There are new updates to BioMedReports.com's database of FDA and Clinical Trial Calendars.
The Medicines Company (NASDAQ: MDCO): The Company plans to enroll approximately 200 patients who discontinue Plavix (clopidogrel) in preparation for cardiac surgery. The aim is to show safe "bridging" of patients during the pre- and post-surgical period of risk. If successful, this approach may form the basis for subsequent regulatory filings, and MDCO also noted that discontinuation of the two CHAMPION trials will result in cost savings of $5M for 2009.
Questcor Pharma (NASDAQ:QCOR): QCOR received notice from the FDA that in order for its supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar Gel (repository corticotropin injection) for the treatment of infantile spasms to be considered a Complete Response, Questcor must perform additional statistical analyses relating to data from one study within the filing and submit this data to the agency.
Pozen (NASDAQ: POZN), AstraZeneca (NYSE: AZN): POZN announced that a decision was made by AZN to have Pozen file the New Drug Application (NDA) for FDA approval of PN 400. Pozen expects to file the NDA by mid-2009 and will receive a $10M milestone payment from AZN once the NDA is formally accepted for review by the FDA.
Emergent BioSolutions (NYSE: EBS): EBS announced that it has submitted a Development Plan for the company's Recombinant Protective Antigen (rPA) anthrax vaccine candidate to the FDA ahead of the 6/15/09 deadline in response to the Department of Health and Human Services (HHS) amendment to its request for proposal to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile.
Insmed (NASDAQ: INSM): INSM reported its quarterly operating results, including an update on the clinical development of IPLEX, for which the Company continues to expect preliminary Phase 2 results in the treatment of Myotonic Muscular Dystrophy (MMD) during 2Q09.
Jazz Pharma (NASDAQ: JAZZ): JAZZ reported its quarterly operating results and provided a clinical development update on JZP-6, which is the Company's sodium oxybate product currently in Phase 3 development for the treatment of fibromyalgia. JAZZ also provided guidance on submitting a NDA for JZP-6 by the end of 2009 seeking FDA approval in the treatment of fibromyalgia.
A full, detailed report on the developments and how they affect upcoming FDA decisions and approvals is available online.
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