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top stories
1. White House officials link pharma tariffs with ‘most favored nation’ pricing program
2. Lilly pauses Mounjaro orders in the UK just before raising its price 
3. Prasad explains why FDA revoked Pfizer's Covid vaccine EUA for children
4. FDA approves updated Covid vaccines, including mRNA shots from Pfizer, Moderna
5. Indivior to reduce headcount, real estate in first stage of broader reorg
6. Genentech’s $700M North Carolina build; Telix gets CRL for imaging agent 
Anna Brown
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Just days before Lilly plans to raise the price of Mounjaro in the UK, the drugmaker has temporarily stopped taking orders for the blockbuster drug to avoid any stockpiling. Read more below.

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Anna Brown
Biopharma Breaking News Reporter, Endpoints News
President Donald Trump (Evan Vucci/AP Images)
1
by Max Bayer

One of the main ques­tions fac­ing the Trump ad­min­is­tra­tion as it seeks to low­er pre­scrip­tion drug prices through ex­ec­u­tive or­der is: How?

Tues­day’s cab­i­net meet­ing seemed to pro­vide an an­swer.

For the first time, top mem­bers of the ad­min­is­tra­tion pub­licly linked the Com­merce De­part­ment’s 232 in­ves­ti­ga­tion in­to phar­ma­ceu­ti­cal prod­ucts — and tar­iffs that are ex­pect­ed to fol­low — with Pres­i­dent Don­ald Trump's "most fa­vored na­tion" plan to get drug­mak­ers to re­duce prices in the US.

Com­merce Sec­re­tary Howard Lut­nick told the pres­i­dent that the com­bi­na­tion of the 232 in­ves­ti­ga­tion and the most fa­vored na­tion pro­gram, which is be­ing led in part by HHS Sec­re­tary Robert F. Kennedy Jr., "re­al­ly gives Bob­by the tools to go ex­e­cute your plan."

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2
by Anna Brown

In an ef­fort to curb “in­ap­pro­pri­ate stock­pil­ing,” Eli Lil­ly said it has mo­men­tar­i­ly halt­ed sup­ply of its block­buster drug Moun­jaro in the UK, just days be­fore it plans to raise its price, a com­pa­ny spokesper­son told End­points News. 

Lil­ly is fo­cused on ful­fill­ing or­ders al­ready placed for Moun­jaro be­fore al­low­ing new or­ders to re­sume on Sept. 1 af­ter the “month-end cut-off,” the spokesper­son added.

The com­pa­ny urges pa­tients to or­der Moun­jaro on­ly based on their cur­rent treat­ment plan to re­duce any fur­ther dis­rup­tions in the UK. The spokesper­son added that there are “le­gal pro­tec­tions” in place by the UK's Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) to pre­vent phar­ma­cies from stock­pil­ing.

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3
by Zachary Brennan

Fol­low­ing the FDA's more lim­it­ed ap­provals of sev­er­al Covid-19 vac­cines on Wednes­day, CBER Di­rec­tor Vinay Prasad laid out why the agency de­cid­ed to re­scind Pfiz­er's emer­gency use au­tho­riza­tion for its mR­NA vac­cine for younger chil­dren, and where it dis­agreed with the com­pa­ny.

In an agency memo re­leased late Wednes­day, Prasad said Pfiz­er ar­gued to the agency that pulling its EUA could make health­care work­ers think there were safe­ty is­sues with its vac­cine. The com­pa­ny al­so said the ac­tion could cre­ate sup­ply short­ages, and that Mod­er­na's la­bel for its vac­cine "does not ad­dress chil­dren who be­gan their se­ries with the Pfiz­er-BioN­Tech Covid-19."

In the memo, Prasad said the CDC had al­ready pro­vid­ed guid­ance on how to con­tin­ue vac­cine se­ries for those who start­ed on Pfiz­er's vac­cine, and al­so that there was­n't ev­i­dence that Mod­er­na won't have enough sup­plies.

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4
by Max Bayer

The FDA on Wednes­day ap­proved up­dat­ed for­mu­las of the Covid-19 vac­cines ahead of the fall res­pi­ra­to­ry sea­son, though the la­bels are more lim­it­ed than in years past.

Vac­cines were ap­proved for Pfiz­er, Mod­er­na and No­vavax for all adults 65 and old­er and peo­ple younger than 65 who are at high­er risk of se­vere dis­ease. Mod­er­na’s Spike­vax will be the on­ly shot avail­able for at-risk chil­dren 6 months to 5 years old af­ter the FDA pulled Pfiz­er's emer­gency use au­tho­riza­tion for Comir­naty in that age range.

Pfiz­er has yet to ask for ap­proval for the youngest kids, so its ap­proval la­bel ap­plies to peo­ple 5 years and old­er. No­vavax's vac­cine was ap­proved for kids and adults 12 and old­er.

HHS Sec­re­tary Robert F. Kennedy Jr. an­nounced the ap­provals in a post on X.

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5
by Ayisha Sharma

In­di­v­ior said it is ex­e­cut­ing the first phase of a mul­ti­year re­struc­tur­ing plan to “max­i­mize the po­ten­tial” of its busi­ness, start­ing with lay­offs and re­al es­tate con­sol­i­da­tion.

The Vir­ginia-based biotech did not dis­close the num­ber of em­ploy­ees it plans to lay off. But the work­force cuts are ex­pect­ed to in­cur sev­er­ance-re­lat­ed charges of $16 mil­lion to $19 mil­lion, ac­cord­ing to an SEC fil­ing shared Tues­day. In­di­v­ior had 1,094 em­ploy­ees at the end of 2024, an an­nu­al re­port states.

The com­pa­ny al­so plans to back out of cer­tain re­al es­tate projects, which could in­cur fees of $15 mil­lion to $22 mil­lion. It al­so ex­pects to in­cur con­sult­ing, le­gal and tax plan­ning ex­pens­es of ap­prox­i­mate­ly $8 mil­lion to $9 mil­lion.

In to­tal, these ear­ly moves mean the com­pa­ny will have to spend be­tween $39 mil­lion to $50 mil­lion for the over­haul in the third and fourth quar­ters of this year.

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6
by Anna Brown

Wel­come to End­points News’ man­u­fac­tur­ing briefs, where we bring you es­sen­tial news on new builds, col­lab­o­ra­tions, re­calls and more.

Roche re­vealed fur­ther in­for­ma­tion on how it would spend its multi­bil­lion-dol­lar man­u­fac­tur­ing in­vest­ment in the US, an­nounc­ing on Mon­day that its sub­sidiary Genen­tech has start­ed build­ing a new site in Hol­ly Springs, NC, worth $700 mil­lion. The new fa­cil­i­ty is ex­pect­ed to cre­ate more than 1,900 jobs and is sched­uled to be op­er­a­tional in 2029, ac­cord­ing to Roche.

The FDA hand­ed Telix Phar­ma­ceu­ti­cals a com­plete re­sponse let­ter for its PET agent, co­de­named TLX250-CDx, the com­pa­ny said Thurs­day. TLX250-CDx is be­ing con­sid­ered for the di­ag­no­sis and char­ac­ter­i­za­tion of clear cell re­nal cell car­ci­no­ma. The agency cit­ed is­sues in the com­pa­ny's chem­istry, man­u­fac­tur­ing and con­trols, and re­quest­ed fur­ther in­for­ma­tion on the scal­ing-up process for TLX250-CDx’s com­mer­cial use. Fur­ther, the FDA filed two Form 483s for two of Telix’s third-par­ty man­u­fac­tur­ers. Telix’s stock sank al­most 19% on the Aus­tralian stock ex­change. Telix’s li­cense part­ner, Hei­del­berg Phar­ma, was due to re­ceive a $70 mil­lion mile­stone pay­ment up­on the as­set's ap­proval.

San­doz is spend­ing CAD $220 mil­lion ($160 mil­lion) to “mod­ern­ize” its part­ner Del­pharm’s fa­cil­i­ties in Boucherville, Cana­da, with help from the Gov­ern­ment of Que­bec, ac­cord­ing to a Thurs­day re­lease. CAD $60 mil­lion ($43.6 mil­lion) is be­ing in­vest­ed by the provin­cial gov­ern­ment, an­oth­er CAD $60 mil­lion ($43.6 mil­lion) from the fed­er­al gov­ern­ment and CAD $100 mil­lion ($72.6 mil­lion) from pri­vate in­vestors.

Sai Life Sci­ences has com­plet­ed the sec­ond phase of its so-called Pro­duc­tion Block at its API man­u­fac­tur