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BioWorld - Wednesday, May 20, 2026
Home » Topics » North America » U.S.

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Ireland plots to safeguard US investment in biomanufacturing sector

Dec. 8, 2025
By Nuala Moran
No Comments
Ireland is taking stock of the implications Trump administration tariffs and drug pricing policies hold for its world-leading biomanufacturing sector, which has been largely built on the back of investment by U.S. pharma companies – and is hugely reliant on exports to the U.S.
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Pills, bottle, scale and-measuring tape

Wave Life, Structure and Ascletis post wins in obesity management

Dec. 8, 2025
By Lee Landenberger
No Comments
With new results from Wave Life Sciences Ltd., Structure Therapeutics Inc. and Ascletis Pharma Inc., obesity management drugs continue to move forward in producing weight loss and move the market.
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Positive phase Ib SCD data perk Fulcrum stock

Dec. 8, 2025
By Randy Osborne
No Comments
On the heels of mixed phase III data from Agios Pharmaceuticals Inc. with mitapivat to treat sickle cell disease (SCD), Fulcrum Therapeutics Inc. wowed investors by way of initial results from the ongoing 20-mg dose cohort in the phase Ib Pioneer trial testing oral, once-daily fetal hemoglobin inducer pociredir.
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IV drips

ASH 2025: New blood cancer therapies trump chemo, older drugs

Dec. 8, 2025
By Karen Carey
No Comments
Targeted therapies and immunotherapies continue to show better results than chemotherapy in investigator-initiated and company-sponsored cancer trials, and newer options demonstrate improvements over older ones, supporting potential shifts in how patients are treated.
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Acute myeloid leukemia

ASH 2025: Speeding AML research with MRD surrogate endpoint

Dec. 8, 2025
By Karen Carey
No Comments
While several targeted therapies are approved for acute myeloid leukemia, a 2023 U.K. study found that median survival following diagnosis was only about seven months, highlighting the need not only for new therapies, but for a faster regulatory strategy. At the American Society of Hematology’s 67th annual meeting in Orlando Dec. 6, researcher Jesse Tettero presented data supporting the use of a measurable residual disease (MRD) surrogate endpoint in acute myeloid leukemia (AML) research.
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Illustration of RNS system placement in brain

Neuropace shows 77% reduction in seizures

Dec. 8, 2025
By Annette Boyle
People with drug-resistant epilepsy have had few other options, but Neuropace Inc. appears on target to provide an alternative. The Nautilus trial of its responsive neurostimulation system for individuals with drug-resistant idiopathic generalized epilepsy showed a 77% reduction in generalized tonic-clonic seizures sustained over 18 months.
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Medtronic Hugo platform

Medtronic’s Hugo robotic system gets FDA nod

Dec. 8, 2025
By Shani Alexander
The U.S. FDA’s clearance of Medtronic plc’s Hugo robotic-assisted surgery (RAS) system is certainly a boon for the company which is betting on the unit to be a key growth driver. While the soft tissue robotics market is dominated by Intuitive Surgical Inc.’s da Vinci system, the space is growing, and Medtronic has the scale, resources and market presence to make headway but there are also a plethora of smaller, versatile and cost-effective systems looking for a piece of the pie.
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V-Wave

J&J V-Wave heart shunt shut down by FDA advisory panel

Dec. 8, 2025
By Holland Johnson
A U.S. FDA advisory panel voted unanimously against approving Johnson & Johnson’s V-Wave Ventura shunt for heart failure patients not helped by medications. The circulatory panel voted emphatically 15-0 against use of the shunt for heart failure patients not helped by medications based on effectiveness and its benefit-risk profile. On the question of safety, the panelists did vote 9-6 in favor of the device.
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FDA logo on textured paper
2025 FDLI Compliance Conference

RRA asks whether industry is even remotely ready for action

Dec. 8, 2025
By Mark McCarty
The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. RRAs were on tap at the 2025 enforcement conference held by the Food and Drug Law Institute, but the session seemed to suggest that industry may not be fully prepared for how the agency will conduct these reviews, but also what it will do with the results.
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Australian coins and bills

Kazia raises AU$50M to advance PI3K/mTOR inhibitor paxalisib

Dec. 5, 2025
By Tamra Sami
No Comments
Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer.
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