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.
FDA Accepts sBLA for Bimekizumab-bkzx in Hidradenitis Suppurativa Treatment
Bimekizumab-bkzx (Bimzelx; Union Chimique Belge) is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin (IL)-17A and IL-17F.
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FDA Approves Zevtera as Antibiotic to Treat 3 New Indications
New indications include Staphylococcus aureus bloodstream (SAB) infections, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.
Study: Biosimilar Competition Did Not Consistently Lower Costs for Patients
The results indicate the need for targeted policies so that biosimilar competition can increase cost savings and affordability for patients with commercial insurance.
Study: African American Veterans With PTSD More Likely to be Re-hospitalized With Stroke
Investigators also found that African American and White veterans had different risk factors for re-hospitalization post-stroke.
Study: Sex-Specific Disparities Found Across Various Cancer Types
Investigators compared the copy number alterations of patients who were male and female using 16 cancer types in The Cancer Genome Atlas Program.
As Polypharmacy Grows, Pharmacists Play Essential Role in Medication Education
By implementing easier systems of education for patients, the consequences of polypharmacy could potentially decrease.
Study: Mutation Found to Make Follicular Lymphoma More Susceptible to Experimental Drug
The mutation impacts BAF proteins and can lead to progression of follicular lymphoma, according to the investigators.
Dostarlimab Plus Chemotherapy Demonstrates Significant Overall Survival Benefit in Endometrial Cancer
In the RUBY phase 3 trial, dostarlimab (Jemperli; GSK) with niraparib (Zejula; GSK) had significant progression free survival compared to the standard of care.
AstraZeneca Caps Inhaled Respiratory Portfolio at $35 For Eligible Patients With Asthma, COPD
The Asthma and Allergy Foundation of America applauded the efforts by AstraZeneca, saying accessibility and affordability can help reduce racial disparities in asthma.
Study: Anxiety, Depression Treatment Linked With Heart Disease Outcomes
Investigators aimed to determine the impact of psychotherapy or psychopharmacologic treatments on adverse outcomes in individuals with coronary artery disease or heart failure.
Study: Tirzepatide Results in Weight Loss for Individuals With Type 1 Diabetes
Tirzepatide is currently approved for management of type 2 diabetes, improving glucose control, facilitating weight loss, and improving cardiovascular disease outcomes.
Study Results Show Low Prevalence of S. Pneumonia Nasopharynx-Oropharynx Colonization
However, investigators found that the prevalence of Streptococcus pneumoniae nasopharynx-oropharynx colonization was higher among younger adults.
Experts Establish First Performance Measures of Lifestyle Medicine Treatments
Investigators identify 32 performance measures in the final set grouped into 10 categories of disease or health condition.
Exposure to Residential Greenness During Pregnancy Associated With Increased Risk of Asthma
The effects were strongest during the spring season and in the third trimester of pregnancy.
Study: mRNA Technology Holds Potential for Delivery of Tau-Targeting Antibodies
Investigators found that mRNA technology for the delivery of antibody therapeutics were used to target tau in Alzheimer disease and can be applied to other tau targets.
FDA Approves Expanded Indication for Tenofovir Alafenamide as Hepatitis B Treatment
The new indication includes pediatric patients aged 6 years and older who weigh at least 25 kg and have compensated liver disease.
FDA Approves Vadadustat for Oral Treatment of Anemia Due to Chronic Kidney Disease
Vadadustat (Vafseo; Akebia Therapeutics Inc) is indicated for individuals with chronic kidney disease who have been receiving dialysis for at least 3 months.
FDA Issues Letters to 6 Companies for Unapproved, Misbranded OTC Analgesic Products
The agency warns consumers against using these products, which are marketed for topical use to relieve pain associated with cosmetic procedures.
FDA Approves Sotatercept-csrk for Pulmonary Arterial Hypertension
Sotatercept-csrk is the first approved activin signaling inhibitor therapy for pulmonary arterial hypertension, which represents a new class of therapy.
FDA Grants Fast Track Designation to Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
In December 2023, nipocalimab (Johnson & Johnson) was granted orphan drug designation for fetal neonatal alloimmune thrombocytopenia.
FDA Grants Orphan Drug Designation to Felzartamab for Kidney Transplant Recipients
Previously, felzartamab received orphan drug designation and breakthrough therapy designation for the treatment of primary membranous nephropathy.
FDA Approves Macitentan, Tadalafil Combination Tablet for PAH
The combination tablet (Opsynvi; Johnson & Johnson) can also be used for individuals with pulmonary arterial hypertension who are being treated with stable doses of macitentan and tadalafil as separate tables.
FDA Expands Label for Bempedoic Acid to Reduce Cardiovascular Risk, With or Without Statins
Bempedoic acid (Nexletol; Esperion) and bempedoic acid and ezetimibe (Nexlizet; Esperion) are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
AstraZeneca to Initiate Trial for Triple-Combination Inhaled Therapy for Chronic Obstructive Pulmonary Disease
The company has announced that the first participants have also been dosed in the ATHLOS phase 3 clinical trial, investigating budesonide/glycopyrronium/formoterol fumarate (Breztri Aerosphere).
V116 Demonstrates Positive Immunogenicity for 21 Pneumococcal Serotypes
Positive data were presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Disease in Cape Town, South Africa.
FDA Approves Givinostat as First Nonsteroidal Drug for Duchenne Muscular Dystrophy
The FDA recommends the dosage of givinostat (Duvyzat; Italfarmaco, ITF Therapeutics) should be based on the individual’s body weight and administered twice daily with food.
Study: PCR-Based Testing Results in Faster, Targeted Treatment for Community-Acquired Pneumonia
When considering community-acquired pneumonia alone, the PCR test identified 113 bacterial detections compared with 57 for the standard of care test.
FDA Approves Rilpivirine for Treatment of HIV for Pediatric Patients 2 and Older
Rilpivirine (Edurant Ped; Johnson and Johnson) is indicated for the treatment of HIV in combination with other antiretroviral therapies in treatment-naïve pediatric patients.
FDA Approves Aprocitentan for Treatment of Hypertension in Combination With Other Drugs
The FDA has only approved aprocitentan (Tryvio; Idorsia) in the 12.5 mg dosage as the effects were similar between the 25 mg and 12.5 mg dosages.
Celltrion USA Submits Biologics License Application for CT-P39, a Biosimilar to Xolair
The BLA includes all indications for Xolair, including asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.