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top stories
1. DC judge rejects Merck’s IRA case more than three years after it was filed
2. Capricor's Duchenne cell therapy gets PDUFA date extended as FDA reviews new data
3. Roche bets up to $2.3B on Hanmi’s early-stage muscle-building obesity asset
4. Option-to-acquire deals remain rare in biotech's buzzy M&A season
5.
news briefing
TwinStrand wins patent case; GSK’s hepatitis B drug approved in Japan
6. Regenxbio hit with another clinical hold for Hunter syndrome gene therapy
7. News on AstraZeneca, Cytokinetics, Novartis and more — what to look out for at ESC 2026
more stories
 
Nicole DeFeudis
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After three years of deliberations, a DC federal judge issued a 17-page opinion rejecting Merck's challenge to Medicare negotiations. One source told me "it was about time" for a decision to come in.

Merck was the first of several drugmakers to challenge the first round of negotiations in court, and it was the last to receive a decision. So far, drugmakers have lost every case where a judge has ruled on the merits, and the Supreme Court has declined to weigh in.

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Nicole DeFeudis
Senior Reporter, Endpoints News
@Nicole_DeFeudis
1
by Nicole DeFeudis

Af­ter lengthy con­sid­er­a­tion, a DC fed­er­al judge on Mon­day re­ject­ed Mer­ck’s chal­lenge to Medicare drug price ne­go­ti­a­tions.

Judge Colleen Kol­lar-Kotel­ly of the US Dis­trict Court...

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2
by Anna Brown

The FDA is push­ing back its de­ci­sion on Capri­cor Ther­a­peu­tics’ prob­lem­at­ic Duchenne mus­cu­lar dy­s­tro­phy ther­a­py to re­view ad­di­tion­al da­ta for a more niche in­di­ca­tion.

The...

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3
by Ayisha Sharma

Roche is spend­ing $190 mil­lion up­front to li­cense a non-in­cretin obe­si­ty drug from South Ko­rea’s Han­mi Pharm.

The deal rep­re­sents the lat­est in a string...

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4
by Kyle LaHucik

Two re­cent deals are fo­cus­ing at­ten­tion on a rel­a­tive­ly rare struc­ture for biotech buy­outs: the op­tion-to-ac­quire.

Drug de­vel­op­ers are on pace to have one of...

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News Briefing: Quick hits from the biopharma web
5
by ENDPOINTS

Twin­Strand Bio­sciences wins patent case: The DNA se­quenc­ing com­pa­ny, which spun out of the Uni­ver­si­ty of Wash­ing­ton, an­nouncedon Mon­day that it won a patent...

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6
by Ayisha Sharma

Re­genxbio said it no longer ex­pects to file for FDA ap­proval of its Hunter syn­drome gene ther­a­py in the near fu­ture af­ter the pro­gram was...