FDAnews Drug Daily Bulletin

The FDA has notified Chelsea Therapeutics that its proposal for using initial results from an ongoing clinical trial of its Northera neurogenic orthostatic hypotension (NOH) drug is not enough to undo the complete response letter it received in March, the orphan-drug maker says.

The FDA has revised its guidance on testing a new drug’s genotoxicity to help drugmakers optimize the standard genetic toxicology battery and better predict potential human risks.

The FDA has approved its first weight-loss drug in 13 years, giving the OK to Arena Pharmaceutical’s Belviq, while requiring a hefty dose of postmarket studies on cardiovascular events.

Germany’s Merck KGaA suffered another setback for its cancer drug Erbitux, which in a trial failed to significantly increase the length of time advanced gastric cancer patients live without their condition worsening.

Italy’s powerful pharmaceuticals lobby has added its voice to a growing chorus of protests from interest groups against planned spending cuts by Mario Monti’s technocrat government.

The New Jersey Nutley Board of Commissioners held their regularly scheduled meeting Tuesday night, a week after pharmaceutical giant Roche announced it was leaving the township.

The Indian central government has decided to set up a venture capital fund which will promote research and development in the pharmaceutical sector.

China will revise its national essential drugs list this year to better meet people’s pharmaceutical demands, a health official said on Tuesday.

The shingles vaccine appears safe in older patients with immune-mediated diseases such as rheumatoid arthritis and Crohn’s disease, researchers reported.