The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

With Bylvay approved last year for progressive familial intrahepatic cholestasis, Albireo looks to add an estimated 25,000 addressable patients to IBAT inhibitor’s label with strong Phase III data in ALGS.

VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.

Plus deals involving Glaukos/iVeena, Daré/Hennepin Life Sciences, Prevail/Lacerta, Chugai/Noile-Immune, Horizon/Q32, EpiAxis/Peptilogics and more.