Updates for: Cardium Therapeutics (AMEX:CXM), AstraZeneca plc (ADR) (NYSE:AZN), Amylin Pharmaceuticals (NASDAQ:AMLN), and Osteotech, Inc. (NASDAQ:OSTE)
Cardium Therapeutics Inc.
(AMEX:CXM)
On 12/3/09, Cardium (CXM) announced that its wholly-owned subsidiary (Tissue Repair Company) submitted a 510(k) premarket notification filing with the FDA seeking marketing clearance of its Excellagen product candidate. The 510k submission covers ExcellagenXL and ExcellagenFX, advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds. The 510(k) submission is based in part on positive findings from the Company’s Phase 2b Matrix clinical study demonstrating substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen, an enhanced, customized collagen-based gel matrix. ExcellagenXL is designed for use by health care professionals in a clinical setting and as an adjunct to standard of care topical wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. The ExcellagenFX kit is designed for use by health care providers in a clinical setting in the treatment of larger soft tissue or tunneling wounds that may occur with pressure, venous and diabetic ulcers, and surgical wounds. The estimated date of 3/3/10 for this entry reflects a 90-day review by the FDA for 510k submissions, but there is no firm decision date set for medical device reviews.
AstraZeneca plc (ADR)
(NYSE:AZN)
On 5/4/09, AZN filed a NDA seeking FDA approval for a combination of low-dose aspirin and esomeprazole (the generic name for the stomach medicine better known as Nexium or the purple pill). AZN is filing for approval of the combination product to reduce the risk of gastric (stomach) and/or duodenal (small intestinal) ulcers in patients at risk for this side effect of aspirin therapy. 3/4/10 is the PDUFA decision date for a standard, 10-month review.
The rest of this article is available to premium members only.
Login or Become a member
