Special Protocol Assessment (SPA) approval has been given to Ark Therapeutics Group plc of London for a phase III pivotal trial of Trinam, a novel gene-based medicine to prevent blood vessel blockage in kidney dialysis patients who have undergone vascular access graft surgery.

Calypso Medical of Seattle announced that the FDA has cleared a new indication for use of implantable Beacon electromagnetic transponders with its external-beam radiation therapy (EBRT), known as GPS for the Body, to continuously track the position of targeted tissue during treatment of prostatectomy patients.

The FDA has accepted a New Drug Application for silodosin, a novel alpha1-adrenoreceptor antagonist, from Watson Pharmaceuticals, Inc., of Corona, Calif. Watson is seeking approval of silodosin for the treatment of BPH symptoms.

The FDA announced that Baxter Healthcare Corporation, of Deerfield, Ill., has temporarily stopped manufacturing multiple-dose vials of heparin due to reports of severe allergic reactions and hypotension in patients who receive high "bolus" doses of the drug.

AMAG Pharmaceuticals, Inc., of Cambridge, Mass., has announced that the FDA has accepted for standard review its New Drug Application (NDA) for ferumoxytol as an IV treatment of iron deficiency anemia in CKD patients.

Simcor (Niaspan/simvastatin), the first fixed-dose combination of two widely prescribed cholesterol therapies, has been approved for use along with diet to lower levels of elevated total cholesterol, LDL cholesterol, and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease when treatment with monotherapies are not considered adequate.

PLC Systems Inc., of Franklin, Mass., has received conditional approval to begin enrollment in a pivotal trial to study the effectiveness of its RenalGuard Therapy and RenalGuard System in the prevention of contrast-induced nephropathy (CIN).

The FDA has cleared NovoLog (insulin aspart [rDNA origin] injection) from Novo Nordisk for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients aged 4-18 years.

Abbott Pharmaceuticals' FreeStyle Navigator Continuous Glucose Monitoring System, which provides minute-by-minute information about the rate and direction of changes in blood sugar levels, has been approved for diabetics.

The FDA issued a communication on March 27 about its ongoing safety review of Regranex (becaplermin gel, Ortho-McNeil), a topical medicine applied directly to the foot and leg ulcers of patients with diabetes.