The FDA has pushed back the decision on the experimental gene therapy for Duchenne Muscular Dystrophy (DMD) until June 22.
Read moreMelanoma Vaccine Update
The FDA has granted breakthrough therapy designation for mRNA-4157 and Pembrolizumab combination for melanoma.
Read moreHumira Biosimilars Now Available in the US
On January 31, 2023, Amgen introduced a biosimilar for one of the pharmaceutical’s industry’s most lucrative products. Amjevita became first of nine biosimilar lookalikes scheduled to launch this year to compete with Humira (adalimumab).
Read moreApproval of Gene Therapy Treatment for CALD Anticipated in September 2022
Lenti-D (elivaldogene autotemcel or eli-cel) is an investigational gene therapy being developed by bluebird bio for the treatment of childhood cerebral adrenoleukodystrophy (CALD). The FDA advisory committee reviewed it in June 2022 and unanimously approved drug/therapy 15-0. The FDA’s scheduled decision date on the therapy is September 16, 2022.
Read moreGene Therapy Update: Beti-cel
This week a decision should be made by the FDA on a new gene therapy, betibeglogene autotemcel (beti-cel). Beti-cel is a one-time autologous product designed to treat transfusion-dependent beta thalassemia.
Read moreStudy Results of Dostarlimab-gxly for Locally Advanced Rectal Cancer
Clinical trial data published in the New England Medical Journal on June 23, 2022, reveal that locally advanced rectal cancer stage II or III with dMMR is sensitive to drug Dostarlimab-gxly.
Read moreStudy results of Enhertu and HER-2 for Metastatic Breast Cancer
For the first time, a targeted medicine can help metastatic breast cancer patients whose tumors express only low levels of HER2.
Read moreKathy Clark to Lead Summit ReSources
Summit Reinsurance Services, Inc. has elevated Kathy Clark, RN, BSN, CMCN, to assistant vice president and director of managed care effective May 31, 2021. With this promotion, Clark assumes responsibility for Summit ReSources, Summit Re’s medical management program, and its staff.
Read moreCell and Gene Therapies: Navigating a Challenging Landscape
Cell and gene therapy will most certainly continue to shift paradigms for manufacturers, patients, healthcare providers and pharmacies for many years. These are groundbreaking technologies which offer hope to millions of individuals that previously had no viable options for treatment or cure.
Read moreKidney Disease Management Collaboration with Renalogic
Summit Reinsurance Services, Inc. announced a strategic collaboration with Renalogic, a solution provider offering risk management services for kidney disease. Renalogic uses a data-driven approach focused on predicting and preventing chronic conditions that lead to dialysis.
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