Regulatory News

  • FDA will look into risk of femur fractures in bisphosphonates

    The FDA will investigate the safety of bisphosphonates, drugs used to treat bone conditions including osteoporosis, in light of reports associating them with atypical subtrochanteric femur fractures. The agency said it did not find a clear connection between the medicines and side effects in data submitted by drug manufacturers.

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  • Cytokinetics' ALS treatment receives FDA's orphan-drug designation

    The FDA granted orphan-drug status to Cytokinetics' treatment candidate for amyotrophic lateral sclerosis, or Lou Gehrig's disease. The compound, CK-2017357, is expected to undergo a midstage trial in the first half of this year.

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  • Etex gets FDA clearance for artificial bone material

    Etex has received FDA clearance for CarriGen, a bone substitute material designed to repair defects in the pelvis, extremities and spine.

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  • FDA adds boxed warning to blood disorder drug WinRho SDF

    The FDA ordered the addition of a boxed warning to WinRho SDF, a blood disorder treatment from Cangene and Baxter International. The product, which is used for immune thrombocytopenic purpura, appears to cause intravascular hemolysis, a red blood cell disorder, in some patients.

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  • FDA unit launches workshops to encourage orphan-drug applications

    The FDA's Office of Orphan Products Development is hosting workshops to encourage research into treatments for rare diseases among drug and biotech companies, academic institutes as well as patient advocates. The first seminar was held last month and resulted in 14 submissions for orphan-drug status out of 29 potential sponsors, but Timothy Coté, director of the division, said he hopes to gather more applications during the second workshop in August.

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  • Guidewire gets second warning letter from FDA

    The FDA issued a warning letter to Guidewire Technologies saying it failed to satisfy standards of good manufacturing practice for producing guidewires used in catheter placement. The company has tried to address the concerns raised in the first letter, but the agency did not find the company's response to be sufficient.

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