Law­mak­ers on a bi­par­ti­san House pan­el con­veyed they are ready to tack­le Chi­na’s grow­ing dom­i­nance in the de­vel­op­ment of new med­i­cines and the in­gre­di­ents that un­der­pin the gener­ic drug mar­ket.

Dur­ing a Wednes­day hear­ing of the House Se­lect Com­mit­tee on Chi­na, wit­ness­es in­clud­ing Strand Ther­a­peu­tics CEO Jake Be­craft and 8VC part­ner Fran­cis­co Gimenez de­scribed Chi­na's grow­ing share of the glob­al clin­i­cal tri­al ecosys­tem. The core rea­son for the shift, they said, was that get­ting hu­man da­ta in the US takes too long and is too cost­ly com­pared to Chi­na, where it is cheap­er and quick­er to ac­crue.

Law­mak­ers ap­peared con­cerned with Chi­na’s gains and fre­quent­ly asked wit­ness­es how the US gov­ern­ment could help make up for lost ground.

John­son & John­son se­cured an FDA ap­proval on Wednes­day for a pso­ri­a­sis pill it ex­pects to be­come a megablock­buster.

Reg­u­la­tors gave the green light to icotrokin­ra, which will be brand­ed as Ico­tyde, in pa­tients 12 and old­er with mod­er­ate-to-se­vere plaque pso­ri­a­sis. There was no im­me­di­ate in­for­ma­tion on pric­ing, but J&J ex­pects peak sales to sur­pass $5 bil­lion an­nu­al­ly if it gets ap­proved in oth­er im­muno­log­ic dis­eases.

As a once-dai­ly oral op­tion, Ico­tyde is ex­pect­ed to com­pete with es­tab­lished pso­ri­a­sis drugs not just on ef­fi­ca­cy but al­so con­ve­nience. Both Ico­tyde and Ab­b­Vie’s Skyrizi — the run­away mar­ket leader with more than $17 bil­lion in sales last year — tar­get IL-23. But Skyrizi is an in­jectable drug, giv­en every 12 weeks. J&J’s Trem­fya is al­so a pso­ri­a­sis in­jectable.

As­traZeneca, Sanofi, Ab­b­Vie and No­var­tis will again face claims that they charged “un­law­ful­ly in­flat­ed prices” un­der the 340B drug dis­count pro­gram, af­ter the case was dis­missed in 2024.

On Tues­day, a fed­er­al ap­peals court re­vived the law­suit, in which Ad­ven­tist Health Sys­tem/West al­leges that the drug­mak­ers “know­ing­ly charged ma­te­ri­al­ly false, un­law­ful­ly in­flat­ed prices for their drugs” and that fed­er­al and state gov­ern­ments lost “hun­dreds of mil­lions of dol­lars” as a re­sult. Ad­ven­tist op­er­ates med­ical clin­ics and fa­cil­i­ties on the West Coast and Hawaii.

The health sys­tem op­er­a­tor brought the case on be­half of the gov­ern­ment. Drug­mak­ers are re­quired to of­fer dis­counts un­der the 340B pro­gram to cer­tain health or­ga­ni­za­tions that serve low-in­come pa­tients.

The FDA will now con­sid­er grant­i­ng its re­gen­er­a­tive med­i­cine des­ig­na­tions to ex­per­i­men­tal ther­a­pies even if they are on clin­i­cal hold, a shift in op­er­at­ing pro­ce­dures that could help small­er biotechs de­vel­op­ing cell and gene ther­a­pies to treat se­ri­ous con­di­tions.

The Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py (RMAT) des­ig­na­tion al­lows com­pa­nies to work ear­li­er and more close­ly with the FDA on an ap­pli­ca­tion, and it in­cludes all the ben­e­fits of the agen­cy's oth­er fast track and break­through des­ig­na­tion pro­grams.

While the agency pre­vi­ous­ly made clear in guid­ance and on its web­site that it will not grant an RMAT des­ig­na­tion "if an IND is on hold or is placed on hold dur­ing the des­ig­na­tion re­view," the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search said in an up­date this week that it's chang­ing course.