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 Benralizumab for Eosinophilic Granulomatosis With Polyangiitis
Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.
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FDA Clears First 1-Year Continuous Glucose Monitoring System for Diabetes
Eversense 365 (Senseonics) is the first long-lasting continuous glucose monitoring (CGM) system, which includes a 365-day sensor and only 1 insertion on Day 1 of every year.
FDA Approves Ocrevus Zunovo for 2 Forms of Multiple Sclerosis
The approval marks the first and only twice yearly, health care professional-administrated injection for both forms of multiple sclerosis (MS).
Remote Interventions From Pharmacists Shown to Improve Blood Glucose Control for Type 2 Diabetes
Data show the value of the pharmacist is clear for patients with type 2 diabetes, as their role can have a significant impact on reductions in hemoglobin A1c.
Expert Discusses Immunotherapy, Antibody Drug Conjugates for Lung Cancer
Christian Rolfo discusses 6 different treatment options that are being developed across immunotherapies and antibody drug conjugates for non–small cell lung cancer and small cell lung cancer.
FDA Authorizes OTC Hearing Aid Software Compatible With Apple AirPods
The Hearing Aid Feature can be customized to the user’s needs by amplifying sounds for individuals 18 years or older who have perceived mild to moderate hearing impairments.
Non-Medical Switch to Infliximab Biosimilar Demonstrates Similar Outcomes for IBD
Investigators obtained real-world evidence to evaluate the clinical outcomes of non-medical switching from the infliximab (Remicade; Janssen Immunology) to a biosimilar.
FDA Approves Guselkumab for Treatment of Ulcerative Colitis
Guselkumab (Tremfya; Johnson & Johnson) is the first and only approved fully human and dual-acting monoclonal antibody blocking interleukin-23 and binding to CD64 receptors.
Exploratory Analysis Shows Favorable Outcomes for Amivantamab-Lazertinib Treatment in NSCLC
As of May 2024, follow-up and exploratory analyses of MARIPOSA show improvements in outcomes for patients with EGRF-mutated non–small cell lung cancer (NSCLC).
Local Therapy Developments Hold Promise for Survival Improvements for NSCLC
In a session at the 2024 World Conference on Lung Cancer, presenters highlight the most significant developments in local therapy for metastatic non–small cell lung cancer and advanced disease.
FDA Grants Orphan Drug Designation to AISA-021 for Systemic Sclerosis
The company also submitted data from the ongoing phase 2 study, demonstrating the improvements of the investigational drug for symptoms of overall disease severity.
FDA Accepts Resubmitted NDA for AXS-07 for Acute Treatment of Migraine
The FDA assigned a Prescription Drug User Fee Action date is January 31, 2025.
FDA Grants Breakthrough Therapy Designation to Sanbexin for Acute Ischemic Stroke
Edaravone and dexborneol sublingual tablets are an innovative first drug to be designed for treatment of stroke and granted this designation.
FDA Grants Orphan Drug Designation for ABD-147 for Neuroendocrine Carcinoma
Previously, the FDA granted fast track designation to ABD-147 (Abdera Therapeutics Inc) for extensive stage small cell lung cancer.
Biosimilar of Xolair shows Similarity in Reducing Asthma Exacerbations
P043 is currently approved for patients 6 years and older with moderate to severe persistent allergic asthma whose disease is inadequately controlled with inhaled corticosteroids.
Digital Therapeutics in Diabetes Show Potential for Improved Disease Management
Pharmacists should be aware of these digital therapeutics, which are often used as an adjunct to medication, to better understand the treatment outcomes.
Nipocalimab Data Submitted for FDA Approval in Generalized Myasthenia Gravis
The application includes data from the Vivacity-MG3 study, demonstrating that individuals who received the drug had superior outcomes compared with the standard of care alone.
Results of Extension Study Show Roflumilast Suitable for Children Aged 2 to 5 Years
In July 2024, the FDA approved the supplemental new drug application for roflumilast cream 0.15% for patients 6 years and older.
FDA Approves True Sight Oncology Comprehensive Test to Identify NTRK Solid Tumors
With diagnostic tools, oncology pharmacists and other health care providers can help to identify treatments that have the best probability of working for a specific patient.
FTC Issues Support Statement for FDA’s Draft Guidance on Interchangeable Biosimilars
The guidance, if finalized, would revise considerations about switching studies for proposed interchangeable biosimilars.
Community Pharmacy-Driven Diabetes Intervention Leads Value-Based Care
Clinical improvements for patients with diabetes seen in a collaboration between the University of North Carolina and Blue Cross and Blue Shield of North Carolina.
Oral Iron Supplementation Remains Gold Standard in Anemia Care
Inflammatory conditions such as celiac disease can require care consideration and monitoring to manage iron deficiency
Tirzepatide Reduces Risk of Progression to Type 2 Diabetes for Patients with Obesity, Overweight
For adults receiving the 15 mg dose, tirzepatide sustained weight loss with an average reduction of 22.9% in body weight compared with 2.1% for the placebo.
FDA Grants Fast Track Designation to 64Cu-SAR-bisPSMA for Prostate Cancer Diagnosis
The proposed diagnostic agent has a long half-life, enables imaging the next day, and correlates to a longer shelf life in the pharmacy.
FDA Grants Orphan Drug Designation to RAG-18 for Duchenne, Becker Muscular Dystrophy
This designation follows the drug's rare pediatric disease designation in July 2024.
SELECT Trial Shows Similar Cardiac Benefits of Semaglutide for Heart Failure
Investigators compare the impact of semaglutide for preserved ejection fraction and reduced ejection fraction, which both have different causes and responses to treatment.
Condition Watch, August 2024: Dermatology
Pharmacy Focus: Alzheimer Drug Pipeline Expands, Promising Therapies in Development
The Alzheimer disease treatment landscape is evolving with new FDA-approved antibody therapies and advancements in biomarker testing to enable earlier diagnosis and intervention.
Study: Biosimilar Etanercept Shows Equivalence With Reference Product for Rheumatoid Arthritis
Biosimilar etanercept (Sunshine Guojian Pharmaceutical) showed similar therapeutic outcomes compared with etanercept (Enbrel; Amgen) specific to rheumatoid arthritis.
FDA Accepts NDA and Priority Review Application for Vimseltinib in Tenosynovial Giant Cell Tumors
Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.