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2,053 stories matching this filter · ← front page

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  • Connect Biopharma's IL-4/IL-13 blocker cuts COPD exacerbations by 85% in Phase 2 trial
    Connect Biopharma reported phase 2 results for its IL-4/IL-13 inhibitor rademikibart in COPD patients. In the Seabreeze STAT study of 159 participants who had recent exacerbations, adding rademiki…
    Fierce Biotech · 22d agoPositive readoutNeutral↗ source
  • VertigoDx receives FDA 510(k) clearance for its portable SmartVertigo diagnostic system
    The U.S. Food and Drug Administration has issued a 510(k) clearance for VertigoDx's portable vertigo assessment tool, allowing it to be marketed in the United States. The system, called SmartVerti…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
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  • Bicara CEO Claire Mazumdar to step down, COO Ryan Cohlhepp to assume leadership in 2027
    Claire Mazumdar, who co‑founded Bicara and has served as its chief executive for almost seven years, announced she will step down at the end of the year. She will take parental leave and then move…
    BioSpace · 22d agoPositive↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 22d agoRegulatoryNeutral↗ source
  • Women-led biotech M&A drops sharply in 2026, only two major deals recorded so far
    Last year saw an unprecedented wave of women-led biotech transactions, with eleven high‑value deals out of 72 total biopharma mergers in 2025. In 2026 the pace has slowed dramatically, with just…
    BioSpace · 22d agoDealNegative↗ source
  • Biopharma must incentivize scientists to make early go-no-go decisions
    The article argues that simply urging scientists to think like entrepreneurs is not enough; biopharma firms need to align rewards with that mindset. Because only about one in ten drug candidates t…
    BioSpace · 22d agoNeutral↗ source
  • Biopharma needs to reward scientists' judgment
    It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
    BioSpace · 22d ago↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to advance PD-1xVEGF bispecific ivonescimab with ADC combos
    AstraZeneca is committing $2 billion to Summit Therapeutics, acquiring a 12% equity stake at a premium to the biotech's closing price. The funding is aimed at accelerating development of the PD‑1xV…
    Fierce Biotech · 23d agoDealPositive↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 23d agoDealPositive↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to fund Phase 3 trials of ivonescimab
    AstraZeneca has agreed to a $2 billion all‑stock investment in Summit Therapeutics. The deal involves the purchase of preferred shares that can be converted into common stock, but it does not inclu…
    BioSpace · 22d agoDealPositive↗ source
  • Novo Nordisk signs $2.6 billion deal with China's Hengrui for oral GLP-1/GIP candidate
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui Pharmaceuticals, paying $300 million upfront for rights to a preclinical GLP-1/GIP dual-receptor agonist. The candidate,…
    Fierce Biotech · 23d agoDealPositive↗ source
  • AstraZeneca puts $2 billion into Summit Therapeutics and partners to test ivonescimab with its oncology pipeline
    AstraZeneca announced a $2 billion equity investment in Summit Therapeutics, acquiring roughly 109,000 shares of convertible preferred stock. The deal will give AstraZeneca about a 12% stake in Sum…
    BioPharma Dive · 22d agoDealNeutral↗ source
  • Curium gains FDA nod for Bexlutry as it eyes challenge to Novartis radioligand therapies
    Curium recently received FDA approval for its radiopharmaceutical Bexlutry, positioning it as a direct competitor to Novartis’ Lutathera. The biotech is also in discussions with the FDA about fili…
    BioSpace · 23d agoApprovalNeutral↗ source
  • Beam Therapeutics sues YolTech and Serapha Bio over alleged theft of base editing trade secrets
    Beam Therapeutics has filed a lawsuit in U.S. District Court in Massachusetts accusing Chinese biotech YolTech Therapeutics and its U.S. partner Serapha Bio of using confidential information to dev…
    BioPharma Dive · 22d agoNegative↗ source
  • Novo to pay Hengrui up to $2.6 billion for rights to weekly obesity pill HRS-1596
    Novo announced a deal with China-based Hengrui Pharma, paying $300 million up front for rights to HRS-1596, a once‑weekly obesity pill. The agreement could rise to $2.6 billion if the candidate me…
    BioPharma Dive · 22d agoDealNeutral↗ source
  • Roche drops anti-myostatin obesity drug after mid-stage trial shows limited weight loss
    Roche announced it will stop development of its anti-myostatin obesity candidate emugrobart after an interim analysis of the Phase 2 GYMINDA trial showed it is unlikely to produce meaningful weight…
    BioSpace · 22d agoNegative readoutNegative↗ source
  • ai3Bio raises $48 million to develop T-helper cell-targeted immune-reset therapies
    ai3Bio, a new biotech startup formed from Corner Therapeutics and Novasenta, announced it has secured $48 million in an early-stage venture capital round. The company aims to create treatments for…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Novo Nordisk licenses weekly oral obesity peptide from Hengrui in up to $2.6 billion deal
    Novo Nordisk has signed a licensing agreement with China's Hengrui Pharma for a once‑weekly oral peptide, HRS‑1596, aimed at obesity and other metabolic conditions. Novo will pay $300 million upfr…
    BioSpace · 22d agoDealNeutral↗ source
  • Highlight Therapeutics reports positive Phase 2b results for BO-112 in high‑risk head and neck basal cell carcinoma
    Highlight Therapeutics announced that its Phase 2b study of BO-112 met the primary endpoint of visual and pathological response at week 24 in patients with localized high‑risk head and neck basal c…
    Fierce Biotech · 23d agoPositive readoutPositive↗ source
  • uniQure shares tumble 41% after Huntington’s gene therapy misses primary endpoint
    uniQure reported updated 48‑month data from its phase 1/2 trial of AMT‑130 in Huntington’s disease. The therapy showed a 44% slowing of disease progression on the composite Unified Huntington’s Dis…
    Fierce Biotech · 23d agoNegative readoutNegative↗ source
  • Regulators Discuss Plans to Streamline Europe’s Drug Approval Process at 2026 RAPS Convergence
    A panel of European regulators gathered at the 2026 RAPS Convergence in Charlotte, North Carolina to discuss ongoing initiatives aimed at simplifying the continent’s regulatory framework. The offi…
    raps · 23d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on requirements for robotically assisted surgical devices
    The FDA has published a draft guidance outlining its thinking on the requirements for bringing certain robotically assisted surgical devices to market. The guidance describes both non-clinical and…
    raps · 23d agoRegulatoryNeutral↗ source
  • Ontario launches $5M QuickStart program to cut clinical trial start-up time to 45 days
    Ontario’s Clinical Trials Ontario has introduced a $5 million QuickStart program that promises to reduce the time needed to launch a clinical trial to as little as 45 days. The initiative is desig…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
  • Biopharma layoffs ease in Q3 2026, but cuts still ongoing
    Recruiters note that biopharma layoff volume in Q3 2026 remained modest, suggesting the sector is moving past the large wave of cuts seen last year. Fierce recorded 21 layoff announcements between…
    Fierce Biotech · 23d agoLayoffsNegative↗ source
  • SK pharmteco hosts webinar on overcoming ADC linker-payload manufacturing challenges
    SK pharmteco’s European and North American teams presented a webinar that explored the full lifecycle of antibody‑drug conjugate (ADC) linker‑payload development, from facility design to final prod…
    BioSpace · 22d agoNeutral↗ source