Bear Stearns Healthcare Conference, In Brief
Executive Summary
Abbott D2E7 advisory committee?: Abbott has "not heard anything at all" about a possible early December FDA advisory committee meeting for its anti-TNF monoclonal antibody D2E7 (adalimumab), CFO Thomas Freyman told Bear Stearns healthcare conference in New York City. Abbott does not believe "having a panel or not having a panel is going to impact our timing at all in terms of product launch." In a separate Bear Stearns presentation, Enbrel marketer Amgen Investor Relations Director Anna McDermott-Vitak said she "would be surprised" if D2E7 was not the subject of an advisory committee meeting. Abbott submitted a BLA for D2E7 in rheumatoid arthritis April 2; the company expects to launch adalimumab in the first half of 2003...
You may also be interested in...
Tricor noninfringement ruling upheld
U.S. federal appeals court upholds Chicago district court judge's noninfringement ruling on Teva's generic version of Abbott's Tricor (fenofibrate) capsules. Teva began marketing a generic of the cholesterol agent after the lower court's March 2002 ruling. In response, Abbott launched a campaign to switch Tricor capsule users to tablets (1"The Pink Sheet" Sept. 30, 2002, p. 27)...
Tricor noninfringement ruling upheld
U.S. federal appeals court upholds Chicago district court judge's noninfringement ruling on Teva's generic version of Abbott's Tricor (fenofibrate) capsules. Teva began marketing a generic of the cholesterol agent after the lower court's March 2002 ruling. In response, Abbott launched a campaign to switch Tricor capsule users to tablets (1"The Pink Sheet" Sept. 30, 2002, p. 27)...
Teva’s Generic Remeron Exclusivity Cut To Five Months By FDA Rules
Teva's generic Remeron (mirtazapine) will have only five months of marketing exclusivity from its approval date due to FDA's current interpretation of the trigger for first-to-file 180-day marketing exclusivity under the Waxman/Hatch Act, Teva reported in its Feb. 18 earnings teleconference