First Participant Dosed in Phase 1/2 Study of Moderna’s Quadrivalent Seasonal Flu mRNA Vaccine
July 13th 2021The study plans to enroll approximately 180 participants to evaluate the safety, reactogenicity, and immunogenicity of its quadrivalent seasonal influenza mRNA vaccine in adults 18 years and older.
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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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Highlights of the Patient Experience with Tavalisse
July 12th 2021Pharmacy Times spoke with Bhavesh Shah, associate chief pharmacy officer for hematology/oncology, about his session titled Stand Strong Against Platelet Destruction With Tavalisse®: A Patient’s ITP Treatment Journey, which he presented at the 2021 ATOPP Summit.
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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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Phase 2 Study Indicates Mirikizumab Induces Mucosal Healing in Patients With Ulcerative Colitis
July 12th 2021According to the investigators, gene changes unique among individuals who responded to mirikizumab indicate that mirikizumab affects a distinct molecular healing pathway when compared to the spontaneous healing that occurred among the cohort administered the placebo.
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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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New Digital Tool Provides Resources for Patients With Small Cell Lung Cancer and Their Caregivers
July 9th 2021In an interview with Pharmacy Times® and Directions in Oncology Pharmacy®, Abizer Gaslightwala, vice president and head of the U.S. Hematology and Oncology division at Jazz Pharmaceuticals discusses the company’s new digital resource, Nothing Small About It.
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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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