective Effect on Kidney for Type 2 Diabetes
In diabetic rats, investigators found a decrease in urine biomarkers and expression of proteins that play a part in renin-angiotensin system (RAS).
FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A
Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.
Positive Data of Coartem for Malaria in Infants Weighing Less Than 5 kg
The data were previously presented at the Multilateral Initiative on Malaria 8th Pan-African Malaria Conference and have been submitted for regulatory review.
FDA Approves sBLA for Adalimumab-adaz as Interchangeable Biosimilar for Humira
A provisional determination is also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar to Humira.
Tivozanib Shows Benefits in Long-Term Survival for Relapsed/Refractory Renal Cell Carcinoma
Investigators noted that the conditional overall survival also had clinically meaningful improvements compared with sorafenib for advanced renal cell carcinoma.
PET Scans Show Promise in Identifying Hidden Inflammation for Those With Multiple Sclerosis
The results also showed that the PET scans could show damage to the individual’s brains, which was correlated with disability and fatigue.
FDA Committee to Review Data Supporting New Drug Application for MDMA for PTSD in June
This is the first FDA advisory committee meeting that will review a potential new posttraumatic stress disorder treatment in 25 years.
Study: 3 Doses of PCV13 Prevents Vaccine-Type Invasive Pneumococcal Disease in Children
The vaccine protected against serotypes 19A and 19F, but statistical significance was not reached for serotype 3.
V116 Elicits Noninferiority Immune Response Compared with PPSV23 for Pneumococcal Disease
Merck presented results from the STRIDE-10 phase 3 trial at the 34th European Society of Clinical Microbiology and Infectious Diseases in Barcelona, Spain.
Compounded, Counterfeit Semaglutide Poses Severe Risk to Patients
Novo Nordisk and Eli Lilly have spoken out against the use of their GLP-1 medications for cosmetic weight loss, emphasizing the proper use of their medications.
Recreational Cannabis Legalization Associated with Decreases in Alcohol, E-Cigarette Use
Retail sales were associated with lower e-cigarette use, although recreational legalization also increased the frequency of cannabis use among adolescents.
FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults
The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.
FDA Approves Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
Naloxone hydrochloride (Amneal Pharmaceuticals Inc) is the generic equivalent to OTC Narcan (Emergent).