FDAnews Drug Daily Bulletin

The FDA is considering elevating staff that deals with drug shortages from the Office of New Drugs to the Office of the Center Director, the agency says.

The FDA has issued dozens of draft and revised draft product-specific guidances that detail its recommendations for bioequivalence (BE) studies to support ANDAs.

The FDA will begin policing compliance with clinical trial submission requirements for ClinicalTrials.gov under a policy change at HHS.

The FDA has approved Abbott’s Humira (adalimumab) for the treatment of adult patients with moderate to severe ulcerative colitis when certain other medicines have not worked well enough.

Extending treatment with Roche’s breast cancer drug Herceptin to two years from the one year current standard is not worthwhile, trial data showed Monday, but shortening treatment to six months also looks unlikely to benefit patients.

AVEO Oncology of Cambridge and Japanese drug maker Astellas Pharma Inc. said Friday that AVEO has submitted a new drug application to the US Food and Drug Administration for a potential treatment for advanced kidney cancer.

The results of a new Phase III trial show that crizotinib, a targeted therapy, is a more effective treatment than standard chemotherapy for patients with advanced, ALK-positive lung cancer, researchers said.

The Chinese Department of Health instructed a licensed drug wholesaler, Sanofi-Aventis Hong Kong Limited, to conduct a total recall of Typhim VI (Typhoid Vaccine) from the market because of a quality issue.

NextWave Pharmaceuticals, an emerging specialty pharmaceutical company, announced FDA approval of Quillivant XR (methylphenidate hydrochloride) for extended-release oral suspension, CII.