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1,335 stories matching this filter · ← front page

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  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 3h agoPositive readoutPositive↗ source
  • Bankrupt Sangamo sells Fabry gene therapy to PTC and prion program to Lilly for $161M
    Sangamo Therapeutics, currently in Chapter 11 bankruptcy, has agreed to divest its Fabry disease gene therapy and several other platforms to raise cash for the restructuring. PTC Therapeutics emer…
    BioSpace · 2h agoDealNeutral↗ source
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  • Zealand Pharma sells rights to rare blood cancer drug rusfertide for up to $100M
    Zealand Pharma entered a royalty purchase and sale agreement with Royalty Pharma, receiving $50 million upfront and the possibility of an additional $50 million after one year. In exchange, Zealan…
    BioSpace · 2h agoDealNeutral↗ source
  • PTC Therapeutics and Eli Lilly to acquire parts of bankrupt Sangamo for up to $264 million
    The gene-editing company Sangamo Therapeutics has filed for bankruptcy, placing its assets up for sale. An auction process has identified two bidders: PTC Therapeutics and Eli Lilly, which togethe…
    Endpoints · 3h agoDealNeutral↗ source
  • July biopharma layoffs down 94% YoY, 466 jobs cut across six companies
    July saw a sharp decline in biopharma workforce reductions, with only 466 employees affected, a 94% drop compared with the same month last year. BioSpace data shows six companies announced or proj…
    BioSpace · 7h agoLayoffsNegative↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 1h agoDealPositive↗ source
  • Avalyn Pharma CEO shares personal moment as company prepares for Nasdaq IPO
    Avalyn Pharma and Generate Biomedicines executives talked about the long hours and challenges of preparing their companies for an initial public offering. Avalyn CEO Lyn Baranowski highlighted a m…
    BioSpace · 7h agoPositive↗ source
  • Italy’s life‑science sector gains clinical strength and venture capital but still trails Europe’s leaders
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Diana Saraceni of Panakès Partners and Fabrizio Calisti of Angelini Ventures about Italy’s life‑science…
    BioSpace · 3h agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3h agoLayoffsNegative↗ source
  • PTC’s $211M bid wins Sangamo auction, teeing up ‘special opportunity’ to enter Fabry market
    PTC Therapeutics has struck a deal to buy Sangamo Therapeutics’ Fabry disease program for $111 million upfront, outbidding Astellas and TerSera Therapeutics for the near-approval gene therapy. Sang…
    Fierce Biotech · 5h ago↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung can…
    Fierce Biotech · 8h ago↗ source
  • Zealand sells its rights to Takeda’s blood cancer drug for $100M ahead of FDA approval decision
    As the FDA mulls whether to approve Takeda and Protagonist Therapeutics’ rusfertide, Zealand Pharma has sold its own rights to the blood cancer drug in return for $100 million.
    Fierce Biotech · 9h ago↗ source
  • Medtronic veteran Bill Shields crosses over to become CEO at valve disease startup
    After 15 years with Medtronic’s structural heart franchise, Bill Shields is leaving the medtech giant to become the chief executive of startup Versa Vascular.
    Fierce Biotech · 11h ago↗ source
  • Seven deaths linked to Neurocrine’s Prader-Willi drug Vykat raise safety concerns
    Clinicians have warned that seven patients who received Neurocrine Biosciences' recently approved Prader-Willi syndrome therapy Vykat have died, prompting a new safety alert for the patient communi…
    BioSpace · 23h agoRegulatoryNegative↗ source
  • Definium’s oral LSD candidate DT120 shows strong anxiety reduction in Phase 3 trial
    Definium Therapeutics reported that its single‑dose oral LSD candidate DT120 achieved a statistically significant reduction in anxiety symptoms in a Phase 3 study of generalized anxiety disorder. T…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • BridgeBio’s ATTR drug Attruby posts strong Q2 sales surge as Alnylam trims Amvuttra outlook
    BridgeBio Pharma reported that its transthyretin amyloidosis treatment Attruby generated $222.4 million in second‑quarter sales, more than triple the $71.5 million earned in the same period a year…
    BioSpace · 1d agoEarningsPositive↗ source
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 1d agoApprovalPositive↗ source
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 19h agoRegulatoryNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 1d agoPositive↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 22h agoDealPositive↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 1d agoDealPositive↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 20h agoRegulatoryNeutral↗ source
  • Eli Lilly sues six U.S. entities over illegal retatrutide sales, urges broader crackdown
    Eli Lilly announced legal action against six U.S. entities accused of selling its experimental obesity drug retatrutide on the black market. The lawsuits target compounding pharmacies, medical spa…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 1d agoDealPositive↗ source