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Synta thinks it has the first Hsp90 inhibitor to have both meaningful cancer activity and a clean safety profile. It plans to start a Phase IIb/III trial of the compound for lung cancer next quarter.
Published on 3/21/2011
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Five Prime's FP-1039 FGF ligand trap is only in Phase I, but its safety profile and clinical potential were enough to command $50 million up front from Human Genome Sciences.
Published on 3/21/2011
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Neurologix is the first to report complete, positive Phase II results for a Parkinson's gene therapy, which aims to replace deep brain stimulation in patients with advanced disease.
Published on 3/21/2011
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Isis, the first company to test a compound against C-reactive protein in the clinic, is readying a Phase II study in multiple myeloma, and is looking to trials in RA and renal diseases as well.
Published on 3/14/2011
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Sangamo says first human data for SB-728-T demonstrate mechanistic proof of concept for autologous cell therapy to treat HIV/AIDS, and hopes to show similar results in viremic patients by year end.
Published on 3/7/2011
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By binding GD2 and releasing IL-2 at the tumor site, Apeiron believes APN301 will be able to deliver a one-two punch in neuroblastoma while avoiding the toxicities of systemic IL-2.
Published on 2/28/2011
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IOM's recommendations for NCI In an April 2010 report commissioned by the National Cancer Institute and the Institute of Medicine said the structure and processes of the entire cancer clinical trials system needs to …
Published on 2/28/2011
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NCI's Clinical Trials Cooperative Groups Program is said to be 'approaching a state of crisis.' But if there is broad agreement it must be fixed, the means for overhauling the system are controversial.
Published on 2/28/2011
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IOM's warning about NCI's Clinical Trials Cooperative Program was not the first, as similar red flags were raised in 1997 about the system, which comprises 3,100 institutions and more than 14,000 investigators.
Published on 2/28/2011
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Aveo believes tivozanib has first-line potential for RCC, and with new partner Astellas, hopes combining the small molecule with chemotherapy in other solid tumors will show its potential to replace Avastin.
Published on 2/21/2011
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Clinical Data got Viibryd approved for depression, where others had failed, after figuring out it didn't need a biomarker, just a modified dosing regimen.
Published on 2/7/2011
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The apoptotic effects of interferon alpha are well established and marketed versions of the cytokine are used to treat a variety of …
Published on 2/7/2011
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Next-generation obesity drug developers say they are aiming to avoid regulatory disaster by focusing on better targets and better preclinical approaches. But it will take a while to prove the case, as it's unlikely …
Published on 2/7/2011
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Obesity Reset Obesity pipeline Despite the regulatory hurdles, there are over 25 clinical programs ongoing in the obesity, including at least eight at large pharmas. (A) In development to treat obesity associated …
Published on 2/7/2011
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ChemoCentryx hopes to compete in the crowded psoriasis space with CCX832, an oral therapy against a novel target, which it aims to show will prove safer than biologics and older systemics.
Published on 1/31/2011
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Lilly's Solpura for exocrine pancreatic insufficiency could be the poster child for why it's a good idea to run head-to-head clinical trials.
Published on 1/24/2011
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Physicians say the full Phase III results for Ariad's ridaforolimus will probably determine whether a 3.1-week increase in median progression-free survival vs. placebo is also clinically significant in metastatic …
Published on 1/24/2011
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MedAvante says it can identify effective CNS drugs that might otherwise be scrapped for lack of efficacy by standardizing and centralizing patient assessments.
Published on 1/24/2011
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Noise-cancelling trials Feel the Noise In one schizophrenia trial, centralized raters from MedAvante Inc. (results on left) detected an efficacy signal in the investigational drug arms that local site raters did not…
Published on 1/24/2011
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Really insufficient PEP talk What ultimately became Solpura began as a classic low-hanging fruit idea when Altus Pharmaceuticals Inc. decided in the mid-1990s to develop a recombinant product that would compete with…
Published on 1/24/2011
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Bristol-Myers is amassing compounds capable of interrogating protein-protein interactions. The 'millamolecules' fall between small molecules and macromolecules in size and could give the benefits of both.
Published on 1/17/2011
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Comparing data from trials of competing JAK-2 inhibitors for myelofibrosis, it's clear Incyte is not only ahead in its development timeline, but also has Phase III results that set a high hurdle for others to beat.
Published on 1/17/2011
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Two deals give Mercator access to antibodies and peptides for targeting protein-receptor pairs identified using an in vivo, patient-based screening platform in-licensed from M.D. Anderson.
Published on 1/17/2011
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Entinostat failed a Phase II study, but Syndax believes it has a path forward in NSCLC based on data from a predefined subgroup with a marker for epithelial tumors.
Published on 1/10/2011
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The stem cell therapy company is readying a Phase I trial of a small molecule discovered using its CNS stem cell lines, with an initial focus on depression.
Published on 1/3/2011