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  • Abcuro raises $66 million to launch Phase 3 trial in muscle-weakening disease after earlier setback
    Abcuro announced it has secured $66 million in financing to support a Phase 3 clinical study targeting a muscle-weakening condition. The funding comes after the company previously reported that it…
    Endpoints · 5d agoDealNeutral↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 5d agoRegulatoryNegative↗ source
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  • Overseas MDMA and psilocybin makers eye U.S. market as regulatory landscape eases
    Companies that produce MDMA and psilocybin for patients abroad are turning their attention to the United States, hoping to leverage experience gained under more permissive foreign rules. Rising pol…
    BioSpace · 6d agoPositive↗ source
  • Redx Pharma pursues new reverse merger with Skye after 2023 setback
    Redx Pharma, a UK biotech focused on ROCK inhibitor therapies for fibrosis, is seeking a reverse merger with Skye to obtain a Nasdaq listing. The company previously attempted a similar transaction…
    Endpoints · 5d agoDealNeutral↗ source
  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 6d agoNeutral↗ source
  • Cytokinetics sues Bristol Myers Squibb over recently granted patent, intensifying rivalry
    Cytokinetics has filed a lawsuit against Bristol Myers Squibb, seeking to invalidate a patent that was recently granted to the latter. The legal action adds a courtroom dimension to an already com…
    Endpoints · 5d agoCRLNegative↗ source
  • MapLight Therapeutics pauses early‑stage programs to focus on lead schizophrenia and Alzheimer’s psychosis candidate
    MapLight Therapeutics announced it is pausing its preclinical and discovery activities. The company said it will redirect resources toward advancing its lead candidate, ML-007C-MA, which is being d…
    Endpoints · 6d agoNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips for possible undeclared gluten
    Exotique Foods Inc of Ontario announced a recall of its Momchipz Veggie Chips in the broccoli florets and cauliflower flavor because the product may contain undeclared gluten. The chips, sold in 3…
    fda recalls · 5d agoCRLNegative↗ source
  • The Hampton Grocers recalls 8-oz Lacnola Lactation Granola over possible Salmonella contamination
    The company announced a recall of its 8-oz Lacnola Lactation Granola due to potential Salmonella contamination. The product was sold nationwide through the company's website and other online retai…
    fda recalls · 5d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to Bristol Myers' iberdomide for relapsed or refractory multiple myeloma
    The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, a small-molecule therapy developed by Bristol Myers Squibb. The approval targets patients with multiple mye…
    Endpoints · 6d agoApprovalPositive↗ source
  • Taiho and Cullinan’s zipalertinib shows progression‑free survival benefit in Phase 3 NSCLC trial
    Taiho Pharmaceutical and Cullinan Therapeutics reported that their EGFR inhibitor zipalertinib, combined with chemotherapy, significantly extended progression‑free survival for patients with advanc…
    BioSpace · 6d agoPositive readoutPositive↗ source
  • 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 · 7d agoPositive readoutPositive↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 6d agoRegulatoryNegative↗ 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 · 7d agoDealNeutral↗ source
  • FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviews
    The Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…
    Endpoints · 6d agoRegulatoryPositive↗ source
  • Karyopharm faces default risk with only a month left to rescue cancer expansion
    Karyopharm Therapeutics, a commercial-stage cancer drugmaker, is confronting severe financial strain as its market capitalization is roughly one‑third of the revenue it expects to generate in 2026.…
    Endpoints · 6d agoNegative↗ source
  • Khartis Therapeutics secures $50 million Series B funding from Forge Life Science Partners, Longwood Fund and Lilly Asia Ventures
    San Diego-based Khartis Therapeutics announced a $50 million Series B financing round. The round was led by Forge Life Science Partners and included participation from Longwood Fund, Lilly Asia Ve…
    Endpoints · 7d agoDealPositive↗ source
  • 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoPositive↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 6d agoDealNeutral↗ 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 · 7d agoNeutral↗ source
  • Grand Central Bakery recalls potato sourdough loaves over possible metal fragments
    Grand Central Bakery of Seattle announced a recall of its potato sourdough bread after discovering that some loaves may contain pieces of metal. The recall includes 20‑oz, 12‑oz and other sized lo…
    fda recalls · 6d agoRegulatoryNegative↗ source