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18 stories matching this filter · ← front page

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STAT875Endpoints677BioPharma Dive255onclive165BioSpace128Fierce Biotech118globenewswire health46raps
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allOncology5253Rare Disease979Cardiology911Hematology813Immunology791Pulmonology650Psychiatry & CNS
  • Amgen’s MariTide stands alone after obesity cull while analysts seek more M&A
    Amgen has discontinued Phase 1 obesity candidate AMG 513, leaving MariTide as its sole weight loss asset. Meanwhile, executives said the company’s late-stage pipeline is largely full and future bus…
    BioSpace · 10h ago↗ 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 · 2d agoNegative readoutNegative↗ source
46
fda recalls31
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fda medwatch21
627
Vaccines544
Endocrinology & Metabolism308
Ophthalmology283
Infectious Disease271
Pain270
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 · 2d agoNeutral↗ source
  • Analysts say Daiichi Sankyo’s ADC pipeline lags rivals as cash flow peaks, cutting expectations
    Jefferies analysts warned that Daiichi Sankyo's early‑stage antibody‑drug conjugate (ADC) pipeline is falling behind competitors, even as the company approaches a peak in cash flow from its existin…
    BioSpace · 6d agoNegative↗ source
  • Regeneron defends M&A stance as cash hoard reaches $18 billion amid trial setbacks
    Analysts on Regeneron's second‑quarter earnings call questioned the company's lack of merger and acquisition activity, pointing to an $18 billion cash reserve and recent clinical trial setbacks. C…
    BioSpace · 6d agoEarningsNeutral↗ source
  • Biopharma layoffs in 2026 often marred by impersonal and poorly timed communications
    Over 50 biopharma companies have announced workforce cuts or plan to do so in 2026. According to a BioSpace survey, the manner in which these layoffs are communicated can leave a lasting negative i…
    BioSpace · 6d agoLayoffsNegative↗ source
  • Sarepta appoints former AbbVie R&D chief Michael Severino as new CEO amid DMD regulatory outlook
    Sarepta Therapeutics announced that Michael Severino, who previously led Tessera Therapeutics and served as AbbVie’s head of research and development, will become the company’s chief executive. Sev…
    BioSpace · 9d agoPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti-CD122 antibody FB102
    Argenx announced it will buy Texas‑based Forte Biosciences in a transaction valued at roughly $2.2 billion. The offer of $77 per share represents an 86 % premium to Forte’s recent average price. T…
    BioSpace · 9d agoDealPositive↗ source
  • MapLight’s schizophrenia pill hits primary endpoint but falls short of challenging BMS’s Cobenfy
    MapLight Therapeutics reported results from its Phase 2 ZEPHYR trial of the oral muscarinic agonist ML-007C-MA in schizophrenia. The trial met its primary endpoint, showing a statistically signifi…
    BioSpace · 9d agoPositive readoutNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 9d agoRegulatoryNeutral↗ source
  • Roche says its late-stage pipeline is full, sees growth through 2030
    Roche's CEO Thomas Schinecker told analysts that the company has 19 investigational medicines that could launch by 2030, indicating a robust late-stage pipeline. He added that the depth of the pip…
    BioSpace · 13d agoEarningsPositive↗ source
  • Webinar: From Clinical to Commercial: Talent Strategies for Biopharma Growth
    This webinar provides an assessment of recent job market activity across biopharma and explores how companies approaching commercial readiness or building out sales and marketing teams can navigate…
    BioSpace · 14d ago↗ source
  • US ‘eroding’ lead in rare diseases a matter of national security: Report
    A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allow…
    BioSpace · 14d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    BioSpace · 16d ago↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 16d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 21d ago↗ source
  • Institutional Perspectives on Treatment Thresholds in PLGG
    Experts weigh PLGG treatment choices, balancing chemo and MEK inhibitors, guided by vision decline, symptoms, tumor growth, and family logistics.
    onclive · 2mo ago↗ source
  • Breast Cancer Experts Preview Abstracts to Watch at the 2026 ESMO Breast Cancer Congress
    Experts in a range of breast cancer subtypes highlight research data being presented at the 2026 ESMO Breast Cancer Congress.
    onclive · 3mo ago↗ source