CLINICAL ROLE -
Ashley Gallagher is an 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.
New Finding for Diabetic Wounds Has Potential for Use in Developing New Therapeutics
Many patients are unaware of wound complication, so it is valuable for pharmacists to communicate prevention methods with all patients with diabetes.
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Study: Sales Price of Originator Declines After Introduction of Biosimilars
Investigators find that this could suggest the biosimilar uptake alone may not be a complete measure of the market competition and lowering prices.
FDA Declines to Approve MDMA for PTSD
Previously, an independent advisory panel for the FDA rejected the use of MDMA-assisted therapy for posttraumatic stress disorder (PTSD), citing concerns of the reliability of the clinical trial data.
FDA Approves First Nasal Spray for Anaphylaxis
neffy is an epinephrine nasal spray for the emergency treatment of allergic reactions in adults and pediatric patients.
FDA Approves Denileukin Diftitox-Cxdl for the Treatment of T-Cell Lymphoma
Denileukin diftitox-cxdl is the only therapy approved for cutaneous T-cell lymphoma that targets IL-2 receptors in malignant T-cells and Tregs.
FDA Approves Carbidopa, Levodopa Extended Release for Parkinson Disease
Carbidopa and levodopa extended-release capsules are a novel, oral formulation that combine immediate-release granules and extended-release pellets.
Results of Study Find Irregular Sleep Patterns Associated With Diabetes Risk
The ADA Clinical Practice Recommendations added sleep assessment for precision medicine in type 2 diabetes, supporting the wealth of information surrounding the association.
Imbrium Therapeutics Submits Investigational NDA for Potential Treatment of Alcohol Use Disorder
Sunobinop binds to and activate nociception/orphanin-FQ peptide receptor, which is a known therapeutic target for substance use disorder.
Biosimilar Market Expected to Grow to $92 Billion by 2031, Data Show
A report from SkyQuest Technology highlights the growth in the oncology and insulin spaces, indicating they will contribute to the most growth.
FDA Accepts sNDA for Cabozantinib With 2 Neuroendocrine Tumor Indications
The drug also receives orphan drug designation for the treatment of pancreatic neuroendocrine tumors and a Prescription Drug User Fee Act target action date of April 3, 2025.
Report: Satisfaction of Mail-Order Pharmacies Rise, Decreases for Community Pharmacies
Customers report that their communication is strong with their pharmacists, but only 51% said their pharmacist was trustworthy.
Roundup: Novel Drug Approvals in 2024
In the first half of 2024, the FDA approved 23 novel drugs for conditions including alopecia areata, Alzheimer disease, small cell lung cancer, bladder cancer, and more.
FDA Extends Approval of Fibryga to Include Bleeding Patients With Acquired Fibrinogen Deficiency
This is the first and only on-demand, virus-inactivated, human plasma-derived concentration option that is indicated for this approval.
FDA Grants Priority Review for Asciminib for Chronic Myeloid Leukemia
The drug previously received breakthrough therapy designation for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia that is in chronic phase.
FDA Grants Breakthrough Device Designation for System Maintaining Weight Loss After GLP-1
The system is an outpatient procedure that resurfaces the mucosal lining, making it easier for the body to maintain healthy metabolism and blood glucose levels.
FDA Grants Orphan Drug Designation to ZMA001 for Pulmonary Arterial Hypertension
The designation is based on animal model studies that have demonstrated superior efficacy in comparison to sildenafil.
FDA Accepts New Drug Application for Suzetrigine to Manage Acute Pain
If approved, the drug would be the first in a new class of medications to treat acute pain in over 20 years.
FDA Extends Palforzia Approval to Children 1 to 3 Years Old With Peanut Allergy
The approval marks the first oral immunotherapy treatment to mitigate allergic reactions, including anaphylaxis.
FDA Approves Long-Acting Injectable Paliperidone for Schizophrenia Treatment
Paliperidone palmitate (Erzofi; Luye Pharma Group) is approved as a monotherapy for schizophrenia and as an adjunct for schizoaffective disorder.
Proposed Trastuzumab Biosimilar Shows Pharmacokinetic Similarity to Reference Product
The similarities were shown for both the US formulation and the EU formulation.
FDA Approves Benzgalantamine for Treatment of Alzheimer Disease
Benzgalantamine (Zunveyl; Alpha Cognition) is a cholinesterase inhibitor indicated for the treatment of mild-to-moderate dementia in adults.
Giroctocogene Fitelparvovec Reduces Total Annualized Bleeding Rate for Hemophilia A
The investigational drug achieved non-inferiority compared to routine Factor VIII.
Patient Affordability Program for Adalimumab Biosimilar Is Launched at GoodRx
Patients without insurance may not be able to afford the biosimilar adalimumab-adbm, even if it is available at a more affordable price than its reference product.
FDA Approves Cerliponase Alfa for Expanded Indication of CLN2 Disease
In April 2017, the drug was approved to treat the slow loss of the ability to walk for symptomatic patients aged 3 and older who had Batten disease.
Intermittent Fasting and Meal Replacements Improved Short-Term Glycemia
A 5:2 intermittent fasting plan combined with meal replacement had better positive outcomes compared with metformin and empagliflozin.
LGBTQ Inclusion Extends to Student Pharmacists Starting Rotations
In the session at the 2024 American Association of Colleges of Pharmacy Annual Meeting, presenters highlighted the importance of fostering inclusion for LGBTQ students.
Experts: Social Determinants of Health Should Be As Important As Clinical Content in Pharmacy Curricula
Educators should prioritize integrating social determinants of health (SDOH) for the next generation of pharmacists.
Education Curricula Need to Incorporate Whole-Person Care Beyond Electives
Students express interest in whole-person care and identify it as a gap in their education.
New Data Suggest Vaccination Reduces Risk of Developing Long Covid
Investigators found that the risk of long COVID decreased over the course of the pandemic.
Better Prevention Strategies Rely on the Monitoring of Outpatient Adverse Drug Events
Currently, limited data show the effect of adverse drug events in the outpatient setting.