Caladrius Biosciences' CD34+ cell therapy for refractory angina treatment was given regenerative medicine advanced therapy status by the FDA.
Amphastar Pharmaceuticals' abbreviated new drug application for isoproterenol hydrochloride injection, USP 0.2 mg/mL, available in 1 mL and 5 mL vials, was approved by the FDA. The drug is therapeutically equivalent to Valeant Pharmaceuticals' Isuprel, which is indicated for uses including treatment of mild or transient heart block episodes that do not need electric shock or pacemaker treatment.
A biologics license application was filed with the FDA by Alexion using a rare disease priority review voucher for orphan drug-tagged ALXN1210, being developed to treat patients with paroxysmal nocturnal hemoglobinuria. The submission was backed by data from two late-stage studies, in which treatment with ALXN1210 every eight weeks showed non-inferiority to Soliris treatment every two weeks on all primary and key secondary endpoints.
The investigational drug quizartinib was found to extend survival in adults with relapsed acute myeloid leukemia and FLT3 internal tandem duplication compared with salvage chemotherapy in 367 patients, based on data from a Phase III study presented at the European Hematology Association's annual meeting. Median overall survival of those treated with quizartinib was 6.2 months versus 4.7 months for patients treated with standard salvage chemotherapy.
Kingdom Farms and owner Kieran Moran have had a civil lawsuit filed against them by the US Attorney's Office in Chicago, accusing them of selling meat and poultry products that were mislabeled and misbranded. The complaint alleges that the company used federal marks of inspection on its products without authorization and was discovered selling about 115 pounds of adulterated and misbranded meat products that did not undergo federal inspection, among other allegations.
ReShape Lifesciences has been notified by the US Patent and Trademark Office that it will receive a patent for its Gastric Vest System, a device designed to promote weight loss in patients with obesity.
The HipGrid Nine fit attachment system has been launched by OrthoGrid Systems for use in outpatient total hip replacement surgeries. The patent-protected system, intended to be integrated with C-arm systems, can be controlled intraoperatively by surgeons and can fully function with any implant system.
The USDA recently invited public comments on the proposed National Bioengineered Food Disclosure Standard, and it notes there is no evidence that links biotech food and health risk. The department said that the government's mandate to label biotech foods "is not expected to have any benefits to human health or the environment."
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