Medical device makers are calling on the FDA's Center for Devices and Radiological Health to provide a database of products that have been approved under the Breakthrough Devices Program, as well as the rationale, as a way to increase transparency. At a recent FDA webinar, Steve Silverman, AdvaMed's vice president of technology and regulatory affairs, recommended publishing metrics including the total time to FDA decision and the number of requests granted versus denied.
The FDA has issued a complete response letter to Immunomedics related to its biologics license application for sacituzumab govitecan to be used as a treatment for patients with metastatic triple-negative breast cancer who have received two or more prior therapies.
An urgent medical device recall has been issued by Medtronic for almost 157,000 dual-chamber pacemakers distributed internationally. The recall notice indicates that due to a design change in an integrated circuit, the affected devices may temporarily lose the ability to pace the heart when programmed in certain modes.
Johnsonville issued a recall for about 48,300 pounds of raw ground pork patty products after receiving consumer complaints of finding black rubber in the products.
Data published in the journal The Lancet showed that patients with newly diagnosed multiple myeloma who were treated with ixazomib as maintenance therapy after undergoing high-dose therapy and an autologous stem cell transplant experienced extended progression-free survival. Results from the study were based on outcomes of 656 randomly assigned patients who were given ixazomib or placebo, and a 28% decreased risk of disease progression or mortality was noted among those taking ixazomib after a median follow-up of 31 months.
Adaptive Biotechnologies announced that its diagnostic test clonoSeq will be covered effective immediately by Medicare contractor Palmetto GBA for Medicare patients diagnosed with B-cell acute lymphoblastic leukemia and multiple myeloma.
A late-stage trial evaluating Revlimid, or lenalidomide, for use as long-term maintenance in patients with newly diagnosed multiple myeloma showed that the regimen resulted in significant improvements in delaying disease progression and extending overall survival, equivalent to a 54% decrease in the risk of disease progression or mortality. The research findings were reported in the journal The Lancet Oncology.
MIT has entered a collaborative partnership with Sigilon Therapeutics to create programmable cell therapeutics to treat chronic illnesses and diseases such as hemophilia and lysosomal storage diseases.
Obsidian Therapeutics and Kyn Therapeutics announced they will work with Celgene to develop experimental cancer immunotherapies aimed at boosting its cancer portfolio. Celgene is being acquired by Bristol-Myers Squibb.
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