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

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U.S. Supreme Court

Device, drug makers weigh in on Janssen’s FCA case

July 25, 2025
By Mark McCarty
Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
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3D map of China

Cryofocus’ asthma device wins FDA breakthrough label

July 25, 2025
By Marian (YoonJee) Chu
Cryofocus Medtech (Shanghai) Co. Ltd. received U.S. FDA breakthrough device designation on July 24 for its cryoablation system for asthma. The Chinese med-tech’s stock (HKEX:6922) rose near 20% over two consecutive days on the Hong Kong Stock Exchange with the news, increasing from HK$5.00 ($.64) July 23 to HK$5.98 nearing the close of trading on July 25.
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Cortium

Corium identifies agent in MS patch

July 25, 2025
By Simon Kerton
The first filing in the name of Grand Rapids, Mich.-headquartered Corium Innovations Inc. confirms the company formerly known as Corium Pharma Solutions Inc. is developing treatments for multiple sclerosis and ulcerative colitis that employ its proprietary Corplex transdermal patch technology.
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Kidneys

Memo's potravitug reduces BK viral load in kidney transplant

July 25, 2025
By Nuala Moran
No Comments
Memo Therapeutics AG is laying plans to advance its BK polyomavirus neutralizing monoclonal antibody potravitug into phase III development after reporting positive phase II results in treating infections in immunocompromised kidney transplant patients.
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U.S. flag and White House podium

Trump administration’s AI action draws props from med tech

July 24, 2025
By Mark McCarty
The Trump administration released an action plan for AI, which includes an exports program for full-stack AI in areas such as health care. The announcement drew the support of the Advanced Medical Technology Association, which described the initiative as an accelerant for the use of AI in health care and a boon to patient outcomes.
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Gray and green glass dollar symbols with arrow pointing up

Boston Sci posts 117% U.S. PFA growth, halves tariff impact

July 24, 2025
By Annette Boyle
Boston Scientific Corp. handily beat expectations for sales growth and profits in the second quarter, led by 117% growth for its Farapulse pulsed field ablation system in the U.S. and 23% overall organic increase in revenue for cardiology. The company cut the expected impact of tariffs by 50% and raised guidance for earnings per share and sales for the year.
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Skin irritation on hands

US FDA approves first hand eczema treatment: Leo Pharma’s Anzupgo

July 24, 2025
By Karen Carey
No Comments
Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The cream, dosed at 20 mg/g and applied topically, will treat moderate to severe cases in those not responsive to, or unable to take, topical corticosteroids.
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Gold dollar sign and blue circular arrows

Modi Ventures raises $88M in second health care fund

July 23, 2025
By Shani Alexander
Modi Ventures closed its second fund with total commitments of $88 million as it continues its mission to invest in companies at the intersection of artificial intelligence, biology and medical technology. The venture capital firm sees the future of health care as a convergence of these technologies.
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Environmental Protection Agency - US EPA

Device sterilizers granted two-year EtO reprieve

July 23, 2025
By Mark McCarty
There are times when a casual observer can’t tell whether the medical device industry’s messaging is getting through to policymakers, but a July 17 announcement by the Trump administration clearly signals the effectiveness of at least one med tech messaging strategy.
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Avalyn inhaler

Avalyn secures $100M for inhaled pulmonary fibrosis candidates

July 23, 2025
By Brian Orelli
No Comments
Following up on the $175 million it raised in September 2023, Avalyn Pharma Inc. secured an additional $100 million in an oversubscribed series D financing round to support development of its inhaled treatments for pulmonary fibrosis.
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