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.
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.
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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.
Bariatric Surgery Improves Adverse Outcomes in Patients with MASH-Related Cirrhosis
This surgery can be significant in reducing the long-term risk of adverse outcomes and decompensation in cirrhosis related to metabolic dysfunction-associated steatohepatitis (MASH).
CUSP06 Granted FDA Fast Track Designation for Patients With Platinum-Resistant Ovarian Cancer
Currently, the Cadherin-6 targeting antibody-drug conjugate is undergoing evaluation in a phase 1a/1b clinical trial.
Brentuximab Vedotin Plus Lenalidomide and Rituximab Receives FDA Approval for Adults With LBCL
The approval follows the ECHELON-3 study, which enrolled adults with relapsed or refractory large B-cell lymphoma.
Chronic Kidney Disease Associated With Abnormal Cerebellar Growth in Pediatric Patients
Reductions in cerebellar volume were associated with cognitive deficits and lower kidney function in those with CKD.
Pharmacists Can Recommend Supplements and Lifestyle Modifications for Patients With Alzheimer Disease
Supplements, such as Prevagen, as well as lifestyle and diet modifications can provide additional support to patients with Alzheimer disease.
FDA Grants Priority Review to Brensocatib for Treatment of Bronchiectasis
If approved, brensocatib will be the first and only approved treatment for bronchiectasis and the first within a new class of medicines, called dipeptidyl peptidase 1 inhibitors.
Phase 3 HYPERION Trial Evaluating Sotatercept-Csrk Ends Prematurely, Moving to Final Analysis
The decision to end HYPERION (NCT04811092) comes after positive results from an interim analysis of the ZENITH trial (NCT04896008).
Investigators Use Sequencing Methods to Identify Triggering Allergen in Patient With EoE
The authors are optimistic that this method can be replicated to identify other allergens that manifest into eosinophilic esophagitis (EoE).
Iclepertin Fails to Show Statistically Significant Effects on Cognition and Functioning in Patients With Schizophrenia
In the phase 3 CONNEX clinical trial program, iclepertin did not meet its primary and secondary end points.
ACR-368 OncoSignature Assay Receives FDA Breakthrough Device Designation for Endometrial Cancer
The indication is for patients with endometrial cancer who may benefit from treatment with ACR-368 (Acrivon Therapeutics).
Machine Learning Shows Promise Predicting Progression of CKD to Kidney Failure
These findings can lay the foundation for the development of machine learning models in chronic kidney disease (CKD) and kidney failure.
Highest SMM Rates in Pregnant People With Chronic Hypertension and Preeclampsia, Preeclampsia Alone
The prevention of preeclampsia may reduce severe maternal morbidity (SMM) risk in pregnant people.