Drug Industry Daily

In observance of the Memorial Day holiday, Drug Industry Daily will not be published Monday, May 27. The next issue will be published Tuesday, May 28.

View the entire issue.

After three hearings on the pressing issue, House lawmakers have not reached a consensus on how to reform federal oversight of compounding pharmacies, casting doubt on whether Congress will be able to pass legislation the FDA says it wants.

The FDA’s plans to reassess the heart risks of GlaxoSmithKline’s (GSK) diabetes drug Avandia have generated conflicting industry-expert comments about the meeting’s purpose.

Johnson and Johnson (J&J) told industry analysts Thursday its Janssen subsidiary plans to submit at least 10 new molecular entities (NMEs) for regulatory approval and more than 25 brand extensions by 2017.

The FDA issued Shionogi an untitled letter for refusing to conduct a postmarketing study required as part of an NDA approval.

Language on traceability requirements in the European Commission’s proposed regulations for innovative “advanced therapies” — drugs based on gene therapy, somatic-cell therapy or tissue engineering — is overly broad and should be clarified in forthcoming guidance, drugmakers say.