Trials & Filings
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July 4, 2008
Relistor subcutaneous injection, a treatment for opioid-induced constipation (OIC), has been approved by the European Commission. The drug, developed by Wyeth and Progenics, is now approved in the 27 member states of the European Union as well as Ice…
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June 30, 2008
GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.
GSK will also submit Phase III efficacy study data from HPV-00…
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June 27, 2008
Centocor's BLA has been submitted to the FDA requesting approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Golimumab is the c…
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June 24, 2008
The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug's application was accepted in February 2008 and its deadline for action was this week. The new action date i…
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June 18, 2008
Pfizer has entered into an agreement with generics manufacturer Ranbaxy Laboratories Ltd. of India to settle all their patent litigation worldwide involving Lipitor. Under the terms of the agreement, Ranbaxy will have a license to sell generic versio…
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June 17, 2008
Genzyme Corp. has submitted marketing applications in both the U.S. and the EU for Mozobil, a drug intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and mul…
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June 16, 2008
Eli Lilly and Co. received approval from the FDA for Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor that has shown efficacy in reduci…
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June 9, 2008
Takeda Global R&D Center reported results from five Phase III studies of alogliptin as an oral treatment for type 2 diabetes, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). Alogliptin administered once…
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June 9, 2008
Amylin Pharmaceuticals, Lilly and Alkermes announced results from a 30-week study comparing the efficacy of exenatide once weekly (a long-acting release formulation of exenatide) to Byetta (the injectable version of exenatide), in type 2 diabetes. Pa…
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June 5, 2008
Merck Serono and development partner ZymoGenetics have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE) to evaluate the efficacy and safety of the drug for the treatment of SLE.
The study is being con…
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June 2, 2008
Amgen reported results from three denosumab studies in cancer patients. A Phase II study of metastatic patients previously treated with IV bisphosphonates found that denosumab normalized a key marker of bone resorption at a greater rate than with IV…
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May 29, 2008
Eli Lilly and Co. has submitted a sNDA to the FDA seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain. The submission is based on clinical trial results in chronic osteoarthritis pain of the knee and…
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May 29, 2008
Wyeth's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers has been granted Fast Track designation by the FDA. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD)…
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May 21, 2008
Sanofi-aventis and Regeneron Pharmaceuticals, Inc. have updated the clinical development program for aflibercept, and provided results from a Phase II study in advanced ovarian cancer. The companies reported that a recent study did not achieve its pr…
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May 20, 2008
KAI Pharmaceuticals has initiated enrollment in a Phase I study of KAI-1678, a first-in-class, isozyme-selective inhibitor of the epsilon protein kinase C pathway. KAI-1678 has been shown to be highly effective at reducing pain responses in a wide va…
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