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BioWorld - Saturday, July 11, 2026
Breaking News: AI co-scientist performs biomedical research ‘at expert level’ in less timeBreaking News: Science fiction realized: BCI tech is here
  • Human heart within crosshairs

    Combination locked out in ATTR-CM? ‘Dead,’ expert says

    The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.
  • HLB, Hengrui receive third US FDA rejection on liver cancer combo

  • MHRA adds economic growth to its drug and device regulation remit

  • Today's news in brief

  • Combination locked out in ATTR-CM? ‘Dead,’ expert says

    The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.
  • HLB, Hengrui receive third US FDA rejection on liver cancer combo

    The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
  • MHRA adds economic growth to its drug and device regulation remit

    Alongside its duties in evaluating safety and effectiveness of drugs and their postmarketing monitoring, the U.K. Medicines and Healthcare products Agency (MHRA) has now been handed a further brief to support economic growth.
  • Today's news in brief

    BioWorld briefs for July 10, 2026.
  • Danaher-Masimo close caps med tech’s strongest first-half since 2022

    Med-tech M&As through the first half (H1) of 2026 reached $75.73 billion in collective value, the highest H1 total since 2022’s $120.4 billion and well above every other year in BioWorld’s records. June contributed $12.21 billion, a rebound from May’s relatively quiet $1.51 billion.
  • Microbial ecology reshapes cancer care, diagnostics and therapies

    Cancer researchers are increasingly turning to the microbiome to understand why some patients respond well to treatment while others face severe complications. Gut microbial communities shift during intensive therapies such as bone marrow transplantation, and those changes influence infection risk, immune recovery and long‑term survival. New advances in microbial sequencing and engineering redefine this community as a measurable clinical parameter that can be monitored, modeled, and even therapeutically reshaped to improve outcomes in oncology and other conditions.
  • Former Astrazeneca employee settles insider trading charges

    The U.S. SEC reached a settlement with Weiguo Zhai resolving insider trading charges related to Astrazeneca plc’s $1.1 billion acquisition of Icosavax Inc. in 2023.

Analysis and data insight

  • Gears with regulatory words

    SEC reform good for life sciences startups, but getting pushback

    Medical technology
    Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of...
  • Tivdak

    Post-Tivdak, research in tissue factor multiplies

    Cancer
    The April 2024 full U.S. FDA approval of Pfizer Inc. and Genmab A/S’ tissue factor-targeting antibody-drug conjugate Tivdak (tisotumab vedotin) for cervical cancer sparked interest from drug developers in the strategy, which has been known about for a while.
  • Blocks with upward arrows

    H1 2026 biopharma financings double from last year, approach pandemic highs

    Financings
    Biopharma financings across all categories totaled $59.76 billion on 567 deals in the first half (H1) of 2026, more than double H1 2025’s $29.53 billion across 501 transactions.
  • China in red on globe

    Behind China’s retractions, a paper-mill economy built on incentives

    Clinical
    To Ivan Oransky, China’s paper-mill problem is best understood as an incentives story. “This is literally organized crime,” the Retraction Watch co-founder told BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for July 10, 2026

  • Financings for July 10, 2026

  • In the clinic for July 10, 2026

  • Other news to note for July 10, 2026

  • Regulatory actions for July 10, 2026

Deals and M&A

  • Astrazeneca nabs PDE3/4 inhibitor for COPD in $2.1B Sino deal

  • Endocrinology becomes Vertex’s fifth pillar with $10B Crinetics buy

  • Vertex buying Crinetics for $10B

  • Novartis to pay $1.5B for Myricx Bio and its novel ADC payloads

  • Astrazeneca returns to tap China’s CSPC in $1.7B discovery deal

  • ‘Cool move’ by Zimmer part of med-tech’s tuck-in deals trend

  • In 2nd deal of week, Ipsen buys Memo’s kidney transplant antibody

  • Deerfield-backed Boulevard, Metis pen $1.6B trispecific TCE deal

  • Zymeworks bolsters royalty stream with Theravance buy

  • Advanced Medical Solutions’ takeout offer worth £659M

Financings

  • Illustration of leg anatomy with target around knee

    Integrant targets cartilage repair with AI-biologics platform

    Medical technology
    For decades, treatment options for osteoarthritis have followed a familiar path: As cartilage deteriorates and pain worsens, conservative therapies eventually give way to joint replacement surgery. Australian regenerative medicine company Integrant Pty Ltd. wants to change that trajectory. Rather...
  • EG427 raises $37.7M series C for HSV gene therapy

    Clinical
  • Neuracle eyes Shanghai IPO as global BCI funding surges

    Medical technology
  • Follow-ons lead a mixed first half of 2026 for med-tech financing

    Analysis and data insight
  • Large VC financings improve in H1 2026

    Analysis and data insight
More in Financings

Medical technology

  • Blue brain with computer chip

    Science fiction realized: BCI tech is here

    After decades of clinical research and false starts, have Brain-Computer Interface (BCI) systems finally arrived? With developments accelerating in the field, BioWorld's special series explores the advancements in the space, looking at the implanted technologies, their potential to transfer care,...
  • Neurovalens granted FDA approval for PTSD therapy for US veterans

    Regulatory
    Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device, which can reduce their symptoms in as little as four weeks. The treatment, designed for at-home use of 30-minute daily sessions, was...
  • Holiday notice

    BioWorld's offices were closed in observance of Independence Day in the U.S. No issue was published Friday, July 3.
  • Bellaseno speeds breast scaffold trial as J&J deal clears path to market

    Clinical
  • US primaries continue to rattle congressional health leadership

    Regulatory
  • Deep brain stimulation from the shallows: tomorrow’s BCI technology?

