Private Company Edition: TVM, Focus/MD Anderson and RA Capital launched new venture capital funds. Also, LianBio’s $310m crossover financing, AavantiBio’s Sarepta-backed $107m series A and Sirnaomics’ $105m series D led recent VC rounds. 

Tender deadline for Roche acquisition of Spark pushed back to 30 October; 21.4% of Spark shares tendered so far. Vertex further diversifies with fourth deal of 2019 – an RNA-targeted collaboration with Ribometrix.

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

US FDA's popular breakthrough therapy designation given to Proteon's vonapanitase for dialysis patients, Synthetic Biologics' ribaxamase to prevent C. difficile infection, and River Vision's teprotumumab for thyroid eye disease; Vericel's cell therapy for heart failure is designated a regenerative medicine advanced therapy.