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BioWorld - Thursday, June 25, 2026
Home » Topics » North America » U.S.

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Proposed CMS rule aims to close fixed combo drug loophole

June 15, 2026
By Karen Carey
No Comments
The Centers for Medicare & Medicaid Services (CMS) proposed a rule June 12 that would codify the Inflation Reduction Act of 2022’s Medicare Drug Price Negotiation Program, establish new negotiation and drug benefit policies, and modify the fixed combination drug policy – the latter of which would negatively impact biopharmas attempting to extend lifecycles of blockbuster products.
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Illustration of amyloid plaques in Alzheimer's disease

Elixiron’s enrupatinib shows upbeat interim phase II AD results

June 15, 2026
By Marian (YoonJee) Chu
No Comments
Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant colony-stimulating factor 1 receptor inhibitor, with plans to move the asset into a biomarker-based and placebo-controlled study.
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Pediatric exam
HLTH Europe

Children overlooked as pediatric innovation struggles for funding

June 15, 2026
By Shani Alexander
No Comments
Even though children make up a quarter of the population, healthcare technologies are not often designed with them in mind. Investment in pediatric innovation remains limited with investors often viewing returns in the space as less predictable. Nevertheless, a number of companies are looking to address this and are developing technologies for kids. Afterall, with huge investments going into longevity R&D, there is a compelling case for addressing health issues at the very early stage, delegates heard at the first annual Pediatric Innovation Summit, held as part of the HLTH Europe conference in Amsterdam on June 15.
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Vaccine vials and syringe

No CNPV needed? Sanofi’s Tzield gains accelerated nod in stage 3 T1D

June 15, 2026
By Jennifer Boggs
No Comments
Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D).
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Dollar sign, downward arrow

Do phase II data Amplify KRAS PDAC promise for Elicio?

June 15, 2026
By Randy Osborne
No Comments
Backers of Boston-based Elicio Therapeutics Inc. may have jumped the gun as they ran away from the firm after data were made public from the phase II Amplify-7P study testing ELI-002 7P in adjuvant KRAS-mutation-driven pancreatic ductal adenocarcinoma (PDAC) following standard locoregional therapy. Wainwright analyst Robert Burns said the results are “more nuanced than they appear” and the sell-off represents “an attractive entry point” for investors. Shares (NASDAQ:ELTX) closed June 15 at $4.08, down $10.77, or 72%, in the wake of news that the trial missed the pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population.
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CAR T and red blood cells
EHA2026

Viva in vivo! At EHA, in vivo CAR T data continues to impress

June 14, 2026
By Anette Breindl
No Comments
Treatment with first-generation CAR T cells regularly sent patients to the intensive care unit. Now, investigators are envisioning a future where CAR T treatment could occur on an outpatient basis. At Sunday’s late-breaking oral session of the 2026 Annual Congress of the European Hematology Association (EHA2026), Lei Fan told his audience that the first-in-human data “support further development of LB-2501 as a potential first-in-class, off-the-shelf, single infusion, no lymphodepletion, outpatient use CAR T therapy.” Fan is a professor of hematology at the First Affiliated Hospital of Nanjing Medical University.
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3D illustration of thyroid in human body with parathyroid glands highlighted

Street canvu MBX phase II HP data more than one way

June 12, 2026
By Randy Osborne
No Comments
With full phase II results in hand, MBX Biosciences Inc. backers are stacking the odds of parathyroid hormone (PTH) peptide prodrug canvuparatide (canvu) against Yorvipath (palopegteriparatide} from Ascendis Pharma A/S, a PTH analog cleared by the U.S. FDA in August 2024 for hypoparathyroidism (HP).
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FDA icons and doctor

Another FDA no for Camurus’ monthly acromegaly drug Oclaiz

June 11, 2026
By Karen Carey
No Comments
In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The drug, which expects to be branded Oclaiz in the U.S. upon approval, is called Oczyesa in the EU and the U.K., where it received marketing authorization in 2025.
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Neck exam
Newco news

Ethyreal launches to treat the underlying cause of Graves’, TED

June 11, 2026
By Brian Orelli
No Comments
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.
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Deal handshake with graphic overlay

Laekna licenses LAE-118 ex-China to Vasque in $527M deal

June 11, 2026
By Tamra Sami
No Comments
Laekna Inc. is handing ex-China rights to internally discovered PI3Kα pan-mutant selective inhibitor LAE-118 to U.S.-based Vasque Bio Inc. in a deal worth up to $527 million, marking another asset-monetization move by the Shanghai company as it looks to fund and accelerate development across its oncology and metabolic disease pipeline.
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