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Retatrutide knockoffs spark legal action
Eli Lilly took its first major enforcement step against the “black market” for retatrutide by filing lawsuits targeting six U.S. companies, alleging they sold unauthorized versions of the...
Freenome’s SimpleScreen earns FDA breakthrough device nod
Freenome won an FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay, aimed at adults ages 50 to 80 with a 20 pack-year smoking history who are not...
Caribou positions allogeneic CAR T for Phase III expansion
Caribou Biosciences moved to widen access to its allogeneic CAR T programs by preparing for a pivotal Phase III trial, citing engineered genome-editing strategies and product optimization. The...
AI monitoring agent delivers outsized trial ROI in oncology modeling
Tufts Center for the Study of Drug Development reported that an AI clinical monitoring agent could generate up to 82 times return on investment (ROI) in oncology trials, using expected net present...
Vaderis closes $152M Series B and starts HHT pivotal Phase III
Vaderis Therapeutics closed an oversubscribed $152 million Series B financing and simultaneously initiated HEROIC, its global Phase III study of engasertib (ALM 301) in hereditary hemorrhagic...
Definium posts another Phase 3 win in generalized anxiety
Definium Therapeutics reported positive top-line results from a late-stage Phase III trial of its oral LSD candidate, DT-120 (lysergide), in generalized anxiety disorder. The company said the...
Neonatal CAR-T/rare immunology: Ribox gets IND for circRNA-based in vivo therapy
Ribox Therapeutics received FDA IND clearance for RXIM-002, a circular RNA (circRNA)-based in vivo CAR-T program delivered via a targeted lipid nanoparticle (tLNP). The company plans to run a...
Natera and Kupando test ctDNA dynamics with innate-immune therapy
Natera and Kupando Therapeutics launched a Phase I collaboration in Germany that will use Natera’s blood-based Latitude circulating tumor DNA (ctDNA) assay to monitor treatment response in skin...
Neurocrine safety signals prompt expert warnings for Vykat XR
Physicians and experts on Prader-Willi syndrome issued new safety warnings about Neurocrine Biosciences’ newly approved Vykat XR. The experts said Vykat XR has been linked to seven deaths and more...
Tufts-style trial ops economics meet regulatory modernization momentum
In parallel with AI-driven efficiency claims for clinical trial monitoring, U.S. policymakers are pushing faster first-in-human trial execution through regulatory modernization initiatives,...
CAR-T access expansion via allogeneic platforms
Caribou Biosciences said it is preparing to widen access to donor-derived CAR T by moving a pivotal Phase III study forward, leveraging its genome editing strategy and product optimization. The...
Definium’s LSD therapy posts additional Phase 3 win in anxiety
Definium Therapeutics reported success in the first of two planned Phase 3 trials of its orally dosed LSD-based therapy for generalized anxiety disorder. The company said the treatment...
Neuro-oncology signal: intranasal NEO100 reaches Phase 2a endpoint
NeOnc Technologies said its intranasal NEO100 met the primary endpoint in a Phase 2a study in recurrent IDH1-mutant high-grade glioma. The company reported six-month progression-free survival of...
Rare disease finance: Vaderis raises to advance engasertib into pivotal testing
Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib into Phase 3 for hereditary hemorrhagic telangiectasia (HHT). The financing coincided with the initiation...
FDA action: Freenome’s SimpleScreen lung test earns Breakthrough device status
Freenome received U.S. FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay. The designation covers the proposed use in adults ages 50 to 80 with at...
Diagnostics and MRD expansion: Natera moves deeper into early cancer detection
Natera said it is preparing to expand beyond minimal residual disease (MRD) and into early cancer detection as regulatory wins add indications for its Signatera liquid biopsy platform. Over the...
Immunotherapy-industry dealmaking: Innate and Sobi expand toward accelerated CTCL filing
Innate Pharma secured a large partnership with Sobi to fund and expand development of lacutamab in cutaneous T-cell lymphoma. Sobi will pay $75 million upfront and $40 million tied to near-term...
CDMO scale and manufacturing reshoring: BMS commits $2.3B Houston campus
Bristol Myers Squibb said it will build a $2.3 billion multi-modal manufacturing campus in Houston to support drug product manufacturing across modalities. The project, designed for late...
Funding for new platforms: Infinimmune raises to enter atopic dermatitis clinic
Infinimmune raised $75 million in a Series A to advance two antibody programs targeting IL-22 and IL-13 for atopic dermatitis. The company says it has identified mechanisms designed to achieve...
Biotech financing and corporate growth: Epicrispr raises $90M for FSHD epigenetic therapy
Epicrispr Biotechnologies raised $90 million in a Series C after sharing early data for a new epigenetic approach to facioscapulohumeral muscular dystrophy (FSHD). The company said the funding...