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Isis Pharmaceuticals has announced data from a Phase I study in which ISIS 301012 produced rapid reductions of its target, apoB-100, with concomitant reductions in low density lipoprotein (LDL or "bad" cholesterol).
Corautus Genetics has reported that the independent data monitoring committee (DMC) has recommended, as the result of its second scheduled interim safety analysis, the continuation of GENASIS ("Genetic Angiogenic Stimulation Investigational Study").
Nymox Pharmaceutical has announced that interim safety analysis of its ongoing multicenter Phase II trial of NX-1207 has revealed no serious drug side effects.
Myriad Genetics has begun enrollment for its Phase III trial of Flurizan in patients with mild stages of Alzheimer's disease is proceeding on schedule.
DOV Pharmaceutical announced it has initiated a Phase III clinical trial of bicifadine, its novel analgesic, in the treatment of postoperative pain following vaginal hysterectomy.
Join FDAnews Thursday, Aug. 18, for "Cross-Labeling Combination Products: Case Studies and Strategies for Success." David Fox and Jeffrey Shapiro will discuss primary mode of action and cross-labeling -- two of today's most divisive regulatory issues affecting combination products. On Aug. 23, join FDAnews for "CDISC's Study Data Tabulation Model: Learn the Basics and Benefits of Data Standards." Experts Gary Walker and Wayne Kubick will explain what CDISC is, what the term "data standards" means, and how sponsor companies and regulatory staff can benefit from standardized data.
CollaGenex Pharmaceuticals has announced that the U.S. Patent and Trademark Office has published on its website that U.S. patent application, serial no. 10/117,709, has been allowed.
Elusys Therapeutics, a developer of targeted anti-infective therapeutics, announced that it has been awarded an additional $5.4 million from the U.S. Government for the continued development of Anthim, the company's antibody therapeutic for the prevention and treatment of anthrax infection.
The FDA has extended an emergency-use-authorization (EUA) for military use of the anthrax vaccine by individuals who face a heightened risk of exposure to the toxin.
Biogen Idec and Protein Design Labs have formed a broad collaboration for the joint development, manufacture and commercialization of three Phase II antibody products.