FDAnews Drug Daily Bulletin

Two House Democrats asked the Government Accountability Office (GAO) to investigate the compounding pharmacy industry to look for gaps in federal and state oversight.

Health Canada has expanded the scope of a pilot project that uses foreign drug reviews to aid in its assessment of new drug submissions, also revising the draft guidance under which the pilot operates.

The FDA has approved a new indication for Celgene’s Abraxane in combo with carboplatin as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) for patients who can’t undergo surgery or radiation therapy.

The Food and Drug Administration has agreed to a priority, or six-month, review of Ariad Pharmaceuticals’ experimental leukemia drug ponatinib, the company said on Wednesday.

Studies with very large effect sizes were usually the result of small samples, with effects that diminished after additional trials were performed, researchers found.

A patient’s genetic makeup may explain the “placebo effect,” in which people perceive that a fake treatment makes them feel better, according to a study that may help researchers design better clinical trials.

The Italian Ministy of Health has prohibited the use and sale of four influenza vaccines produced by the pharmaceutical company Novartis.

AstraZeneca’s new boss Pascal Soriot didn’t mess about when on his first day on the job he announced the suspension of the drugs group’s $3.6 billion share buy-back program.

Lupin plans to launch at least 15 new generic products in the United States in the current fiscal year ending March 2013, as it looks to push up sales in the world’s biggest drug market.