Trials & Filings
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November 30, 2007
AstraZeneca has completed enrollment of patients in the ZEST (Zactima Efficacy Study versus Tarceva) study, the first of four Phase III trials for the investigational once-daily oral anti-cancer drug vandetanib. Data from the study is expected in 200…
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November 27, 2007
Valeant Pharmaceuticals has reached full enrollment in RESTORE2, its second Phase III study of retigabine in the treatment of epilepsy. Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently publis…
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November 26, 2007
Akorn, Inc. has received approval from the FDA for its supplemental BLA for a unit-dose preservative-free Tetanus Diphtheria vaccine. The company expects to launch the vaccine in 1Q08.
In March 2007, Akorn announced that it had entered into an exc…
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November 26, 2007
MedImmune has begun dosing patients in the first Phase I trial of CAM- 3001, a fully human MAb targeting the alpha subunit of the granulocyte-macrophage colony stimulating factor receptor (GM-CSFR). The study is designed to evaluate the safety and to…
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November 21, 2007
Merck has suspended enrollment in clinical trials for the investigational Aurora kinase inhibitor, MK-0457, pending analysis of all efficacy and safety data for the drug. The decision was based on preliminary safety data, in which a clinical safety f…
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November 20, 2007
Genmab and GlaxoSmithKline initiated a Phase III program with ofatumumab to treat rheumatoid arthritis (RA). The program will begin with two studies (GEN410/OFA110635 and GEN411/OFA110634) in two patient populations. One study will include patients w…
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November 19, 2007
A Phase II trial of Genentech's Avastin showed that the MAb, administered alone or in combination with irinotecan chemotherapy, demonstrated encouraging six-month progression-free survival (PFS) and objective response rate in patients with relapsed g…
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November 12, 2007
Cephalon has submitted an sNDA to the FDA to market Fentora for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions. Breakthrough pain is characterized by its rapid onset, moderate-to-severe intensity, and rel…
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November 8, 2007
Merck Serono, a division of Merck KGaA, has submitted an MAA to the EMEA for sapropterin dihydrochloride (Kuvan in the U.S.) as an oral treatment for patients suffering from significant hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) or tetr…
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November 5, 2007
Daiichi Sankyo Co., Ltd. and Eli Lilly plan to begin a large Phase III trial in 2Q2008 to compare prasugrel, an investigational oral antiplatelet agent, against Bristol-Myers Squibb's clopidogrel (Plavix/Iscover) in medically managed patients with ac…
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October 29, 2007
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted an NDA for paliperidone palmitate to the FDA. The drug -- a once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophre…
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October 22, 2007
Schering-Plough released not-bad news about its novel oral thrombin receptor antagonist (TRA), as two Phase II studies in patients with vascular disease showed that TRA does not increase the rate of major or minor bleeding in patients with acute coro…
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October 12, 2007
Gilead Sciences, Inc. has submitted a sNDA to the FDA and a Type II variation to the EMEA for marketing approval of Viread for the treatment of chronic hepatitis B in adults. Viread is currently approved in the U.S. and EU for the treatment of HIV as…
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September 26, 2007
Genzyme Corp. and Bayer Schering Pharma AG began the first of two planned Phase III trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).
The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Ef…
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September 24, 2007
Pfizer received approval from the European Commission (EC) for Celsentri (maraviroc) for treatment-experienced HIV patients. Maraviroc, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients…
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