Drug Industry Daily

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The FDA plans to hold a two-day public meeting in July on the challenges of standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products — part of a commitment the agency made to drugmakers under the most recent user-fee agreement.

The FDA issued two enforcement alerts Tuesday highlighting an ever-present quality hurdle for drugmakers: keeping particulates out of their products.

Pfizer has halted its Phase III study of inotuzumab ozogamicin to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma, putting a slight dent in the drugmaker’s oncology pipeline.

A new study on direct-to-consumer (DTC) marketing of statin drugs suggests the prevalence of such ads promotes over-diagnosis in patients that may not be at risk for cardiac events.

Deston Therapeutics’ three-year dispute with the FDA appears to have reached the end of the road after the agency Monday denied Destin’s request to allow it to sell an unapproved drug.

Australia’s Therapeutic Goods Administration (TGA) Tuesday released revisions to 2,000 good manufacturing practice (GMP) codes that apply to biologic drugs, blood and tissue components and cellular therapy products.