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.

A marketing application was filed with the FDA by Eli Lilly and Co. for lasmiditan as an acute treatment for adult patients with migraine with or without aura.

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.

Pfizer's epoetin alfa for anemia was launched in the US. The drug is a biosimilar of Amgen's Epogen and Johnson & Johnson's Procrit.

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.