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BioWorld - Thursday, March 5, 2026
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Spikevax vial and product packaging

    Moderna to pay up to $2.25B to settle COVID-19 patents case

    In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine.
  • China approves first noninvasive therapy for cervical precancer

  • UCB inks $1.1B deal for Antengene’s autoimmune bispecific TCE

  • Can-Fite’s namodenoson shows promise in early pancreatic cancer trial

  • Today's news in brief

  • Moderna to pay up to $2.25B to settle COVID-19 patents case

    In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine.
  • China approves first noninvasive therapy for cervical precancer

    China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
  • UCB inks $1.1B deal for Antengene’s autoimmune bispecific TCE

    Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing a potential $1.1 billion deal to license Antengene Corp.’s ATG-201. ATG-201 is a CD19/CD3 bispecific TCE antibody aimed at autoimmune disorders, though specific indications were not disclosed.
  • Can-Fite’s namodenoson shows promise in early pancreatic cancer trial

    Can-Fite Biopharma Ltd.’s namodenoson met the safety endpoint in its phase IIa open-label study in advanced pancreatic ductal adenocarcinoma patients, a readout that left investors hopeful for survival data, expected to be disclosed later this year.
  • Today's news in brief

    BioWorld briefs for March 4, 2026.
  • FDA’s rare disease toolbox not fully used

    At the current pace of innovation in the U.S. rare disease space, developing and approving therapies for just half of the 10,000-plus known rare diseases would take more than 160 years, Bradley Campbell, president and CEO of Amicus Therapeutics Inc., recently told the Senate Committee on Aging.
  • Sanofi licenses Sino Biopharm’s JAK/ROCK drug for $1.4B

    On the heels of China’s approval of Sino Biopharmaceutical Ltd.’s rovadicitinib, Sanofi SA is now inlicensing the first-in-class dual JAK/ROCK inhibitor in a deal worth more than $1.4 billion.
  • Polares raises $50M for mitral valve system

    Polares Medical SA raised $50 million in a series C financing round for Mrace, its posterior leaflet replacement system designed to treat mitral regurgitation.
  • Alternative splicing strategy shows promise for Rett syndrome

    A therapeutic strategy based on alternative splicing of the MECP2 gene could restore protein levels in Rett syndrome, a neurological disorder caused by mutations in that gene. Scientists at Baylor College of Medicine have successfully tested this approach both in vitro and in vivo in a mouse model that produces some functional protein, correcting the altered gene expression and improving neuronal functions.

Analysis and data insight

  • Microscopic image of clear cell carcinoma, the most common type of renal cell carcinoma.

    Cas and effect: Merck’s phase III ripples HIF-2α space

    Clinical
    Oddsmakers wasted no time figuring the market chances after Merck & Co. Inc. rolled out data from the phase III Litespark-011 study testing its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), when used with tyrosine kinase inhibitor Lenvima (lenvatinib, Eisai Co.) in...
  • Woman applying skin cream to elbow

    Adquey finds hatchway, still more in PDE4

    Regulatory
    The U.S. FDA clearance Feb. 20 of East Windsor, N.J.-based Acrotech Biopharma Inc.’s PDE4 inhibitor Adquey (difamilast ointment 1%) for mild to moderate atopic dermatitis brought renewed focus on the mechanism, where other drugs are already approved and more are stocking developers’ pipelines...
  • Test tubes, capsules, dropper

    Phase III wins lift Alumis, Corcept shares in January

    Clinical
    BioWorld tracked 144 clinical trial readouts across phases I through III in January 2026, down from 215 in December. January included 15 phase III trials reporting positive results and three that failed to meet key endpoints. By phase, the month’s updates consisted of 60 from phase I, 44 from phase...
  • Gold chain link engraved with "partnership"

    Biocom 2026: Pharmas give advice on partnering

    Conferences
    At Biocom’s Global Partnering and Investor Conference, representatives from the business development departments at various pharmaceutical companies provided an update on their appetites for deals. The mood was fairly upbeat because, let’s face it, large pharma has become dependent on external...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for March 4, 2026

