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FDA, Clinical Trial Calendars: Cancer Drug Updates from ASCO

Bullish Bankers (June 5th, 2009) Writes:

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.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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CuraGen Caught in the Middle – Analyst Blog

Zacks Market Commentaries (April 9th, 2009) Writes:
CuraGen Caught in the Middle - Hold Rating Maintained Future remains uncertain under strategic initiativesRecently, CuraGen Corp. (CRGN) declared that it is undertaking a review of a broad range of strategic alternatives to enhance shareholder value.The company revealed that these alternatives may range from selling or licensing CR011, the company's lead drug candidate, to acquiring additional assets or business lines, to selling the company. CuraGen will retain an investment bank to assist the Board with its strategic review.The company has retained JSB-Partners to identify potential acquirers of its drug candidate CR011-vcMMAE. CR011-vcMMAR is under phase II studies for advanced melanoma and breast cancer. In an ongoing phase II multi-center study in heavily pretreated patients with breast cancer, CR011 is well tolerated and there is early evidence of activity. Phase II program in melanoma also continues to show promising activity. ...

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