FDA’s Peter Marks says educating academics about CMC would help them understand why it is necessary to do things in a standardized way. He predicts the field will move away from individual manufacturing platforms in the next five to 10 years.

Daily notebook from the J.P. Morgan Healthcare Conference:  Roche expects continued high interest in partnering; Vir explains cost-cutting gives it a stronger base; bluebird provides Lyfgenia performance to date; Sage details Zurzuvae launch trajectory; and Madrigal lays out next steps in NASH. 

An uptick in deals and an improving macro-economic outlook laid the groundwork for a rosier sentiment across much of the industry at the annual health care conference.

Public Company Edition: Syndax grossed $230m in a follow-on public offering based on positive results for its menin inhibitor in leukemia, but the FOPO was an outlier relative to other companies, which relied on private placements, debt and other options to raise cash in a tough market.