  • Financings for March 4, 2026

  • In the clinic for March 4, 2026

  • Other news to note for March 4, 2026

  • Regulatory actions for March 4, 2026

Deals and M&A

  • Radnet acquires Gleamer for up to €230M

  • Boehringer drops OSE’s cancer drug in MASH, where GLP-1s march on

  • Asahi Kasei’s $920M Aicuris buy boosts its antiviral armory

  • GSK nabs two Frontier Biotech siRNA assets in $1B deal

  • Returning to pulmonary hypertension, GSK buys 35Pharma

  • Astellas and Vir in $1.3B deal for CD3 T-cell engager

  • Neurosoft partners with Science Corp. to advance BCI system

  • Gilead brings Arcellx fully under the fold for $7.8B

  • Harbour Biomed spins out newco in $1.2B CTLA-4 deal

  • Novartis sells India subsidiary to private equity firm for $159M

Financings

  • IPO money

    TSLP still plays well, Generates $400M IPO

    Respiratory
    Generate Biomedicines Inc. proved that enthusiasm hasn’t waned for TSLP as a target by pricing an IPO selling 25 million shares at $16 each for proceeds of $400 million. Generate’s lead compound is phase III-stage TSLP-targeting antibody GB-0895 and the company’s assigned Nasdaq ticker is GENB. The...
  • Biocom 2026: The state of venture capital investments

    Analysis and data insight
  • Innovacell’s $91M Tokyo IPO to fund incontinence cell therapies

    Aging
  • 2025 report: Spain’s Catalonia region a European life sciences leader

    Europe
  • First profit in six years positions Leo Pharma for long-awaited IPO

    Dermatologic
More in Financings

Medical technology

  • Whole slide image illustrating the detection of key histological structures such as glands and cells.

    Digital pathology speeds diagnostics, but tends to take shortcuts to do so

    Science
    Computational pathology, which assesses molecular-level features of diseases directly from tissue images (rather than testing the tissue via methods such as staining or sequencing) is making rapid strides.
  • NICE recommends leadless pacemakers to treat slow heart rhythms

    Cardiovascular
    The U.K.’s National Institute for Health and Care Excellence (NICE) recommendation that leadless cardiac pacemakers be used as the standard of care for people with slow heart rhythms (bradyarrhythmias) is a boon for more than 2 million individuals living with the condition. The use of the...
  • US med-tech companies bullish about 2026

    U.S.
    U.S. med-tech companies are optimistic about the year ahead and believe that they are well positioned to navigate geopolitical headwinds and the uncertainty that they bring. Their technologies, which span neurosurgery and tissue reconstruction to cardiology and radiation protection, address...
  • FDA approves Allurion’s gastric balloon system

    Regulatory
  • Europe’s med-tech companies navigating geopolitical headwinds in 2026

    Europe
  • Medtronic’s diabetes unit Minimed seeks $784M in IPO

    Diabetes
  • Grail shares plunge after Galleri test misses primary endpoint

    Clinical
More in Medical technology

Newco news

  • 3D illustration of a chain of amino acid or biomolecules called protein

    Omnigeniq’s journey from space science to drug design

    Cancer
    A project that started as a bioreactor to assist astronauts in deep space to keep medications safe in a microgravity environment could help pharma companies model how drugs behave in the human body. Omnigeniq unveiled at the J.P. Morgan Healthcare conference the first computer model of a human...
  • Neural network

    Vesalic targeting toxic muscle exosomes in motor neuron diseases

    Neurology/psychiatric
    Newco Vesalic Ltd. has formed to take forward research indicating extracellular vesicles secreted by skeletal muscle cells carry toxic payloads that are key drivers of motor neuron diseases, including amyotrophic lateral sclerosis. The discovery of this process, which is largely external to the...
  • Interleukin 17 (IL-17)

    Quantx raises $85M to advance oral immunology drugs

    Financings
    After closing an oversubscribed $85 million series B round, Quantx Biosciences Inc. is gearing up to begin clinical trials of its two lead immunology compounds, a STAT6 oral small-molecule inhibitor and an IL-17 oral small-molecule inhibitor.
  • Park Tae-yong, vice president and cofounder, Galux

    AI meets antibody design: Galux draws $29M series B for drug R&D

    Financings
    Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering. 
  • T cells attacking cancer

    Vibrant aims to tame EGFR tumors with masked TCEs

    Cancer
    After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked T-cell engager (TCE) for treating EGFR-positive solid tumors.
More in Newco news

Regulatory

  • Vanda scores hearing to review Hetlioz in jet lag disorder

  • Experts: Regulatory roadblocks stalling rare disease therapies

  • ACIP grows by two ahead of next meeting

  • Changing US FDA trial default a global matter

  • US taking a closer look at China biotech subsidies

  • Ninth Circuit agrees with Lilly in royalty dispute

  • Jiuyuan seeks approval of Wegovy biosimilar in China

  • Another lawsuit challenges changes to ACIP, US vaccine schedule

  • State of the biopharma industry filled with uncertainty

  • Leadership churn continues at the CDC

U.S.

