In general news, President Trump flew to Paris to celebrate Bastille Day, meaning France’s President Macron realizes that Trump and his populist movement are a real force in France. Recall, Marie Le Pen almost won the election. In Washington, the Republican healthcare bill continues to stall. In Sports, Trump attended the women’s US Open golf tournament played at his New Jersey course, and 35-year-old Roger Federer won his record 8th Wimbledon.
In healthcare business news, Zimmer-Biomet’s (ZBH) CEO Dvorak resigned, pressured out by investors.
On the data front, the clinical hold on Concert Pharma’s (CNCE) alopecia trial was lifted.
From the FDA, Novartis (NVS) won approval from an advisory committee for its modified T-cell therapy, or CAR-T, to treat a rare relapsed or refractory pediatric B-cell acute lymphoblastic leukemia (ALL). JNJ won approval for Tremfya (guselkumab), yet another psoriasis drug.
Medtronic’s (MDT) CoreValve was approved for intermediate risk TAVR. Amicus Therapeutics (FOLD) was granted permission to file for approval on migalastat to treat Fabry disease without additional trials. And in other regulatory news, the DOJ and FBI made the largest ever series of arrest for criminal prescribing of pain pills. 115 licensed professionals (i.e. doctors, pharmacists, and nurses) were rounded up.