Rick Paz­dur, the head of the FDA's drug of­fice, is ex­pect­ed to leave the agency less than a month af­ter step­ping in­to the role.

His ex­it comes af­ter he was per­son­al­ly lob­bied by Com­mis­sion­er Mar­ty Makary to take the job, and was giv­en as­sur­ances that he would be shield­ed from some of the chaot­ic dy­nam­ics that have af­fect­ed oth­er parts of the FDA, ac­cord­ing to pre­vi­ous re­port­ing by End­points News.

But he quick­ly clashed with Makary over a new Na­tion­al Pri­or­i­ty Vouch­er pi­lot pro­gram, say­ing that it may be il­le­gal. And he pushed back on at­tempts by Makary’s re­quests for la­bel changes and to pull cer­tain un­spec­i­fied drugs, End­points has re­port­ed.

WuXi AppTec’s re­prieve from a Wash­ing­ton crack­down may not last.

The Pen­ta­gon has re­port­ed­ly con­clud­ed WuXi AppTec should be added to a list of com­pa­nies that aid the Chi­nese mil­i­tary. Such a des­ig­na­tion would height­en scruti­ny of the com­pa­ny, and once again make it a tar­get of the pro­posed Biose­cure Act that seeks to re­strict Chi­nese bio­phar­ma con­trac­tors.

A let­ter sent Oct. 7 by Deputy De­fense Sec­re­tary Stephen Fein­berg to the heads of con­gres­sion­al de­fense com­mit­tees rec­om­mend­ed adding eight com­pa­nies, in­clud­ing WuXi AppTec, to the Pen­ta­gon’s so-called 1260H list, Bloomberg News re­port­ed. It’s un­clear why Fein­berg rec­om­mend­ed WuXi AppTec for the list, and the Pen­ta­gon did not re­spond to a re­quest for com­ment.

The let­ter, which has not been made pub­lic, re­port­ed­ly did­n't in­clude the re­lat­ed com­pa­ny WuXi Bi­o­log­ics.

The Amer­i­can Hos­pi­tal As­so­ci­a­tion has asked a fed­er­al court to block a con­tro­ver­sial pi­lot pro­gram for the gov­ern­men­t's 340B re­bate mod­el from tak­ing ef­fect on Jan. 1.

In a law­suit filed Mon­day, plain­tiffs called the re­bate pi­lot “un­law­ful, un­nec­es­sary, un­ex­plained, and sub­stan­tive­ly un­rea­son­able.” They re­quest­ed Maine's fed­er­al dis­trict court is­sue a tem­po­rary re­strain­ing or­der to stop the gov­ern­ment from im­ple­ment­ing the pro­gram while the case plays out.

Cre­at­ed in 1992, the 340B pro­gram has been a di­vi­sive is­sue for drug­mak­ers and hos­pi­tals. The pro­gram re­quires drug com­pa­nies to pro­vide dis­count­ed prices to health cen­ters that qual­i­fy, such as those serv­ing low-in­come or rur­al com­mu­ni­ties. The drug in­dus­try claims the pro­gram has grown rife with fraud and abuse, while hos­pi­tals con­tend 340B helps stretch lim­it­ed re­sources.

A New York fed­er­al judge has re­vived a $6.7 bil­lion con­tract dis­pute re­lat­ed to Bris­tol My­ers Squibb’s 2019 ac­qui­si­tion of Cel­gene.

US Dis­trict Judge Jesse Fur­man ruled on Mon­day that UMB Bank has stand­ing to chal­lenge Bris­tol My­ers on be­half of share­hold­ers, but dis­missed two of the plain­tiff's claims.

The case stems from a con­tin­gent val­ue rights agree­ment that re­quired FDA ap­proval for Zeposia, Breyanzi and Abec­ma by cer­tain dead­lines for Cel­gene share­hold­ers to re­ceive a pay­out.

The com­pa­ny got ap­proval for Breyanzi 36 days too late, ren­der­ing the CVRs worth­less.

UMB has ac­cused Bris­tol My­ers of al­leged­ly de­lay­ing the ap­proval, avoid­ing a $6.7 bil­lion pay­out. Fur­man dis­missed UMB’s first case against Bris­tol My­ers in 2024 af­ter de­ter­min­ing that the bank­ing as­so­ci­a­tion had not yet been prop­er­ly ap­point­ed as a trustee for share­hold­ers. UMB re­filed in 2024.