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BioWorld - Wednesday, November 19, 2025
Breaking News: Arrowhead’s plozasiran cleared for FCS; Ionis patent duel awaitsBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Apple Watch pulseox

    Analysts see tide turning toward Masimo in Apple patent war

    A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.
  • Jefferies says health care showing resilience despite challenges

    The health care sector continues to be strong and adaptable despite the challenges over the past year, according to a report by global investment bank Jefferies. High interest rates, geopolitical uncertainty and policy shifts have added caution to the industry, but leaders are adapting well.
  • Analysts see tide turning toward Masimo in Apple patent war

    A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.
  • Jefferies says health care showing resilience despite challenges

    The health care sector continues to be strong and adaptable despite the challenges over the past year, according to a report by global investment bank Jefferies. High interest rates, geopolitical uncertainty and policy shifts have added caution to the industry, but leaders are adapting well.
  • Pulsed field ablation lifts Medtronic Q2 results

    Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.
  • Aesculap clears its legal troubles with $38.5M OIG settlement

    Aesculap Implant Systems LLC has seen its share of bad news recently, but the company seems to have cleared the legal deck with an agreement to pay $38.5 million per a Nov. 17 announcement by the U.S. attorney’s office for the district of Eastern Pennsylvania.
  • ‘Encyclopedia’ of xenotransplantation reveals drivers of immune rejection

    By transplanting a pig kidney into a brain-dead person, researchers have been able to conduct the first long-term study of the physiological processes occurring in both the transplant recipient and the pig organ for 61 days. The findings were published in the Nov. 14, 2025, issue of Nature in two papers – one focusing on physiological and immunological measurements, the other on multiomics.
  • Today's news in brief

    BioWorld MedTech briefs for Nov. 18, 2025.

Sponsored content

Digital health

  • Illustration showing cross-section of bladder with tumor on bladder wall

    Minze, Medtronic partner on overactive bladder care in EMEA

    Urology
    Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral...
  • South Korea flag with stock chart, gold coins

    South Korea ramping up investment in medical device R&D

    Regulatory
    A four-way interagency initiative in South Korea, started in 2020, is working to bolster funding for the local medical device industry and grow homegrown devices for the global market.
  • SK Biopharm execs

    SK Bio, Eurofarma launch Mentis Care for digital epilepsy care

    Newco news
    SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture (JV) called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.
  • Pomdoctor

    Pomdoctor closes $20M IPO to grow mobile health platform in China

    Financings
    Pomdoctor Ltd. raised $20 million through a Nasdaq IPO on Oct. 8, with the funds geared to expand its mobile health platform for chronic diseases in China.
More in Digital health

Today's news in brief

  • Appointments and advancements for Nov. 18, 2025

  • Financings for Nov. 18, 2025

  • In the clinic for Nov. 18, 2025

  • Other news to note for Nov. 18, 2025

  • Regulatory actions for Nov. 18, 2025

Regulatory

  • Scrutiny of NIH funding cuts, potential retaliation continues

  • WISeR model said to create incentives to deny claims

  • Exactech morphs into Advita Ortho after passing on a 10-year CIA

  • FDA clears Withings Beamo, ‘thermometer of the future’

  • EPA eases up on PFAS reporting requirements

  • FDA staff argue AI hallucinations can be minimized, but only at a cost

  • Amended stopgap spending bill includes full 2026 funding for FDA

  • TGA updates ad guidelines to include social media

  • Magstim gets FDA nod for chronic pain treatment

  • MDCG announces pilot for coordination of EU clinical trials

Financings

  • European continent with visible borders and curvature of the Earth

    Europe’s life science sector navigating headwinds

    Europe
    While Europe’s biotech sector continues to face headwinds, med tech appears to be weathering the storm more effectively. Uncertainty in the U.S., heightened competition from China and a persistent lack of capital are all impacting the investment landscape, delegates heard at the LSX Investival...
  • China’s Cornerstone Robotics raises $200M series D round

    Gastrointestinal
  • Siemens reducing its stake in Healthineers to a significant minority

    Europe
  • Q3 slowdown fails to derail med-tech’s 2025 financing rebound

    IPO
  • Med-tech financings reach $26.6B as sector recovery continues

    IPO
More in Financings

Newco news

  • Blue heart and data grid

    Tulyp emerges from stealth with pressure-driven perfusion system

    Clinical
    Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical...
  • Symbyx light therapy shows sustained benefits in Parkinson’s

    Gastrointestinal
    The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.
  • Trogenix raises £70M series A for glioblastoma gene therapy trial

    Financings
    Newco Trogenix Ltd. has emerged from incubation and raised £70 million (US$94.1 million) in a series A, as it prepares the ground for a U.S/U.K. clinical trial of a novel gene therapy construct in glioblastoma multiforme that is due to start at the beginning of 2026.
  • IMU Biosciences' platform reshaping immune system understanding

    Cancer
  • FDA gives nod to Respiree wearable for home care

    Regulatory
  • Phyxiom looks to transform outcomes for patients with asthma, COPD

    Respiratory
  • Aclarion's Nociscan nearly doubles spine surgery success

    Digital health
More in Newco news

Deals and M&A

  • Businessperson completing checklist

    Alcon reports strong 3Q, unsure about Staar merger

    Ophthalmic
    Alcon AG reported its financial results for the three- and nine-month periods ending Sept. 30, 2025. For the third quarter of 2025, sales were $2.6 billion, up 6% on a reported basis and up 5% on a constant currency basis, as compared to the same quarter of the previous year.
  • Deal illustration

