Medical Article

Praxis Precision Medicines’ essential tremor drug ulixacaltamide met the goals of two Phase 3 clinical trials, paving the way for discussions with the FDA about a new drug application. The once-daily pill could become the first approved treatment for this movement disorder affecting an estimated 7 million Americans. The post Persistence Pays Off for Praxis…

To be eligible qualify for the FDA’s new Commissioner’s National Priority Voucher program, a drug must meet certain national health interests. Qualifying medicines could be reviewed in one to two months, down from the standard 10 months to a year. The post FDA Pilot Program Shortens Drug Reviews; ‘We Have Got to Modernize the Agency,’…

This test can be thought of as a crystal ball for cancer survivors and research has found it can predict with near certainty whether a patient’s cancer will recur. So why aren’t more patients getting the test? The post A Crystal Ball for Cancer Survivors appeared first on MedCity News.

In Phase 1/2 results for 12 patients at least one year after receiving the cell therapy, zimislecel, Vertex Pharmaceuticals reported all participants achieved blood glucose in the target range and 10 of the 12 were free of exogenous insulin as of the data cutoff. Vertex expects to complete enrollment in the pivotal portion of the…