  • FDA-approved-stamp2.png

    Dwarfism drug gets FDA accelerated approval for Ascendis

    Endocrine/metabolic
    Ascendis Pharma A/S’ Yuviwel (navepegritide) gained U.S. FDA accelerated approval Feb. 27 for children 2 and older with the rare genetic bone growth disorder achondroplasia, also known as dwarfism, winning the company a rare pediatric disease priority review voucher
  • Uniqure sinks as FDA demands new trial for Huntington’s gene therapy

    Clinical
  • Atrium Tx launches with Avidity's RNA ticker and cardio assets

    Cardiovascular
  • R-MDMA phase II cheers up Ataibeckley in SAD

    Clinical
  • United unveils newly partnered soft mist inhaler; Mannkind sinks

    Respiratory
More in U.S.

Europe

  • Illustration of a T cell

    Quell delivers first data showing Tregs prevent liver transplant rejection

    Clinical
    Quell Therapeutics Ltd. has delivered the first clinical data indicating its chimeric antigen receptor (CAR) T regulatory cell therapy, QEL-001, can enable liver transplant patients to be weaned off long-term immunosuppression.
  • Theravance slashes R&D as hypotension asset fails again

    Clinical
    Another phase III failure of Theravance Biopharma Inc.’s norepinephrine reuptake inhibitor ampreloxetine to treat symptomatic neurogenic orthostatic hypotension, this time in patients with the rare disease multiple system atrophy, means the end of the company’s R&D efforts. Cutting its workforce in...
  • Moderna’s combo flu/COVID vaccine gets thumbs up in EU

    Infection
    The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19.
  • Vivtex’s oral drug delivery approach draws Novo in $2.1B deal

    Diabetes
  • Supreme Court ruling not a death knell for US tariffs

    Analysis and data insight
  • Novo’s next-gen obesity drug fails to beat Lilly's Zepbound

    Clinical
  • China tops US in January drug approvals

    Analysis and data insight
More in Europe

Clinical

  • PWS phase III HERO’s journey stalled, Aardvark digs into data

    Endocrine/metabolic
    The busy Prader-Willi syndrome (PWS) space took another hit as did shares of Aardvark Therapeutics Inc. (NASDAQ:AARD), which closed March 2 at $5.47, down $7.02, or 56%, after the company disclosed a voluntary pause of the phase III Hunger...
  • Systimmune’s iza-bren hits phase III breast cancer goals in China

    Cancer
    In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with...
  • Bladder phase II sinks Protara, LMs phase III wins for Palvella

    Cancer
    Almost three months to the day after Protara Therapeutics Inc. made known positive interim data from the phase II trial testing cell-based therapy TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs),...
  • Gossamer slides on phase III readout of seralutinib in PAH

    Cardiovascular
    An “outsized placebo response” is not stopping Gossamer Bio Inc. from seeking a path to potential approval of inhaled tyrosine kinase inhibitor seralutinib in pulmonary arterial hypertension (PAH), but the missed primary endpoint in the phase III...
  • Eylea threatened Inlyta Ocular’s phase III win with Axpaxli?

    Ocular
    Ocular Therapeutix Inc.’s wet age-macular degeneration candidate, Axpaxli, beat anti-VEGF therapy Eylea (aflibercept) from Regeneron Pharmaceuticals Inc. in the phase III head-to-head trial called Sol-1, but not by enough of a margin for Wall...
  • Compass nears NDA; psilocybin scores again in resistant depression

    Neurology/psychiatric
    Positive results from the second of two phase III trials set Compass Pathways plc’s synthetic psilocybin treatment, COMP-360, on track for a potential U.S. FDA approval within a year as the first classic psychedelic cleared for treatment-resistant...
More in Clinical

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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.


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  • 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

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