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BioWorld - Thursday, January 1, 2026
Home » Topics » North America » U.S.

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U.S. flag on columned building

J&J escapes $20M infringement award

Oct. 7, 2025
By Mari Serebrov
Johnson & Johnson Medtech won out over a jury verdict that found the company’s Depuy Synthes liable for $20 million for infringing a patent claimed by Rasmussen Instruments LLC.
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Vaccine vial and syringe

Latest ACIP recommendations added to CDC vaccine schedules

Oct. 7, 2025
By Mari Serebrov
No Comments
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
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Hand holding thin piece of film

Taho submits US NDA for first apixaban oral dissolving film

Oct. 7, 2025
By Marian (YoonJee) Chu
No Comments
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
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Antibodies

Kyorin snags Hinge Bio’s multispecific antibody

Oct. 7, 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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Fiasp

IRA forecloses Novo Nordisk challenge to Medicare negotiations

Oct. 7, 2025
By Mari Serebrov
No Comments
Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.
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Person testing glucose level

Biomea’s ‘durable’ menin inhibitor advancing in hard-to-treat diabetes

Oct. 7, 2025
By Karen Carey
No Comments
Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
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IV drip

Lexeo, FDA position Friedreich ataxia therapy for accelerated path

Oct. 7, 2025
By Lee Landenberger
No Comments
Lexeo Therapeutics Inc. feels like it’s in a faster lane to a BLA for its Friedreich ataxia cardiomyopathy gene therapy after talking with the U.S. FDA. The agency told Lexeo that LX-2006 could be on the accelerated approval path if there is a mingling of the company’s data and studies.
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Layer 7 Cortical Interface

Precision Neuro’s minimally invasive BCI effective in early studies

Oct. 6, 2025
By Shani Alexander
The brain-computer interface (BCI) system being developed by Precision Neuroscience Corp. is capable of capturing high-resolution brain signals and stimulating areas without damaging the cortical surface, according to a study published in Nature Biomedical Engineering.
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Illustration of cryoblation procedure in breast

Icecure gets FDA nod for Prosense cryoablation in breast cancer

Oct. 6, 2025
By Holland Johnson
Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.
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Decorative scales of justice in a courtroom

US Fed Circuit hands Stryker a win over PTAB

Oct. 6, 2025
By Mari Serebrov
While the final word has yet to be written, Stryker Corp. came out the biggest winner in a dispute involving four related patents owned by Osteomed LLC, part of Colson Associates’ Acumed.
Read More
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