Dyax will complete its rolling BLA submission for its DX-88 investigational treatment for hereditary angioedema early in the fourth quarter, based on positive results from a second Phase III trial.
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ImClone Systems has treated its first patient in a Phase III clinical trial of IMC-1121B, its antivascular endothelial growth factor receptor-2 monoclonal antibody, in women with metastatic breast cancer.
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Bioniche Life Sciences has received positive feedback from its data safety monitoring committee for the company’s first Phase III clinical trial using Urocidin to treat non-muscle-invasive bladder cancer.
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Using polysaccharide technology licensed from Stellar Pharmaceuticals, Watson Pharma has successfully concluded its Phase III study with Uracyst for patients with interstitial cystitis (IC).
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Dendreon has started the second of two Phase II trials using Provenge, an investigational active cellular immunotherapy, for the treatment of advanced prostate cancer.
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Patients allergic to dust mites halved their consumption of inhaled steroids by using ALK-Abello’s investigational vaccine tablets in a Phase II/III study.
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Palatin Technologies completed its Phase IIa clinical trial of PL-3994, a long-acting natriuretic peptide receptor A agonist for treating heart failure.
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As part of a licensing agreement with Can-Fite BioPharma, Seikagaku (SKK) will begin a Phase I trial in Japan using Can-Fite’s CF101 to treat rheumatoid arthritis (RA).
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Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid is the management report that examines the most problematic areas in negotiating indemnification clauses. This report highlights the key topics you need to address and provides insight into the types of agreements that are generally accepted standards in the industry.
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Clinical Trial Inspections: How to Prevent a Bad Outcome is brought to you by RxTrials Institute. Discover how to confidently navigate the FDA’s inspectional process: before, during and after a GCP inspection. Use the clinical trial compliance tool created by a former FDA inspector, customize an auditing checklist and capture your most critical endpoint data, and put best practices to work when auditing and training your research staff.
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