The FDA has placed vTv Therapeutics’ phase 3 trial for cadisegliatin on hold more than two years after the biotech stacked its remaining chips on the Type 1 diabetes drug.

NewAmsterdam Pharma’s drug reduced cholesterol in patients with a genetic disorder by 41% at Week 52, confirming the therapy’s efficacy but falling outside of the range shown in a previous study.

Earlier this month, Flagship Pioneering hinted that another Big Pharma may soon join its growing fleet of collaborators. Now, GSK has sailed into view.

Dexcom’s stock slid by about 40% following its second-quarter earnings report after the diabetes sensor maker said it saw not only fewer customers but also fewer dollars per customer—driving revenue below expectations and the company’s “high standards” both in the U.S. and internationally.

Chemomab Therapeutics has shared phase 2 results it claims show CM-101 is a triple threat in primary sclerosing cholangitis (PSC), simultaneously tackling fibrosis, inflammation and cholestasis. But the pitch fell flat with investors, who sent the biotech’s stock down around 18% when the market opened.

Just over a month after announcing its new Clinical Data Studio, Medidata has its first big customer. Eisai announced July 25 that it is incorporating Medidata’s data studio into its clinical trial management platform.

Charles Baum, M.D., Ph.D., who oversaw Mirati Therapeutics’ $5.8 billion sale to Bristol Myers Squibb last year, is taking the helm of young biotech Terremoto Biosciences.

Edwards Lifesciences is dropping about $1.6 billion on a pair of acquisitions to bolster its structural heart portfolio.

After 15 years as head of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., is retiring.