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BioWorld - Friday, February 13, 2026
Home » Topics » North America » U.S.

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US flag and HHS logo

Pallone, DeGette push back on FDA, other HHS dismissals

March 3, 2025
By Mark McCarty
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
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Regulatory icons

US PTO peels back 2022 memo on discretionary denials of IPRs

March 3, 2025
By Mark McCarty
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
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Brain and neural networks

Precision Neuroscience initiates brain computer interface study

March 3, 2025
By Shani Alexander
Precision Neuroscience Inc. recently partnered with Beth Israel Deaconess Medical Center to test its brain computer interface, the Layer 7 Cortical Interface, during craniotomy procedures.
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Woman steadying hand tremor

DMC’s phase III tremor finding shakes Praxis theory

Feb. 28, 2025
By Randy Osborne
After Study 1’s independent data monitoring committee said the experiment will likely fall short of its primary endpoint with ulixacaltamide in essential tremor, Praxis Precision Medicines Inc. plans to wait for full data from Study 1 as well as Study 2 in the Essential 3 phase III program before deciding on regulatory moves.
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Illustration of Magnet Biomedicine's Trueglue platform

Magnet, Eli Lilly sign $1.25B molecular glue deal for oncology

Feb. 28, 2025
By Karen Carey
About 17 months after emerging from stealth with its Trueglue discovery platform, Magnet Biomedicine Inc. has joined with Eli Lilly and Co. to discover, develop and commercialize molecular glue therapeutics for oncology. “It’s a really important deal, especially given the discovery of Trueglues is something Magnet is pioneering,” CEO Brian Safina told BioWorld. The deal includes $40 million in up-front and near-term payments, including an equity investment, as well as potential milestone payments, bringing the deal total to more than $1.25 billion, plus tiered royalties.
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Google Pixel Watch 3 Loss-of-pulse

FDA clears loss-of-pulse detection on Google Pixel Watch 3

Feb. 28, 2025
By Annette Boyle
The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.
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Tug-of-war illustration

Novelty of PCCP filings a source of drag for FDA, industry

Feb. 28, 2025
By Mark McCarty
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
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Rebound arrows
Index insights

Biopharmaceutical index drops in 2024, but starts new year on a rebound

Feb. 27, 2025
By Amanda Lanier
The BioWorld Biopharmaceutical Index (BBI) ended 2024 down 2.24%, despite hitting a peak of 25.19% in late August. While it remained in positive territory through November, up 3.58%, the steady decline through the later months of the year pushed the index into the red by December’s close.
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Ryoncil

Mesoblast prices pediatric stem cell treatment at $1.55 million

Feb. 27, 2025
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
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Uncertainties for Kallyope’s nutrient receptor agonists for obesity

Feb. 27, 2025
By Karen Carey
The prospects of an oral obesity candidate used as a monotherapy or combination therapy is in question after Kallyope Inc. posted disappointing phase II data on a government website, indicating that its lead candidate, K-757, failed to meet all endpoints.
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