CLINICAL ROLE -
Gillian McGovern is an associate editor at Pharmacy Times®. She graduated from Rowan University in 2023 with a BA in Writing Arts and concentrations in Publishing & Writing for the Public, Technical & Professional Writing, and Creative Writing.
FDA Grants Fast Track Designation to AVB-114 for Crohn Disease Perianal Fistulas
The designation was granted after positive results from the phase 1 STOMP-I clinical trial (NCT01915927).
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Emapalumab-Lzsg Receives FDA Priority Review for Treatment of Children and Adults With HLH/MAS
The action follows pooled data from 2 studies that enrolled patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still disease.
Patients With CKD at Elevated Risk of Kidney Failure and Acute Ischemic Stroke
Additional risk factors included older age and advanced chronic kidney disease (CKD) stage.
Tenecteplase Receives FDA Approval, Marking First New Stroke Medication in Nearly 30 Years
In a clinical trial, tenecteplase was shown to be a comparable alternative to alteplase.
Google’s Pixel Watch 3 Loss of Pulse Detection Feature Receives FDA Clearance
The feature is expected to be available to US users in late March 2025.
FDA Approves Odactra Label Expansion to Include Children With House Dust Mite Allergy
The updated indication now includes pediatric patients aged 5 through 11 years.
Daily Vitamin E Achieves Liver Histology Improvements in Patients With MASH
Patients with metabolic dysfunction-associated steatohepatitis (MASH) receiving 300 mg of vitamin E daily presented improved steatosis, lobular inflammation, and fibrosis stages.
Age-Specific Monitoring and Emergency Treatment Enhance Safety in Patients Receiving Allergen Immunotherapy
Health care professionals and patients must recognize that rapid administration of adrenaline is the only first-line treatment for anaphylaxis.
Gepotidacin’s Potential FDA Approval and Novel Mechanism Treating UTIs
If approved, gepotidacin (GSK) will be a new oral agent added to the treatment paradigm for urinary tract infections (UTIs).
Pharmacists Play Key Role When Individualizing Treatments for UTIs
Pharmacists must consider drug Interactions, allergies, and comorbidities when treating patients with urinary tract infections (UTIs).
FDA Approves Miudella, First Hormone-Free, Copper IUD in Over 40 Years
The newly-approved intrauterine device (IUD) prevents pregnancy in people of reproductive potential for up to 3 years.
Tenofovir Amibufenamide Comparable to TDF in the Treatment of Chronic Hepatitis B
Although tenofovir amibufenamide and tenofovir disoproxil fumarate (TDF) had similar effects, the former resulted in better renal safety and did not impact lipid levels.
Study Finds Fewer Than 1% of US Clinical Trials Enroll Pregnant Participants
The authors note that this lack of inclusion can leave important safety and efficacy questions unanswered.
FDA Accepts New Drug Application for Dordaviprone to Treat Recurrent H3 K27M-Mutant Diffuse Glioma
The designation is supported by pooled data from 4 clinical trials.
Study: Certain Hormonal Contraceptives Increase Risks of Ischemic Stroke, Myocardial Infarction
Levonorgestrel-releasing intrauterine devices were not found to increase women’s risks of these conditions.
Omalizumab Shows Superiority Over Immunotherapy in Stage 2 of OUtMATCH Study
The FDA-approved treatment did not cause as many adverse events as immunotherapy when treating patients with multi-food allergy.
B-Together Trial Demonstrates Efficacy of Bepirovirsen Followed By Peg-IFN for HBV
The long-term durability of response will be evaluated in the B-Sure trial (NCT04954859), which will enroll patients with hepatitis B virus (HBV) from B-Together (NCT04676724).
FDA Grants Fast Track Designation to BRTX-100 to Treat Chronic Lumbar Disc Disease
Currently, the agent is undergoing evaluation in a phase 2 clinical trial to determine its safety and efficacy.
Chenodiol, First Treatment for Cerebrotendinous Xanthomatosis, Receives FDA Approval
This marks the first FDA-approved treatment for this rare lipid storage disease.
VP250 Is Safe and Effective Treatment for Young Children With Peanut Allergy
In children aged 1 to 3 years, the VP250 peanut patch was superior to placebo in the desensitization to peanuts and increasing the peanut dose that triggers allergic symptoms.
Later-Onset Menopause Associated With a Lower Risk of Heart Disease, Study Finds
These findings may lead to new therapies to help reduce the risk of heart disease in women who are at risk.
Larsucosterol Did Not Show Statistical Significance Compared With Placebo in Phase 2b AHFIRM Trial
Although larsucosterol did not show statistical significance, it showed clinically meaningful trends in 90-day mortality in patients with severe alcohol-associated hepatitis.
Study Finds Gut Microbiota Associated With Development of Food Allergy, Sensitivity in Infants
The authors are optimistic that these findings may help develop defenses to prevent food allergies in at-risk infants.
Treating Recurrent Pericarditis With Rilonacept and What Future Research May Entail
Future research can explore the underlying cause of recurrent pericarditis with systemic Sjögren syndrome and the combination of rilonacept with immunosuppressive therapies.
Gut-Brain Axis, Chronic Inflammation Important Targets for Treating CKD and Depression
The authors suggest future research should consider inflammation and the gut as potential therapeutic targets improve depression in patients with chronic kidney disease (CKD).
FDA Approves Vimseltinib for the Treatment of Adults With Symptomatic TGCT
The indication is for symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
The Role of Pharmacists in Optimizing Care for Seizures in Neonatal Patients
Pharmacists can help patients and their caregivers manage seizures, assess seizure control, and recommend appropriate treatments such as phenobarbital or rescue medications.
Pharmacists Educate and Bridge Communication Gaps for Patients With Pericarditis
Pharmacists can help educate patients, identify adverse events, and help patients communicate with other health care professionals or drug companies.
Study Finds Easy-to-Implement Treatment Strategy for Children With Peanut Allergy
After gradually consuming increased doses of peanut butter, children who could initially tolerate about half a peanut could consume 3 tablespoons without an allergic reaction.
Pharmacists Play a Crucial Role Monitoring Patients With Psoriasis and Psoriatic Arthritis
Through frequent interactions, pharmacists can discuss patients' treatment satisfaction, adherence issues, or potential adverse events.