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Anna Brown
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In a bid to prevent shortages, Eli Lilly has been stockpiling its obesity pill ahead of its potential approval in the US. These pills are likely to fly off the shelves, as seen with Novo Nordisk's own oral drugs. Read more below.

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Anna Brown
Biopharma Breaking News Reporter, Endpoints News
1
by Jared Whitlock

The Pen­ta­gon on Fri­day briefly added WuXi AppTec to a list of com­pa­nies that aid the Chi­nese mil­i­tary be­fore with­draw­ing the fil­ing with no ex­pla­na­tion.

If the list is re­post­ed as is, the des­ig­na­tion would height­en scruti­ny of the biotech sup­pli­er and make it a tar­get of the re­cent­ly passed Biose­cure Act that re­stricts fed­er­al con­tracts with bio­phar­ma sup­pli­ers that are deemed for­eign ad­ver­saries. Biose­cure de­fers to the Pen­tagon's 1260H list of Chi­nese mil­i­tary com­pa­nies.

The ul­ti­mate de­ci­sion may have far-reach­ing con­se­quences. The Shang­hai-based com­pa­ny start­ed out decades ago of­fer­ing on­ly lab ser­vices be­fore ex­pand­ing in­to drug dis­cov­ery, de­vel­op­ment and man­u­fac­tur­ing. WuXi AppTec con­trols a large share of the con­tract re­search mar­ket and has said it works with the 20 largest phar­ma­ceu­ti­cals.

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2
by Anna Brown

Eli Lil­ly is con­tin­u­ing to stock­pile its obe­si­ty pill or­for­glipron months ahead of its ex­pect­ed US launch.

In a Thurs­day SEC fil­ing, the drug­mak­er said it has $1.5 bil­lion in “pre-launch in­ven­to­ries” as of Dec. 31, “pri­mar­i­ly re­lat­ed” to or­for­glipron.

Last Feb­ru­ary, Lil­ly said it had al­ready stock­piled $548 mil­lion worth of the oral GLP-1 can­di­date, ready to be dis­trib­uted as soon as the drug gains reg­u­la­to­ry ap­proval. Or­for­glipron is ex­pect­ed to be ap­proved by the FDA in April.

The In­di­anapo­lis-based com­pa­ny is ready­ing its sup­ply while ri­val No­vo Nordisk has an ear­ly lead in the oral GLP-1 space. No­vo launched its We­govy pill last month, with pre­scrip­tion rates quick­ly ramp­ing up. No­vo said this week that it plans to ex­pand a fac­to­ry in Ire­land to make its drug.

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3
by Max Gelman

Ul­tragenyx an­nounced Thurs­day af­ter­noon that the FDA would not take up its re­cent gene ther­a­py ap­pli­ca­tion. Ad­di­tion­al­ly, it will lay off about 10% of its em­ploy­ees as part of a re­struc­tur­ing, fol­low­ing a bumpy 2025.

Ul­tragenyx re­ceived an “in­com­plete re­sponse let­ter” on Thurs­day, say­ing US reg­u­la­tors want­ed “ad­di­tion­al sup­port­ive doc­u­men­ta­tion” re­gard­ing re­spons­es to its pre­vi­ous re­jec­tion for the gene ther­a­py, known as UX111, last year. Ul­tragenyx’s treat­ment is de­signed for pa­tients with San­fil­ip­po syn­drome type A.

Dur­ing the com­pa­ny’s fourth-quar­ter earn­ings call, CEO Emil Kakkis said the agency typ­i­cal­ly re­ceives this in­for­ma­tion “dur­ing an in­spec­tion, and we were pre­pared to do so, but we will now pro­vide this sup­port­ive doc­u­men­ta­tion as a part of our BLA re­sub­mis­sion.”

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4
by Nicole DeFeudis

John­son & John­son said it will spend more than $1 bil­lion to build a cell ther­a­py man­u­fac­tur­ing plant in Penn­syl­va­nia as part of its broad­er com­mit­ment un­veiled last year to in­vest more than $55 bil­lion in the US through ear­ly 2029.

A J&J spokesper­son said Wednes­day that con­struc­tion is ex­pect­ed to be­gin lat­er this year, with the site be­com­ing ful­ly op­er­a­tional in 2031. J&J and oth­er large phar­ma com­pa­nies have pledged to spend bil­lions of dol­lars in the US amid Pres­i­dent Don­ald Trump’s on­shoring push.

The new plant will ex­pand J&J’s large foot­print in Penn­syl­va­nia, where it al­ready has 10 fa­cil­i­ties. The project is sup­port­ed by a $41.5 mil­lion state in­vest­ment and is ex­pect­ed to cre­ate more than 500 jobs over the next 12 years, Gov. Josh Shapiro said Wednes­day.

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5
by Anna Brown

Charles Riv­er Lab­o­ra­to­ries said de­mand for its ser­vices is build­ing back up af­ter near­ly a year of un­cer­tain­ty around tar­iffs and drug pric­ing.

With “tar­iff stuff be­ing sort of over, and what­ev­er pric­ing sit­u­a­tions be­tween Wash­ing­ton and phar­ma com­pa­nies, we think that's sort of passed them. So de­mand seems to be im­prov­ing,” Charles Riv­er CEO Jim Fos­ter said Wednes­day dur­ing the com­pa­ny’s 2025 earn­ings re­sults.

The ser­vice provider al­so named Glenn Cole­man as CFO start­ing on April 6, af­ter Flavia Pease stepped down from the role in Sep­tem­ber. Ker­ry Dai­ley has been ap­point­ed chief le­gal of­fi­cer, a new­ly-cre­at­ed role, and will start on March 30.

Charles Riv­er’s stock CRL was down near­ly 4% on Wednes­day morn­ing.

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6
by Alexis Kramer

Eli Lil­ly is chal­leng­ing a de­ci­sion over how the FDA clas­si­fied its ex­per­i­men­tal, next-gen obe­si­ty shot, in a case that could af­fect the abil­i­ty of com­pounders to ri­val it.

On Thurs­day, Lil­ly filed a no­tice to ap­peal a Sep­tem­ber dis­trict court de­ci­sion that said the FDA didn’t vi­o­late the law when it de­cid­ed to clas­si­fy re­ta­tru­tide as a drug in­stead of a bi­o­log­ic. Lil­ly is bring­ing the case to the US Court of Ap­peals for the Sev­enth Cir­cuit.