Diana Ernst, RPh, Author at MPR

Diana Ernst, RPh

All articles by Diana Ernst, RPh

Novel Treatment for Schizophrenia Gets FDA’s Breakthrough Therapy Designation

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SEP-363856 (Sunovion), an investigational treatment for schizophrenia. SEP-363856 is believed to work by activating trace amine-associated receptor 1 (TAAR1) in addition to 5-HT1A receptors; unlike other antipsychotics, this novel agent does not bind to D2 or 5-HT2A receptors. The Breakthrough Therapy designation was…

FDA to Review New HIV Pre-Exposure Prophylaxis Therapy

The supplemental New Drug Application (sNDA) for Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets; Gilead), for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in those who are HIV-negative and at risk for HIV, has been submitted to the Food and Drug Administration (FDA) for review.

Vedolizumab Tops Adalimumab in Head-to-Head Ulcerative Colitis Trial

Vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, was found to be superior to adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC), according to results from a phase 3b head-to-head trial.