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439 stories matching this filter · ← front page

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  • Lisata Therapeutics cuts 72% of staff after merger with Kuva falls through and files lawsuit
    Lisata Therapeutics announced it is cutting about 72% of its full‑time workforce after a planned merger with Kuva Labs collapsed. The company had 21 full‑time employees at the end of 2025, so roug…
    BioSpace · 17d agoLayoffsNegative↗ source
  • Vertex unfazed by competitive IgAN space as FDA verdict looms
    Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said…
    BioSpace · 17d agoEarningsNeutral↗ source
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Endocrinology & Metabolism384
Infectious Disease360
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 17d agoCRLNegative↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports share sale by APMH Invest under its buyback program
    On August 4, 2026, Danske Bank A/S filed a market‑abuse regulation report detailing a change in share ownership. The filing shows that APMH Invest A/S sold a portion of its Danske Bank shares on a…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank discloses managerial transactions per Danish regulator on Aug 4, 2026
    Danske Bank A/S issued a notification on 4 August 2026 regarding transactions made by individuals who hold managerial responsibilities. The disclosure follows the EU Market Abuse Regulation, requi…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports ongoing share buy-back related sales by APMH Invest
    Danske Bank A/S filed a notification on 4 August 2026 concerning transactions made by persons with managerial responsibilities. The filing, identified as notification no. 61/2026, complies with th…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports ongoing share buy-back and manager-related share sales
    Danske Bank A/S disclosed that, as part of its share repurchase programme, APMH Invest A/S is continuously selling shares on a proportional basis. The filing notes that the transactions are made b…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank files mandatory disclosure of manager transactions under EU market abuse rules
    Danske Bank A/S submitted a notification on 4 August 2026 detailing transactions made by individuals with managerial responsibilities, as required by the Danish Financial Supervisory Authority and…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports share sale by APMH Invest under its buyback program
    On August 4, 2026 Danske Bank A/S filed a regulatory disclosure detailing a change in share ownership among its reporting parties, as required by the EU market abuse regulation. The filing states…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports changes in shareholdings of senior staff on Aug 4, 2026
    Danske Bank A/S filed a market abuse regulation report on 4 August 2026 that records changes in share ownership by senior employees and persons closely linked to them. The filing, identified as re…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank files EU market-abuse disclosure of senior staff share transactions
    Danske Bank submitted a filing on 4 August 2026 reporting changes in shareholdings by its senior employees in line with the EU market-abuse regulation. The report lists transactions carried out by…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Supernus and Indivior merge to form CNS-focused company with 11 marketed drugs and $2.2B revenue target
    Supernus Pharmaceuticals and Indivior Pharmaceuticals announced an all‑stock merger of equals, creating a central nervous system‑focused company that will combine their product lines and operations…
    BioSpace · 18d agoDealPositive↗ source
  • Novo Nordisk’s Phase 3 failure of IL-6 drug ziltivekimab rattles inflammation-focused pipeline
    Novo Nordisk reported that its late-stage IL-6 inhibitor ziltivekimab did not achieve its primary goal in the Phase 3 ZEUS trial, which was designed to lower cardiovascular complications. The disa…
    BioSpace · 18d agoNegative readoutNegative↗ source
  • Analysts deem AstraZeneca-BMS merger unlikely despite market buzz
    Analysts say that talks between AstraZeneca and Bristol Myers Squibb are unlikely to result in a merger because the two companies have overlapping product lines that would attract heavy antitrust s…
    BioSpace · 18d agoDealNeutral↗ source
  • Phase 3 failure of AstraZeneca/Ionis antisense drug Wainua shakes ATTR-CM market, opens space for other developers
    AstraZeneca and Ionis Pharmaceuticals reported that their antisense therapy Wainua did not achieve a significant cardiovascular benefit in a Phase 3 trial for transthyretin amyloid cardiomyopathy (…
    BioSpace · 18d agoNegative readoutNeutral↗ source
  • BioNTech appoints Sobi CEO Guido Oelkers as new chief, founders to launch separate mRNA biotech
    BioNTech announced that Guido Oelkers, current chief executive of Swedish Orphan Biovitrum (Sobi), will assume the role of CEO in early 2027. The move follows the earlier decision of co‑founders U…
    BioSpace · 18d agoNeutral↗ source
  • Biologics surge drives CMOs and CDMOs to boost sterile fill-finish and prefilled syringe capacity
    Biologics, biosimilars and GLP-1 therapies are increasing demand for sterile injectable products, prompting contract manufacturers to expand capacity. CMOs and CDMOs are adding fill-finish, lyophi…
    BioSpace · 18d agoPositive↗ source
  • BD recalls specific lots of intraosseous needle sets over obturator removal issues
    BD announced a voluntary recall of certain lots of its intraosseous vascular access system needle sets after users reported difficulty removing the obturator after placement. The issue is linked t…
    fda medwatch · 18d agoCRLNegative↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 18d agoRegulatoryNeutral↗ source
  • Amgen discloses cybersecurity breach affecting patient data
    Amgen reported a cybersecurity incident that resulted in the exfiltration of protected patient health information and other proprietary data stored in cloud services managed by third‑party provider…
    BioSpace · 18d agoRegulatoryNegative↗ source
  • Biotech leaders urge faster IND process as FDA launches TrialBlazer pilot
    The U.S. Department of Health and Human Services has introduced Operation TrialBlazer, a pilot program aimed at simplifying the investigational new drug (IND) application and approval process. The…
    BioSpace · 18d agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 18d agoCRLNegative↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 18d agoRegulatoryNeutral↗ source