Tag: FDA

  • AstraZeneca Invests $2 Billion in Summit Therapeutics for Experimental Cancer Drug Partnership

    AstraZeneca Invests $2 Billion in Summit Therapeutics for Experimental Cancer Drug Partnership

    AstraZeneca has agreed to invest USD 2 billion in Summit Therapeutics and will collaborate on clinical trials combining their cancer drugs. The deal centers on Summit’s experimental drug ivonescimab, which is currently under review by the US Food and Drug Administration for a form of lung cancer.

    Under the terms, AstraZeneca will purchase newly issued preferred shares convertible into Summit common stock at USD 18.36 per share, above Summit’s Monday closing price of USD 15.48. The investment values Summit at approximately USD 2 billion and will give AstraZeneca rights equivalent to about 12% of Summit’s outstanding common stock (10.6% when including shares potentially issued later). Summit expects the purchase to close by the end of the week, subject to standard conditions.

    Summit plans to use the funds to advance ivonescimab, a therapy created by Chinese drugmaker Akeso. Summit holds rights to develop and market the drug in several regions outside China. The drug is already approved for certain lung cancer patients in China but remains experimental in the United States and Europe.

    The companies also signed a clinical trial agreement to study ivonescimab alongside AstraZeneca’s sonesitatug vedotin, starting with gastrointestinal cancers. Each company will supply its own drug and share trial costs, retaining rights to their respective treatments. Additionally, a non-binding preliminary agreement outlines potential trials pairing ivonescimab with other AstraZeneca cancer drugs, though a further definitive agreement is required.

    Ivonescimab targets PD-1 and VEGF proteins, helping the immune system fight cancer while blocking tumor blood vessel growth. Sonesitatug vedotin is an antibody-drug conjugate designed to deliver a cancer-killing agent to specific cells.

    Separately, the FDA is reviewing Summit’s application for ivonescimab combined with chemotherapy in advanced non-small-cell lung cancer patients with EGFR gene mutations who previously received targeted therapy. The FDA target decision date is November 14, 2026. The gastrointestinal cancer trials announced Monday have not yet begun.

    Summit Therapeutics shares rose more than 15% in extended trading after the announcement on September 28.

  • Danone Recalls So Delicious Frozen Dessert Over Hard Objects in Cashew Inclusions

    Danone Recalls So Delicious Frozen Dessert Over Hard Objects in Cashew Inclusions

    Danone USA has voluntarily recalled select pints of its So Delicious Dairy Free Salted Caramel Cluster frozen dessert after consumers reported finding small stones and other hard objects in the cashew inclusions. The recall, announced September 15, affects products sold nationwide, including at major retailers like Walmart, Target, and Kroger.

    Affected Products and Codes

    The recall covers Salted Caramel Cluster Non-Dairy Frozen Dessert pints with SKU 136603 and UPC 744473476138. Only pints with best-by dates on or before April 3, 2028 are included. No other So Delicious flavors, codes, or products are part of this recall.

    Why the Recall Was Issued

    Danone stated that consumer complaints prompted the company to investigate. After identifying the issue, it notified the U.S. Food and Drug Administration (FDA) and began working with retailers to remove the affected pints from shelves. The company says the problem has been corrected, and new shipments are not affected.

    Retailers Affected

    The recalled dessert was carried by several major retailers across the country:

    • Walmart included the product in its September 15 recall notice, listing select stores in numerous states, Washington, D.C., and Puerto Rico.
    • Target also listed the same UPC (744473476138) in its grocery recalls on that date.
    • Kroger and its affiliated supermarket banners sold the dessert in certain regions.

    Shoppers are urged to check the UPC and best-by date on each pint to see if their purchase is affected.

    What Consumers Should Do

    Do not consume any pint that matches the recalled codes. Customers who purchased the affected product can contact So Delicious Consumer Care at 1-833-367-8975 (Monday–Friday, 9 a.m.–6 p.m. ET) to request a refund or replacement coupon. Have the SKU, UPC, and best-by date ready when calling.

    Second Recall for This Flavor

    This is the second recall involving the same Salted Caramel Cluster flavor. In December 2025, Danone recalled pints due to possible small stones and hard material in the cashew inclusions, affecting best-by dates before August 8, 2027. The latest action expands coverage through April 3, 2028. Other So Delicious Dairy Free products remain unaffected and are still available in stores.

    For the latest recall updates, always check the FDA website or your retailer’s recall page.

  • Insignary Introduces Clarity On-Demand: Pay-Per-Project SBOM Generation Without Annual Contracts

    Insignary Introduces Clarity On-Demand: Pay-Per-Project SBOM Generation Without Annual Contracts

    Toronto, Canada – July 15, 2026 – Insignary Inc., a leader in software supply chain security and binary software composition analysis (SCA), today announced the launch of Insignary Clarity On-Demand, a self-service, pay-per-project offering that provides immediate access to patented SCA and Software Bill of Materials (SBOM) generation — with no annual subscription required.

    Most traditional SCA tools rely on what software claims to contain rather than what it actually contains. Clarity On-Demand addresses this gap by analyzing compiled binaries to detect every open-source component, including those from AI-generated code, vendor libraries, and statically linked binaries that bypass package managers.

    Designed for Flexibility and Urgency

    Clarity On-Demand is built for two primary audiences:

    • Teams evaluating Insignary Clarity before committing to a full enterprise deployment.
    • Smaller organizations that need professional-grade SBOM generation and vulnerability visibility for a specific project without an ongoing subscription.

    With regulatory deadlines looming — including Canada’s Bill C-8 (Critical Cyber Systems Protection Act) and the U.S. FDA’s requirement for SBOMs in premarket submissions for connected cyber devices — organizations can no longer wait for annual procurement cycles.

    “You cannot verify an SBOM by reading the manifest that created it. You verify an SBOM by examining the software that was actually built, shipped, and deployed. Clarity On-Demand makes that level of verification accessible to any organization — from a development team preparing for its first compliance audit to an enterprise team evaluating binary SCA for the first time.” — Taek Wan Kim, President & CEO, Insignary

    What Clarity On-Demand Includes

    Each subscription provides two weeks of access for a single user and a single project. Within that window, users can:

    • Generate a complete SBOM from source code and compiled binaries
    • Receive automated license and security risk alerts
    • Identify components associated with known patent licensing risks
    • Receive alerts for known exploits tied to identified components

    Clarity On-Demand is available on a self-service, pay-per-project basis with plans based on scan volume. First-time users receive 50% off their first project. Full pricing details are available at insignary.com/clarity-on-demand.

    Why Binary-Level Analysis Matters

    The U.S. National Security Agency (NSA) specifically recommends that national security system owners “obtain SBOMs and associated vulnerability and code quality information from analysis of software binaries.” Clarity On-Demand extracts fingerprints directly from compiled binary code using Insignary’s patented technology, ensuring no component goes undetected.

    Trusted by Governments and Global Enterprises

    Insignary’s technology is already used by government organizations and global leaders across electronics, defense, financial services, automotive, manufacturing, medical devices, and other sectors. Key partners include BearingPoint (exclusive distributor in Europe), Cybertrust Japan, and TechMatrix.

    About Insignary

    Insignary Inc. is a Toronto-based cybersecurity company specializing in binary software composition analysis and software supply chain security. Its patented technology identifies open-source components, vulnerabilities, and software provenance directly from compiled binaries without requiring access to source code. For more information, visit www.insignary.com.

    Contact

    Principal Solutions Architect
    Jessica Lee
    Insignary
    jessicalee@insignary.com

    This is a paid press release published via CyberNewswire, a PR newswire syndication platform for cybersecurity companies.