FDAnews Drug Daily Bulletin

Dendreon shareholders strafed the Seattle biotechnology company’s leadership with criticism at Wednesday’s annual meeting, upset at the stock’s 82 percent decline in the past year.

Raptor Pharmaceutical announced that the FDA has accepted for filing its new drug application (NDA) for its investigational drug candidate, cysteamine bitartrate delayed-release capsules (RP103), for the potential treatment of nephropathic cystinosis.

Competition in the eye drug market is heating up, with an experimental drug from private U.S. biotech Ophthotech showing impressive results when added to Roche’s Lucentis in a large mid-stage clinical trial.

Danish drugmaker Lundbeck said on Thursday it would cut around 600 jobs in its commercial organization in Europe to reduce costs.

Teva Pharmaceutical Industries said its multiple-sclerosis treatment administered three times a week reduced the annual relapse rate by more than 34 percent compared with a placebo in a one-year clinical trial.

The House appropriations subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending.

The EU Ombudsman June 4 criticized the European Medicines Agency’s (EMA) lack of transparency and guidelines for deciding when to require drugmakers to carry out pediatric clinical trials.

Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say.