Trials & Filings
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March 8, 2011
Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA.
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February 14, 2011
Genentech’s Phase III study evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint.
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February 14, 2011
BrainStorm Cell Therapeutics, Inc. has been granted orphan drug designation for its NurOwn autologous adult stem cell candidate for the treatment of amyotrophic lateral sclerosis (ALS), referred to as Lou Gehrig's Disease.
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February 14, 2011
BioSante Pharmaceuticals, Inc. achieved positive safety data in its Phase III program for LibiGel (testosterone gel) in development for the treatment of female sexual dysfunction (FSD) and hypoactive sexual desire disorder (HSDD) in menopausal women.
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February 14, 2011
Tarsa Therapeutics, Inc. has completed its global Phase III ORACAL trial with once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis.
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January 24, 2011
MuDelta to get accelerated review
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January 17, 2011
Abbott Laboratories has withdrawn its centralized marketing authorization application with Europe’s EMA for Ozespa, briakinumab, 100 mg solution for injection, for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to
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December 22, 2010
GlaxoSmithKline and Theravance have initiated a Phase IIb study to evaluate the efficacy and safety of GSK961081 (‘081), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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December 22, 2010
Corcept Therapeutics Inc. achieved positive results from its Phase III study of Corlux for the treatment of Cushing's Syndrome.
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December 10, 2010
Pfizer is voluntarily withdrawing Thelin (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in the EU, Canada and Australia, where the drug is approved.
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December 10, 2010
Genentech, a member of the Roche Group, achieved positive results from a Phase II study evaluating a combination of pertuzumab and Herceptin plus chemotherapy in women with early-stage, HER2-positive breast cancer.
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