Trials & Filings
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June 10, 2010
Human Genome Sciences, Inc. (HGS) has submitted a BLA to the FDA for approval to market Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE).
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June 3, 2010
Novartis Pharmaceuticals Corp.’s Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint in patients with advanced pancreatic neuroendocrine tumors (NET).
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June 3, 2010
Perrigo Co. has received approval from the FDA for its aNDA for OTC Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack, for the treatment of vaginal yeast infections.
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June 2, 2010
Amgen received approval from the FDA for Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
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June 1, 2010
Breast cancer drug to get accelerated review from FDA
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May 28, 2010
Amgen has received approval from the EMEA for Prolia (denosumab) for osteoporosis.
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May 27, 2010
Peregrine Pharmaceuticals achieved positive results from a Phase II trial evaluating bavituximab in combination with paclitaxel and carboplatin chemotherapy in patients with advanced breast cancer.
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May 26, 2010
Genzyme received marketing approval from the FDA for Lumizyme (alglucosidase alfa), produced at the 4000 L bioreactor scale at its manufacturing facility in Geel, Belgium.
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May 24, 2010
Biogen Idec and Abbott began enrollment in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX) in patients with relapsing-remitting multiple sclerosis (RRMS).
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May 20, 2010
Galapagos NV has initiated a Phase I trial for GLPG0492, its candidate drug for cachexia (loss of weight and muscle mass) and potentially other indications, such as Duchenne muscular dystrophy.
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May 19, 2010
Roche and Biogen Idec are discontinuing development of ocrelizumab in rheumatoid arthritis (RA) following analysis of the safety efficacy results.
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May 18, 2010
Revotar Biopharmaceuticals achieved positive results in Phase IIa Ozone Study with Bimosiamose for COPD.
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May 17, 2010
NeoPharm, Inc.’s IL13-PE38QQR (IL13-PE) has been granted orphan drug designation by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
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May 14, 2010
Neotropix began enrolling patients in a Phase II trial to assess the efficacy of the novel oncolytic virus, NTX-010, in patients with extensive stage small cell lung cancer (SCLC).
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May 13, 2010
Chimerix, Inc. has initiated a Phase I study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV).
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