Today Biogen Idec and Elan Corporation, plc announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels.
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Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.
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AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.
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GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.
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AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.
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Genentech, a member of the Roche Group, today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.
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AstraZeneca today announced the presentation of important new data from studies of FASLODEX (fulvestrant) Injection at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium taking place from 4-8 December at the Henry B. Gonzalez Convention Center, San Antonio, Texas.
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Food allergies are on the rise, affecting 15 million Americans. And according to a new study published in the December issue of Annals of Allergy, Asthma and Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI), pesticides and tap water could be partially to blame.
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Off-label use of tetanus–diptheria–acellular pertussis vaccine in senior patients results in no more adverse events than the tetanus and diphtheria vaccine, a US study shows.
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Seattle Genetics, Inc. announced today that ADCETRIS (brentuximab vedotin) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides (MF). MF is the most common type of cutaneous T-cell lymphoma (CTCL).
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Meat lovers living in the central and southern regions of the country might be opting for a vegetarian lifestyle if meat comes with an unwanted side of a life-threatening allergic reaction. According to a study presented at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), the lone star tick inhabiting these regions is the primary reason for what's known as a meat induced alpha-gal allergic reaction.
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Epinephrine is the first line of treatment for patients suffering from anaphylaxis, a life-threatening allergic reaction.
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Avoiding sweet treats like pumpkin bread and cookies this holiday season might not be necessary for children with egg allergies. New studies presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting found 56 percent of allergic children can tolerate baked hen's egg, while 55 percent outgrow their egg allergy entirely.
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Peanut allergies are rising among American children and one reason might be due to economic status. According to a new study presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, greater rates of peanut allergy are found in families with higher economic status. This supports the "hygiene hypothesis" of many allergists.
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Imagine a world where you could never dine away from home, wear makeup, smell of sweet perfumes or eat a large percentage of food on store shelves. According to allergists at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting that is kicking off today in Anaheim, Calif., that is the world for 2 to 3 percent of individuals living with a spice allergy.
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Santarus, Inc. and Pharming Group NV today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.
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AstraZeneca today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy. The Phase III study is designed to evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg in this patient population.
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Sanofi Pasteur, the vaccines division of Sanofi, presented today an overview of Phase II and Phase III clinical trials for its investigational quadrivalent influenza vaccine (QIV).
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Sanofi Pasteur, the vaccines division of Sanofi, announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for a quadrivalent formulation of its Fluzone (Influenza Virus Vaccine).
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Savient Pharmaceuticals, Inc. and its wholly owned subsidiary, Savient Pharma Ireland Limited, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for KRYSTEXXA for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
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