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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.
Study: Pharmacokinetics, Safety Comparable Between CT-P13 Autoinjector and Pre-Filled Syringe
The FDA previously accepted the biologic license application for CT-P13 as a subcutaneous formulation.
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FDA Approves Selarsdi as Biosimlar to Stelara in an Intravenous Formulation
In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
FDA Adds Intravenous Fluids to List of Drug Shortages
The additions include Dextrose 70% intravenous (IV) solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution, which were affected by Hurricane Helene.
New Test Shows Promise in Accuracy of Food Allergy Diagnostics
The gold standard of testing for food allergies is an oral food challenge test where patients consume the allergen, such as peanut extract, under supervision.
Study: Inactivated Vaccines Prevent Influenza for Children, Remaining Effective After COVID-19 Pandemic
Investigators state that health care providers should consider the potential use of 2 doses to increase the effectiveness against influenza B.
Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide From Drug Shortage List
The lawsuit alleges that the action was taken without the required notice and disputes the agency’s warning of “localized supply disruption,” while calling for more transparency.
FDA Approves Inavolisib With Palbociclib and Fulvestrant for Breast Cancer
The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients who would benefit from the treatment.
FDA Grants Marketing Authorization for Rapid COVID-19/Influenza Antigen Test
Healgen Rapid Check COVID-19/Flu A&B Antigen Test is the first OTC test to detect influenza to be granted a marketing authorization outside of Emergency Use Authorizations.
Stem Cell-Derived Islets Functionally Cure Patient With Type 1 Diabetes
The analysis assessed the feasibility of autologous transplantation of chemically-induced pluripotent stem cell-derived islets for type 1 diabetes.
No Difference Observed for Any Mental Illness and Uptake of First COVID-19 Vaccine Dose For Patients With, Without Mental Illness
However, the results also showed that vaccination rates were lower in those who are unmedicated for their mental illness and those with substance use disorders.
Two Scientists Receive 2024 Nobel Prize for Discovery of MicroRNA
Victor Ambros and Gary Ruvkun received the 2024 Nobel Prize in Physiology or Medicine for discovering microRNA and its role in gene regulation.
Baloxavir Marboxil Shows Reduction in Influenza Transmission
Investigators report the study met its primary end point, demonstrating that a single, oral dose reduced the transmission by those infected to others in their household.
FDA Grants Orphan Drug Designation to PPL-002 for the Treatment of Danon Disease
Currently, Danon disease has a poor prognosis and does not have any pharmaceutical therapeutics for treatment or management.
Data Supports Approval of Biosimilar Aflibercept for Diabetic Macular Edema
In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.
FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-low, HER2 Ultralow Breast Cancer
The designation was based on results from the DESTINY-Breast06 trial, evaluating fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) compared with chemotherapy.
Study Results Show Flu Vaccination Not Associated With Risk of Adverse Perinatal Outcomes
The findings support current recommendations for pregnant individuals or those who might become pregnant during the influenza season, specifically those with successive pregnancies.
FDA Grants Rare Pediatric Disease Designation to BPM31510IV for Primary CoQ10 Deficiency
Treatment for primary coenzyme Q10 (CoQ10) deficiency can include high-dose oral CoQ10 supplementation, but not all patients respond to this treatment.
Real-World Data Confirms Protective Effects of SGLT-2 Inhibitors for Diabetic Kidney Disease
The results validate the protective benefits of the sodium–glucose cotransporter-2 inhibitors on renal function for those with type 2 diabetes.
FDA Approves Ustekinumab-Aauz as Biosimilar for Stelara
Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.
SURVEY: Few Adults Plan to Get Respiratory Vaccinations for 2024-2025 Season
Approximately 75% of adults trust their physicians, nurses, and pharmacists either a great deal or a lot, highlighting the importance of pharmacists for patient education.
FDA Grants Rare Pediatric Disease Designation to MDL-101 for Congenital Muscle Dystrophy
MDL-101 is a proposed novel precision medicine that targets the LAMA1 gene, causing LAMA2 congenital muscular dystrophy type 1a.
Zoster Vaccination Lowers Risk of Shingles for Patients With Inflammatory Bowel Disease
Currently, the CDC recommends the recombinant zoster vaccine (Shingrix, RZV; GSK) for the prevention of herpes zoster and related complications.
FDA Approves Cobenfy, Previously KarXT, for Treatment of Schizophrenia
Xanomeline and trospium chloride is the first in a new class, offering a new approach with selectively targeting M1 and M4 receptors.
Maternal Influenza Shows Association With Increased Risk of Childhood Seizures
Investigators found a significant association for febrile seizures, but not with epilepsy.
Pfizer Withdraws Voxelotor From Approved Markets, Will Discontinue Trials
The discontinuation comes after a review of the medication by the European Medicines Agency which found that “the total number of deaths was higher than anticipated.”
FDA Grants Rare Pediatric Disease Designation to EXG-34217 for Dyskeratosis Congenita
Treatment is typically tailored to the individuals, with HCT being the only curative treatment bone marrow failure, but long-term outcomes are generally poorer due to toxicities.
Biosimilars Provide VA With Cost Savings for Treatment of Psoriasis
Additional education can address ambivalence for patients and providers, which can start at the pharmacist level, as they are essential sources of information for patients.
Women With Prior Knowledge of COVID-19 Vaccine More Likely Receive Vaccination While Pregnant
Investigators reported that more than half of individuals had great knowledge about protecting themselves from COVID-19.
FDA Accepts sNDA of Roflumilast Foam for Scalp and Body Psoriasis
The FDA assigned a Prescription Drug User Fee Act action date of May 22, 2025.
ESMO Data Show Durvalumab Improves Overall Survival, Event-Free Survival in Hepatocellular Carcinoma and Bladder Cancer
In 2 studies, durvalumab improved overall survival for those with unresectable hepatocellular carcinoma and event-free survival for muscle-invasive bladder cancer.