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BioWorld - Saturday, February 28, 2026
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Women handshake with virology graphics

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

    In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.
  • R-MDMA phase II cheers up Ataibeckley in SAD

  • FDA approves Allurion’s gastric balloon system

  • Biocom 2026: The state of venture capital investments

  • CROI 2026 highlights depression and cognitive vulnerability in HIV

  • Today's news in brief

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

    In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.
  • R-MDMA phase II cheers up Ataibeckley in SAD

    The psychedelic and psychedelic-like drug space made another stride as Ataibeckley Inc. disclosed positive top-line data from a double‑blind, placebo‑controlled, first-in-patient phase IIa study testing oral R-MDMA therapy EMP‑01 in adults with social anxiety disorder (SAD).
  • FDA approves Allurion’s gastric balloon system

    The U.S. FDA approved Allurion Technologies Inc.’s premarket application for its swallowable gastric balloon system, which features its Smart Capsule, for weight loss. The clearance is boon for the company as GLP-1 agonists gets increasingly adopted to treat obesity. The approval also brings to the market a new non-invasive option to patients looking for alternative ways to lose weight.
  • Biocom 2026: The state of venture capital investments

    At Biocom’s Global Partnering and Investor Conference, venture capitalists (VCs) on multiple panels offered their thoughts on the state of venture investing and offered advice for startups interested in securing funding. Sentiment for early stage investment was somewhat mixed, but trended negative as VCs acknowledged that it’s a tough environment in which to raise capital.
  • CROI 2026 highlights depression and cognitive vulnerability in HIV

    The effects of aging pose an additional challenge for people with HIV due to the neurological and psychological consequences that persist despite antiretroviral therapy. At the Conference on Retroviruses and Opportunistic Infections (CROI) held Feb. 22-25, 2026, in Denver, the scientific community examined how the virus affects the brain, how the reservoir is established in the CNS, and which genetic, immunological or treatment-related factors influence cognitive health.
  • Today's news in brief

  • Jiuyuan seeks approval of Wegovy biosimilar in China

    China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
  • Wave of deals lifts large-cap biopharma stocks

    The BioWorld Biopharmaceutical Index finished 2025 up 24.07%, building slightly on its 23% gain recorded at the end of November. While the increase trailed the Nasdaq Biotechnology Index’s 32.4% rise for the year, it outperformed the broader Dow Jones Industrial Average, which advanced 12.97%.
  • US taking a closer look at China biotech subsidies

    U.S. scrutiny of China’s trade practices, especially in the biotech sector, continues to escalate as the U.S. International Trade Commission launches two factfinding investigations Congress mandated in the fiscal 2026 appropriations.
  • Ninth Circuit agrees with Lilly in royalty dispute

    Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT.

Analysis and data insight

  • 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...
  • Tablets form silhouette of world map

    Changing US FDA trial default a global matter

    Regulatory
    The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director...
  • One dice with a green checkmark, red X and gray question mark.

    State of the biopharma industry filled with uncertainty

    Regulatory
    While the annual State of the Union address has morphed over the years from a summation of the state of the U.S. government and the president’s legislative agenda into political theater on both sides of the aisle, President Donald Trump did include some recommendations to Congress in his Feb. 24...
  • US flag, money, global currency symbols, tariff arrow

    Supreme Court ruling not a death knell for US tariffs

    Regulatory
    The ramifications of the U.S. Supreme Court’s decision Feb. 20 that shot down President Donald Trump’s reciprocal tariffs issued under the International Emergency Economic Powers Act are rippling across the world. And Trump’s immediate response to that ruling – a proclamation imposing a temporary...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for Feb. 27, 2026

  • Financings for Feb. 27, 2026

  • In the clinic for Feb. 27, 2026

  • Other news to note for Feb. 27, 2026

  • Regulatory actions for Feb. 27, 2026

Deals and M&A

  • 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

  • CSL taps Lilly to de-risk IL-6 drug following dismal earnings

  • Gilead-Genhouse's $1.5B+ deal boosts synthetic lethality push

  • Merger deal renews Faeth in Sensei; Piktor brightens, stock jumps

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...
  • 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
  • VCs launch coalition to strengthen Europe life sciences investment

