| |
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.
Disclosure: No positions.
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
Certain sections of this report contain forward-looking statements that are based on our reporters' expectations, estimates, projections and assumptions. Words such as "expects," "anticipates," "plans," "believes," "scheduled," "estimates" and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.
All forward-looking statements speak only as of the date of this report or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company's behalf are qualified by the cautionary statements in this section. BiomedReports.Com does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this report.
|
![BiomedReports.com Publishes New FDA Calendar Updates for Insmed and Jazz Pharma - FDA Calendar Updates for Insmed [NASDAQ: INSM], Jazz Pharma [NASDAQ: JAZZ] and others](https://www.przoom.com/images/nophoto.gif "BiomedReports.com Publishes New FDA Calendar Updates for Insmed and Jazz Pharma - FDA Calendar Updates for Insmed [NASDAQ: INSM], Jazz Pharma [NASDAQ: JAZZ] and others")
garza[.]biomedreports.com 
