June was a busy month for the FDA with the approval of two gene therapies, Elevidys (delandistrogene moxeparvovec-rokl) and Roctavian (valoctocogene roxaparvovec-rvox), and one cellular therapy Lantidra (donislecel-jujn). See more about these therapies.
Read moreFirst Allogeneic Cellular Therapy Approved for Type 1 Diabetes
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 moreUnderstanding Chronic Kidney Disease
Thirty-seven million Americans, or one in every seven people, have chronic kidney disease (CKD). Surprisingly, however, 90% of these people are not aware they have this disease.
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 moreData Analytics Can Improve Postpartum Outcomes
In order to identify at-risk women and create proper treatment plans as early as possible, it is essential to embrace technology that includes predictive data and information. This approach comes at a critical time when the U.S. has the highest maternal mortality rate among industrialized countries, especially for women of color.
Read moreGene Therapy Update
As we look to the immediate future, there are two gene therapies currently up for review; the Biologic License Applications (BLAs) for each have been submitted and accepted. These therapies address hemophilia A and B.
Read moreTriple Negative Breast Cancer and Pembrolizumab (Keytruda)
In honor of breast cancer awareness month, we highlight recent gains related to an aggressive subtype of the disease that has typically been difficult to treat: triple negative breast cancer.
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