FDAnews Drug Daily Bulletin

Clinical trial sponsors could have an easier time qualifying trial sites and training investigators as a new Big Pharma initiative aims to standardize these procedures and support mutual recognition of qualification and training.

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials.

Following setbacks in recent months for Janssen’s blood-clot drug Xarelto, the company has responded to an FDA complete response letter (CRL) on one sNDA for the drug and has re-submitted a separate sNDA.

An experimental drug designed to treat a genetic condition that is the most common cause of inherited mental retardation helped patients develop better social skills, according to a small study published in a major medical journal Wednesday.

European regulators on Friday recommended approval of a Novartis’ drug Votubia for the treatment of non-cancerous kidney tumors in patients with a rare genetic disease known as tuberous sclerosis complex.

Acton Pharmaceuticals said it has secured approval from the U.S. Food and Drug Administration of its supplemental New Drug Application for an inhaled steroid to treat asthma.

Iowans don’t have to travel far too find clinical trials of new medications being developed by pharmaceutical makers.

A Philadelphia judge thwarted an attempt by Johnson & Johnson attorneys to prevent an Inquirer reporter from entering a courtroom during jury selection Thursday for a Risperdal trial scheduled to start Monday.

Despite concerns of a global economic slowdown, the Biotech Industry has impressed investors with strong gains in 2012.