Diana Ernst, RPh

Most Recent Articles by Diana Ernst, RPh

FDA Approves Additional Breast Cancer Indications for Kisqali

By Jul 18, 2018

In addition, Kisqali has also been approved in combination with fulvestrant to treat postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

Intelence Indication Expanded to Include Younger HIV Patients

By Jul 18, 2018

The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.

Positive Phase 3 Results for Novel OA Pain Treatment Tanezumab

By Jul 18, 2018

The 16-week, double-blind, placebo-controlled, multicenter, parallel-group study included 698 patients who were randomized to 3 treatment groups: 2 doses of tanezumab 2.5mg; 1 dose of tanezumab 2.5mg followed by tanezumab 5mg, or 2 doses of placebo; each injection was administered once every 8 weeks.

Evidence for Clobazam Monotherapy Use in Focal, Generalized Seizures Reviewed

By Jul 17, 2018

Researchers searched various databases to identify trials that compared clobazam monotherapy to placebo or another antiepileptic drug in patients with ≥2 unprovoked seizures or a single acute symptomatic seizure requiring short-term continuous treatment.

Dilanubicel Gets Orphan Drug Status for Reduction of Morbidity/Mortality Associated With HSCT

By Jul 17, 2018

Dilanubicel is a universal donor, off-the-shelf-, ex vivo expanded hematopoietic stem and progenitor cell investigational product that provides rapid, transient hematopoiesis while also inducing long-term immunologic benefits.

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