BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Sunday, December 7, 2025
Breaking News: ASH 2025: Casgevy for kids? Expanding, improving SCD gene therapiesBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Blue test tubes and dropper

    Natera envisions cancer-testing future with $450M Foresight buy

    Natera Inc. completed the acquisition of Foresight Diagnostics Inc. in a deal structured as $275 million up front plus contingent payments of up to $175 million based on achieving certain milestones for revenue and reimbursement coverage. The companies expect to close the transaction in the second quarter of 2026.
  • Cancer blood test maker Freenome going public with $330M SPAC

  • Boston Sci brings next-generation Rezūm EVO Console to the UK

  • Today's news in brief

  • Natera envisions cancer-testing future with $450M Foresight buy

    Natera Inc. completed the acquisition of Foresight Diagnostics Inc. in a deal structured as $275 million up front plus contingent payments of up to $175 million based on achieving certain milestones for revenue and reimbursement coverage. The companies expect to close the transaction in the second quarter of 2026.
  • Cancer blood test maker Freenome going public with $330M SPAC

    Freenome Holdings Inc. reported it is going public via a special purpose acquisition company. The company said it expects to raise $330 million, which it plans to use for the 2026 launch of its blood-based screening tests for multiple cancers. Backed by an affiliate of Perceptive Advisors - Perceptive Capital Solutions Corp. (PCSP) – and joined by RA Capital, the arrangement includes a commitment of $240 million in equity investments plus about $90 million more held by the SPAC’s trust fund. Other notable investors, including ADAR1 Capital, Bain Capital Life Sciences, and Farallon Capital Management have signed on to participate in the deal.
  • Boston Sci brings next-generation Rezūm EVO Console to the UK

    The first procedure to treat benign prostatic hyperplasia with Boston Scientific Corp.’s next-generation Rezūm EVO Console was successfully completed in the U.K. The device, which recently received CE mark, is intended to be used with the Rezūm Water Vapor Therapy, a minimally invasive treatment that uses water vapor to reduce prostate tissue.
  • Today's news in brief

    BioWorld MedTech briefs for Dec. 5, 2025.
  • FDA’s use of generalist field investigators creating new dilemmas

    The U.S. FDA’s recent switch toward more routine use of generalist field investigators might be seen in some quarters as an attempt to do more with less, but a session on the topic at the Food and Drug Law Institute’s annual enforcement conference in Washington seems to suggest that this reversal of historic practice presents at least as many problems as solutions for industry.
  • Hippocratic loath? ‘Harm’ threat from ACIP’s proposed HBV shift

    Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, which took up – again – the matter of hepatitis B virus (HBV) vaccine scheduling, a day after the panel voted not to vote on such guidance.
  • Høeg appointment as acting CDER director tied to vaccine strategy?

    After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks.

Sponsored content

Digital health

  • South Korean won

    Cha Group to Acquire Majority Stake in Kakao Healthcare

    Deals and M&A
    Kakao Healthcare Corp. plans to secure ₩100 billion (US$68 million) through two investment deals with Cha Biomedical Group and outside investors by early next year. The transactions, expected to close by the first quarter of 2026, will make Cha the controlling shareholder of Kakao Healthcare with a...
  • 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.
More in Digital health

Today's news in brief

  • Appointments and advancements for Dec. 5, 2025

  • Financings for Dec. 2, 2025

  • In the clinic for Dec. 4, 2025

  • Other news to note for Dec. 5, 2025

  • Regulatory actions for Dec. 5, 2025

Regulatory

  • ACIP votes on changes to hep B immunization delayed once again

  • AI legislation seen as unlikely to pass anytime soon

  • Axogen's Avance secures FDA approval for nerve repair

  • Roche gains US, EU nod for whooping cough test as cases surge

  • CDRH will emphasize risk management in CY 2026

  • More uncertainty at FDA as Pazdur plans to resign

  • Medicare’s competitive bidding program draws opposition

  • NICE to bump cost effectiveness thresholds for HTAs

  • Boston Sci's Farapoint secures CE mark

  • OIG sees potential for savings in Medicare CGM coverage

Financings

  • Evoke SCS system

    Saluda to expand spinal cord stimulation market in AU$231M IPO

    Neurology/psychiatric
    Saluda Medical Pty Ltd. announced a AU$231 million ($152.7 million) initial public offering on the Australian Securities Exchange to scale up its U.S. footprint for its Evoke spinal cord simulation system for chronic pain.
  • Kestra follows IPO with $138M upsized offering

    Cardiovascular
  • Ireland sees record VC funding in life sciences, health tech

    Europe
  • EIB, Angelini Ventures to invest €150M in European startups

    Europe
  • Jefferies says health care showing resilience despite challenges

    Conferences
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

  • Gray and green glass dollar symbols with arrow pointing up

    Med-tech deals rebound with a $1.37B surge in Q3

    Med-tech dealmaking totaled $1.72 billion through the first three quarters of 2025, signaling a potential rebound in the works from the subdued activity seen in 2024, when publicly reported full-year deal value reached $2.12 billion. Q3 was the strongest quarter so far this year, contributing $1.37...
  • M&A letters over missing puzzle pieces

