→ Just a few weeks after Clovis execs $CLVS agreed to pay more than $20 million to settle an SEC probe into the way they lied about the roci data, the company has won a breakthrough drug designation from the FDA that has investors in good humor. The BTD goes to Rubraca (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor-directed therapy and taxane-based chemotherapy. Its stock was up 10% in early trading Tuesday.
→ Synlogic’s board has decided to hand a permanent promotion to Aoife Brennan, who’s been running the show since Jose Carlos Gutiérrez-Ramos unexpectedly departed back in May. Brennan joined the company in 2016 as the chief medical officer.
→ Revamping its operations around the world, Novo Nordisk is now establishing a manufacturing site in Fremont, CA where it plans to make the stem cell therapies it’s putting through the clinic. “Our ambition is to develop stem cell-based therapies for a range of serious chronic diseases where we see significant unmet medical need,” said Jacob Sten Petersen, corporate vice president and head of stem cell research & development (R&D). “The reliable, large-scale supply of therapies is a vital component in our efforts, so I am delighted that we have established this facility that further demonstrates our strong commitment to this field.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,900+ biopharma pros who read Endpoints News by email every day.Free Subscription