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BioWorld - Monday, June 15, 2026
Home » Topics » North America » U.S.

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Black dollar sign on ombre blue background

Dren draws $600M up front from Sanofi in $1.9B antibody deal

March 20, 2025
By Lee Landenberger
Sanofi SA is getting deeper into oncology and immunology therapy development through buying Dren Bio Inc.’s myeloid cell engager for deep B-cell depletion, DR-0201. The deal could reach as high as $1.9 billion for privately held Dren. Sanofi is paying a hefty $600 million up front, and milestone payments to come could add up to $1.3 billion.
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WO2025049953-A1, “Conductive microwire-based biochemical sensors for real-time neurological monitoring.”

Neurothread biosignal monitoring could sew up neurological diagnoses

March 20, 2025
By Simon Kerton
Researchers from The Ohio State University have filed for protection of Neurothread, a wire-type neurotransmitter-sensing platform that utilizes the cross-section of commercially available ultrathin microwires as microelectrodes.
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Evoque valve sizes

US Medicare’s TTVR aligns closely with draft, T-TEER devices en route

March 20, 2025
By Mark McCarty
The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.
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Prescription pad

Legislation would authorize AI to write prescriptions

March 19, 2025
By Mark McCarty
The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.
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Website of The Federal Trade Commission

Trump halves the FTC, firing Democratic commissioners

March 19, 2025
By Mari Serebrov
The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.
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Black Diamond lands $780M Servier deal for RAS/RAF candidate

March 19, 2025
By Jennifer Boggs
Black Diamond Therapeutics Inc. is getting $70 million up front and could earn up to $710 million in milestone payments in a deal with Servier for phase I-stage BDTX-4933, a small-molecule candidate targeting both RAS mutations and RAF alternations for treating solid tumors, including non-small-cell lung cancer.
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Product recall concept image

Latest device recalls include Medtronic embolization devices

March 19, 2025
By Mark McCarty
The U.S. FDA has posted several class I recalls in recent days, including a removal of one model of the Medtronic Vascular’s Pipeline Vantage embolization device due to insufficient apposition to the vessel wall.
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FDA icons

FDA hits Q’Apel Medical with warning for design changes to Hippo

March 19, 2025
By Mark McCarty
The U.S. FDA warning letter to Q’Apel Medical Inc., of Fremont, Calif., lists several deviations from the regulation, but the agency said the company’s Hippo device for is misbranded because Q’Apel had failed to file with the agency for changes to the device design.
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Nandoun Abeysekera, founder and CEO, Avasa
Newco news

New Zealand’s Avasa develops world-first arterial coupler

March 19, 2025
By Tamra Sami
New Zealand med-tech startup Avasa Ltd. has developed an arterial coupler that could save surgeons 30 minutes in the operating room to better connect arteries.
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Ono scoops Ionis' hematology candidate sapablursen for up to $940M

March 18, 2025
By Tamra Sami
Ono Pharmaceutical Co. Ltd. struck a licensing deal with Ionis Pharmaceuticals Inc. for sapablursen, which is in phase II trials for polycythemia vera. Under terms, Osaka, Japan-based Ono gains an exclusive license to develop and commercialize sapablursen worldwide. Carlsbad, Calif.-based Ionis will be responsible for completing the ongoing phase II Imprssion study, while Ono will be responsible for subsequent development, regulatory filings and commercialization.
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