CSL Behring dis­closed a "tem­po­rary glob­al stock­out" of its gene ther­a­py for he­mo­phil­ia B that it says could de­lay treat­ment for some pa­tients.

In a let­ter to the pa­tient com­mu­ni­ty pub­lished this week, Deb­o­rah Long, CSL se­nior vice pres­i­dent of med­ical af­fairs, said the short­age of Hem­genix “re­flects the com­plex­i­ty of man­u­fac­tur­ing gene ther­a­pies.” She wrote that there was no is­sue with safe­ty or ef­fec­tive­ness and that the com­pa­ny was work­ing with reg­u­la­to­ry bod­ies to en­sure sta­ble sup­ply of the ther­a­py mov­ing for­ward.

A com­pa­ny spokesper­son said in an emailed state­ment that “the glob­al stock­out is due to a pre­lim­i­nary test re­sult that is cur­rent­ly un­der in­ves­ti­ga­tion.”

As­traZeneca has added more de­tails on how it will use its $15 bil­lion bud­get to ex­pand in Chi­na — and the UK phar­ma is bet­ting on cell ther­a­py.

As­traZeneca said Thurs­day it will be build­ing a cell ther­a­py re­search cen­ter and a sep­a­rate fac­to­ry in Shang­hai, where it is head­quar­tered in Chi­na.

The re­search cen­ter will be home to ear­ly-stage re­search, in­clud­ing vi­ral vec­tor and plas­mid de­vel­op­ment, and man­u­fac­tur­ing for clin­i­cal-stage as­sets. The hub, to be named the As­traZeneca Gra­cell Cell Ther­a­py In­no­va­tion Cen­ter, re­flects the phar­ma's pur­chase of the cell ther­a­py biotech Gra­cell Biotech­nolo­gies an­nounced in 2023.

Al­so on Thurs­day, As­traZeneca said it signed a mem­o­ran­dum of un­der­stand­ing de­signed to sup­port clin­i­cal re­search and start­up com­pa­nies in Chi­na. The MOU will bring tal­ent from the Uni­ver­si­ty of Glas­gow and King's Col­lege Lon­don, to­geth­er with As­traZeneca, the Shang­hai Sci­ence and Tech­nol­o­gy Com­mis­sion and HS­BC.

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 the Chi­nese Com­mu­nist Par­ty, 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.

The bio­phar­ma in­dus­try is look­ing for cre­ative ways to cush­ion the ef­fect of the Trump ad­min­is­tra­tion’s “most fa­vored na­tion” deals on US pric­ing.

Two lawyers who work with bio­phar­ma com­pa­nies told End­points News that they’ve had an uptick in in­quiries on whether amend­ing li­cens­ing con­tracts could be a way to do so.

A typ­i­cal type of li­cens­ing agree­ment is when a drug de­vel­op­er li­cens­es an as­set to a large com­mer­cial part­ner in ter­ri­to­ries where the de­vel­op­er can't ex­e­cute the launch it­self, said Adam Gold­en, an M&A and IP trans­ac­tions lawyer at Fresh­fields. The phar­ma part­ner would roll out the prod­uct and pay roy­al­ties, which can be a per­cent­age of the drug’s sales, and mile­stone pay­ments back to the biotech.

Ter­raPow­er Iso­topes, a sub­sidiary of founder Bill Gates' nu­clear com­pa­ny Ter­raPow­er, is build­ing an ac­tini­um-225 fac­to­ry in Philadel­phia. Pro­duc­tion will start in 2029.

Ter­raPow­er Iso­topes said it re­viewed 350 po­ten­tial lo­ca­tions in the US and chose the Bell­wether Dis­trict in Philadel­phia due to its prox­im­i­ty to "crit­i­cal in­fra­struc­ture.” The com­pa­ny is al­so ex­pand­ing ca­pac­i­ty to a sep­a­rate site in Everett, WA, to make the same iso­tope.

Mean­while, Eli Lil­ly is in­vest­ing 20 bil­lion Japan­ese yen ($126 mil­lion) to grow its Seishin fac­to­ry in Kobe, Japan, which will in­clude new pro­duc­tion lines. The com­pa­ny will al­so con­struct a new ware­house at the site. The fa­cil­i­ty sup­plies drugs to the Japan­ese mar­ket.

In oth­er man­u­fac­tur­ing news: