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1. Lonza sells capsule and health ingredients unit to UK's Lone Star for $2.2B upfront
2. Incyte becomes third company to receive CRL over issues at Novo Indiana factory
3. Lilly plots GLP-1 pill production boost in China, $500M pledge to South Korea
4. Evotec plans up to 800 job cuts, four site closures in next phase of reorganization
5. Ipsen pulls cancer drug from market over safety risks
6. Lilly warns of impurity risk in certain compounded forms of Mounjaro and Zepbound
7. Hims agrees to limit compounding, ending feud with Novo Nordisk
8. Sandoz reorg ahead of 'golden decade' for biosimilars; Sanofi to shed Latin America generics business
Reynald Castaneda
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In another blow to the Catalent site in Indiana, Incyte received a complete response letter in its bid to expand the label for Zynyz. Regeneron and Scholar Rock were also handed CRLs due to issues at the facility, now owned by Novo Nordisk. Read more below.

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Reynald Castaneda
Deputy Editor, Endpoints News
1
by Nicole DeFeudis

Lon­za agreed to sell its cap­sules and health in­gre­di­ents busi­ness to a UK-based in­vest­ment firm for $2.2 bil­lion up­front.

The sep­a­ra­tion has been a long time com­ing for Lon­za, which first di­vulged plans to di­vest the unit in De­cem­ber 2024. At the time, CEO Wolf­gang Wien­and was about six months in­to his role and said the Swiss man­u­fac­tur­er is “not the best own­er any­more" for CHI.

In a news re­lease Fri­day, Lon­za called the deal the “last and most sig­nif­i­cant step” to com­plete its trans­for­ma­tion in­to a “pure-play CD­MO.” The deal with Lone Star Funds is ex­pect­ed to close in this year's sec­ond half.

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2
by Anna Brown

The FDA has hand­ed In­cyte a com­plete re­sponse let­ter for a la­bel ex­pan­sion of the com­pa­ny's mon­o­clon­al an­ti­body Zynyz over is­sues at a third-par­ty man­u­fac­tur­ing site in In­di­ana that was for­mer­ly owned by Catal­ent.

In­cyte’s sup­ple­men­tal BLA for Zynyz as a treat­ment for metasta­t­ic non-small cell lung can­cer was re­ject­ed due to prob­lems with the fac­to­ry’s “reg­u­la­to­ry com­pli­ance,” ac­cord­ing to an SEC fil­ing.

There were no is­sues di­rect­ly re­lat­ed to Zynyz, in­clud­ing with the drug's ef­fi­ca­cy, safe­ty and third-par­ty drug sub­stance man­u­fac­tur­er, the fil­ing states. The ap­pli­ca­tion was sup­port­ed with da­ta from In­cyte’s Phase 3 POD1UM-304 study.

In­cyte is now the third com­pa­ny to re­ceive a CRL due to on­go­ing is­sues at the trou­bled fa­cil­i­ty in Bloom­ing­ton, IN. Last year, Re­gen­eron and Schol­ar Rock were al­so hit with CRLs for drugs made at the fac­to­ry, which is now owned by No­vo Nordisk.

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3
by Anna Brown

Eli Lil­ly is mak­ing moves in East Asia.

The In­di­anapo­lis drug­mak­er said Wednes­day it is ear­mark­ing $3 bil­lion over the next decade to in­crease its man­u­fac­tur­ing foot­print in Chi­na. Ear­li­er this week, Lil­ly said it is in­vest­ing $500 mil­lion in South Ko­rea over the next five years through a mem­o­ran­dum of un­der­stand­ing with the gov­ern­ment.

Lil­ly’s Chi­na bud­get will be used to boost lo­cal pro­duc­tion of its GLP-1 pill or­for­glipron and oth­er oral drugs. Or­for­glipron is un­der re­view by Chi­nese reg­u­la­tors for obe­si­ty and type 2 di­a­betes.

There are cur­rent­ly no GLP-1 weight loss pills avail­able in Chi­na, mean­ing Lil­ly could be the first to mar­ket there, with no re­ports of No­vo Nordisk fil­ing for ap­proval in the coun­try. No­vo’s Ry­bel­sus, which is an oral ver­sion of semaglu­tide, is ap­proved in Chi­na for type 2 di­a­betes.

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4
by Nicole DeFeudis

Evotec plans to close an­oth­er four sites and cut about a sixth of its staff amid a broad­er, mul­ti-year shake-up.

It’s the lat­est round of lay­offs for the Ger­man biotech and man­u­fac­tur­er, which has cut hun­dreds of em­ploy­ees over the last two years. The com­pa­ny al­so changed CEOs, shut­tered its gene ther­a­py unit, and closed five sites be­tween 2024 and 2025.

Evotec said Tues­day it will re­duce its foot­print to 10 fa­cil­i­ties. As a re­sult, the com­pa­ny ex­pects to elim­i­nate up to 800 po­si­tions. Last month, Evotec said it had rough­ly 4,800 glob­al em­ploy­ees.

Evotec’s CEO Chris­t­ian Wo­jczews­ki said in a news re­lease that the next phase of its re­or­ga­ni­za­tion will “po­si­tion the com­pa­ny for sus­tain­able, high-qual­i­ty growth.” The com­pa­ny ex­pects its plans will be “sub­stan­tial­ly im­ple­ment­ed by the end of 2027.”

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5
by Nicole DeFeudis

Ipsen is pulling its can­cer drug Tazverik from the mar­ket af­ter an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee found safe­ty con­cerns in a con­fir­ma­to­ry tri­al.

The com­mit­tee re­port­ed cas­es of sec­ondary can­cers that be­gin in blood-form­ing tis­sue, al­so known as hema­to­log­ic ma­lig­nan­cies, in a fol­lic­u­lar lym­phoma study dubbed SYM­PHO­NY-1. The tri­al pit­ted Tazverik plus the im­munother­a­pies lenalido­mide and rit­ux­imab as a sec­ond-line treat­ment against the lat­ter two stan­dard-of-care med­i­cines alone.

Ipsen said it’s with­draw­ing Tazverik im­me­di­ate­ly for all of its ap­proved us­es, in­clud­ing fol­lic­u­lar lym­phoma and ep­ithe­lioid sar­co­ma. A spokesper­son de­clined to com­ment on the num­ber of hema­to­log­ic ma­lig­nan­cies ob­served in the tri­al, and said that more re­search is nec­es­sary.

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