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BioWorld - Tuesday, May 19, 2026
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Global vaccine illustration

So far, ACIP vaccine recommendations in line with the world

Oct. 2, 2025
By Mari Serebrov
No Comments
While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.
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Digital pills on a circuit board
Drug design, drug delivery & technologies

Pharma pools structural data to boost power of AI in drug discovery

Oct. 2, 2025
By Nuala Moran
No Comments
Pharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model. Each of the partners is contributing data from several thousand experimentally determined protein:ligand interactions, creating one of the most diverse datasets and the richest chemistry assembled to date for model training.
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Elutia Elopro drug eluting bioenvelope

Boston Sci closes Elutia deal, projects 10% growth through 2028

Oct. 1, 2025
By Annette Boyle
Boston Scientific Corp. continues to prove out its strategy of active acquisitions combined with industry-leading organic growth with the closing of its $88 million acquisition of Elutia Inc.’s Bioenvelope business and very positive targets for growth presented during its investor day on Sept. 30.
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Female healthcare professional holding dollar sign

Convatec commits over $1B to R&D in UK, US

Oct. 1, 2025
By Shani Alexander
Convatec Group plc plans to invest more than $1 billion in the U.S. and U.K. over the next decade as it looks to accelerate its research and development (R&D) ambitions.
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U.S. at night from space with circuit board overlay

AI problems suggest need for independent validation institute

Oct. 1, 2025
By Mark McCarty
AI seems to suggest that a world of problems with health care spending may become more manageable, but Stephen Bittinger, a shareholder in the D.C. office of the law firm of Polsinelli PC told BioWorld that all the headaches surrounding validation of these algorithms suggests a need for an independent AI validation institute.
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Geneoscopy RNA-FIT-test

Geneoscopy seeks coverage for Colosense, but specificity a problem

Oct. 1, 2025
By Mark McCarty
The market for colorectal cancer screening tests seems poised to heat up considerably with a recent request for Medicare coverage for Genoscopy’s Colosense test, but some who commented on the proposal have misgivings about the lower level of specificity seen in the Colosense relative to the Cologuard.
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Laptop displaying FDA logo

New FDA submissions stalled during US government funding lapse

Oct. 1, 2025
By Mari Serebrov
No Comments
Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill.
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Antibodies

Kyorin snags Hinge Bio’s multispecific antibody

Oct. 1, 2025
By Tamra Sami
No Comments
Kyorin Pharmaceutical Co. Ltd. is licensing Hinge Bio Inc.’s multispecific antibody-based therapy HB-2198 in Japan for multiple autoimmune indications, starting with systemic lupus erythematosus.
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Digital pills on a circuit board

Pharma pools structural data to boost power of AI in drug discovery

Oct. 1, 2025
By Nuala Moran
No Comments
Pharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model.
Read More
Vial and syringe with DNA

CRL blocks Menkes disease treatment CUTX-101

Oct. 1, 2025
By Lee Landenberger
No Comments
A U.S. FDA complete response letter (CRL) citing manufacturing concerns has stepped into the way of a rare genetic disorder treatment. Fortress Biotech Inc. and its subsidiary, Cyprium Therapeutics Inc., said the letter in response to the NDA for CUTX-101, an injectable formulation of copper histidinate, noted cGMP deficiencies at the facility where the Menkes disease treatment is manufactured.
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