Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...

The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which first won FDA approval in 1986. “Facing the threat of generic competition to its lucrative franchise, ViroPharma inundated the FDA with regulatory and court filings—forty-six in all—to delay the FDA’s approval of generic Vancocin Capsules. That number is, by far, the mo...

In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week. FDA's drug review process has long been recognized as the gold standard globally (FDA even mentioned that gold standard moniker in congressional testimony ) and as recently as 2008, ...

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has issued a report declining to recommend Shire's Elvanse (Lisdexamfetamine dimesylate) for the treatment of attention deficit/hyperactivity disorder (ADHD).  The drug has been approved in Germany since March 2013 as part of a comprehensive ADHD treatment program in children aged six years and over when response to previous treatment with the drug methylphenidate was inadequate.  The basi...

Biopharmaceutical manufacturer Shire withdrew its Biologics License Application (BLA) for Fabry drug Replagal (agalsidase alfa) after the US Food and Drug Administration (FDA) indicated that the company needed to conduct more clinical trials. Ireland-based Shire's withdrawal of its application on 15 March was reportedly due to the perception that FDA's demands would create a "significant delay" that would push back any possible approval of the product by years. FDA has ...