Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the
FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Bristol-Myers (NYSE: BMY): On 5/26/09, BMY announced that the FDA granted full approval for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate). Sprycel, an oral tyrosine kinase inhibitor, was originally approved under the accelerated approval regulations of Subpart H for new drugs for serious or life-threatening illnesses of the Food, Drug and Cosmetic Act, based on its effectiveness on hematologic and cytogenetic response rates in CML.
Hemispherx Biopharma (AMEX: HEB): Investors and chronic fatigue syndrome patients eagerly anticipating approval from the FDA on the Company's Ampligen may have to wait as much as 1-2 additional weeks for a decision according to the company's latest news release and Form 8K filing. Late-day trading has shares of HEB trading up 25% on the news as investors interpreted the development as a positive sign that approval for the drug may be coming. Read the full feature story on BioMedReports.com at this article link.
iCAD Inc. (NASDAQ: ICAD): On 5/26/09, ICAD submitted data to the FDA seeking 510(k) clearance of its VeraLook computer-aided detection technology for CT colonography (CTC), or "virtual" colonoscopy. CTC employs cutting-edge, advanced visualization technology to produce three-dimensional images that permit a thorough and minimally invasive evaluation of the entire colorectal structure.
