FDA May Seek Blanket Consent Of Industry For Release Of Trade Secret Info
FDA is seeking alternatives to the current practice of obtaining industry consent on a case-by-case basis in order to share confidential commercial information and trade secrets with foreign governments, FDA Associate Director for International Agreements Merton Smith said at a Dec. 8 public meeting.
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Bristol seeks injunction against Immunex paclitaxel ANDA, citing infringement of two Taxol use patents.
BRISTOL SEEKS INJUNCTION AGAINST IMMUNEX PACLITAXEL ANDA (75- 184) in a lawsuit filed Jan. 8 in Newark, N.J. federal court. The suit claims that the Immunex application for paclitaxel violates two patents covering a three-hour infusion schedule for Bristol-Myers Squibb's $941 mil. oncology product Taxol. The use patent runs through August 2012, almost 20 years after the approval of Taxol in the U.S. ("The Pink Sheet" June 30, 1997, p. 8).
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