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81 stories matching this filter · ← front page

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  • Astellas teams up with Boston miniprotein startup to explore AI-designed tiny proteins
    Astellas Pharma announced a partnership with a Boston-based startup that specializes in miniproteins, small engineered proteins that can serve as therapeutic agents. The startup leverages artifici…
    Endpoints · 7h agoDealPositive↗ source
  • EyePoint's Phase 3 trial fails, prompting 53% staff cuts; Lilly signs China drug delivery partnership
    EyePoint, a Watertown, Massachusetts biotech, reported that its experimental therapy did not meet primary endpoints in a Phase 3 study, marking a setback for the company. Following the trial failu…
    Endpoints · 1d agoNegative readoutNegative↗ source
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fda medwatch92
globenewswire health73
fda press53
1616
Psychiatry & CNS1106
Ophthalmology843
Endocrinology & Metabolism686
Pain654
Nephrology633
  • Iambic Therapeutics CEO discusses $150 million IPO and AI's evolving role in drug development
    Iambic Therapeutics completed a $150 million initial public offering, raising fresh capital and seeing its share price climb to about $24.50, roughly a 50% increase from earlier in the week. CEO T…
    BioPharma Dive · 4d agoDealPositive↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 4d agoDealPositive↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 6d agoRegulatoryPositive↗ source
  • Rudy Tanzi says he may be nearing a cheap, safe Alzheimer’s prevention pill
    Rudolph Tanzi has spent decades pursuing a way to stop Alzheimer’s disease before it starts. As a leading researcher, he has long spoken about the need for a simple, widely accessible solution. T…
    Endpoints · 7d agoPositive↗ source
  • Merck's diabetic eye-disease drug hits primary goal but faces commercial doubts
    Merck announced results from a pivotal trial of its ophthalmology candidate remigromig, aimed at treating diabetic macular edema. The study achieved its primary endpoint, demonstrating that remigr…
    Endpoints · 8d agoNegative readoutNegative↗ source
  • Bausch + Lomb CEO Brent Saunders abruptly departs after failed multibillion-dollar sale
    Brent Saunders, known as a leading dealmaker and one of the highest-paid executives in biopharma, has left his role as chief executive of Bausch + Lomb. His departure ends a second stint as CEO of…
    Endpoints · 8d agoNegative↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 8d agoNeutral↗ source
  • AI startup Chai Discovery inks GSK deal to develop biologics using artificial intelligence
    Chai Discovery, an artificial‑intelligence focused biotech, has signed a collaboration agreement with GlaxoSmithKline to create biologic medicines using its AI platform. The partnership will lever…
    Endpoints · 11d agoDealPositive↗ source
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 12d agoNegative readoutNegative↗ source
  • Kodiak Sciences' Zenkuda shows non-inferior six-month dosing vs Eylea, shares double
    Four years ago Kodiak Sciences saw its share price plunge about 80% after its lead eye-disease candidate failed a head-to-head trial against Regeneron's Eylea, wiping out roughly $2 billion in mark…
    BioPharma Dive · 18d agoPositive readoutPositive↗ source
  • Bayer outlines $2.2 billion Ohio plant that will add roughly 600 jobs
    Bayer announced its plan for a new manufacturing complex in New Albany, Ohio, with an investment of about $2.2 billion. The facility is expected to create roughly 600 new jobs in the region, suppo…
    Endpoints · 17d agoPositive↗ source
  • Aviceda Therapeutics to wind down after Phase 2 failure in geographic atrophy program
    Aviceda Therapeutics, a biotech focused on geographic atrophy, announced it is winding down operations. The decision follows a Phase 2 trial that did not meet its endpoints, halting plans to move…
    Endpoints · 18d agoNegative↗ 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 · 21d agoRegulatoryNeutral↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 22d agoPositive readoutPositive↗ 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 · 22d agoPositive readoutPositive↗ source
  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 26d agoPositive readoutNeutral↗ source
  • Merck's $1.3B EyeBio investment yields first ophthalmology success
    Merck's strategic move to re-enter ophthalmology has begun to show results after its 2024 acquisition of EyeBio. The company committed $1.3 billion upfront for EyeBio, aiming to broaden its pipeli…
    Endpoints · 26d agoDealPositive↗ source
  • Beacon Therapeutics reports successful gene-therapy trial for rare X-linked retinitis pigmentosa
    Beacon Therapeutics announced that its gene-therapy candidate for X-linked retinitis pigmentosa (XLRP) achieved its primary endpoint in a pivotal trial. The result marks a breakthrough for the rar…
    Endpoints · 29d agoPositive readoutPositive↗ source
  • Novo outlines diversification strategy with new pipeline assets and bolt-on deals
    Novo Pharmaceuticals' chief executive Maziar Mike Doustdar used the company's recent capital-markets day in London to lay out a diversification plan. He said the rebranded firm will focus on expand…
    Endpoints · 29d agoDealPositive↗ source
  • Beacon eye gene therapy hits mark in late-stage study
    Beacon claimed the findings represent the first time a treatment for X-linked retinitis pigmentosa, a rare and potentially blinding condition, met its main goal in a pivotal trial.
    BioPharma Dive · 29d agoRegulatoryNeutral↗ source
  • Roche partners with Dualitas Therapeutics in up to $1 billion deal to screen bispecific antibodies for immune diseases
    Roche has committed $36.5 million up front to biotechnology startup Dualitas Therapeutics under a research partnership that could total up to $1 billion in milestone payments and royalties. The agr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Sling Therapeutics raises $123M to fund Phase 3 trial of former Astellas cancer drug for thyroid eye disease
    Investors have committed $123 million to Sling Therapeutics, a small Michigan biotech focused on eye‑disease treatments. The funding will support a Phase 3 clinical trial of a drug originally deve…
    Endpoints · 1mo agoDealPositive↗ source
  • Sling banks $123M for an experimental thyroid eye disease pill
    A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and Viridian's Lumvoa.
    BioPharma Dive · 1mo ago↗ source