Trials & Filings
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March 13, 2009
Pfizer's Phase III trial of Sutent has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, or pancreatic neuroendocrine tumors.
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March 10, 2009
Eurand's EUR-1073 has been granted orphan drug designation for the treatment of ulcerative colitis in pediatric patients. Orphan drug status is granted to promote the development of drugs for diseases that affect fewer than 200,000 patients.
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March 3, 2009
Auxilium Pharmaceuticals, Inc. has submitted a BLA to the FDA for Xiaflex (clostridial collagenase for injection), a novel orphan-designated biologic for the treatment of Dupuytren's contracture.
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February 27, 2009
Genzyme received approval from the FDA for Synvisc-One (hylan G-F 20), for the relief of pain associated with osteoarthritis (OA) of the knee.
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February 24, 2009
Pfizer is terminating Phase III development programs for the investigational compounds esreboxetine for fibromyalgia and PD 332,334 for generalized anxiety disorder (GAD), following a review of the development and commercial portfolios in the Primary Care
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February 24, 2009
MAP Pharmaceuticals’ initial Phase III trial of Unit Dose Budesonide (UDB) for the potential treatment of pediatric asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline in nighttime and daytime symptom scores,
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February 9, 2009
GTC Biotherapeutics and Ovation Pharmaceuticals, Inc. received approval from the FDA for ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
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February 6, 2009
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted multiple applications to the FDA for the treatment of schizophrenia.
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February 2, 2009
Pfizer has discontinued a Phase III study of its investigational drug axitinib for the treatment of advanced pancreatic cancer. Based on an interim analysis, an independent Data Safety Monitoring Board (DSMB) found no evidence of improvement in the p…
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January 23, 2009
Merck Serono's Phase III CLARITY trial of its oral formulation of cladribine met the two-year primary endpoint of clinical relapse rate reduction in patients with relapsing-remitting multiple sclerosis (MS).
The two…
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January 23, 2009
Alnylam Pharmaceuticals' IND application for ALN-VSP has been cleared by the FDA to begin enrolling patients in a Phase I trial. ALN-VSP, an RNAi therapeutic for the treatment of liver cancers, including hepatocellular carcinoma and other solid tumor…
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January 22, 2009
Janssen-Cilag received approval from the European Commission for Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or are intolerant to other systemic therapies including ciclosporin, m…
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January 21, 2009
Roche received approval from the European Commission for RoActemra (tocilizumab, known as Actemra outside of the EU), to treat patients with rheumatoid arthritis (RA). RoActemra, in combination with methotrexate (MTX), is indicated for the treatment…
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January 19, 2009
Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal wome…
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January 19, 2009
The Multiple Myeloma Research Consortium (MMRC) and Merck initiated a Phase IIb study of Zolinza (Merck's vorinostat), an oral histone deacetylase (HDAC) inhibitor, in combination with Velcade (Millennium's bortezomib) for Injection, a proteasome inh…
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