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BioWorld - Wednesday, December 31, 2025
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Digital pills on a circuit board

Medidata CEO says digital therapeutics, drugs future of patient treatment

March 28, 2025
By Shani Alexander
Digital therapeutics coupled with drugs has the potential to transform health care and change the way patients are treated, Anthony Costello, CEO of Medidata Solutions Inc., told BioWorld. Medidata recently strengthened its partnership with Click Therapeutics Inc., following an investment from its parent company Dassault Systèmes SE, which will see the two companies working to develop new therapies to improve the experience of patients.
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Environmental Protection Agency - US EPA

EPA to reconsider air standards for ethylene oxide

March 28, 2025
By Mark McCarty
In a move that undoubtedly has the unspoken support of the medical device industry, the U.S. Environmental Protection Agency (EPA) reported it will revisit several rules governing emissions that affect a broad swath of industries.
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Australia flag with microscope, test tubes

Australia looks to Asia as Trump administration threatens funding

March 28, 2025
By Tamra Sami
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
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Illustration of hole in vessel wall with repair process in progress

Sanofi adds to hemophilia arsenal with FDA nod for Qfitlia

March 28, 2025
By Jennifer Boggs
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors, and joins the small but growing group of non-factor therapy options, with the advantage of a broad label and a convenient dosing regimen.
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Doctor measuring patient's waist

Novo Nordisk licenses Lexicon’s preclinical obesity drug in $1B deal

March 28, 2025
By Karen Carey
As companies continually search for next-generation obesity prospects, one of the leaders in the disease space, Novo Nordisk A/S, has obtained an exclusive license to a preclinical-stage, first-in-class, small-molecule inhibitor of Acyl-CoA synthetase 5 (ACSL5) developed by Lexicon Pharmaceuticals Inc.
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Myst it again: Milestone gets a CRL for its heart spray

March 28, 2025
By Lee Landenberger
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way. 
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Brain illustrated with pills
Neurology/psychiatric

Disease-modifying Alzheimer’s drugs are ‘drivers of change’

March 28, 2025
By Nuala Moran
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
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Vykat XR

First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars

March 27, 2025
By Karen Carey
Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%.
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US flag and HHS logo

HHS to cut staffing levels by 20,000 under efficiency initiative

March 27, 2025
By Mark McCarty
The U.S. Department of Health and Human Services HHS reported a plan to reduce staffing by 10,000 in an immediate reduction, which when paired with retirement initiatives will drop staffing by as many as 20,000.
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Nanosonics Coris endoscope reprocessing platform

FDA clears Coris system for cleaning reprocessed endoscopes

March 27, 2025
By Tamra Sami
The U.S. FDA gave the green light to Nanosonics Ltd.’s Coris system via de novo clearance for reducing infection risk by delivering improved cleaning outcomes for flexible endoscopes, especially the complex channels of endoscopes that are prone to biofilm build up.
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