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

Bladder Cancer

Trodelvy Gets Accelerated Approval for Urothelial Cancer

Brian Park, PharmD

April 16, 2021

The accelerated approval was based on data from the multicenter, open-label, phase 2 TROPHY study.

News

Gemtesa Now Available for Overactive Bladder Treatment

Brian Park, PharmD

April 13, 2021

Gemtesa is an oral, once-daily, small molecule beta-3 adrenergic agonist.

Diabetes

Ozempic Injection 1mg Now Available as a Single Monthly Pen

Brian Park, PharmD

April 13, 2021

Anavip contains venom-specific F(ab’)2 fragments of immunoglobulin G that bind and neutralize venom toxins.

Hypogonadism

Kyzatrex Under Review for Primary and Secondary Male Hypogonadism

Brian Park, PharmD

March 16, 2021

Kyzatrex is an investigational, oral testosterone undecanoate softgel that utilizes lymphatic absorption and phytosterols to increase bioavailability and provide a favorable pharmacokinetic profile.

Kidney Cancer

Fotivda Approved for Relapsed/Refractory Advanced Renal Cell Carcinoma

Brian Park, PharmD

March 15, 2021

The approval was based on data from a phase 3 TIVO-3 study that compared tivozanib to sorafenib in adults with relapsed or refractory advanced RCC after 2 or more prior systemic therapies.

Chronic Kidney Disease (CKD)

FDA to Review Difelikefalin for Chronic Kidney Disease-Associated Pruritus

Brian Park, PharmD

March 11, 2021

The NDA submission is supported by data from the pivotal phase 3 KALM-1 and KALM-2 trials.

Bladder Cancer

Tecentriq Indication for Prior-Platinum Treated Bladder Cancer Withdrawn

Brian Park, PharmD

March 10, 2021

In 2016, the FDA granted accelerated approval to Tecentriq for prior-platinum treated metastatic urothelial carcinoma based on tumor response rate and duration of response.

Bladder Cancer

Imfinzi Indication for Urothelial Carcinoma Withdrawn

Brian Park, PharmD

February 26, 2021

Under the accelerated approval program, if a confirmatory trial does not show clinical benefit, the FDA can take steps to remove the drug or indication.

Overactive Bladder (OAB)

Botox Approved for Neurogenic Detrusor Overactivity in Pediatric Patients

Brian Park, PharmD

February 15, 2021

The approval is supported by data from a phase 3 study that assessed the efficacy and safety of Botox in patients aged 5 to 17 years with urinary incontinence due to NDO and using clean intermittent catheterization.