Guilford Paclimer
Executive Summary
IND filing for paclitaxel injection product expected by year-end for ovarian cancer treatment. Paclimer's delivery system reduces the need for the high concentrations of paclitaxel in Bristol-Myers Squibb's Taxol that cause side effects, the company said. Paclimer would only require one or two injections during a 16-week period. Pre-clinical results of paclitaxel vs. Paclimer (4 mg/kg in both arms) showed 10% survival for paclitaxel at 120 days compared to 50% for Paclimer. At 40 mg/kg, paclitaxel showed 60% survival at 120 days compared to 90% for Paclimer
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth