Brian Park, PharmD

Drug Information Specialist https://www.renalandurologynews.com

Brian Park, PharmD, is a Drug Information Specialist at MPR. A graduate of the Ernest Mario School of Pharmacy, Rutgers University, Brian worked as a pharmacy manager at Stop & Shop Pharmacy for 8 years. He is a certified diabetes care pharmacist.

All articles by Brian Park, PharmD

Lupus Nephritis

Voclosporin NDA for Lupus Nephritis Submitted to FDA

Brian Park, PharmD

May 28, 2020

The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.

Prostate Cancer

Olaparib Approved for Metastatic Castration-Resistant Prostate Cancer

Brian Park, PharmD

May 21, 2020

The FDA has approved Lynparza® (olaparib; AstraZeneca and Merck) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.

Anemia

Vadadustat Noninferior to Darbepoetin Alfa for Anemia in Patients With Dialysis-Dependent CKD

Brian Park, PharmD

May 7, 2020

The studies compared the efficacy and safety of vadadustat to darbepoetin alfa in adult patients on dialysis with anemia due to CKD.

Bladder Cancer

New Dosing Schedule Approved for All Keytruda Indications

Brian Park, PharmD

May 1, 2020

The FDA has approved the supplemental Biologics License Application (sBLA) for Keytruda® (Merck) to include an additional recommended dosage of 400mg every 6 weeks across all adult indications.

Men's Health Update

Remestemcel-L Looks Promising in COVID-19 Patients With Moderate to Severe ARDS

Brian Park, PharmD

April 28, 2020

We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.”

Indication: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Chronic Kidney Disease (CKD)

Dapagliflozin To Be Evaluated in COVID-19 Patients With Cardiovascular, Metabolic, or Renal Risk Factors

Brian Park, PharmD

April 24, 2020

A phase 3 trial to evaluate dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a potential treatment for patients hospitalized with coronavirus disease 2019.

Upper tract urothelial carcinoma

Jelmyto Approved for Low-Grade Upper Tract Urothelial Cancer

Brian Park, PharmD

April 16, 2020

The Food and Drug Administration (FDA) has granted expedited approval of Jelmyto (mitomycin for pyelocalyceal solution; UroGen Pharma) for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). The approval was based on data from the ongoing open-label, single-arm, phase 3 OLYMPUS study that assessed the efficacy of Jelmyto in 71 adults…

Chronic Kidney Disease (CKD)

Dapagliflozin CKD Trial Stopped Early Due to “Overwhelming Efficacy”

Brian Park, PharmD

April 2, 2020

The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.

Anemia

Triferic AVNU Approved for Iron Replacement and Hemoglobin Maintenance in Dialysis Patients

Brian Park, PharmD

April 1, 2020

The FDA has approved the New Drug Application for Triferic AVNU®.

Diabetes

Update for SGLT2 Inhibitors: Temporary Discontinuation Prior to Surgery Recommended

Brian Park, PharmD

March 25, 2020

The FDA has approved safety labeling changes for sodium glucose co-transporter-2 (SGLT2) inhibitors. These include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin.

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