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  • Merck reports positive phase 2b results for anti-TL1A antibody in hidradenitis suppurativa
    Merck announced that its experimental anti-TL1A antibody achieved a positive outcome in a phase 2b study. The trial enrolled patients with moderate to severe hidradenitis suppurativa, a chronic in…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • 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 · 1mo agoPositive readoutNeutral↗ source
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  • 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 · 1mo agoRegulatoryPositive↗ source
  • 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 · 1mo 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  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ 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 · 1mo agoApprovalNeutral↗ source
  • US charges two Indian nationals in counterfeit Ozempic distribution scheme
    The U.S. Attorney’s Office for the Middle District of Florida and the DOJ’s Criminal Division announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals, for…
    fda press · 1mo agoRegulatoryNegative↗ 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 · 1mo agoNegative readoutNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ source
  • Enanta cuts 37 jobs as it pivots toward immunology and awaits key antiviral trial readouts
    Enanta Pharmaceuticals announced it is laying off 37 employees as it refocuses resources ahead of upcoming trial readouts. The company said the decision was part of a fiscal year‑end review to rig…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • Biotech firms must align operating models with their unique DNA, not rely on generic SMID templates
    The article points out that two biotech firms with similar head counts, pipelines and growth plans can operate very differently. One may build extensive internal development infrastructure, while t…
    Fierce Biotech · 1mo agoNeutral↗ source