Protocols

Novo Nordisk blueprints new stem cell manufacturing site; Clovis bags a BTD for Rubraca

→ 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.”


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