BioWorld - Monday, February 10, 2025
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  • Businessman signing documents

    Trump’s executive orders stacking up, along with challenges

    Carrying out his campaign promises to reform government, President Donald Trump signed 46 executive orders (EOs) between Jan. 20-31 that have been published in the Federal Register. Of those, 26 were signed after noon and between all the inaugural events on Trump’s first day in office. Since then, he’s signed at least eight more orders, and the administration has issued numerous memos, several of which are intended to implement the EOs. Given the quantity, scope and content of the EOs Trump has issued over the past few weeks, it’s no surprise that they’ve generated controversy, a lot of uncertainty and at least a few court challenges.

  • Trump’s executive orders stacking up, along with challenges

    Carrying out his campaign promises to reform government, President Donald Trump signed 46 executive orders (EOs) between Jan. 20-31 that have been published in the Federal Register. Of those, 26 were signed after noon and between all the inaugural events on Trump’s first day in office. Since then, he’s signed at least eight more orders, and the administration has issued numerous memos, several of which are intended to implement the EOs. Given the quantity, scope and content of the EOs Trump has issued over the past few weeks, it’s no surprise that they’ve generated controversy, a lot of uncertainty and at least a few court challenges.

  • Mixed reactions from Asia on biotech implications of Trump 2.0

    “This current administration is like nothing that we've seen before,” said a managing partner of a global venture capital firm who spoke to BioWorld on the condition of anonymity. “President Trump’s first term was bad,” he said, “but nobody knows what’s coming.” “This is truly nationalism at its worst, because he won on the campaign [largely] to protect American jobs, claiming that Americans have been unfairly treated.” And it's not just China, he said, but India and other countries will also likely be affected.

  • TYK2s to tango, TED dead? Alumis/Acelyrin merger a capital idea

    In a deal that Cantor Fitzgerald analyst Eric Schmidt characterized as “capital recycling at its best,” Alumis Inc. and Acelyrin Inc. are merging in an all-stock transaction. The combined pipelines include Alumis’ most advanced prospect, ESK-001, an oral, next-generation, allosteric inhibitor of tyrosine kinase 2 (TYK2). ESK-001 is undergoing the phase III Onward study for moderate to severe plaque psoriasis as well as the phase II Lumus bid in systemic lupus erythematosus.

  • Admin's actions toward science agencies 'not a measured reappraisal'

    In the early days of the second Trump administration, what will happen to various government science agencies is not yet clear. Given the communications blackout imposed on agencies including the NIH and the CDC, most of what is known comes from anonymous sources and secondhand reports. Executive orders affecting the agencies are also still in the process of being interpreted, as well as subject to multiple legal challenges.

  • Genomic study paves way for multimorbidity treatments

    A large-scale study cross-referencing genomic data from multiple sources with primary care health records has identified genetic overlaps in 72 chronic diseases, opening the way for a more holistic approach to researching, treating and preventing multimorbidity.

  • Speculations rise on US tariff impact on global pharma industry

    For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.

  • My, Sionna: IPO upsized to pretty one at $191M

    Sionna Therapeutics Inc. has opened on Nasdaq in the year’s fourth IPO, this one priced at the upper end of its original per-share range at $18. The cystic fibrosis therapy developer is looking for gross proceeds of about $191 million by offering 10.58 million shares of common stock. On Feb. 7, shares (NASDAQ:SION) closed the day 39% upward at $25.

  • Trump administration presents a mixed picture for med tech

    The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.

BioWorld Insider Podcast

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Analysis and data insight

  • ROI meter

    Low sales, safety concerns doom biopharma’s ROI for mega-M&As

    Deals and M&A
    BioWorld’s three-part analysis of M&As sought to discover successful transactions and to understand the trend of multibillion-dollar deals that have become commonplace in the last decade. Instead, more than 80% of the acquisitions explored simply indicate that buyers are paying too much, suggesting...
  • 3D illustration of cancer in crosshairs

    Scorpion stinger bringer of more PI3Kα inhibitor deals?

    Cancer
    Eli Lilly and Co.’s end last year to its PI3Kα inhibitor program didn’t mean the pharma player was giving up on the target – far from it, as signaled by the potential $2.5 billion deal signed recently to take over Scorpion Therapeutics Inc. and gain rights to phase I/II-stage STX-478 for breast...
  • Golden dollar coins

    Few biopharma mega-mergers hit the jackpot

    Deals and M&A
    Due diligence plays a significant role in M&A transactions, but the eventual return on investments don’t always add up to the purchase price. While some companies such as Abbvie Inc. and Bristol Myers Squibb Co. – as shown in part one of this three-part series – have succeeded in acquiring products...
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Today's news in brief

Deals and M&A

Financings

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Science

  • Antibody prevents severe bird flu in macaques

    Immune
    Scientists at the University of Pittsburgh have tested a broadly neutralizing antibody that binds the stem of a protein against H5N1 avian influenza, which prevented severe disease in nonhuman primates and was effective for at least 8 weeks. The scientists remark on the potential of the design...
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Newco news

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Regulatory

U.S.

  • 3D illustration of acute myeloid leukemia cells

    Kura/Kyowa Kirin’s ziftomenib hits phase II endpoints in AML

    Clinical
    Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the...
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Europe

  • Arctic Therapeutics explores Alzheimer’s with $28M series A

    Financings
    Icelandic genomics company Arctic Therapeutics has closed a €26.5 million (US$27.6 million) series A, enabling it to assess if its lead drug AT-001, designed to treat a rare inherited amyloid disease, also could be used to treat more common forms of dementia, including Alzheimer’s disease. The...

  • EMA investigating potential semaglutide link to eye disease

    Regulatory
    The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10,...
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Clinical

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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.


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