FDAnews Drug Daily Bulletin

Drugmakers whose products are authorized in the EU can expect regular, risk-based and independent audits of their pharmacovigilance systems, and they should be prepared to communicate any safety risks with regulators and health professionals, according to two new guidelines related to the 2010 pharmacovigilance law that took effect July 2.

Bedford Laboratories is voluntarily recalling three lots of its chemotherapy drug leucovorin calcium after receiving complaints of crystalline particulates in a small number of vials.

The FDA issued an untitled letter to Validus Pharmaceuticals claiming the drugmaker’s website published misleading claims for its bipolar disorder drug Equetro.

Novartis drug Afinitor, expected to become a major seller for the Swiss drugmaker, was approved by European regulators to treat women with a certain type of breast cancer, the company said on Monday.

Gilead Sciences said it plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval for the medicine in 2014.

McKesson Corp. will pay $151 million to 29 states over allegations the company artificially raised Medicaid drug prices for years, the latest settlement over claims the pharmacy supply chain overcharged for prescription medications.

Arena Pharmaceuticals said it transferred marketing rights for the diet pill Belviq (lorcaserin HCl) to its partner Eisai, which will market the drug in the U.S. and apply for approval in other North and South American countries.

Tonix Pharmaceuticals announced that the clinical portion of a human study of a solution version of TNX-102 2.4-mg sublingual tablets has completed.

Roche is expected to make a dramatic growth in China.