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442 stories matching this filter · ← front page

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  • Merck’s anti‑TL1A antibody tulisokibart fails Phase 2b in systemic sclerosis lung disease but succeeds in hidradenitis suppurativa
    Merck reported mixed Phase 2b results for its anti‑TL1A monoclonal antibody tulisokibart, acquired in the 2023 Prometheus Biosciences purchase. In patients with systemic sclerosis‑associated inter…
    BioSpace · 17d agoNegative readoutNeutral↗ source
  • Pfizer adds $2.5 billion to restructuring, targeting $6 billion savings by 2029
    Pfizer announced an additional $2.5 billion in cost reductions as part of its ongoing restructuring program. The new cuts focus on technology and simplification across commercial, R&D and manufact…
    BioSpace · 17d agoNegative↗ source
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  • As portfolio erodes, BMS stands to gain a lot from rumored AstraZeneca merger
    While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be mo…
    BioSpace · 17d agoDealNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 17d agoRegulatoryNeutral↗ source
  • 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 · 16d 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
  • 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
  • Blank Slate Creamery recalls vegan coconut fudge sandwiches over undeclared egg allergen
    Blank Slate Creamery of Ann Arbor, Michigan announced a recall of its 4.5‑ounce vegan non‑dairy frozen dessert coconut fudge sandwiches because the product may contain egg, an undeclared allergen.…
    fda recalls · 16d agoCRLNegative↗ 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
  • 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