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995 stories matching this filter · ← front page

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  • Kyverna reports one-year mobility gains and safety for CAR-T miv-cel in stiff-person syndrome, bolstering FDA filing plans
    Kyverna Therapeutics presented data from its Phase 2 KYSA-8 trial of miv-cel, a CAR-T therapy aimed at stiff-person syndrome (SPS). The study followed 26 patients for one year. At the one-year mar…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 27d agoDealPositive
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Nephrology645
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  • Eli Lilly earmarks up to $3.25 billion for partnership with InnoCare Pharma
    Eli Lilly announced an upfront payment of $100 million to Beijing‑based InnoCare Pharma to start work on drug candidates for five targets that have critical unmet medical needs. The agreement also…
    BioSpace · 27d agoDealNeutral↗ source
  • Radioligand therapy gains momentum as experts discuss expanding patient impact
    In a recent episode of the Denatured podcast presented by Curium, host Jennifer Smith-Parker spoke with Mike Patterson, CEO North America, and Sabine Brookman-May, Vice President and Head of Global…
    BioSpace · 27d agoPositive↗ source
  • FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
    FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site. Inspectors observed that the ph…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 27d agoNegative readoutNeutral↗ source
  • Merck’s eye-drug matches Lucentis in vision improvement but raises safety concerns
    Merck reported results from its Phase 2b/3 BRUNELLO trial of remigromig, a Wnt-pathway agonist for diabetic macular edema. The drug achieved non-inferior improvement in best-corrected visual acuit…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • Basecamp Research secures $140 million Series C to accelerate AI-designed drug pipeline
    Basecamp Research announced closing a $140 million Series C financing round to further develop its AI-driven drug discovery platform. The round was led by venture firm S32 and included participati…
    BioSpace · 27d agoDealPositive↗ source
  • Senators question FDA nominee as agency issues rule to cut animal testing
    The latest FDA briefing highlighted two key developments: a Senate hearing on the agency’s next leader and a new regulation targeting animal testing. During the confirmation hearing, senators pres…
    raps · 27d agoRegulatoryNeutral↗ source
  • FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review
    The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
    raps · 27d agoRegulatoryNeutral↗ source
  • Series B funded biotechs expand hiring, Tenpoint Therapeutics raises $85M for eye-health pipeline
    Companies that secured series B rounds this year are scaling up their staff, making them attractive targets for biopharma talent. Tenpoint Therapeutics, based in Warren, New Jersey, announced an $…
    BioSpace · 27d agoDealPositive↗ source
  • AI-driven interviews risk alienating biotech and pharma job seekers, experts warn
    AI interview tools are being introduced by biotech and pharma firms to speed up candidate screening, but they can create negative experiences for applicants. Candidates described frustrations such…
    BioSpace · 27d agoNegative↗ source
  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 27d agoRegulatoryNeutral↗ source
  • Senators Question FDA Nominee Overton as Agency Issues New Rule to Cut Animal Testing
    Senators on the Senate Health Committee interrogated President Trump's nominee to lead the FDA, Dr. Janet Overton, during her confirmation hearing. Lawmakers focused on her views about the agency's…
    raps · 27d agoRegulatoryNeutral↗ source
  • Senate grills Trump’s FDA nominee Heidi Overton on agency priorities
    Heidi Overton, President Trump’s nominee to lead the U.S. Food and Drug Administration, appeared before the Senate for a confirmation hearing on September 24, 2026. Senators from both parties aske…
    raps · 27d agoRegulatoryNeutral↗ source
  • US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
    In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as…
    BioSpace · 27d ago↗ source
  • Backed by NVIDIA, Basecamp bags $140M to advance AI-designed drugs
    Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
    BioSpace · 27d ago↗ source
  • Roche and Ionis report Phase 3 success for RNA therapy sefaxersen in IgA nephropathy
    A late‑stage Phase 3 trial of the Roche‑Ionis RNA‑targeted drug sefaxersen met its primary endpoint, showing a statistically significant reduction in proteinuria for patients with primary IgA nephr…
    BioSpace · 28d agoPositive readoutPositive↗ source
  • Ionis and Otsuka's RNA therapy Ulefnersen shows functional and survival gains in rare FUS-ALS in Phase 3 trial
    Ionis Pharmaceuticals and Otsuka Pharmaceutical reported that their antisense oligonucleotide drug Ulefnersen improved both functional impairment scores and overall survival in a Phase 3 study of p…
    BioSpace · 28d agoPositive readoutPositive↗ source
  • China’s $522 bn biotech push fuels US competition and partnership opportunities
    Chinese biotech is entering a rapid growth phase, with the government’s new five-year plan targeting about $522 billion in revenue by 2030 and aiming for at least 25% of first-in-class drugs worldw…
    BioSpace · 28d agoDealPositive↗ source
  • Amgen's Sjögren's drug dazodalibep meets primary endpoint in Phase 3 trial
    Amgen reported that its experimental therapy for Sjögren's disease, dazodalibep, achieved the primary goal in a late‑stage study. The Phase 3 OASIZ 301 trial enrolled roughly 621 patients with mod…
    BioSpace · 28d agoPositive readoutPositive↗ source
  • Novartis signs up to $900 million deal with China's BoomRay for preclinical radioligand therapy
    Novartis has licensed a preclinical radioligand therapy from BoomRay Pharmaceuticals, a Suzhou‑based biotech, in a deal that could be worth up to $900 million. The agreement includes an undisclose…
    BioSpace · 28d agoDealPositive↗ source
  • Novo outlines $23B revenue goal, cuts 4,000 jobs and expands Wegovy manufacturing amid investor skepticism
    Novo held its Capital Markets Day to detail a plan to reach $23 billion in sales by 2035. The company announced another round of layoffs, trimming its workforce by 4,000 people and leaving the head…
    BioSpace · 28d agoNeutral↗ source
  • Job postings in Pennsylvania’s biopharma sector surge 213% as nine companies ramp up hiring
    Job postings for biopharma roles in Pennsylvania have jumped dramatically, with BioSpace reporting a 213% year‑over‑year increase in August and overall postings tripling compared with the previous…
    BioSpace · 28d agoPositive↗ source
  • Pharma companies compete for scarce manufacturing talent as reshoring ramps up
    As pharmaceutical firms expand or add U.S. manufacturing sites to bring production back home, they are finding it hard to staff the plants. The industry faces a limited pool of qualified workers,…
    BioSpace · 28d agoNeutral↗ source