    Europe
More in Financings

Medical technology

  • Medical technology concept

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

    Europe
    This year, European med-tech companies continue to navigate an uncertain macro environment created by the reciprocal tariffs on goods entering the U.S., their primary market. Some companies though are adapting supply chains and manufacturing strategies, while others are looking to diversify into...
  • Medtronic’s diabetes unit Minimed seeks $784M in IPO

    Diabetes
    Minimed Group Inc., Medtronic plc’s diabetes business, is looking to raise up to $784 million in its IPO. Medronic last May revealed plans to spin off the unit as an independent public company and expected to complete the separation within 18 months.
  • Grail shares plunge after Galleri test misses primary endpoint

    Clinical
  • Medtronic sees first cases with Hugo robotic platform

    U.S.
  • US GAO: March-ins not much of a solution for Rx prices

    Analysis and data insight
  • AI transforming med tech in 2026; clinical need drives investments

    Diagnostics
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

  • Another lawsuit challenges changes to ACIP, US vaccine schedule

  • Leadership churn continues at the CDC

  • US Fed Circuit protects 101 passage for some gene therapy patents

  • Immedica wins US FDA nod for Loargys to treat ARG1-D

  • Novo’s next-gen obesity drug fails to beat Lilly's Zepbound

  • February ACIP meeting not happening

  • New FDA guidance details ‘plausible mechanism’ pathway

  • Vanda gets FDA nod for atypical antipsychotic Bysanti

  • China tops US in January drug approvals

  • Japan endorses two iPSC drugs for approval under CEA pathway

U.S.

  • Illustration of human heart with DNA structure background

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

    Cardiovascular
    Targeting rare cardiomyopathy conditions with no approved disease-modifying therapies, Atrium Therapeutics Inc. started operations in San Diego, assuming the public listing and technology once held by Avidity Biosciences Inc., an RNA company acquired by Novartis AG for about $12 billion. Novartis...
  • United unveils newly partnered soft mist inhaler; Mannkind sinks

    Respiratory
  • Vivtex’s oral drug delivery approach draws Novo in $2.1B deal

    Diabetes
  • Bladder phase II sinks Protara, LMs phase III wins for Palvella

    Clinical
  • Gossamer slides on phase III readout of seralutinib in PAH

    Clinical
More in U.S.

Europe

  • 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.
  • Report calls for EU members to pull together on biopharma strategy

    Analysis and data insight
    Hand wringing over what support Europe’s biopharma sector needs to stay competitive has intensified since the European Commission unveiled its proposal for an EU Biotech Act in December 2025, and the latest contribution to the debate is a comparative analysis of how 10 countries have strengthened...
  • Bioversys tuberculosis combo targets drug resistance

    Infection
    Antibiotics specialist Bioversys AG has reported the first clinical proof-of-concept data for alpibectir (BVL-GSK098) in combination with ethionamide in pulmonary tuberculosis, with phase IIa early bactericidal activity data published in the New England Journal of Medicine.
  • Unnatural Products signs $1.8B cardio pact with Novartis

    Cardiovascular
  • MHRA proposes path forward for CE-marked devices

    Medical technology
  • Compass nears NDA; psilocybin scores again in resistant depression

    Clinical
  • Calla Lily, Merck partner on intravaginal drug delivery platform

    Medical technology
More in Europe

Clinical

  • 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...
  • 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...
  • After thalassemia win, Agios advances mitapivat, tebapivat in SCD

    Hematologic

    Agios Pharmaceuticals Inc. is preparing to present a mixed bag of phase III Rise Up data to the U.S. FDA in hopes of “full approval” for mitapivat in sickle cell disease (SCD), which would make it its third indication in rare hematology.

  • Australia launches world-first pediatric mRNA brain cancer trial

    Vaccine
    A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in...
  • Viking to push oral GLP-1/GIP drug into phase III obesity trial

    Regulatory

    Viking Therapeutics Inc. said after-market hours Feb. 11 that it plans to advance its oral dual GLP-1/GIP receptor, VK-2735, into a phase III trial for obesity in the third quarter of 2026. VK-2735 is a novel dual glucagon-like peptide-1 and...

  • Dwarfism golden gate? Bridgebio’s infigratinib phase III hits

    Musculoskeletal
    Bridgebio Pharma Inc. kept the phase III wins coming, this time with positive top-line results from Propel 3, the global phase III pivotal study of oral infigratinib, designed to inhibit FGFR3 signaling in children with achondroplasia.
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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