On June 28, 2023, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.
Read moreSickle Cell Disease: Hope for the Future
Every June 19, we observe World Sickle Cell Day to raise international awareness of sickle cell disease and the challenges patients and families face when handling the disease. Sickle cell disease is a group of inherited red blood cell (RBC) disorders that affect hemoglobin, the protein that carries oxygen through the body.
Read moreGene Therapy Update: SRP-9001 delandistrogene moxeparvovec for DMD
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 moreSpecialty Pharmacy Services Collaboration with AscellaHealth
Summit Reinsurance Services, Inc. announced a strategic collaboration with AscellaHealth, a pharmacy benefit manager offering innovative specialty drug programs developed as specialized solutions to the biggest drivers of pharmacy claims.
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