Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.

The Swiss start-up will conduct a Phase II study on a compound that may reduce or prevent pre-term labor contractions, licensed from Merck Serono. It hopes to follow in the footsteps of another women's health company, PregLem, which provided exceptional returns with the same CEO and similar investors.

Two stem cell specialists will soon become the latest to take their chances on the public markets: Cardio3 Biosciences and Cellular Dynamics have both announced plans for initial public offerings (IPOs).

Shire Pharmaceuticals is known for its acquisitive buy-late, maximize-market strategy. Flemming Ornskov, the company's new CEO, plans to continue that approach, firstly by applying it to acquisitions in ophthalmology, an area in which he has specialized. However, with many recent acquisitions yet to mature to revenue-generation, and with big indication areas for Shire like ADHD at risk from generic and branded competition, the pressure is on the new CEO – even before he officially starts work.