The Trump ad­min­is­tra­tion has been barred from car­ry­ing out its sweep­ing plan to re­struc­ture and down­size the De­part­ment of Health and Hu­man Ser­vices, fol­low­ing a court or­der that al­so ap­plies to about 20 oth­er fed­er­al agen­cies.

The late Thurs­day de­ci­sion by a Cal­i­for­nia judge ex­tends an or­der halt­ing HHS Sec­re­tary Robert F. Kennedy Jr.’s plan, which called for con­sol­i­dat­ing the health agency from 28 di­vi­sions in­to 15, and fir­ing about 10,000 full-time em­ploy­ees. That ef­fort has led to mass de­par­tures at the FDA and has sparked con­cern that the changes could cause de­lays and oth­er dis­rup­tions with drug reg­u­la­tion.

The pre­lim­i­nary in­junc­tion grant­ed by Dis­trict Judge Su­san Ill­ston ap­plies to HHS and oth­er agen­cies across the fed­er­al gov­ern­ment. It blocks them from "fur­ther im­ple­ment­ing" re­duc­tion in force and re­or­ga­ni­za­tion plans to the ex­tent that they would ex­e­cute di­rec­tives from the White House or the Of­fice of Man­age­ment and Bud­get and Of­fice of Per­son­nel Man­age­ment.

Gilead’s Trodelvy has passed an­oth­er late-stage test in cer­tain pa­tients with metasta­t­ic triple-neg­a­tive breast can­cer (TNBC) — a win the com­pa­ny says could pave the way for the drug to be­come a foun­da­tion­al treat­ment in the ag­gres­sive dis­ease.

The TROP2-di­rect­ed ADC pro­duced a “high­ly sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful im­prove­ment” in the pro­gres­sion-free sur­vival pri­ma­ry end­point of the Phase 3 AS­CENT-03 study, ac­cord­ing to a Fri­day re­lease.

The study com­pared Trodelvy with physi­cian’s choice of chemother­a­py in 540 peo­ple with first-line lo­cal­ly ad­vanced, in­op­er­a­ble, or metasta­t­ic TNBC. The pa­tients are ei­ther PD-L1 neg­a­tive or in­el­i­gi­ble for im­munother­a­py. Over­all sur­vival da­ta were not ma­ture at the time of the analy­sis.

Ku­ra On­col­o­gy said one-quar­ter of pa­tients with cer­tain forms of ad­vanced acute myeloid leukemia went in­to com­plete re­mis­sion af­ter re­ceiv­ing its tar­get­ed ther­a­py.

In 112 pa­tients from both its Phase 1b and Phase 2 stud­ies who re­ceived ziftomenib, 25% achieved com­plete re­mis­sion ei­ther with full or par­tial hema­to­log­ic re­cov­ery. This oc­curs when some blood counts haven’t ful­ly re­cov­ered, but pa­tients don’t re­quire blood trans­fu­sions as fre­quent­ly as they once did. Over­all, 35% of pa­tients re­spond­ed to treat­ment.

In the Phase 2 study alone, 23% of 92 pa­tients achieved com­plete re­mis­sion with full or par­tial hema­to­log­ic re­cov­ery. That meant the study met its pri­ma­ry end­point, with a p-val­ue of p=0.0058.

The KOMET-001 study en­rolled pa­tients with acute myeloid leukemia that re­turned or stopped re­spond­ing to treat­ment. The pa­tients in the study had leukemia with NPM1 mu­ta­tions, which ac­count for around one-third of AML cas­es.