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 moreFDA Approval of Aduhelm (Aducanumab) for Alzheimer's Disease
On June 7, 2021 the FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s. The first new treatment in over 17 years, its approval has not come without controversy.
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.
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.
Read moreAre You Ready? Preparing for Gene and Cell Therapies Coming Down the Pipeline
Gene and cell therapies can be life changing but come with expensive price tags. As more therapies are FDA approved, payers are looking for options to control the spiraling cost of specialty pharmacy and to project future financial risk related to new therapies coming to market.
Read moreGene Therapy for Hemophilia A: Valrox may be the world’s most expensive one-time treatment
Should it be approved, BioMarin is considering pricing Valrox, a gene therapy drug aimed at hemophilia A, at $2 million to $3 million for the single treatment.
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