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  • Amneal, South Korea-based Hanmi enter GERD drug deal

    BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

  • FDA approves new use of Pfizer vaccine

    NEW YORK — The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

    Pfizer announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for children and adolescents ages 6 years to 17 years for active immunization against the 13 Streptococcus pneumonia serotypes the vaccine covers. For this group, Prevnar 13 is administered as a one-time dose to patients who have never received it.

  • FDA accepts application for Genzyme MS drug

    CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

    Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

  • CDC: Flu still strong across central U.S.

    ATLANTA — If the flu were a storm cloud, the influenza virus is hovering over America's Bread Basket on its way to the Southwest, according to data provided through the U.S. Outpatient Influenza-like Illness Surveillance Network. 

    The Centers for Disease Control and Prevention on Friday reported that 4.3% of patient visits reported through ILINet were due to influenza-like illness, above the national baseline of 2.2%. But as the map indicates, influenza rates are declining up and down the East Coast and is most virulent in Texas and states west.

  • New indication approved for Genentech drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

    The FDA announced the approval of Avastin (bevacizumab) combined with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy for treating colorectal cancer that has spread to other parts of the body, also known as metastatic colorectal cancer, or mCRC.

    The drug is also approved for treating lung cancer, kidney cancer and brain cancer.

  • FDA approves Gleevec for most common pediatric cancer

    SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

    The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

  • Johns Hopkins researchers track flu through Twitter

    BALTIMORE — "Too sick to go to work, but not sick enough not to tweet about it" Twitter users are helping to predict flu trends. Johns Hopkins researchers recently created a Twitter search method that helps differentiate between people merely tweeting about the flu in general and those who are actually sick, the university announced Thursday. The new tweet-screening method not only delivers real-time data on flu cases, but also filters out online chatter that is not linked to actual flu infections. 

  • Perrigo, Ther-Rx announce availability of Gynazole-1

    ST. LOUIS — Perrigo and a subsidiary of K-V Pharmaceutical Co. have launched a new drug for yeast infections in women, the two companies said.

    Perrigo and Ther-Rx Corp. announced the availability of Gynazole-1 (butoconazole nitrate vaginal cream) in the 2% strength for treating yeast infections in nonpregnant women.

    Ther-Rx has a partnership with Perrigo to manufacture the drug.

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