The CDC’s vac­cine ad­vi­so­ry pan­el de­layed a Thurs­day vote on when chil­dren should re­ceive the he­pati­tis B vac­cine, the sec­ond time they’ve post­poned ac­tion in a pe­ri­od of con­fu­sion and frus­tra­tion over the lan­guage of the guid­ance.

The Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, whose mem­bers were re­placed whole­sale by HHS Sec­re­tary Robert F. Kennedy Jr. ear­li­er this year, is now sched­uled to vote on new he­pati­tis B vac­cine guid­ance on Fri­day.

The cause of the new de­lay was con­fu­sion about the vot­ing lan­guage and the amount of time mem­bers had to con­sid­er it. On Thurs­day, com­mit­tee mem­ber Joseph Hi­bbeln — a pro­fes­sor and psy­chi­a­trist — raised con­cerns with shifts in the vot­ing lan­guage, claim­ing that it had changed three times over three days. The ex­act lan­guage mem­bers were vot­ing on wasn’t avail­able to the pub­lic as it was be­ing de­bat­ed, but it has since been made avail­able.

The num­ber of child deaths al­leged­ly caused by Covid-19 vac­cines like­ly will be low­er than the 10 ini­tial­ly men­tioned in an in­ter­nal email from FDA vac­cines and bi­o­log­ics head Vinay Prasad, two agency sources fa­mil­iar with the in­ves­ti­ga­tion told End­points News.

One of the peo­ple, both of whom spoke on con­di­tion of anonymi­ty, said the num­ber of deaths will like­ly be eight or nine once the in­ves­ti­ga­tion is fi­nal­ized. The per­son al­so said that Prasad's in­ves­ti­ga­tion, as de­tailed in the email to CBER staff last week, has­n't de­fin­i­tive­ly con­firmed that the deaths were caused by the vac­cines.

Prasad claimed in the email that an agency re­view team looked at 96 deaths that oc­curred from 2021 to 2024, and "con­cludes that no few­er than 10 are re­lat­ed." Prasad said that "if any­thing, this rep­re­sents con­ser­v­a­tive cod­ing, where vac­cines are ex­cul­pat­ed rather than in­dict­ed in cas­es of am­bi­gu­i­ty. The re­al num­ber is high­er."

Large phar­ma com­pa­nies that have made “most fa­vored na­tion” deals with the White House will have un­til the end of Pres­i­dent Don­ald Trump’s cur­rent term to ful­fill some of their com­mit­ments to in­vest in the US, ac­cord­ing to a frame­work of the agree­ments re­viewed by End­points News.  

The doc­u­ment, ti­tled a “let­ter of agree­ment,” is a tem­plate that ap­pears to for­mal­ize agree­ments be­tween com­pa­nies and the US De­part­ment of Com­merce. Its au­then­tic­i­ty was con­firmed by mul­ti­ple sources in­volved in those ne­go­ti­a­tions.

The ex­act amounts com­pa­nies will have to in­vest in the US are be­ing ne­go­ti­at­ed in­di­vid­u­al­ly, ac­cord­ing to two drug­mak­ers in­volved in talks. At least one ex­pects to ful­fill the en­tire­ty of its multi­bil­lion-dol­lar pledge by the Jan. 1, 2029 dead­line.

A pi­o­neer­ing gene ther­a­py from Na­tion­wide Chil­dren's Hos­pi­tal is bring­ing rare op­ti­mism to a field that has long strug­gled to de­vel­op such treat­ments for cer­tain neu­rode­vel­op­ment dis­or­ders.

In Sep­tem­ber, 8-year-old Maxwell Freed be­came the first per­son to re­ceive a gene ther­a­py for SLC6A1, a rare con­di­tion that caus­es seizures, de­vel­op­men­tal de­lays and autism-like symp­toms, Na­tion­wide Chil­dren’s in Colum­bus, Ohio an­nounced Thurs­day. The med­i­cine has im­proved Maxwell’s mood, mus­cle tone and co­or­di­na­tion, en­abling a se­ries of firsts, in­clud­ing rid­ing a bike.

“He’s see­ing the world for the first time through a brain that is wak­ing up,” his moth­er, Am­ber Freed, told End­points News. “He’s much more in­ter­est­ed in the world around him.”

Cres­cent Bio­phar­ma made a set of sweep­ing moves Thurs­day morn­ing, no­tably with its strat­e­gy of bring­ing its PD-1xVEGF to Chi­na.

Boston-based Cres­cent signed a two-way deal with Kelun-Biotech, in which both com­pa­nies will have ac­cess to some of each oth­er­s' as­sets. Cres­cent said that clin­i­cal tri­al prepa­ra­tion is un­der­way and that it se­cured a $185 mil­lion pri­vate place­ment.

In­vestors ap­peared to ap­pre­ci­ate Cres­cen­t's moves. Its share price CBIO rose 15% in pre­mar­ket trad­ing.

The news be­gins with Cres­cent out-li­cens­ing the Greater Chi­na rights to its can­cer drug can­di­date CR-001 to Kelun-Biotech. Kelun will pay Cres­cent $20 mil­lion up­front and up to $30 mil­lion in mile­stones for the rights to the PD-1xVEGF drug can­di­date.