Ake­so Bio­phar­ma won first-line ap­proval in Chi­na for its lung can­cer drug ivonescimab, a new im­munother­a­py that it be­lieves will top Mer­ck­'s megablock­buster PD-L1 drug.

As part of the ap­proval, the com­pa­ny dis­closed the ad­di­tion­al da­ta from a piv­otal tri­al in which it went head-to-head against Keytru­da and won, re­veal­ing the first sur­vival da­ta from the ex­per­i­ment. Ivonescimab, a bis­pe­cif­ic an­ti­body that tar­gets PD-1 and VEGF, has quick­ly be­come one of the most close­ly watched can­cer drugs in de­vel­op­ment.

In the tri­al, an in­ter­im over­all sur­vival analy­sis showed that ivonescimab re­duced the risk of death by 22% com­pared with Keytru­da. The analy­sis took place ear­li­er than planned for the study, and be­cause of that was not sta­tis­ti­cal­ly sig­nif­i­cant. The haz­ard ra­tio was 0.77.

Ab­b­Vie CEO Rob Michael said the com­pa­ny will in­vest $10 bil­lion in the US over the next decade, as the threat of phar­ma­ceu­ti­cal-spe­cif­ic tar­iffs looms.

Ab­b­Vie an­nounced plans in its first-quar­ter earn­ings to add four new man­u­fac­tur­ing sites to its US net­work. It’s the lat­est phar­ma com­pa­ny to com­mit bil­lions of dol­lars to boost­ing its US foot­print. Ab­b­Vie CFO Scott Reents said po­ten­tial in­dus­try-spe­cif­ic tar­iffs are “dif­fi­cult to quan­ti­fy in the ab­sence of ac­tu­al pol­i­cy de­tails,” but added that Ab­b­Vie is “ac­tive­ly prepar­ing for a num­ber of po­ten­tial sce­nar­ios.”

“In terms of po­ten­tial mit­i­ga­tion in the near term, we could take in­ven­to­ry man­age­ment ac­tions or se­cure al­ter­nate sources of API,” Michael said.

FDA Com­mis­sion­er Mar­ty Makary is ramp­ing up his pub­lic pres­ence, re­cent­ly sit­ting for an in­ter­view with Meg­yn Kel­ly and par­tic­i­pat­ing in an HHS event on re­mov­ing some dyes from the Amer­i­can food sys­tem.

In an in­ter­view with PB­S' "New­sHour" co-an­chor and co-man­ag­ing ed­i­tor Am­na Nawaz on Thurs­day, Makary ex­pand­ed on his ef­forts to ex­pe­dite drug ap­provals, es­pe­cial­ly for rare dis­eases, and ad­dressed re­ports that HHS Sec­re­tary Robert F. Kennedy Jr. is con­sid­er­ing the re­moval of Covid-19 vac­cines from the child­hood vac­cine sched­ule. The in­ter­view was part of the World Econ­o­my Sum­mit host­ed by the out­let Se­mafor.

Here are four key take­aways from the in­ter­view:

• The ‘plau­si­ble mech­a­nism’ path­way and few­er ran­dom­ized stud­ies 

CHARLESTON, SC — HHS Sec­re­tary Robert F. Kennedy Jr. said Fri­day that 35 states had signed up to par­tic­i­pate in a new pay­ment mod­el meant to im­prove ac­cess to and low­er costs for gene ther­a­pies for sick­le cell dis­ease.

The lev­el of par­tic­i­pa­tion in the vol­un­tary mod­el is “un­prece­dent­ed” and rep­re­sents a “re­al win-win” for states and pa­tients with Med­ic­aid, Kennedy said dur­ing a short speech at the Na­tion­al Coun­cil of In­sur­ance Leg­is­la­tors’ spring meet­ing in Charleston, SC.

The pro­gram "il­lus­trates a broad­er prin­ci­ple that I want to re­al­ize through­out HHS. Peo­ple as­sume that bud­get cuts trans­late in­to worse ser­vice for ben­e­fi­cia­ries, and I don’t think it has to be that way,” he said. (Re­pub­li­can law­mak­ers have been con­sid­er­ing cuts to fed­er­al fund­ing for Med­ic­aid.) “When we adopt cut­ting-edge tech­nolo­gies and make tough but fair ne­go­ti­a­tions with in­dus­try, we can cut costs and im­prove pa­tient care.”