Eli Lil­ly has bud­get­ed $3.5 bil­lion for a new weight loss in­jectable and de­vice fac­to­ry in Lehigh Val­ley, PA, which will man­u­fac­ture its next-gen obe­si­ty drug re­ta­tru­tide.

The fac­to­ry will al­so pro­duce oth­er weight loss med­i­cines and cre­ate 850 jobs, the drug­mak­er said Fri­day. Con­struc­tion is ex­pect­ed to start this year and the site will be op­er­a­tional in 2031.

Re­ta­tru­tide is a triple-G drug, mean­ing it tar­gets GIP, GLP-1 and glucagon re­cep­tors. It is in mul­ti­ple Phase 3 tri­als, with Lil­ly re­port­ing da­ta from one of these stud­ies in De­cem­ber. Lil­ly is ex­pect­ed to an­nounce sev­en ad­di­tion­al late-stage read­outs this year.

Lil­ly’s block­buster weight loss in­jec­tion tirzepatide is a GIP/GLP-1 re­cep­tor ag­o­nist.

The FDA has start­ed ac­cept­ing pitch­es for drug­mak­ers to par­tic­i­pate in the agency’s PreCheck pro­gram, a new ini­tia­tive aimed to speed up the con­struc­tion of US man­u­fac­tur­ing sites.

The agency said it will se­lect an ini­tial co­hort of fa­cil­i­ties for the pro­gram based on the med­i­cines the site will man­u­fac­ture, the sta­tus of the build­ing’s con­struc­tion, and the site's abil­i­ty to quick­ly pro­duce prod­ucts for the US mar­ket. The FDA will pri­or­i­tize fac­to­ries that will pro­duce “crit­i­cal” drugs for the US, ac­cord­ing to a Sun­day press re­lease.

The agency’s PreCheck pro­gram, an­nounced last Au­gust, is a two-phase ap­proach. The first phase will al­low drug man­u­fac­tur­ers to com­mu­ni­cate with the FDA ear­li­er, be­fore a fa­cil­i­ty is op­er­a­tional, through “pre-op­er­a­tional re­views.” The sec­ond phase will in­volve pre-sub­mis­sion meet­ings be­tween the agency and man­u­fac­tur­ers to re­solve any fac­to­ry-re­lat­ed is­sues.

The FDA has de­liv­ered a com­plete re­sponse let­ter to Aque­s­tive Ther­a­peu­tics for its al­ler­gy med­ica­tion due to is­sues over the drug’s pack­ag­ing.

The agency de­clined to ap­prove Aque­s­tive’s al­ler­gy patch called Ana­phylm in pa­tients weigh­ing 30 kg or more, the com­pa­ny said Mon­day. Ana­phylm is a small film that’s placed in­side the mouth, re­leas­ing adren­a­line as it dis­solves.

The FDA found is­sues in the com­pa­ny's hu­man fac­tors (HF) val­i­da­tion study, which showed dif­fi­cul­ty in open­ing Ana­phylm’s pouch and in­cor­rect film place­ment. The FDA be­lieves that could have "sig­nif­i­cant safe­ty” is­sues if pa­tients can’t prop­er­ly place the film, ac­cord­ing to the Mon­day re­lease.

Ul­tragenyx has re­sub­mit­ted its ap­proval re­quest for a rare dis­ease gene ther­a­py af­ter the FDA re­ject­ed it last sum­mer.

UX111 is an AAV gene ther­a­py de­signed to treat San­fil­ip­po syn­drome type A. The com­pa­ny is again seek­ing ac­cel­er­at­ed ap­proval us­ing a nov­el bio­mark­er, part of a push by bio­phar­ma to test the FDA’s ap­petite to ease ac­cess for rare dis­ease drugs.

But in Ju­ly, the agency turned down the drug af­ter an in­spec­tion of a man­u­fac­tur­ing fa­cil­i­ty raised con­cerns. Ul­tragenyx said Fri­day that its re­sub­mis­sion in­cludes “com­pre­hen­sive” re­spons­es to those con­cerns, in ad­di­tion to longer-term da­ta from pa­tients. If the agency ac­cepts the re­sub­mis­sion, Ul­tragenyx said the de­ci­sion could come in the third quar­ter of this year.

Take­da’s in­com­ing CEO took a firm stance against Pres­i­dent Don­ald Trump’s “most fa­vored na­tion” deals with drug­mak­ers on Thurs­day, while Sanofi and Roche shared new de­tails about their ne­go­ti­a­tions with the White House.

“In gen­er­al, MFN is not an ap­proach that we sup­port,” Take­da’s CEO-elect Julie Kim said dur­ing the com­pa­ny’s earn­ings call. “Hav­ing price con­trols and im­port­ing one com­po­nent of health­care sys­tems that have very, very dif­fer­ent struc­tures does not make sense for the US.”

Trump has now se­cured 16 MFN deals with drug­mak­ers, af­ter send­ing 17 let­ters to phar­ma CEOs last Ju­ly that de­mand­ed they low­er prices in the US. Kim’s com­ments come just weeks af­ter Trump called on Con­gress to cod­i­fy his MFN deals in­to law, which could po­ten­tial­ly sweep in drug­mak­ers be­yond those ini­tial 17.

Ther­mo Fish­er Sci­en­tif­ic is clos­ing its chem­i­cal analy­sis man­u­fac­tur­ing site in Franklin, MA, due to “cur­rent cus­tomer de­mands,” a com­pa­ny spokesper­son told End­points News. Op­er­a­tions there will be phased out by the end of the year with “much of the work” trans­ferred to oth­er US sites. Many of the 80 work­ers that will be af­fect­ed by the shut­down will be re­lo­cat­ed to oth­er fa­cil­i­ties in Mass­a­chu­setts, the spokesper­son added.

Charles Riv­er Lab­o­ra­to­ries is al­so clos­ing its cell ther­a­py fa­cil­i­ty in Hanover, MD, as it is "not a strate­gic fit," a com­pa­ny spokesper­son told End­points. Client work at the site will be tran­si­tioned to oth­er fa­cil­i­ties in Charles River's net­work by the end of Q2. The lay­offs in­volv­ing 20 staffers will take ef­fect in March, ac­cord­ing to a WARN no­tice.