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Revised Organogenesis/Novartis Deal Ensures Sure-Footing For Vitrix Trials

This article was originally published in The Gray Sheet

Executive Summary

Organogenesis plans to enter pivotal clinical trials for its Vitrix living dermal replacement for deep diabetic foot ulcers this spring after amending a 1996 exclusive marketing agreement with Novartis covering Apligraf, announced Feb. 26.

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Advanced Tissue Sciences

Firm announces submission of a premarket approval application to FDA for its Dermagraft wound dressing to treat diabetic foot ulcers. Clinical trials for the Dermagraft, which will be marketed by Smith & Nephew, indicate that the product heals significantly more ulcers than control treatment, the firm says in an Aug. 25 release. Competitor Organogenesis received an approvable recommendation from FDA's General and Plastic Surgery Devices panel in May (1"The Gray Sheet" May 15, 2000, p. 8)

Sun's Halol Site Faces FDA Action

FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.

Dr Reddy’s And Hikma Win Big On US Vascepa Patents

In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.




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