Agency recommendation for randomized controlled trials in ultra-rare pediatric disease is unworkable for various reasons, say advocates and sponsors who seek use of the accelerated approval pathway based on changes in heparan sulfate levels.

Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.

Eisai and Lilly were the biggest winners at the 19^th Annual Scrip Awards in a glittering ceremony at the Dorchester in London’s Mayfair, hosted by the actor and comedian Jon Culshaw.

Smart Women’s Choice agrees to consent decree requiring it to halt production and sales of namesake brand product promoted as being hormone-free and with claims including “immobilizing sperm” and “preventing fertilization.” Related company with similar name, product and claims continues sales.