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.
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.
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