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96 stories matching this filter · ← front page

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  • Novartis scraps mid-stage radiopharma asset as Pluvicto soars
    The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.
    BioSpace · 1d ago↗ source
  • Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
    Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics spa…
    BioSpace · 1d ago↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
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Fierce Biotech · 2d ago
↗ source
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    Fierce Biotech · 2d ago↗ source
  • From Big Pharma to specialty: why moving closer to the patient changes everything
    Working at a Big Pharma has its benefits, but there are limitations too. SERB Pharmaceuticals’ Thomas Kolaras discusses how moving to a midsize company creates new opportunities for sharpened think…
    BioSpace · 2d ago↗ source
  • Celldex ends skin disease program after failing phase 2 test
    A phase 2 study of Celldex’s barzolvolimab in a chronic skin disease has missed its primary endpoint, driving the biotech to end development in the indication and raising doubts about an upcoming e…
    Fierce Biotech · 2d ago↗ source
  • AI data becomes sticking point in biopharma dealmaking
    As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
    BioSpace · 2d ago↗ source
  • Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts
    With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
    BioSpace · 2d ago↗ source
  • ‘We’re moving quickly’: Startup bags rare disease drug as Thiel-backed CEO eyes $50M fundraise
    A rare disease startup with a mission to repurpose proven drugs has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
    Fierce Biotech · 2d ago↗ source
  • Samsung Biologics targets $1.8B PolyPeptide buyout to expand in obesity
    With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
    BioSpace · 2d ago↗ source
  • Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challenge
    A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifep…
    Fierce Biotech · 2d ago↗ source
  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 2d ago↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.<br>
    Fierce Biotech · 2d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 2d ago↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 2d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 2d ago↗ source
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 2d ago↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 2d ago↗ source
  • Jupiter enters psychedelics space with $100M deal for PharmAla's MDMA drug
    Jupiter Neurosciences will pay $3.3 million upfront to Canada's PharmAla Biotech for U.S. rights to an MDMA drug to treat neuropsychiatric disorders.
    Fierce Biotech · 3d ago↗ source
  • Agios says adios to sickle cell program over lackluster phase 2 data
    A phase 2 study of Agios Pharmaceuticals’ next-generation pyruvate kinase activator has failed to support continued development in sickle cell disease, leading the company to ax an indication for t…
    Fierce Biotech · 3d ago↗ source
  • Novartis drops phase 2 radioligand therapy, but CEO’s commitment to modality ‘unchanged’
    Novartis has dropped a phase 2-stage radioligand therapy after the candidate disappointed in the clinic.
    Fierce Biotech · 3d ago↗ source
  • Indian generics maker Lupin seeds US spinout Kaveri with cash, clinical-phase cancer assets
    Lupin has spun out two clinical-phase cancer drug candidates to create Kaveri Therapeutics, a U.S.-based startup that plans to raise cash for further development. Kaveri’s programs hit targets purs…
    Fierce Biotech · 3d ago↗ source
  • Roche taps Foundation Medicine’s chief as new North America Diagnostics lead, creates new commercial role
    Dan Malarek is leaving his role as chief executive of Roche’s sequencing subsidiary Foundation Medicine as he takes up the mantle as President and CEO of Roche Diagnostics North America.
    Fierce Biotech · 3d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 3d ago↗ source
  • ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
    Axiom Biosciences intends to pursue an IPO on the Hong Kong Stock Exchange (HKEX), followed by a co-listing on the Nasdaq—a strategy the company claims is the first U.S. biotech to use.
    Fierce Biotech · 3d ago↗ source