FDA and News Updates for GlaxoSmithKline (NYSE:GSK), Matrixx (Nasdaq: MTX) and Caraco (Amex: CPD)
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GlaxoSmithKline (NYSE:GSK) -- On 7/6/09, a study, published in Tuesday's issue of The Lancet, said that as well as protecting against the two most common virus types, the vaccine also provides protection against the next three most common cancer-causing virus types. Glaxo said the additional efficacy could translate into approximately 11 to 16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against the two most common types alone. It is the first time for any cervical cancer vaccine that significant protection has been shown against pre-cancerous lesions not containing the two most common virus types, Glaxo said in a statement. "This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection ... beyond what had at first been anticipated," said Thomas Breuer, head of global clinical R&D at GSK Biologicals. Glaxo is waiting for approval in the U.S. market for Cervarix. U.S. approval was delayed in June.
Matrixx Initiatives, Inc. (Nasdaq: MTXX)-- On 07/06/09 Hagens Berman Sobol Shapiro announced that they are investigating reports of possible securities law violations by Matrixx Initiatives, Inc. (Nasdaq: MTXX), the makers of Zicam products, over the drug maker´s reported failure to provide the Food and Drug Administration (FDA) with more than 800 reports relating to the loss of sense of smell associated with the Zicam Cold Remedy intranasal products. According to the FDA, Matrixx was required to provide reports of adverse reactions to the agency per the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which President Bush signed into law Dec. 22, 2006. In a letter to Matrixx, the FDA informed Matrixx it concluded that certain Zicam products may pose serious risks to consumers who use them, and that Matrixx marketing practices violate several laws relating to the products. Previously, the company issued a release stating that they would defend themselves vigorously against all lawsuits.
Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD)-- On 07/06/09 the company announced that it is in the process of instituting an indefinite reduction in its workforce of approximately 350 employees in order to align its expenses with the current voluntary cessation of its manufacturing operations in connection with the recent action by the United States Food and Drug Administration (the "FDA"). The timing of the resumption of manufacturing operations, in whole or in part, depends on the outcome of discussions with the FDA. This should have no effect on distributed product sales that we market in the US. The Company may recall some employees to assist us in any remedial action plan that is developed based on such discussions.
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