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  • 27 March 2010

    Poniard Pharma suspends efforts to obtain regulatory approval for picoplatin in SCLC

     Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, announced a clinical and regulatory update on its lead product candidate, picoplatin. Following a detailed analysis of primary and updated data from the phase 3 SPEAR study of picoplatin in small cell lung cancer (SCLC) and an evaluation of the ongoing New Drug Application (NDA) process with the US Food and Drug Administration (FDA), the company has decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time.

  • 23 March 2010
    FDA Temporarily Suspends Use of Rotarix Vaccine

    March 22, 2010 — The US Food and Drug Administration (FDA) announced today viral contamination of GlaxoSmithKline's Rotarix vaccine. The agency is recommending that doctors stop using the vaccine until further investigations are complete.

    An independent academic research team testing the product recently identified porcine circovirus 1 in the vaccine and notified regulators.

  • 20 March 2010
    High-Dose Simvastatin Associated With Increased Risk for Myopathy

     March 19, 2010 — Simvastatin (Zocor, Merck/Schering-Plough Pharmaceuticals), used at the highest approved dose of 80 mg, is associated with an increased risk for myopathy, including rhabdomyolysis, according to the US Food and Drug Administration (FDA).

  • 17 March 2010
    GVK Bio opens new clinical pharmacology unit in Ahmedabad

    GVK Biosciences, a contract research organization, has commissioned its new clinical pharmacology unit (CPU) in Ahmedabad. The facility adds 110 beds to the company's existing capacity of 144 beds and will conduct a range of tests on healthy volunteers.

  • 6 March 2010
    FDA Approves New Somatropin Injection Pen for Growth Hormone Disorders

    March 5, 2010 — The US Food and Drug Administration (FDA) has approved a prefilled somatropin (rDNA origin) injection pen (Norditropin FlexPro, Novo Nordisk, Inc) for the treatment of growth hormone disorders in adult and pediatric patients. The product, an updated version of the company's NordiFlex pen introduced in 2004, is expected to be available in the second quarter of 2010.

  • 3 March 2010
    US FDA approves velaglucerase alfa for injection to treat rare genetic disorder Gaucher disease

    The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

    Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. Without this enzyme, harmful amounts of a certain fatty substance (lipid) can build up in the liver, spleen, bones, bone marrow and nervous system, and can prevent cells and organs from working properly. About one in 50,000 to one in 100,000 people in the general population have Gaucher disease.

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