Drug Industry Daily

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Pfizer will pay $60 million to resolve Foreign Corrupt Practices Act charges, but its proactive corporate compliance program allowed it to avoid even harsher penalties — including imposition of an outside corporate monitor.

Pfizer, Johnson & Johnson (J&J) and Elan’s termination of their late-stage program for investigational Alzheimer’s drug bapineuzumab following the second failed study may not negatively impact the companies but could foreshadow a bleak outlook for the future of Alzheimer’s drug development, analysts say.

Johnson & Johnson (J&J) is facing two new federal investigations into its marketing practices for a drug and a device, just as it is hammering out a settlement over off-label allegations for its antipsychotic Risperdal.

TAMPA, Fla. — Now that CBER’s all-electronic Direct Recall Classification (DRC) program has been extended to non-blood products, problems with biologic drugs flagged in electronic biological product deviation reports (eBPDRs) may trigger recalls of those products under the program.

Forest Laboratories has been hit with an untitled letter after two of its sales reps implied that weight loss while using Daliresp tablets — listed as an adverse reaction — could be beneficial for overweight chronic obstructive pulmonary disease (COPD) patients.