CML Healthcare's NDA for a "novel formulation" of fenofibrate (Abbott's triglyceride-lowering agent TriCor) deemed "approvable" by FDA Jan. 13, company says. The agency requested additional details relating to chemistry, manufacturing and labeling for the NDA which was filed in December 2002. In March 2003, Fournier, the French company that licenses TriCor to Abbott, filed suit against CML Healthcare in Puerto Rico federal court. A U.S. federal appeals court recently upheld Chicago federal judge's noninfringement ruling on Teva's generic version of the drug (1"The Pink Sheet" March 31, 2003, In Brief)...

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...

Teva CEO Kåre Schultz believes his prediction is coming true for the Truxima biosimilar in-licensed from Celltrion, as he gave the latest update on Teva’s efforts to settle significant legal issues around the US opioid crisis.