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736 stories matching this filter · ← front page

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  • Novartis and BMS pause CAR-T trials after fatal immune syndrome cases
    Novartis has halted several immunology and neurology studies of its CAR T candidate rapcabtagene autoleucel after three patients experienced fatal immune effector cell‑associated hemophagocytic syn…
    BioSpace · 13d agoRegulatoryNegative↗ source
  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 13d agoDealPositive↗ source
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Infectious Disease464
  • GSK to start Phase 3 trial of mRNA flu vaccine after strong mid-stage results
    GSK announced it will begin a Phase 3 trial of its mRNA-based influenza vaccine, with enrollment slated to start in September. In a Phase 2 study of 971 adults, the investigational vaccine, which…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Nine midsize biopharma firms join Trump MFN drug pricing program, covering 89% of branded market
    Nine midsize biopharma companies have agreed to voluntarily participate in the Trump administration's Most Favored Nation drug pricing program, adding to the 17 large pharmaceutical firms that prev…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 13d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 13d agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 13d agoDealNeutral↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in vivo CAR-T therapy
    Arsenal Biosciences announced another round of layoffs, eliminating 99 positions, which represents the majority of its workforce after a prior 50% reduction last year. The cuts are part of a strat…
    BioSpace · 13d agoLayoffsNegative↗ source
  • Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis
    Biomarin has granted Ascendis a non-exclusive, worldwide license to use navepegritide, the active ingredient in the latter company’s recently approved achondroplasia drug Yuviwel, in exchange for 1…
    BioSpace · 14d agoApprovalPositive↗ source
  • Takeda and Protagonist Therapeutics receive FDA approval for rusfertide (Mimrylo) to treat polycythemia vera
    The FDA approved rusfertide, to be sold as Mimrylo, for the treatment of polycythemia vera, a rare blood cancer, marking a key win for Takeda and its partner Protagonist Therapeutics. The decision…
    BioSpace · 14d agoApprovalPositive↗ source
  • US biotech edge erodes as China overtakes in trials and research, raising security concerns
    The United States is losing its lead in biotech as China now conducts more clinical trials and publishes more natural‑science papers. China passed the U.S. six years ago in trial numbers and soon…
    BioSpace · 14d agoNegative↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 14d agoDealPositive↗ source
  • Eli Lilly to acquire Merida Biosciences in up to $2.9 billion deal for precision antibody-degrading therapies
    Eli Lilly announced it will purchase Massachusetts‑based Merida Biosciences, adding a platform that can selectively degrade disease‑causing antibodies. The transaction could total up to $2.875 bil…
    BioSpace · 14d agoDealPositive↗ source
  • Arrowhead’s plozasiran shows favorable safety in severe hypertriglyceridemia late-stage trials
    Arrowhead presented late-stage data for its RNA interference therapy plozasiran, marketed as Redemplo, in severe hypertriglyceridemia at the European Society of Cardiology 2026 meeting in Munich.…
    BioSpace · 14d agoPositive readoutNeutral↗ source
  • BMS leverages Celgene merger to revive neuroscience pipeline amid delayed readouts
    Bristol Myers Squibb, long recognized for its oncology work, is re‑investing in neurological and psychiatric disease programs, a move rooted in assets gained from its 2019 $74 billion Celgene merge…
    BioSpace · 14d agoNeutral↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 14d agoRegulatoryNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 14d agoRegulatoryNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 14d agoRegulatoryPositive↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 16d agoApprovalPositive↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 17d agoApprovalPositive↗ source
  • Phase 3 trial shows Wainua fails to improve outcomes in ATTR-CM, hazard ratio 1.14
    AstraZeneca and Ionis Pharmaceuticals presented detailed results from the Phase 3 trial of their antisense oligonucleotide Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardi…
    BioSpace · 17d agoNegative readoutNegative↗ source
  • Priovant's Lisraya receives first FDA approval as oral therapy for dermatomyositis
    The U.S. Food and Drug Administration has cleared Priovant Therapeutics' daily TYK2/JAK1 inhibitor tablet, marketed under the name Lisraya, for the treatment of dermatomyositis in adults. Lisraya…
    BioSpace · 17d agoApprovalPositive↗ source
  • BioNTech stops Phase 2 colorectal cancer mRNA vaccine trial after futility findings
    BioNTech announced that it is ending its Phase 2 study of a personalized mRNA vaccine for resected colorectal cancer after the trial failed to show the needed benefit. The news sent the company’s s…
    BioSpace · 17d agoNegative readoutNegative↗ source
  • BioXcel files for Chapter 11 bankruptcy, selling assets to Teva for up to $125 M
    BioXcel Therapeutics announced it has filed for Chapter 11 bankruptcy and plans to sell all of its assets. Teva Pharmaceuticals will serve as the stalking horse bidder, proposing an upfront paymen…
    BioSpace · 17d agoDealNegative↗ source
  • AstraZeneca and Amgen’s Tezspire eyes Dupixent’s EoE stronghold after late-stage trial win
    Analysts note that AstraZeneca and Amgen have secured a late‑stage trial win for Tezspire, positioning the drug as a possible challenger to Dupixent in eosinophilic esophagitis (EoE). Dupixent re…
    BioSpace · 17d agoPositive readoutPositive↗ source