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Abeona’s launch plans stymied by false-positive sterility test Read in browser
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top stories
1. CDMOs don’t expect immediate impact from ‘most favored nation’ deals
2. WuXi AppTec plants 'flag down' in Europe with new Munich headquarters 
3. Abeona’s skin disease cell therapy launch stymied by false-positive sterility test
4. Merck KGaA still in tariff talks with the White House, weeks after deal was announced 
5. Catalent lays off more gene therapy workers in Baltimore
6. Chinese biotechs are shedding their fast-follower reputations as innovation surges
7. KalVista defies sales expectations again for hereditary angioedema drug
Anna Brown
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Novartis opened a new factory in Carlsbad, CA, on Monday to make its radioligand therapies. The factory is Novartis' third facility in the US, and will make Pluvicto and Lutathera. Stay tuned as we keep a close eye on how radiopharma drugmakers continue to boost their production footprints.

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Anna Brown
Biopharma Breaking News Reporter, Endpoints News
2025 Convention on Pharmaceutical Ingredients confab in Frankfurt. (Credit: Anna Brown)
1
by Anna Brown

As the White House con­tin­ues to roll out “most fa­vored na­tion” deals with drug­mak­ers, con­tract man­u­fac­tur­ing ex­ecs don’t an­tic­i­pate any pric­ing pres­sure to im­pact their busi­ness­es — for now.

End­points News spoke with ex­ec­u­tives from man­u­fac­tur­ers, in­clud­ing Ther­mo Fish­er, Fu­ji­film, Re­ci­pharm and Siegfried, on the side­lines of the Con­ven­tion on Phar­ma­ceu­ti­cal In­gre­di­ents con­fab in Frank­furt. They all said they’ve seen no im­pact yet from Pres­i­dent Don­ald Trump’s push to bring US drug prices in line with cheap­er rates paid abroad.

“ is en­tire­ly on the phar­ma com­pa­nies that have to man­age those pric­ing as­pects,” said Anil Kane, Ther­mo Fish­er’s glob­al head of tech­ni­cal and sci­en­tif­ic af­fairs.

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WuXi AppTec US/EU President Richard Connell at the Financial Times' 2025 Global Pharma and Biotech Summit (courtesy Financial Times)
2
by Anna Brown

LON­DON — WuXi AppTec is cre­at­ing its first Eu­ro­pean head­quar­ters at its ex­ist­ing fa­cil­i­ty in Ger­many, the com­pa­ny’s US and EU pres­i­dent Rick Con­nell said Wednes­day.

“The time is right now to put the flag down and say, we're here. We're here to stay,” Con­nell said dur­ing the Fi­nan­cial Times’ Glob­al Phar­ma and Biotech Sum­mit in Lon­don.

The new head­quar­ters will be lo­cat­ed at the com­pa­ny’s site in Mu­nich, which is home to its drug dis­cov­ery ser­vice sub­sidiary called Cre­lux. WuXi AppTec al­so has a sec­ond Eu­ro­pean site in Cou­vet, Switzer­land, which pro­vides ser­vices in oral sol­id dose man­u­fac­tur­ing.

“While we have big op­er­a­tions in Asia and big op­er­a­tions in the US, we've on­ly had these two sites in Eu­rope, yet we have sev­er­al hun­dred cus­tomers here in Eu­rope,” Con­nell added.

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3
by Anna Brown

Abeona Ther­a­peu­tics said the com­mer­cial roll­out of its rare skin dis­ease cell ther­a­py has hit a road­bump, de­lay­ing the treat­ment of its first pa­tient by sev­er­al months.

Al­though the com­pa­ny not­ed on Wednes­day morn­ing that there is high pa­tient de­mand for its prod­uct, caus­ing its stock ABEO to ral­ly by as much as 18% at mar­ket close that day. Zevaskyn, ap­proved in April, has a $3.1 mil­lion price tag and is among the most ex­pen­sive ther­a­pies world­wide.

Zevaskyn is for chil­dren and adults with re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa, a rare, ge­net­ic skin dis­ease in which pa­tients are sen­si­tive to blis­ters and wounds. Af­ter a biop­sy of the pa­tien­t's own skin cells, sheets of skin with func­tion­al ver­sions of col­la­gen are made and then ap­plied to the pa­tient dur­ing surgery.

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Merck KGaA CEO Belén Garijo (L) and CFO Helene von Roeder (Arne Dedert/picture alliance via Getty Images)
4
by Anna Brown

Mer­ck KGaA is still in ne­go­ti­a­tions with the White House to de­ter­mine how much its drug prod­ucts will be ex­empt from Pres­i­dent Don­ald Trump’s up­com­ing phar­ma­ceu­ti­cal tar­iffs, CFO He­lene von Roed­er said.

"It's a lit­tle bit ear­ly to give you ex­act guid­ance on how we're look­ing at it,” von Roed­er said dur­ing its third-quar­ter earn­ings call with the me­dia on Thurs­day.

The com­pa­ny’s North Amer­i­can arm EMD Serono an­nounced the deal in a splashy event at the White House last month. It agreed to low­er prices of its IVF treat­ments and use "most fa­vored na­tion" pric­ing for fu­ture drugs, in ex­change for its prod­ucts and in­gre­di­ents to be ex­empt from the De­part­ment of Com­merce's Sec­tion 232 phar­ma in­ves­ti­ga­tion.

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5
by Anna Brown

Catal­ent will let go of more gene ther­a­py staff in Mary­land over con­tin­ued is­sues in de­mand from a "large com­mer­cial cus­tomer," a com­pa­ny spokesper­son told End­points News.

A to­tal of 77 work­ers will be laid off in the state, in­clud­ing 14 em­ploy­ees from Catal­ent’s gene ther­a­py fac­to­ry in Bal­ti­more at the Uni­ver­si­ty of Mary­land BioPark, ac­cord­ing to a WARN no­tice pub­lished on Nov. 6. The lay­offs will take ef­fect Jan. 5.

In Au­gust, Catal­ent cut its head­count by 350 work­ers at the Bal­ti­more fac­to­ry over an "un­ex­pect­ed shift in de­mand" from an un­known cus­tomer. Catal­ent de­clined to name the com­pa­ny in ques­tion, but one of its large cus­tomers there is Sarep­ta Ther­a­peu­tics. Sarep­ta has faced a re­cent drop in de­mand for its Duchenne gene ther­a­py Ele­v­idys due to dis­clo­sures of pa­tient deaths and paused ship­ments.

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6
by Ayisha Sharma

LON­DON — Chi­na’s biotech sec­tor is steadi­ly mov­ing be­yond a “me-too” ap­proach to drug de­vel­op­ment thanks to a surge in qual­i­ty tal­ent, reg­u­la­to­ry flex­i­bil­i­ty and