    GE Healthcare expands imaging line with $2.3B Intelerad buy

    Imaging
    GE Healthcare Technologies Inc. agreed to purchase medical imaging company Intelerad Medical Systems Inc. for $2.3 billion in cash, boosting its capabilities in cardiology and radiology. The deal, expected to close in the first half of 2026, advances GE Healthcare's dual strategies of expanding...
  • Abbott sign

    Abbott makes cancer screening play with $21B Exact Sciences buy

    Cancer
    Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences shareholders $105 per share in cash, a nearly 50% premium to Exact’s unaffected share price on Nov. 19. That represents a total equity value of...
  • Raining 100 dollar bills

    Solventum agrees to acquire Acera for up to $850M

    Dermatologic
    Solventum Corp. continued its restructuring with a second significant acquisition this year, the proposed purchase of privately held Acera Surgical Inc. for $725 million in cash plus up to $125 in contingent cash payments based on achievement of specified milestones. St. Louis.-based Acera...
  • Digital globe illustrating pharma trade, tariffs

    Med-tech collaborations outpace 2024 with a 15% value rise

    Med-tech M&A activity cooled in October, with the total disclosed deal value reaching $1.68 billion, a step down from September’s $4.84 billion and well below several stronger months earlier in the year.
More in Deals and M&A

U.S.

  • Cassidy leans in harder on AMA’s CPT coding committee

  • Fractyl procedure sustains weight loss after GLP-1s

  • SS Innovations SSi Mantra surgical robot sees increasing demand

  • Prognomiq launches Provue Lung LDT for early lung cancer ID

  • Cardiology societies laud Medicare coverage of EP procedures at ASCs

  • ARPA-H sees a bright future for autonomous surgery microbots

  • CMS terminates Treatment Choices model in ESRD final rule

  • CMR Surgical targets US with Versius Plus robotic system

  • Abbott mum on malfunction behind Freestyle Libre 3 recall

  • Could restricting diversity efforts stall women’s health research?

Europe

  • Male hair loss

    Cosmo data positive for first new hair-loss approach in decades

    Clinical
    Shares of Cosmo Pharmaceuticals NV rose sharply on Dec. 3 following top-line pivotal phase III data showing a statistically significant and clinically meaningful improvement in male androgenetic alopecia patients receiving clascoterone 5%, the first topical androgen receptor inhibitor, which uses...
  • Brainomix 360 Stroke increases endovascular thrombectomy rates

    Clinical
  • Xeltis secures $55M for vascular access conduit

    Clinical
  • Edwards shows benefits of early TAVR in asymptomatic severe AS

    Clinical
  • Overture Life receives CE mark for Davitri platform

    Regulatory
More in Europe

Asia-Pacific

  • Diag.nose.ai

    Diag-nose.io develops respiratory disease precision diagnostics

    Respiratory
    A precision medicine diagnostic system developed by Diag-Nose Medical Pty. Ltd. could potentially transform the management of chronic respiratory diseases. Co-founders Eldin Rostrom, David Yen, Brian Wang and Josie Xu set out to explore why patients with similar respiratory symptoms respond so...
  • China’s Cornerstone Robotics raises $200M series D round

    Financings
    Cornerstone Robotics Ltd. raised an oversubscribed $200 million series D round to accelerate commercialization of its flagship product, the Sentire Endoscopic Surgical System.
  • TGA updates ad guidelines to include social media

    Regulatory
    Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.
  • Med-tech financings reach $26.6B as sector recovery continues

    Financings
  • UNESCO adopts ethical standards for neurotechnology

    Artificial intelligence
  • Advancell sets new radiopharma standard in prostate cancer

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

    Regulatory
More in Asia-Pacific

Clinical

  • Archeon’s Eolife increases survival rates after cardiac arrest

    Cardiovascular
    Archeon Medical SAS reported data from a study showing its real-time ventilation feedback device Eolife increased the survival rates of patients suffering out‑of‑hospital cardiac arrests. Furthermore, all the survivors in the Eolife group achieved...
  • Ocean Dx sepsis test matches gold standard in early study

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

    Conferences
    Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year data from the OCEAN trial suggests that some patients may not need these DOACs after...
  • FISH&CHIPS serves up appetizing news for Heartflow

    Conferences
    Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7%...
  • MMI gets IDE for robotic microsurgical study in Alzheimer’s

    Neurology/psychiatric
    Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.
  • 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...
More in Clinical

BioWorld Insider Podcast

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

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years
Subscribe

BioWorld MedTech

Actionable and timely intelligence on advances in medical devices and technologies for 20+ years
Subscribe

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region
Subscribe

BioWorld Science

Essential discovery and preclinical research news to support crucial drug R&D decisions at the earliest stages
Subscribe

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, BioWorld Science and BioWorld Asia in a single, easy to access subscription
Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • NME Digest
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing