Diana Ernst, RPh

Most Recent Articles by Diana Ernst, RPh

Lenti-D Gets Breakthrough Tx Designation for Cerebral Adrenoleukodystrophy

By May 24, 2018

This investigational lentiviral-based gene therapy is currently being studied in the Phase 2/3 Starbeam Study, a 2-year study assessing the safety and efficacy of Lenti-D in boys ≤17 years old with CALD.

FDA: Updated Safety Alert Regarding Benzocaine-Associated Methemoglobinemia

By May 23, 2018

The Agency is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population.

Yonsa Approved for Metastatic Castration-Resistant Prostate Cancer

By May 23, 2018

The approval of Yonsa was based on 2 randomized, placebo-controlled, multicenter Phase 3 studies in patients with mCRPC.

Prolia Approved for Glucocorticoid-Induced Osteoporosis

By May 22, 2018

The efficacy and safety of Prolia in the treatment of patients with glucocorticoid-induced osteoporosis was assessed in the 12-month primary analysis of a 2-year, randomized, multicenter, double-blind, parallel-group, active-controlled study (N=795).

Doptelet Approved for Chronic Liver Disease Patients With Thrombocytopenia

By May 21, 2018

The approval of Doptelet was based on results from the ADAPT-1 (N=231) and ADAPT-2 trials (N=204), 2 identically-designed multicenter, randomized, double-blind, placebo-controlled studies.

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