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1,917 stories matching this filter · ← front page

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  • 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 · 22d agoApprovalNeutral↗ source
  • Zealand and Roche's amylin analog shows modest weight loss at middle dose, lagging behind Lilly's in Phase 2 trial
    Zealand and Roche reported new data from their Phase 2 obesity trial of an amylin analog at a recent conference. The earlier topline results in March had been viewed as disappointing. The updated…
    Endpoints · 22d agoNegative readoutNegative↗ source
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  • 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 · 22d agoRegulatoryNegative↗ source
  • Beam Therapeutics sues Chinese scientists and firms YolTech, Serapha Bio over alleged gene-editing technology theft
    Beam Therapeutics, a Cambridge-based company developing CRISPR base editing therapies, has filed a lawsuit. The suit names two Chinese scientists and the biotech firms YolTech and Serapha Bio, acc…
    Endpoints · 22d agoNegative↗ source
  • PhRMA appoints former House Majority Leader Eric Cantor as new president and CEO
    Former House Majority Leader Eric Cantor has been selected to lead PhRMA, the industry trade group representing pharmaceutical companies. The announcement was made on Tuesday, following earlier re…
    Endpoints · 22d agoNeutral↗ source
  • Ascletis pursues oral IL-17A inhibitor for psoriasis as Invivyd readies COVID-19 filing
    Ascletis, a biotech listed in Hong Kong, is developing a small‑molecule IL-17A inhibitor in pill form to treat psoriasis. The company aims to challenge the current injectable therapies that target…
    Endpoints · 22d agoRegulatoryNeutral↗ source
  • UniQure shares tumble as Huntington's gene therapy shows reduced benefit over time
    UniQure announced new follow-up data from its experimental gene therapy for Huntington's disease, indicating the treatment's effect may diminish with longer observation. The additional year of dat…
    Endpoints · 22d agoNegative readoutNegative↗ 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
  • ARCH Venture Partners and Population Health Partners launch China-based sleep-disorder startup Somnivera
    ARCH Venture Partners and Population Health Partners have teamed up again to create a new China-focused biotech, Somnivera, aimed at developing therapies for sleep disorders. The partnership follo…
    Endpoints · 22d agoDealPositive↗ source
  • Fresenius Kabi partners with Waltz Health to sell biosimilars directly to employer health plans
    Fresenius Kabi announced it will begin selling biosimilar medicines directly to employer-sponsored health plans. The company is working with Waltz Health, a marketplace owned by Eversana, to help…
    Endpoints · 22d agoDealPositive↗ source
  • Former Spark co-founder Steven Altschuler launches new immune-resetting biotech
    Steven Altschuler, who co-founded Spark Therapeutics, has announced the formation of a new biotech that aims to reset the immune system. The venture is positioned to address autoimmune diseases, a…
    Endpoints · 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
  • AI health startup Ortet launches with $500M backing from former Genentech AI team
    Ortet, a new health-technology company, announced its launch on Tuesday. The firm was founded by three former AI scientists and engineers who previously worked at Roche's Genentech division. Orte…
    Endpoints · 22d agoDealPositive↗ source
  • Novo pays $300 million upfront to license Hengrui’s weekly oral GLP-1/GIP weight-loss drug
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui for a preclinical weekly oral GLP-1/GIP receptor agonist aimed at weight loss. The deal involves an upfront payment of $…
    Endpoints · 22d agoDealPositive↗ source
  • FDA approves Egetis Therapeutics' Emcitate for rare X linked disease shortening life expectancy to 35 years
    Egetis Therapeutics announced that the U.S. Food and Drug Administration has granted approval for its drug Emcitate. The therapy is intended for patients with a rare X linked genetic disorder that…
    Endpoints · 22d agoApprovalPositive↗ source
  • SK pharmteco commits over $200 million to expand CDMO infrastructure, adding 100 jobs over five years
    SK pharmteco announced a plan to invest at least $200 million in building out its development and manufacturing infrastructure over the next five years. The funding is aimed at expanding the compa…
    Endpoints · 22d agoPositive↗ source
  • Swedish biotech AnaCardio secures $70.9M Series B to advance heart failure drug
    Swedish biotech AnaCardio announced a Series B financing round that raised €62.5 million ($70.9 million). The capital will be used to move its chronic advanced heart failure drug toward registrati…
    Endpoints · 22d agoDealPositive↗ source
  • BioNTech to shut three German manufacturing sites after sale talks fall through
    BioNTech announced it will close three of its manufacturing facilities in Germany. The decision follows months of searching for buyers for the sites. The company said it was unable to secure a dea…
    Endpoints · 22d agoDealNegative↗ 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
  • Oura cancels planned IPO citing market uncertainty despite strong demand
    Oura, known for its smart ring, announced it is withdrawing its initial public offering. The company said the decision was driven by ongoing uncertainty in the IPO market, even though it continues…
    Endpoints · 22d agoDealNeutral↗ source
  • UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
    The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2…
    BioSpace · 22d ago↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 23d agoApprovalPositive↗ source
  • Kodiak Sciences reports Phase 3 success for Zenkuda, matching Eylea in wet AMD
    Kodiak Sciences announced that its experimental therapy Zenkuda achieved comparable efficacy to the market‑leading anti‑VEGF drug Eylea in a late‑stage trial for wet age‑related macular degeneratio…
    Endpoints · 23d agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source