Clinical News

Oliceridine (Olinvyk; Trevena, Inc) is an intravenous opioid agonist indicated in adults for management of acute severe pain in a hospital or controlled clinical setting.

Early data from a phase 3 trial showed that baricitinib combined with remdesivir improved recovery in patients hospitalized with COVID-19 compared with remdesivir alone.

The FDA issued a safety alert about efficacy and potential safety concerns with a combination therapy being studied for the treatment of breast cancer.

Oral azacitidine (Onureg; Celgene) is approved for patients in first remission with acute myeloid leukeimia.

Primary updates to the guidance includes the composition of the 2020-2021 flu vaccines and the recent licensures of 2 new influenza vaccines.

Risdiplam (Evrysdi; Genentech) is the only SMA therapy that can be administered at home.

Esketamine (Spravato; Janssen) CIII nasal spray is the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.

A panel has given a “weak recommendation” for the use of remdesivir in patients with severe coronavirus disease 2019.

Empagliflozin (Jardiance; Eli Lilly) met the primary end point of a study for adults with heart failure with reduced ejection fraction with or without diabetes.

Moderna announced interim analysis results of its investigational COVID-19 vaccine candidate, mRNA-1273, from an ongoing phase 1 study.

Fostemsavir (Rukobia, ViiV Healthcare) is indicated for use in heavily treatment-experienced adults with multidrug resistant HIV-1 infection.

Pharmacists can and must play an active role in guiding patients on the selection of laxatives which are supported by sound evidence.

The fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase (Phesgo; Genentech) can be administered subcutaneously for patients with HER2-positive breast cancer.

Julie Ann Justo, infectious diseases clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy, discusses the latest data from Gilead's trials for Remdesivir, a potential COVID-19 treatment.

In an open letter, Gilead Chairman and CEO Daniel O’Day announced the price of remdesivir treatment for COVID-19.

Officials with the FDA approved fenfluramine (Fintepla, Zogenix) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

On February 27, 2020, the FDA approved an intravenous solution of amisulpride (Barhemsys; Acacia Pharma) to treat and prevent postoperative nausea and vomiting.

Here's a roundup of this week's coronavirus-related news.

The phase 2/3 trials will evaluate remdesivir (Gilead) in pediatric patients, from newborns to adolescents, who have contracted severe COVID-19 symptoms.

In studies presented this month at the European E-Congress of Rheumatology 2020, investigators revealed positive findings for the infliximab biosimilar CT-P13 (Inflectra, Remsima), which is developed by Celltrion of Incheon, Republic of Korea.

The FDA updated its fact sheet on the co-administration of remdesivir with chloroquine phosphate or hydroxychloroquine.

An exploratory analysis of 2 phase 3 trials evaluating ribociclib (Kisqali, Novartis) plus endocrine therapy in advanced breast cancer showed positive results.

Officials with the FDA have approved imipenem, cilastatin, and relebactam (Recarbrio, Merck) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia. 

Impax requested that pharmacists who have dispensed Impax’s epinephrine injection, USP auto-injector 0.3 mg since December 20, 2018 contact all patients who received the device and provide instructions for inspection.

Targeted therapy osimertinib (Tagrisso) demonstrated significant improvements in disease-free survival in patients with localized non-small cell lung cancer (NSCLC) who were treated following surgery.

Although several therapeutic agents have been evaluated for the treatment of COVID-19, none have yet shown to be effective.

Results from a phase 3 study showed that galcanezumab-gnlm (Emgality, Eli Lilly) significantly improved work productivity and health and well-being between migraine attacks.

Filgotinib achieved all primary end points of the phase 2b/3 study in patients with moderate-to-severe ulcerative colitis.

New data showed that treatment with hydroxychloroquine was associated with increased mortality in hospitalized patients with COVID-19. 

Migraine is one of the most common neurologic disorders in children and adolescents with a prevalence of 7.7%.