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Fdanewsdrugdailybulletin

Oct. 2, 2012

Vol. 9 No. 193

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CDER Director’s Office May Take Over ‘Crisis’ Management of Drug Shortages

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. Read More

FDA Issues 48 Product-Specific Bioequivalence Guidances

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

HHS Hands FDA Responsibility for ClinicalTrials.gov Accuracy

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

FDA Approves Abbott Humira as Ulcerative Colitis Therapy

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. Read More

Cancer Trials Show One Year on Roche’s Herceptin Is Best

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. Read More

AVEO Seeks FDA Approval for Drug Designed to Treat Advanced Kidney Cancer

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. Read More

Phase III Trial Shows Crizotinib Superior to Single-Agent Chemotherapy for ALK-Positive Lung 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. Read More

Total Recall of Typhim VI

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. Read More

NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR for Once-Daily Treatment of ADHD

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