The Pharmacy Times® Pharmacy Hospital Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to hospital and health-system pharmacists.
January 23rd 2025
The fast-track designation follows the FDA orphan drug designation that was granted for DYNE-101 in September 2023 for the same treatment population.
5-Day Radiation Regimen Safe, Effective for Individuals With Severe Prostate Cancer
August 5th 2021According to the investigators, the findings demonstrate that a 5-day regimen of stereotactic body radiotherapy, a form of external beam radiation therapy that uses a higher dose of radiation, had a 4-year cure rate of 82%.
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FDA Grants Atezolizumab Priority Review as Adjuvant Treatment for Certain Patients With NSCLC
August 3rd 2021According to a press release from Roche, the FDA is reviewing the company’s Biologics License Application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
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Novel Drug Combination Serves as Potential Treatment for Acute Myeloid Leukemia
August 3rd 2021MDM2 inhibitors and BET inhibitors, which show limited efficacy against acute myeloid leukemia (AML) as monotherapies, are potent against AML when used in combination, according to a study published in Nature Communications.
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Expert: COVID-19 Vaccine Mandates in Health System Reflect Patient-Centered Approach
August 3rd 2021Anna Legreid Dopp, PharmD, CPHQ, senior director of clinical guidelines and quality improvement at ASHP, said their organization was proud to sign onto a recent statement urging health care organizations to mandate COVID-19 vaccines for their employees.
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Addressing Logistical Challenges of CAR T Therapy Administration in Inpatient, Outpatient Settings
August 2nd 2021Pharmacy Times interviewed Craig Freyer, PharmD, BCOP, and Andrew Lin, PharmD, BCOP, to discuss how to manage the logistical challenges that arise during the administration of CAR T therapy in inpatient and outpatient settings for patients with multiple myeloma.
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Clinical Trial Shows Safety, Efficacy of Monthly Oral Islatravir for HIV-1 Prevention
August 2nd 2021The investigators noted that the levels of islatravir in peripheral blood mononuclear cells remained above the efficacy pharmacokinetics threshold for PrEP for both doses studied (60 mg and 120 mg) for 8 weeks following the last study dose.
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FDA Approves Insulin Glargine-yfgn as First Interchangeable Biosimilar Insulin Product for Diabetes
July 29th 2021Insulin glargine-yfgn is the first interchangeable biosimilar product for the treatment of diabetes approved in the United States, which can provide patients with alternative, equally effective options for treating diabetes that could be more cost effective.
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Biktarvy Demonstrates Efficacy, Viral Suppression in Treatment-Naïve Adults With HIV
July 28th 2021A pooled analysis of a 48-week open-label extension of a pair of phase 3 studies found that 99% of patients with HIV who initiated treatment using bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets maintained an undetectable viral load through 4 years of follow-up.
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