Specialty Pharmacy

The historical health data collected using wearable devices can now be used as secondary endpoints in trials, allowing researchers to monitor responses in real-time without invasive procedures.

After over 2 decades, the first inhaled product with a novel mechanism of action has been approved by the FDA for the treatment of chronic obtrusive pulmonary disorder.

Teplizumab (Tzield; Sanofi) has the potential to delay type 1 diabetes and the onset of stage 3 diabetes, but must be started in stage 1 of the disease.

Semaglutide was found to have effects on glycemia, inflammation, and heart failure outcomes in sub analyses.

Based on these results, tirzepatide could be first medication approved for treatment of obstructive sleep apnea in patients with obesity.

After being previously approved in June 2023 under an Accelerated Approval process, the FDA has granted an expanded approval for non-ambulatory individuals and individuals 4 years of age or older.

The potential to optimize medication efficacy and safety across diverse populations is garnering attention in various health care settings.

Pharmacy Times will be at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida from June 21 to June 24, 2024.

Although the committee's vote is non-binding, it does raise questions about optimal evaluation of psychedelics in clinical trials.

The new findings were presented as an oral presentation at the 2024 European Calcified Tissue Society Congress, held from May 25, 2024, to May 28, 2024.

Anti-amyloid antibody administration decreased plaque volume in clinical trials of patients with early AD, indicating that passive immunotherapies could be a promising treatment for the disease.

A 1-time infusion of valoctocogene roxaparvovec had demonstrated sustained bleed control and factor VIII expression in patients with hemophilia A.

The default-mode network method, which was analyzed using functional magnetic resonance imaging scans, was approximately 80% accurate when predicting dementia up to 9 years prior to a diagnosis.

Individuals with very low- to intermediate-risk myelodysplastic syndromes treated with luspatercept (Reblozyl; Bristol Myers Squibb) achieved improvements in hemoglobulin levels.

Elafibranor (Iqirvo; GENFIT) is a first-in-class, once daily oral peroxisome proliferator-activated receptor for the treatment of primary biliary cholangitis.

The new approval increases the previous dosing for surface area treatment from 25 cm2 to up to 100 cm2.

The authors noted that these networks have a significant role in intellectual ability, physical coordination, working memory, emotional processing, and overall mental health.

Imetelstat (Rytelo; Geron Corp) is a first-in-class telomerase inhibitor.

According to investigators, the primary and key secondary end points were met during the 52-week placebo-controlled period of the trial.

With its ability to decode genetic variations influencing drug response, pharmacogenomics holds immense promise in reshaping health care delivery.

Mirikizumab met both co-primary end points and all secondary end points at week 52, according to results presented at Digestive Disease Week in Washington DC.

For patients with a blood eosinophil count of 150 cells/µL or greater, tezepelumab had a significant reduction of approximately 37% in the rate of moderate or severe exacerbations.

The panelists expressed concerns about clinical trial data and concluded that the benefits do not outweigh the risks, but the FDA does not have to follow their recommendation.

In addition to racial inequities in access to care, socioeconomic challenges are very common for the specialty medications necessary in MS.

Providers, the community, health systems, and health policies can all play a part in addressing various challenges in care for obesity.

Understanding patients’ specific experiences and challenges is crucial to helping them improve medication adherence.

This is the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS, enabling a more comprehensive understanding of ocrelizumab’s safety.