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.
Communicating With Care and Compassion: A Key to Unlocking Health Care Disparity
July 15th 2021White continued to discuss how being self-aware, using the right language, modeling behaviors that support belonging, and fostering an environment with psychological safety is the goal as a a health care provider.
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The FDA has granted enfortumab vedotin-ejfv both a regular approval and a new indication expansion for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received 1 or more prior lines of therapy.
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COVID-19 Antibody Study Demonstrates Importance of Second Vaccine Dose, Updates to Vaccine
July 14th 2021Vaccinated individuals overall had large amounts of antibodies present compared to infected individuals, suggesting that vaccination both protects against becoming infected and reduces the likelihood of transmitting the virus to others.
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Because viral clearance is compromised if HIV is allowed to replicate for an extended period of time—resulting in extensive damage to the immune system—controlling HIV with antiretroviral therapy may be critical to preventing this type of viral evolution in SARS-CoV-2 in patients with advanced HIV.
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Pharmacist Medication Insights: Margetuximab for Metastatic HER2-Positive Breast Cancer
July 13th 2021Margetuximab-cmkb (Margenza) was approved in December 2020 in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which for metastatic disease.
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Patent Filed for Application of Ibezapolstat in the Treatment of C. Difficile Infection
July 12th 2021This action follows a recently completed phase 2a clinical trial, which demonstrated that 100% of the 10 enrolled patients met the study's primary and secondary efficacy endpoints of clinical cure at end of treatment as well as sustained clinical cure with no recurrence of CDI when examined on a 28-day follow-up visit.
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FDA Expands Indication, Grants Regular Approval for Urothelial Cancer Therapy
July 9th 2021The FDA granted accelerated approval in 2019 to enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery, or in a locally advanced or metastatic urothelial cancer setting.
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Impact of FDA Approval of Infigratinib on the Field of Cholangiocarcinoma Treatment
July 9th 2021Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the importance of the FDA’s expedited approval process for infigratinib in the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
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Study: Myocarditis Following Second COVID-19 Vaccine Dose Rare, Should Not Discourage Vaccination
July 9th 2021A retrospective case series published in JAMA Cardiology found that although there are rare instances of myocarditis—inflammation of the heart muscle—in younger men following COVID-19 vaccination, the greater risk for heart damage and death comes from COVID-19 infection.
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