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FDA halts Daiichi‑Merck ADC trial: enrollment paused after excess deaths
The FDA placed a partial hold on Daiichi Sankyo and Merck & Co.’s global Phase 3 program for their investigational antibody‑drug conjugate (ADC) after investigators paused enrollment citing a...
Takeda’s TYK2 pill clears Phase 3... firm prepares 2026 FDA filing
Takeda reported that zasocitinib, the oral TYK2 inhibitor acquired in a $4 billion deal, met co‑primary and key secondary endpoints in two Phase 3 trials for plaque psoriasis, including...
Lilly’s oral GLP‑1 succeeds in maintenance setting – FDA review accelerated
Eli Lilly’s oral GLP‑1 candidate orforglipron met primary and key secondary endpoints in the Phase 3 Attain‑Maintain trial, demonstrating superior weight‑maintenance versus placebo over 52 weeks...
CEPI plugs tens of millions into Moderna’s H5 mRNA shot... Phase 3 next
The Coalition for Epidemic Preparedness Innovations (CEPI) agreed to fund up to $54.3 million to advance Moderna’s mRNA‑1018 H5 avian influenza vaccine into Phase 3 testing. The move follows...
Liver‑directed mRNA reboots aged immunity: mouse data boost vaccines and ICI
MIT researchers reported in Nature that transient liver‑targeted mRNA delivery of trophic factors (DLL1, FLT3L, IL‑7) restored naive and stem‑like T cell populations in aged mice, improving...
Engineered dendritic cells capture tumor EVs: two bioengineering routes show potency
Teams led by Michele De Palma at EPFL reported complementary bioengineering strategies that enable dendritic‑cell progenitors to internalize tumor‑derived extracellular vesicles (EVs) and prime...
Early Parkinson signal: two small molecules activate GCase—CNS and peripheral data
Two small‑molecule programs aimed at activating glucocerebrosidase (GCase) in Parkinson’s disease reported early signals of target engagement. Gain reported substrate reduction in the CNS for its...
Addition Therapeutics raises major rounds for RNA 'jumping gene' insertion platform
Addition Therapeutics closed a large financing to advance its PRINT (Precise RNA‑Mediated Insertion of Transgenes) platform, which uses RNA and retrotransposon biology delivered by lipid...
Liquid biopsy advances: VolitionRx’s Capture‑Seq and Personalis ctDNA predict responses
Two independent diagnostic advances highlight liquid biopsy momentum. VolitionRx published a preprint describing Capture‑Seq, a ChIP‑Seq adaptation targeting cell‑free CTCF‑DNA complexes; the...
Regulatory shakeup: FDA voucher program and White House pricing pacts raise concerns
STAT reported that the FDA’s new Commissioner’s National Priority Review voucher program has drawn political involvement at the highest levels, with White House and agency officials influencing...
Daiichi‑Merck lung ADC program: FDA imposes partial hold after excess deaths
The FDA placed a partial clinical hold on Daiichi Sankyo and Merck & Co.’s global Phase 3 antibody‑drug conjugate (ADC) program after the sponsors paused enrollment citing a "higher than...
Moderna’s H5 pandemic shot: CEPI plugs $54.3M to push candidate into Phase 3
The Coalition for Epidemic Preparedness Innovations (CEPI) agreed to provide up to $54.3 million to Moderna to advance its mRNA‑1018 H5 avian influenza vaccine into Phase 3 testing after U.S....
Takeda’s TYK2 drug clears Phase 3: Company sets 2026 filing plans
Takeda reported that zasocitinib, the TYK2 inhibitor it acquired in a $4 billion deal, met co‑primary and key secondary endpoints in two pivotal Phase 3 trials for plaque psoriasis. The company...
Lilly’s oral GLP‑1 orforglipron: maintenance trial meets endpoints
Eli Lilly reported positive top‑line results from the Phase 3 Attain‑Maintain trial showing its oral GLP‑1 receptor agonist orforglipron helped patients maintain weight after prior treatment with...
Liver‑targeted mRNA restores aged immunity in mice — potential translational path
Two independent reports from MIT researchers showed that delivering mRNAs encoding key trophic factors to hepatocytes transiently restored T cell numbers and function in aged mice, improving...
Personalis MRD ctDNA test predicts immunotherapy response across tumor types
A Phase I clinical study published in Clinical Cancer Research showed Personalis’ NeXT Personal minimal residual disease (MRD) whole‑genome sequencing assay predicted immunotherapy response across...
DBV’s Viaskin peanut patch wins pivotal Phase 3 — BLA planned
DBV Technologies reported positive top‑line results from its pivotal Phase 3 Vitesse trial of the Viaskin peanut patch in children aged 4–7. The study met its primary endpoint: 46.6% of treated...
Addition Therapeutics emerges with 'jumping gene' LNP platform and $106.5M raise
Addition Therapeutics unveiled its Precise RNA‑Mediated Insertion of Transgenes (PRINT) platform and raised $106.5 million to advance all‑RNA, lipid nanoparticle (LNP)‑based gene insertion...
AI tools for life sciences attract capital — Edison and Manifold score fresh funding
Two AI companies targeting scientific research secured significant financing: Edison Scientific raised a $70 million seed round to scale autonomous research software, and Manifold closed an $18...
Regulation tightens: FDA eases RWE rules while DOJ‑HHS widen False Claims scrutiny
Two regulatory shifts this week add both permissiveness and pressure across biopharma compliance. The FDA issued final guidance that relaxes restrictions on using de‑identified real‑world evidence...