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23 September, 2026
Endpoints 11 - Virtual Experience
September 28: Don Ingber of the Wyss Institute joins our Endpoints 11 virtual day for a fireside chat, alongside interviews with the honorees and gala highlights. Open to everyone, free to join. Register now.
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The Miss­ing Lay­er in On­col­o­gy Re­al-World Da­ta
top stories
1. FDA adcomm raises questions on effectiveness of Grail's cancer test
2. Baby KJ's gene-editing drug cost $1.65M to make, Fyodor Urnov says
3. Updated: Roivant reports Phase 2b lupus failure for an FcRn drug
4.
in focus
In a changed world for cystic fibrosis, a family's fight reveals a new gap in care
5. Roche kidney drug's Phase 3 win sets up path to accelerated approval
Max Bayer
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Tomorrow's a big day for Heidi Overton, who's set to testify in her confirmation hearing to lead the FDA. The nominee will face members of the Senate HELP Committee, chaired by Bill Cassidy (R-LA), a staunch defender of vaccines. Overton is expected to have to defend her push for the MMR vaccine to be split into three individual shots, part of a sweeping presidential executive order.

But Overton recently received a hefty bit of political cover. Former FDA commissioners Scott Gottlieb and Mark McClellan backed her in a new op-ed, calling her "the right pick in a difficult moment."

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Max Bayer
Senior Reporter, Endpoints News
1
by Zachary Brennan

Mem­bers of the FDA's Mol­e­c­u­lar and Clin­i­cal Ge­net­ics Pan­el and FDA of­fi­cials on Wednes­day raised ques­tions about Grail's next-gen­er­a­tion se­quenc­ing test for the ear­ly de­tec­tion...

Read the full story
2
by Ayisha Sharma

OX­FORD, Eng­land— The world's first ther­a­py de­signed to fix a pa­tien­t's unique ge­net­ic mu­ta­tion cost $1.65 mil­lion to make, a key fa­cil­i­ta­tor of the project...

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3
by Max Gelman

One of Roivant’s lead­ing au­toim­mune pipeline can­di­dates failed a Phase 2b study in a form of lu­pus, the com­pa­ny said Wednes­day morn­ing.

The pro­gram, known...

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Grand River Aseptic Manufacturing
Beyond Capacity and Cost: Strategic Decisions in Fill-Finish CDMO Partnerships
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Endpoints In Focus
4
by Andrew Dunn

KNOXVILLE, TN— Stephanie Mar­quart met the de­liv­ery guy be­fore he could reach her front door. She’d been ob­ses­sive­ly re­fresh­ing the track­ing page, trac­ing the...

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5
by Elizabeth Cairns

Roche moves clos­er to en­ter­ing an in­creas­ing­ly crowd­ed kid­ney dis­ease mar­ket where No­var­tis, Cal­lid­i­tas, Tra­vere, Ot­su­ka and Ve­ra al­ready have ap­proved drugs.

The Swiss phar­ma...

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