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BioWorld - Tuesday, May 26, 2026
Home » Topics » North America » U.S.

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Stock merger illustration

Zimmer Biomet in $168M buy of ortho robotics maker Monogram

July 14, 2025
By Holland Johnson
Zimmer Biomet Holdings Inc. reported it is buying orthopedic robotics maker Monogram Technologies Inc. for an upfront payment of $4.04 per share in cash, corresponding to an equity value of approximately $177 million and an enterprise value of about $168 million.
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Cyber security padlock

Preemption of state privacy law on tap in cybersecurity hearing

July 14, 2025
By Mark McCarty
The continuing proliferation of U.S. state privacy law drew the attention of developers of med-tech wearables for some time, but a recent Senate hearing delivered the news to Congress that a failure to preempt it will slow digital health innovation to a crawl.
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Product recall concept image

US FDA posts raft of early device alerts in June, July

July 14, 2025
By Mark McCarty
The U.S. FDA recently posted three alerts under the agency’s early alert program, including an alert for the V6 and V8 versions of the Sigma Spectrum infusion pumps by Baxter International Inc., which was the result of a mix-up in software installation.
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PBM practices a threat to future of biosimilars, FTC, DOJ told

July 14, 2025
By Mari Serebrov
No Comments
Once again, U.S. legislative reforms to rein in pharmacy benefit manager (PBM) business practices missed a ride to finally becoming law. This time, they were kicked out of the Trump administration’s budget reconciliation bill that was signed into law July 4. House Resolution 1, as first passed in the lower chamber, included a few PBM reforms, but they were deleted from the Senate version that ultimately became law because the parliamentarian ruled they didn’t meet the restrictions placed on reconciliation measures.
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Mink surges on salvage therapy success with Agent-797

July 14, 2025
By Karen Carey
No Comments
The complete remission of a testicular cancer patient receiving Mink Therapeutics Inc.’s allogeneic, off-the-shelf invariant natural killer T-cell therapy Agent-797 with nivolumab drove the company’s shares up by 730% July 11. The results, published in Nature’s Oncogene, described the complete, durable remission of a 49-year-old man with a germ cell neoplasm, showing no evidence of disease two years after receiving a single infusion.
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Astrazeneca’s baxdrostat solid in phase III hypertension trial

July 14, 2025
By Jennifer Boggs
No Comments
Astrazeneca plc reported results from its BaxHTN phase III trial showing aldosterone synthase inhibitor (ASI) baxdrostat met primary and secondary endpoints in patients with uncontrolled or treatment-resistant hypertension. The news marks a positive outcome of the company’s $1.8 billion gamble on Cincor Pharma Inc. in 2023, and keeps baxdrostat in the race with Mineralys Therapeutics Inc., which has said it anticipates a pre-NDA meeting this year for its ASI, lorundrostat, after reporting pivotal hypertension data in March 2025.
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Gears with regulatory words

OIG won’t oppose drugmaker payment for companion diagnostic

July 11, 2025
By Mark McCarty
Companies in the life sciences must tread carefully when it comes to the Anti-Kickback Statute, but a recent advisory opinion by the Office of Inspector General lends little clarity on the point.
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Website of Cell, a peer-reviewed scientific journal

NIH capping science journal fees for open access published research

July 11, 2025
By Nuala Moran
No Comments
The National Institutes of Health has opened another front in its cost cutting drive, saying it will cap the fees science journals charge for publishing papers authored by researchers it funds.
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Abstract blue human heart with red cardio pulse line and red circle

Capricor gets CRL for cell therapy BLA in rare disease

July 11, 2025
By Lee Landenberger
No Comments
Capricor Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The company’s CEO said the letter was unexpected.
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PTAB hands Exact a loss in Geneoscopy patent dispute

July 10, 2025
By Mark McCarty
The med tech patent wars opened a new front in the region of screening tests for colorectal cancer, pitting Exact Sciences Corp., of Madison, Wisc., against St. Louis-based Geneoscopy Inc.
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