Trials & Filings
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October 20, 2010
Boehringer Ingelheim wins approval from the FDA for Pradaxa, the first new oral anticoagulant in the U.S. in more than 50 years.
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October 15, 2010
Mylan Pharmaceuticals, Inc. received approval from the FDA for its ANDAs for the generic versions of antihypertensive drugs Hyzaar Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar Tablets, 25 mg, 50 mg and 100 mg.
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October 11, 2010
Curis, Inc. and Genentech have initiated a Phase II trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).
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October 5, 2010
Novartis has discontinued development of albinterferon alfa-2b for the treatment of chronic hepatitis C, and Mycograb, an antifungal agent to treat invasive candidiasis in adults.
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September 28, 2010
Pfizer has discontinued the SUN 1120 Phase III trial evaluating Sutent in combination with prednisone for advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen.
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September 16, 2010
GlaxoSmithKline and Genmab have decided to refocus the development program for ofatumumab in autoimmune indications.
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September 14, 2010
AMRI has selected a compound from its research program for the treatment of irritable bowel syndrome (IBS) to advance to preclinical testing.
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September 1, 2010
Archimedes Pharma Ltd. was granted marketing authorization from the European Commission for its lead product, PecFent, a fentanyl nasal spray for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid thera
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September 1, 2010
Allergan, Inc. received approval from the FDA for Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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August 27, 2010
Shire has been granted marketing authorization by the European Commission for VPRIV, a human cell line-derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.
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August 19, 2010
Human Genome Sciences and GlaxoSmithKline have been granted a priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE).
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August 19, 2010
CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months.
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August 17, 2010
Eli Lilly and Co. will stop development of semagacestat, a gamma secretase inhibitor in Phase III development as a potential treatment for Alzheimer's disease.
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August 10, 2010
Elan Corp. and Transition Therapeutics, Inc reported results from a Phase II study of ELND005 (Scyllo-inositol) in patients with mild to moderate Alzheimer’s disease.
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