In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.

Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.

Named after Swiss mountains, Granite Bio AG emerged from stealth with $70 million in funds through a series B to advance two immunology treatments incubated at Versant Ventures.

Synthetic Design Lab Inc., which emerged from stealth with a $20 million seed round and a platform technology aimed at advancing the antibody-drug conjugate (ADC) space, began with its founders identifying a single clear goal: how to deliver more payload to a target cancer cell.

“They are not zombies, they are fallen angels.” That is view of Nick Johnston, a U.K-based banker who has come up with a new plan to rescue listed companies whose market capitalizations have fallen below the cash in hand after failures in clinical development programs.

Bioxodes SA is gearing up fundraising for a follow-up study to the newly released interim phase IIa results of its lead asset in preventing secondary damage after an intracerebral hemorrhagic stroke. Data from the first 16 patients in the phase IIa study show BIOX-101 hit its primary safety and secondary endpoints in an indication that has no approved treatment.