    Clinical
  • Roche launches Axelios 1 sequencing platform to rival Illumina

    Europe
More in Medical technology

Newco news

  • Antibodies illustration

    Oblenio’s $62M series B for trispecific antibody in autoimmune diseases

    Financings
    A year and a half from its formation, Oblenio Bio has generated positive nonhuman primate data for LBL-051 in chronic autoimmune diseases and closed a $62 million series B to move the trispecific T-cell engager into the clinic.
  • Art concept for monoclonal antibodies

    Bionyra closes $165M series A to develop antibodies for inflammation

    Financings
    Bionyra Pharma has emerged with a $165 million oversubscribed series A and a portfolio of three antibodies with extended half-lives that are designed to offer improvements over existing classes of monoclonal antibodies for treating chronic inflammatory diseases.
  • Neck exam

    Ethyreal launches to treat the underlying cause of Graves’, TED

    Conferences
    Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.
  • 3D rendering of β2-Adrenergic receptor GPCR protein molecule embedded in lipid bilayer membrane.

    Skape Bio unlocks GPCR targets with de novo-designed miniproteins

    Science
    Modulating G protein-coupled receptors (GPCRs) is one of the major challenges in biomedicine. These are flexible proteins with small, deep binding pockets. The scientific community has explored small molecules, antibodies and nanobodies to develop ligands. Skape Bio Inc. is betting on creating...
  • Heart and lungs

    Newco news: Oorja energizes with $30M for IPF

    Respiratory
    Oorja Bio Inc., named after the phonetic spelling of “energy” in Sanskrit, secured $30 million from founding investor Westlake Biopartners in a series A financing round to advance its in-licensing approach to develop drugs for idiopathic pulmonary fibrosis (IPF) and other fibrotic and...
More in Newco news

Regulatory

  • COVID-19 injuries, posting of CRLs on HHS’ 2027 rulemaking agenda

  • 340B reforms coming to the congressional table

  • Opus aligns with FDA on rare eye disease gene therapy trial

  • Vera’s Trutakna wins FDA nod as first dual inhibitor for IgAN

  • CMS takes second run at lower reimbursement for 340B drugs

  • Wuxi Apptec seeks immediate relief from US listing

  • Some clinical trials in China under US congressional scrutiny

  • Orca’s T-cell therapy approach to HSCT wins FDA nod as Tregzi

  • FDA clears first flight of Precheck Rx manufacturing pilot

  • NEJM paper on Tavneos pivotal trial retracted by academic authors

U.S.

  • Data flow concept

    AI co-scientist performs biomedical research ‘at expert level’ in less time

    Science
    While biomedical resources in the form of specialized tools, hundreds of thousands of published papers and huge repositories of ‘omics, health records and other data, are growing exponentially, discovery is getting slower and more expensive. That is the perspective from which scientists at Stanford...
  • Ionis, AZ shares down on unexpected Wainua flop in cardiomyopathy

    Clinical
  • Forte, First Tracks soar on CD122 success in vitiligo; celiac next

    Clinical
  • Seres’ SER-155 takes on immune checkpoint inhibitor-related enterocolitis

    Clinical
  • With tardy Tvardi phase I win, skin in STAT3 game plus GI

    Clinical
More in U.S.

Europe

  • EU flags at European Commission building

    EMA reverses its stance on Acadia’s Rett syndrome therapy Daybu

    Cardiovascular
    Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file.
  • Ascending BCI systems deepen national security, ethical concerns

    Analysis and data insight
    Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are...
  • J&J brings dual-energy cardiac ablation technology to Europe

    Medical technology
    Johnson & Johnson this week launched its dual-energy Thermocool Smarttouch SF platform in Europe bringing another option to physicians looking to enhance their electrophysiology procedures. The system combines radiofrequency (RF) and pulsed field ablation in one device to treat atrial fibrillation,...
  • EMA to pull Amgen’s Tavneos over ‘incorrect and misleading’ data

    Regulatory
  • Investors bet on transformative BCI tech for neuro disorders

    Analysis and data insight
  • Merck to buy Bio-Techne for $11.3B to boost life sciences portfolio

    Deals and M&A
  • Next wave of BCI firms builds on pioneers to tackle challenges

    Analysis and data insight
More in Europe

Clinical

  • Island Pharma targets Ebola species lacking approved treatments

    Infection
    Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare...
  • Phase II DMD Trailhead data hike Satellos’ stock

    Musculoskeletal
    Pending talks with regulators, Satellos Bioscience Inc. may seek accelerated approval in Duchenne muscular dystrophy (DMD) for SAT-3247, which yielded positive results in the adult phase II Trailhead study. Shares of Toronto-based Satellos...
  • Genentech’s KRAS G12C inhibitor divarasib shines in NSCLC phase III

    Cancer
    Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients.
  • Yes we Can-Fite PDAC; phase IIa results add momentum

    Cancer
    The data mill continues to churn out encouraging results in pancreatic ductal adenocarcinoma (PDAC), with shares of Ramat Gan, Israel-based Can-Fite Biopharma Ltd. benefiting from the latest, phase IIa dispatch that pushed shares (NYSE:CANF) up...
  • Vistagen's SAD slump: lead pherine, fasedienol, fails again

    Neurology/psychiatric
    Top-line phase III Palisade-4 results of Vistagen Therapeutics Inc.’s fasedienol showed the intranasal pherine candidate failed to hit primary and secondary endpoints in the acute treatment of social anxiety disorder (SAD), issuing a near death...
  • Relaxed on Abivax: UC phase III cancer answer quells fretting

    Gastrointestinal
    Wall Street breathed easier, and shares of Abivax SA found relief as further phase III data from the Abtect maintenance trial were disclosed with obefazimod in ulcerative colitis (UC).
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:

  • Finding a better, longer-lasting fix in opioid overdose
  • 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

View all

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