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Join FDAnews Wednesday, March 14, for "Strategies to Defend Against Generic Patent Challenges." In this 90-minute interactive audioconference, founder Paul Berghoff and partners Aaron Barkoff and Joshua Rich of McDonnell Boehnen Hulbert & Berghoff will present the strategies critical to your company's defense against patent challenges. On March 15, join FDAnews for "Off-Label Promotion: Prepare for Increased Enforcement." In this 90-minute audioconference with Q&A session, noted attorney Alan Minsk will describe the issues to consider when interacting with healthcare professionals and provide strategies to minimize the risk of off-label promotion violations.
Pfizer announced that the FDA has approved Lipitor to reduce the risk of nonfatal heart attacks, fatal and nonfatal strokes, certain types of heart surgery, hospitalization for heart failure and chest pain, all in patients with heart disease.
Alkermes has completed patient enrollment in a Phase I/II clinical study of ALKS 29, the company's undisclosed oral compound for the treatment of alcohol dependence.
Phenomix has announced the completion of a multinational Phase IIa clinical trial of PHX1149, a novel orally administered inhibitor of DPP4 for the treatment of Type 2 diabetes mellitus.
Replidyne has completed its Phase II clinical trial using faropenem medoxomil in pediatric patients with acute otitis media, a common infection of the middle ear.
Savient Pharmaceuticals announced it has reached its Phase III enrollment target of 200 patients in its two placebo-controlled six-month clinical trials.