Trials & Filings
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November 3, 2008
Pfizer received approval from the FDA for Toviaz extended release tablets for the treatment of overactive bladder (OAB) symptoms. The once-daily drug can help regulate the involuntary contractions of the bladder associated with OAB over a period of 2…
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November 3, 2008
Halozyme Therapeutics started a Phase II study of recombinant human hyaluronidase enzyme (rHuPH20) co-formulations with Humulin R (regular insulin human injection) and with Humalog (insulin lispro) in Type 1 diabetic patients. This study is designed…
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November 3, 2008
Cephalon, Inc., received approval from the FDA for Treanda for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-contai…
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October 24, 2008
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a NDA to the FDA for carisbamate, an investigational compound for the adjunctive treatment of partial onset seizures in patients 16 years of age and ol…
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October 10, 2008
Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
The agency indicated that du…
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October 7, 2008
Genentech and Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously…
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October 2, 2008
Merck has decided not to seek regulatory approval for taranabant, an investigational drug to treat obesity, and is discontinuing its Phase III development program for taranabant in obesity. The drug is similar to Acomplia, the Sanofi-Aventis obesity…
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September 30, 2008
Enzon Pharmaceuticals, Inc. received approval from the Commission of the European Communities for designation of Oncaspar-IV, the next-gen pegylated L-asparaginase, as an orphan medicinal product.
Orphan drug designation creates…
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September 24, 2008
Dyax Corp. has completed its BLA for DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review; if granted, this would set a target date of six months from receipt of the completed submission for the FDA…
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September 24, 2008
Takeda's U.S. subsidiary, Takeda Global Research & Development Center, Inc., has submitted an NDA for alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.
Alogliptin is a DPP-4 inhibitor; that class slows the inactivat…
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September 19, 2008
A new study of Novartis' MF59-adjuvanted vaccine showed that it rapidly induced protective antibody levels against diverse strains of avian flu. In the study, individuals immunized six years earlier with an MF59 adjuvanted H5N3 (clade 0) vaccine moun…
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September 16, 2008
GlaxoSmithKline and XenoPort, Inc. have submitted a NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the…
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September 15, 2008
Talecris Biotherapeutics, Inc. received approval from the FDA for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating…
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September 15, 2008
Pfizer updated safety and efficacy results for its investigational compound CP-751,871 in patients with non-small cell lung cancer (NSCLC). Results from a Phase II, randomized, non-comparative study showed 54% of patients with Stage III/IV treatment-…
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September 15, 2008
ProStrakan Group received approval from the FDA for Sancuso (Granisetron Transdermal System), the first patch to provide five days of control of nausea and vomiting for patients undergoing chemotherapy.
Chemotherapy-induced naus…
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