    CG Bio, Nexgel developing long-acting drug delivery system

    Aging
    Nexgel Biotech Co. Ltd. and CG Bio Co. Ltd. agreed to co-develop a thermosensitive polyphosphazene hydrogel-based long-acting drug delivery platform through a new collaboration agreement signed Oct. 31.
  • Hand pointing to IPOs on line graph

    Medline lines up IPO, Billiontoone hits the road

    Cancer
    Medline Inc. filed a public S1 with the SEC Oct. 28, moving the IPO first signaled in December 2024 closer to reality. The Northfield, Ill.-based medical supply distributor did not disclose the number of shares to be offered or their price, but Renaissance Capital expects the IPO to raise about $5...
  • Pen and ripped contract

    Staar adjourns Alcon merger meeting until November

    Merger
    Staar Surgical Co. reported on Oct. 24 that it had adjourned its special meeting of stockholders scheduled in connection with its proposed $1.5 billion sale to Alcon AG in the face of objections from some of its major shareholders and at least three proxy firms.
  • Hand, stylus pointing at graph on screen

    Med tech so far in 2025 mixed with optimism, challenges

    Financings
    It has been a positive year for med tech compared to previous years, said Antoine Papiernik, chairman and managing partner at Sofinnova Partners. The IPO market has reopened, several large financing deals have closed, and new players have entered the sector.
More in Deals and M&A

U.S.

  • CLOSURE-AF study not the end of the line for LAAC devices

  • OCEAN study hints at no need for DOACs after afib ablation

  • FISH&CHIPS serves up appetizing news for Heartflow

  • Synchron raises $200M to accelerate Stentrode BCI platform

  • MMI gets IDE for robotic microsurgical study in Alzheimer’s

  • UNESCO adopts ethical standards for neurotechnology

  • China lifts Illumina ban, clears Pacbio’s Sequel II CNDx

  • PTO restores interested party disclosure mandate for PTAB proceedings

  • FDA dodges QMSR bullet as ISO rejects changes to 13485

  • CMS reduces required term of medical therapy in RDN final memo

Europe

  • Blood cells and bacteria

    Ocean Dx sepsis test matches gold standard in early study

    Clinical
    A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly from whole blood, returned 100% sensitivity and 100%...
  • SPT Labtech expands partnerships to boost firefly platform

    Diagnostics
  • UK’s MHRA eyes rare disease framework for therapeutic products

    Regulatory
  • Baxter advances patient blood management with Floseal

    Regulatory
  • Oxford Nanopore, Biomérieux launch Ampore-TB test

    Infection
More in Europe

Asia-Pacific

  • 3D illustration showing presence of tumor inside prostate gland

    Advancell sets new radiopharma standard in prostate cancer

    Clinical
    Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
  • Blood test breakthrough could transform Alzheimer’s diagnosis

    Clinical
    Australian scientists have developed a simpler, less invasive way to detect Alzheimer’s disease that could make it easier for patients to access emerging disease-modifying therapies. Researchers from Australia’s Commonwealth Scientific and Industrial Research Organisation have identified...
  • CDSCO issues draft guidance for medical device software

    Regulatory
    India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.
  • Radiopharm Theranostics raises AU$35M to advance pipeline

    Financings
  • Chugai licenses Rani’s robotic drug delivery technology in $1B deal

    Deals and M&A
  • More evidence piles up in favor of total arterial revascularization

    Clinical
  • China’s NMPA seeking closer ties to regional regulators

    Regulatory
More in Asia-Pacific

Clinical

  • Cutting balloons match lithotripsy for clearance of calcification

    Conferences
    Results of the Shortcut study, presented last week at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco, indicated that cutting balloon angioplasty matched intravascular lithotripsy in coronary artery preparation of...
  • UK researchers developing glucose-powered bioelectronics

    Neurology/psychiatric
    Scientists in the U.K. are developing glucose-powered bioelectronics to advance the use and capabilities of implantable medical devices. A research team, led by the University of Bath, received £2.1 million (US$3.3 million) in funding from the...
  • Sparrow feathers nest with C$10M for Stethophone expansion

    Financings
    Sparrow Acoustics Inc., dba Sparrow Bioacoustics Inc., closed a C$10 million (US$7.15 million) financing round to support continued adoption of its U.S. FDA-cleared Stethophone platform, which allows bioacoustics detection of structural and...
  • Data suggest more than 10M people in the US have bad heart valves

    Conferences
    The prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal...
  • Data from Partner 3 low-risk affirms TAVR even with SAVR

    Conferences
    Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients,...
  • Will Medtronic’s RDN study drive Spyral-ing growth?

    Conferences
    Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research...
More in Clinical

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One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


Recent episodes:

  • Esperion Therapeutics CEO Sheldon Koenig
  • Trying this at home: Bioxcel steps closer to an sNDA for Igalmi
  • The importance of balancing AI and people in drug development
  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
  • Mega money well spent? Mammoth mergers fall short of the dream
  • Healing the health divide for women
  • Modifi gets creative on the rocky road to a multibillion-dollar buyout
  • A quantum leap into the future of drug development
  • Gene and cell therapies will propel innovation, says Astellas CCO

View all

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