The FDA has warned StemGenex Biologic Laboratories for selling an unapproved stem cell product as part of a crackdown on sales of regenerative medicines for unapproved indications. The warning letter also noted manufacturing process violations that could create a risk of microbial contamination.
Regenxbio's RGX-181, being developed as a one-time therapy for late-infantile neuronal ceroid lipofuscinosis type 2 disease, was given orphan drug status by the FDA.
The FDA has granted Canon Medical Systems USA clearance to market its Vantage Orian 1.5 Tesla MRI scanner, which comes with a 71 cm bore, as well as Pianissimo and Pianissimo Zen technologies for quiet operation.
European regulators have given Diabeloop CE mark approval for its DBLG1 technology, a self-learning and customizable device for monitoring and maintaining glucose levels. The system, which can imitate the insulin-dispensing functions of the pancreas, connects to an insulin patch pump and a continuous blood glucose monitoring system to predict glucose levels and enable optimal pump control.
Testing by the Government Accountability Office revealed that two dietary supplements, which were sold as ginkgo-based memory boosters, do not contain the ingredient or contain a lower amount than marketed. The FDA will review the GAO report and may conduct further investigation.
Ultragenyx intends to submit a US marketing application for long-chain fatty acid oxidation disorder candidate UX007 next year. The submission will be backed by data from a midstage study.
Patients with myelofibrosis who were given escalated doses of ruxolitinib experienced diminished symptoms and improved splenomegaly during early therapy, according to a study in the Journal of Hematology & Oncology. However, taking ruxolitinib also raised the risk of developing grade 3/4 anemia and/or thrombocytopenia, which would require supplementary transfusions or dose reductions.
San Diego-based Synthorx has filed to launch an initial public offering to raise $100 million for development of its enhanced cytokine drugs. The added financing will allow Synthorx to support dose escalation and expansion studies for its investigational cancer therapy using interleukin-2 and to create autoimmune disorder treatments using the same compound.
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