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Late Friday, Bioniche Life Sciences (BNHLF.PK) reported that global rights to Urocidin are being returned to it from Endo Pharmaceuticals (NASDAQ:ENDP), a subsidiary of Endo Health Solutions. It was announced on November 5th that a second Phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer being conducted by Endo was being discontinued. The trial, which was a randomized, active-controlled, open-label, multi-center study, was created to compare Urocidin with mitomycin C in the intravesical treatment of patients suffering from BCG recurrent or refractory non-muscle-invasive bladder cancer. The trial was not recruiting at the expected rate and, subsequent to talks with the FDA concerning the clinical trial design, Endo elected to end the trial prior to its scheduled completion. The two firms thus came to an accord that a mutually favorable path forward for the drug is to return global rights to Bioniche for which Endo will receive a royalty on future revenue.
Aegerion Pharmaceuticals (NASDAQ:AEGR) said Monday that its Juxtapid (lomitapide) capsules used as an adjunct to a low-fat diet and other lipid-lowering treatments to decrease low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B (apo B) and non- high-density-lipoprotein cholesterol (non-HDL) in patients with homozygous familial hypercholesterolemia (HoFH) has been approved by the FDA. Aegerion is a biopharmaceutical firm that is dedicated to the development and commercialization of novel, life-altering therapies for patients suffering from debilitating, often fatal, and rare diseases.
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Invacare Corporation (NYSE:IVC) was notified on Monday that the United States District Court for the Northern District of Ohio has okayed the terms of the previously reported consent decree of injunction with the FDA which relates to previously announced inspectional observations at the firm’s corporate facility and its Taylor Street wheelchair manufacturing facility as well. The decree constrains production and design activities at the two Elyria facilities until they are certified to be in compliance with FDA regulations by an independent third-party expert and then approved by the FDA.
AMAG Pharmaceuticals (NASDAQ:AMAG) said Monday that it has submitted a supplemental new drug application to the FDA for Feraheme (ferumoxytol) Injection for Intravenous (IV) use, which seeks FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia in adult patients suffering from chronic kidney disease to all adult patients with IDA who have failed or could not tolerate oral iron treatment. The application includes data from two well-controlled phase III clinical evaluations of more than 1,400 patients.
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