The FDA for the first time is fac­ing phar­ma-backed crit­i­cism of its new prac­tice of pub­licly re­leas­ing par­tial­ly redact­ed drug re­jec­tion let­ters.

The law firm Cov­ing­ton & Burl­ing, on be­half of an un­named phar­ma­ceu­ti­cal com­pa­ny client, filed a cit­i­zen pe­ti­tion dat­ed Mon­day with the FDA seek­ing to re­form the rules around the FDA's re­lease of in­for­ma­tion in the let­ters that may be com­pet­i­tive­ly sen­si­tive, and po­ten­tial­ly open the agency up for a law­suit. Cov­ing­ton did not re­spond to a re­quest for com­ment on which com­pa­ny filed the cit­i­zen pe­ti­tion.

"This com­pet­i­tive­ly sen­si­tive, non­pub­lic in­for­ma­tion that is be­ing re­leased un­der FDA’s new CRL prac­tice is pre­cise­ly the type of in­for­ma­tion that FDA is re­quired to pro­tect from dis­clo­sure un­der black-let­ter fed­er­al law," the cit­i­zen pe­ti­tion said.

Bridge­Bio On­col­o­gy Ther­a­peu­tics is re­plac­ing CEO Eli Wal­lace, putting its CSO Pe­dro Bel­tran in the role, and mak­ing board mem­ber Neil Ku­mar ex­ec­u­tive chair­man.

The changes come as there’s been grow­ing com­pe­ti­tion in can­cer over drugs that tar­get KRAS, a dif­fi­cult but com­pelling ap­proach to treat­ing tu­mors. Bridge­Bio On­col­o­gy has three such pro­grams in ear­ly clin­i­cal test­ing: a pan-KRAS drug in sol­id tu­mors, a KRAS G12C in­hibitor in non-small cell lung can­cer, and a small mol­e­cule drug that tar­gets the re­la­tion­ship be­tween RAS and PI3Kα, which can help dri­ve can­cer growth.

The com­pe­ti­tion in the KRAS space put added pres­sure on the com­pa­ny to move quick­ly to get ef­fi­ca­cy da­ta, ac­cord­ing to two peo­ple fa­mil­iar with the think­ing be­hind the lead­er­ship changes.

Ab­b­Vie has pro­vid­ed new de­tails about its $100 bil­lion pledge to the US, bud­get­ing $1.4 bil­lion for its first man­u­fac­tur­ing cam­pus in North Car­oli­na.

Con­struc­tion of the 185-acre cam­pus in Durham, NC, will start this year with the aim of fin­ish­ing by late 2028, be­fore the end of Pres­i­dent Don­ald Trump’s term.

The White House has re­cent­ly pushed drug­mak­ers to fin­ish con­struc­tion of their pledged fa­cil­i­ties dur­ing Trump's tenure, oth­er­wise they could face tar­iffs. Com­pa­nies cur­rent­ly build­ing in the US face 20% tar­iffs, but this will in­crease to 100% if the builds aren't com­plet­ed by Jan­u­ary 2029.

The cam­pus, lo­cat­ed near the Re­search Tri­an­gle Park, will use ar­ti­fi­cial in­tel­li­gence to man­u­fac­ture Ab­b­Vie's im­munol­o­gy, neu­ro­science and on­col­o­gy drugs, ac­cord­ing to the Wednes­day re­lease. The site will cre­ate 734 new jobs.

The Cen­ters for Medicare and Med­ic­aid Ser­vices has de­layed a key pi­lot pro­gram fo­cused on Medicare cov­er­age for obe­si­ty med­ica­tions, af­ter in­sur­ance plans in­di­cat­ed they wouldn’t par­tic­i­pate at this time.

Abe Sut­ton, head of the Cen­ter for Medicare and Med­ic­aid In­no­va­tion, told End­points News in an in­ter­view Thurs­day that health plans were hes­i­tant to join the pi­lot, cit­ing in­sta­bil­i­ty in the Medicare Part D mar­ket and un­known uti­liza­tion of the drugs.

“They shared with us that it was im­por­tant that we take a beat and give them a chance to col­lect da­ta so that they could un­der­write this ef­fec­tive­ly in a fu­ture time pe­ri­od,” Sut­ton said.

Sanofi CEO Paul Hud­son bet big on im­munol­o­gy. When Belén Gar­i­jo takes over as CEO next week, she will have to de­cide whether to con­tin­ue that wa­ger.

The di­rec­tion Gar­i­jo elects to pur­sue will like­ly have ram­i­fi­ca­tions not just for Sanofi’s R&D fu­ture, but for the com­pa­ny’s iden­ti­ty. Un­der Hud­son, Sanofi went all-in on im­munol­o­gy, try­ing to tack­le a wide range of dis­eases, from eczema and asth­ma to mul­ti­ple scle­ro­sis and rare neu­roin­flam­ma­to­ry con­di­tions.