FDA Com­mis­sion­er Mar­tin Makary sent an email to staff this week an­nounc­ing plans to fur­ther con­sol­i­date the agency’s op­er­a­tions out­side of med­ical prod­uct re­views and in­spec­tions.

Hu­man re­sources, ac­qui­si­tions, trav­el, bud­get, FOIA/dis­clo­sures, fa­cil­i­ties, com­mu­ni­ca­tions and IT would now fall un­der “a uni­fied ap­proach,” Makary wrote in the Wednes­day email re­viewed by End­points News.

It’s un­clear how many ad­di­tion­al po­si­tions would be cut with this con­sol­i­da­tion. Makary said the plan would “elim­i­nate du­plica­tive ser­vices, in­crease cross-com­mu­ni­ca­tions across the FDA and de­liv­er more con­sis­tent, ef­fi­cient and re­spon­sive sup­port” for the drug, bi­o­log­ics and de­vice cen­ters, among oth­ers.

Un­like the thou­sands of staff cuts in April, which were most­ly im­me­di­ate and fi­nal, Makary said that "no fi­nal de­ci­sions have been made" for this lat­est re­or­ga­ni­za­tion plan. He al­so said that any changes would re­quire "in­ter­nal re­view and ex­ter­nal no­ti­fi­ca­tion process­es," in­clud­ing with Con­gress and the pub­lic.

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee will meet on Ju­ly 17 to dis­cuss a po­ten­tial re­launch of GSK’s mul­ti­ple myelo­ma drug Blenrep.

The com­mit­tee will con­sid­er GSK's ap­pli­ca­tion to bring Blenrep back to the US rough­ly three years af­ter it was pulled from the mar­ket. GSK told End­points News in De­cem­ber that Blenrep could even­tu­al­ly gen­er­ate £3 bil­lion ($4 bil­lion) per year glob­al­ly in the sec­ond-line set­ting if it is ap­proved.

Blenrep won ac­cel­er­at­ed ap­proval in 2020 as a monother­a­py for fifth-line mul­ti­ple myelo­ma pa­tients, but GSK an­nounced two years lat­er that it failed a con­fir­ma­to­ry study. The drug was pulled from the US mar­ket in 2022 at the FDA’s re­quest, but now GSK is pur­su­ing a “fun­da­men­tal­ly dif­fer­ent pa­tient type,” the com­pa­ny's se­nior VP of US on­col­o­gy Kavya Gopal told End­points in De­cem­ber.

Just a few months ago, Chris Shibu­tani was ask­ing Bris­tol My­ers Squibb ex­ec­u­tives about their strat­e­gy dur­ing the drug­mak­er's quar­ter­ly earn­ings calls.

As of Mon­day, the re­cent­ly de­part­ed Gold­man Sachs re­search an­a­lyst will now be ask­ing ques­tions with­in the walls of Bris­tol My­ers. The long-time bio­phar­ma and health­care in­dus­try an­a­lyst is now the phar­ma gi­ant's chief strat­e­gy of­fi­cer.

"Hav­ing spent so many years as an an­a­lyst and be­ing on those calls — and be­ing fa­mil­iar with the is­sues, the tone and the di­a­logue — and I think it's with that lens that I look for­ward to be­ing a mem­ber of the team as we're tack­ling some of the is­sues in­ter­nal­ly," Shibu­tani said.

His re­mit will be broad, span­ning "op­er­a­tional ex­e­cu­tion" and steer­ing Bris­tol My­er­s' "ap­proach to ex­ter­nal part­ner­ships and in­sti­tu­tion­al col­lab­o­ra­tions, fos­ter­ing in­no­va­tion and dri­ving sus­tain­able growth," ac­cord­ing to the com­pa­ny's web­site.

As­traZeneca is fur­ther tight­en­ing its re­la­tion­ship with Chi­na, an­nounc­ing a new re­search part­ner­ship with CSPC Phar­ma­ceu­ti­cals on Fri­day.

CSPC will re­ceive $110 mil­lion up­front for the part­ners to de­vel­op pre­clin­i­cal oral can­di­dates for dif­fer­ent chron­ic dis­eases, in­clud­ing one small mol­e­cule ther­a­py for an undis­closed im­muno­log­i­cal dis­ease, ac­cord­ing to a Fri­day re­lease.

CSPC will use its AI drug dis­cov­ery tech­nol­o­gy to study pro­tein bind­ing pat­terns. As­traZeneca will have the ex­clu­sive rights to li­cense and com­mer­cial­ize the as­sets glob­al­ly.

CSPC is el­i­gi­ble to re­ceive up to $1.62 bil­lion in de­vel­op­ment mile­stones and up to $3.6 bil­lion in sales mile­stone pay­ments. CSPC may al­so get sin­gle-dig­it roy­al­ties de­pend­ing on the an­nu­al sales of the as­sets.