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Novartis’ GanLum hits Phase III goal — a new weapon against resistant malaria
Novartis reported Phase III data for GanLum (ganaplacide + lumefantrine) showing noninferiority to standard artemisinin‑based therapy and cure rates that meet WHO thresholds. The trial enrolled...
Medicxi closes €500m fund: European VC doubles down on asset‑centric biotech bets
London‑based Medicxi announced the close of its fifth fund, Medicxi V, raising €500 million to invest in asset‑centric biotech companies. The oversubscribed fund continues Medicxi’s strategy of...
Lilly pays $2.6B to access ABL’s Grabody‑B brain‑shuttle — CNS delivery deals accelerate
Eli Lilly struck a license and research agreement with ABL Bio worth up to $2.6 billion to leverage Grabody‑B, a BBB‑penetrating bispecific platform designed to ferry therapeutics into the central...
Nilo launches with $101M: neuro‑immune biotech backs neural circuit approach to inflammation
Nilo Therapeutics announced a $101 million Series A to develop therapies that modulate neural circuits to restore immune homeostasis. Founded by leaders in neurobiology and immunology, Nilo will...
FDA unveils plausible‑mechanism pathway — a roadmap for bespoke gene‑editing therapies
Top FDA officials published a new regulatory framework—often called the “plausible mechanism” pathway—to accelerate approvals for personalized gene‑editing and bespoke therapies when randomized...
Korro pivots after RNA‑editing miss — layoffs, strategy rewrite follow disappointing data
Korro Bio reported that its RNA‑editing candidate for alpha‑1 antitrypsin deficiency fell short of projected functional protein levels after a single dose. The company is cutting roughly one‑third...
Day One to acquire Mersana — buyer bets on B7‑H4 ADC with milestone‑heavy package
Day One Pharmaceuticals agreed to acquire Mersana Therapeutics for $129 million up front and up to $285 million in total contingent value tied to Emi‑Le (emiltatug ledadotin), a B7‑H4‑targeting...
Pfizer seals Metsera buyout: obesity biotech goes to pharma
Pfizer completed its acquisition of Metsera, finalizing a deal that industry sources valued at up to $10 billion. The transaction ends a heated bidding contest with Novo Nordisk and transfers...
Multi-omics maps pig-to-human kidney rejection: drugs reverse immune attack
Researchers performed a detailed multi-omics analysis after transplanting a genetically engineered pig kidney into a brain-dead human recipient and tracked immune and physiological signals over 61...
Novartis’ GanLum meets Phase 3 bar: new antimalarial advances
Novartis reported Phase 3 data showing its ganaplacide–lumefantrine combination (GanLum) met the trial’s noninferiority endpoint and achieved cure rates at or above WHO targets. The company said...
FDA unveils regulatory path for bespoke gene-editing therapies
Top FDA officials published a new regulatory roadmap to accelerate approval of individualized gene-editing treatments for ultra-rare diseases, building on the case of Baby KJ. The guidance —...
Grabody-B deal with Lilly: ABL Bio inks $2.6B platform pact
ABL Bio signed a license and research agreement with Eli Lilly worth up to $2.6 billion to deploy its Grabody-B blood–brain-barrier shuttle across multiple CNS programs. The deal includes a $40...
Kura’s ziftomenib cleared by FDA: new option for NPM1‑mutant AML
The FDA approved Kura Oncology and Kyowa Kirin’s oral menin inhibitor ziftomenib (Komzifti) for relapsed/refractory NPM1-mutant acute myeloid leukemia based on phase II single-arm data. Regulatory...
Vector safety spotlight: AAV assay challenges and HSV‑1 vector mutations
Two studies raised safety and assay concerns in viral vector-based gene therapy. First, work on AAV neutralization assays highlighted matrix effects that can distort antibody readouts, urging...
Ultra‑mild methylation sequencing debuts: UMBS‑seq fixes bisulfite damage
Researchers unveiled UMBS‑seq, an 'ultra‑mild' DNA methylation sequencing method published in Nature Communications, addressing DNA damage and inconsistency problems in traditional bisulfite and...
Allen Institute launches Brain Knowledge Platform: 34M cells, AI models
The Allen Institute released the Brain Knowledge Platform (BKP), a consolidated AI‑driven resource standardizing over 34 million single-cell brain datasets across 22 species. The platform pairs...
Medicxi raises €500M fund to back asset‑centric biotech startups
Europe’s Medicxi closed a €500 million fifth fund to back asset‑centric biotech companies across development stages, the firm announced in a press release. The oversubscribed raise follows recent...
FDA clears Komzifti — Kura’s menin inhibitor approved for NPM1‑mutant AML
The FDA granted approval to ziftomenib (Komzifti) for relapsed or refractory acute myeloid leukemia with NPM1 mutations, marking Kura Oncology’s first approved therapy. The decision relied on the...
Pig kidney runs 61 days: Multi‑omics trace rejection and rescue
Researchers performed a genetically engineered pig kidney transplant into a brain‑dead human decedent and maintained graft function for 61 days while collecting serial samples for comprehensive...
Novartis’ GanLum hits Phase III goal — potential new tool against resistance
Novartis reported Phase III data showing its antimalarial combination GanLum (ganaplacide + lumefantrine) met the primary non‑inferiority endpoint versus the artemisinin‑based standard of care...