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  • Amgen drops Phase 1 obesity drug AMG 513, leaving MariTide as its only weight-loss candidate and eyes early-stage deals
    Amgen announced it is halting development of AMG 513, a Phase 1 obesity therapy, leaving MariTide as its sole weight‑loss asset. The company said its late‑stage pipeline is largely full, so future…
    BioSpace · 1mo agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 1mo agoEarningsNeutral↗ source
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  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 1mo agoDealNeutral↗ source
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 1mo agoPositive↗ source
  • Aurora Therapeutics drops PKU program and trims staff
    Aurora Therapeutics, a gene-editing startup founded by Jennifer Doudna, announced it is abandoning its lead phenylketonuria (PKU) program. The decision follows growing competition in the PKU field…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • Novo Nordisk shares slide 6% after Wegovy pill sales miss despite earnings beat
    Novo Nordisk reported second‑quarter results that beat both revenue and profit forecasts, posting a profit of $5.15 billion. The company’s oral Wegovy obesity pill generated $496 million in sales,…
    BioSpace · 1mo agoEarningsNegative↗ source
  • BioNTech trims full-year COVID-19 vaccine sales outlook by up to 20% amid weak demand
    BioNTech announced it is lowering its full-year sales guidance for its COVID-19 vaccine. The company cut the midpoint of its outlook by almost 20%, moving the range to €1.6-1.9 billion from the pr…
    BioSpace · 1mo agoEarningsNegative↗ source
  • Pathos AI signs two cancer deals, including $2 bn contract with China's Alphamab and partnership with AstraZeneca
    Pathos AI announced two new collaborations to expand its oncology pipeline, one with AstraZeneca and another with a subsidiary of China's Alphamab Oncology. The deal with Jiangsu Alphamab Biopharm…
    BioSpace · 1mo agoDealPositive↗ source
  • Pfizer CEO says $7 billion cash ready for bolt‑on acquisitions and dividend will stay intact
    During its second‑quarter earnings call, analysts asked Pfizer if the company would increase M&A spending as rivals rush to buy biotech assets. CEO Albert Bourla replied that Pfizer currently has…
    BioSpace · 1mo agoDealPositive↗ source
  • 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 · 1mo 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 · 1mo agoNegative↗ source
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source