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1 October, 2025
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De­sign It Right: Eval­u­at­ing AAV Man­u­fac­tura­bil­i­ty Through Mol­e­c­u­lar and Up­stream Op­ti­miza­tion
spotlight
 
top stories
1. Takeda stops all work in cell therapy 
2. Halozyme to spend $750M upfront to buy Elektrofi, a biologics tech delivery company
3. FDA rejects treatment for rare copper deficiency over manufacturing
4. Exclusive: French startup's gene therapy dramatically reduces urinary incontinence in spinal cord injury patients
5. Ansa Biotechnologies closes $54.4M Series B to boost US DNA manufacturing 
6.
news briefing
Enanta aims to raise $50M as it advances RSV therapy; Hinge, Kyorin make a deal
7. After building Ochre Bio, Jack O'Meara's newest biotech raises $21M for neuro siRNAs
8. FDA approves Novartis' BTK inhibitor for chronic hives
9. Vertanical unpacks Phase 3 success for cannabis-based painkiller
more stories
 
Jaimy Lee
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If you’re still trying to unpack President Trump’s whirlwind drug pricing announcement with Pfizer, join us on YouTube at 1:30 p.m. ET. We'll discuss what happened with Brookings senior fellow Marta Wosińska, biotech political consultant Nick Shipley, and Max Bayer, who was at the White House for Tuesday’s event. See you there!

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Jaimy Lee
Deputy Editor, Endpoints News
1
by Lei Lei Wu

Take­da is dis­con­tin­u­ing its cell ther­a­py ef­forts af­ter it al­ready pared back its work in the field.

It’s an­oth­er blow to a cell ther­a­py in­dus­try that has fall­en out of fa­vor as com­pa­nies strug­gled to de­vel­op next-gen­er­a­tion cell ther­a­pies that were both ef­fec­tive and could make the com­plex and ex­pen­sive treat­ments more wide­ly ac­ces­si­ble.

The Japan­ese phar­ma­ceu­ti­cal com­pa­ny said Wednes­day that the de­ci­sion was “part of a strate­gic port­fo­lio pri­or­i­ti­za­tion process." It al­so said it's search­ing for an ex­ter­nal part­ner for its cell ther­a­py pro­grams.

Take­da has been un­der­go­ing a mul­ti­year re­vamp that led the com­pa­ny to cut pro­grams from its pipeline over con­sec­u­tive quar­ters. In June, Julie Kim will re­place Christophe We­ber as Takeda's CEO.

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Helen Torley, Halozyme CEO
2
by Kyle LaHucik

Halozyme Ther­a­peu­tics is buy­ing a peer in drug de­liv­ery tech­nol­o­gy with a $750 mil­lion deal for pri­vate­ly-held Elek­trofi, the com­pa­nies said Wednes­day morn­ing.

Halozyme has built up a broad suite of big phar­ma part­ner­ships over the years, help­ing large drug­mak­ers turn in­jectable med­i­cines in­to sub­cu­ta­neous­ly de­liv­ered treat­ments. That in­cludes arrange­ments with Roche, Bris­tol My­ers Squibb, Eli Lil­ly and oth­ers. Its tech­nol­o­gy can help ex­tend the time that block­buster med­i­cines main­tain their dom­i­nance in the mar­ket by ex­tend­ing patent life and giv­ing pa­tients eas­i­er-to-use for­mu­la­tions.

The biotech's shares HA­LO were up al­most 4% on Wednes­day. The deal is ex­pect­ed to close this quar­ter.

Elek­trofi has al­so built a ros­ter of large phar­ma clients — in­clud­ing Lil­ly, John­son & John­son, Take­da and ar­genx — that work with the start­up to make eas­i­er-to-use bi­o­log­ics.

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3
by Lei Lei Wu

The FDA has re­ject­ed a cop­per re­place­ment ther­a­py for a rare and fa­tal ge­net­ic con­di­tion called Menkes dis­ease, Fortress Biotech and its sub­sidiary Cypri­um Ther­a­peu­tics an­nounced Wednes­day morn­ing.

Sen­tynl Ther­a­peu­tics, a US sub­sidiary of In­dia-based Zy­dus Life­sciences, took over the de­vel­op­ment of CUTX-101 from Cypri­um Ther­a­peu­tics in 2023. But Cypri­um is still in line to re­ceive a pri­or­i­ty re­view vouch­er and up to $129 mil­lion in mile­stone pay­ments if the prod­uct is ap­proved. The re­jec­tion comes af­ter the FDA pre­vi­ous­ly de­layed its de­ci­sion dead­line by three months to Sept. 30.

The ap­proval was de­nied due to man­u­fac­tur­ing is­sues at the fa­cil­i­ty where CUTX-101 is made. The fa­cil­i­ty re­cent­ly re­spond­ed to the FDA’s Sep­tem­ber re-in­spec­tion, ac­cord­ing to Fortress’ press re­lease, and Sen­tynl plans to meet with the FDA and re­sub­mit its ap­pli­ca­tion.

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