SILVER SPRING, Md. – The FDA Tuesday began facing some of the complexities it must deal with in developing regulations and guidelines for makers of follow-on biologics, or biosimilars, as various stakeholders in eight-minute presentations at a public meeting spelled out some of their ideas and concerns, such as whether biosimilars should carry the same generic-type name, known officially as the international nonproprietary name (INN), as the innovator drugs on which they are based. (BioWorld Today)

WASHINGTON – While an FDA complete response letter (CRL) is generally bad luck for most companies, the one Vivus Inc. received for its experimental weight-loss drug Qnexa (phentermine/topiramate) failed to spook investors Friday. (BioWorld Today)