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Servier buys Day One: $2.5B deal expands rare oncology portfolio
Servier agreed to acquire Day One Biopharmaceuticals for about $2.5 billion in cash, securing Ojemda (tovorafenib), an FDA‑approved therapy for pediatric low‑grade glioma, and Day One’s early‑ to...
Petrelintide falls short: amylin candidate underwhelms vs. Lilly
Roche and Zealand Pharma reported midstage results for petrelintide showing a mean placebo‑controlled weight loss of about 9% (10.7% absolute) at 42 weeks—below investor expectations and well...
FDA clears Perimeter’s Claire: AI imaging for breast‑conserving surgery
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑powered wide‑field optical coherence tomography device that provides surgeons with high‑resolution, real‑time imaging...
Modulating CAR‑T: ITK inhibition and ketone boost efficacy in preclinical work
Two independent preclinical approaches report improved CAR‑T performance: targeting ITK (interleukin‑2‑inducible T‑cell kinase) remodels T‑cell signaling to enhance anti‑CD19 CAR‑T activity, while...
CAR‑astrocytes clear amyloid: cellular immunotherapy for Alzheimer’s in mice
Researchers at Washington University engineered astrocytes to express chimeric antigen receptors (CAR‑As) that target amyloid‑β and reported dramatic effects in mouse models: a single prophylactic...
DnD assay unmasks hidden resistance: new high‑throughput antibiotic test
Scientists introduced the dilution‑and‑delay (DnD) susceptibility assay, a high‑resolution, high‑throughput method designed to detect low‑frequency or masked antibiotic resistance that escapes...
Microrobots shrink to medical scale: Penn builds solar‑powered devices
University of Pennsylvania researchers built sub‑millimeter robots equipped with sensors, a motor and an onboard computer, powered by tiny solar cells. The devices, described by Marc Miskin and...
Japan approves first iPSC therapy for Parkinson’s: regenerative milestone
Japan granted regulatory approval to the world’s first therapy derived from induced pluripotent stem cells (iPSCs) for Parkinson’s disease, marking a major regulatory milestone for regenerative...
FDA’s vaccines and biologics chief to leave in April — second exit
Vinay Prasad will depart his role overseeing vaccines and biologics at the U.S. Food and Drug Administration at the end of April, ending a tumultuous tenure marked by several high‑profile...
Servier pays $2.5B for Day One — gains pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for approximately $2.5 billion in cash, taking ownership of Day One’s marketed pediatric glioma therapy Ojemda (tovorafenib) and its broader...
FDA doubles down on sham‑control demand — uniQure dispute escalates
The FDA reiterated it will require a sham‑controlled randomized trial for uniQure’s AMT‑130 gene‑therapy program in Huntington’s disease, despite objections from the company about the ethics and...
FDA fast‑tracks Tecvayli–Darzalex combo: national‑priority clearance
The FDA granted rapid approval to Johnson & Johnson’s Tecvayli in combination with Darzalex Faspro for previously treated multiple myeloma under the agency’s Commissioner’s National Priority...
Perimeter’s Claire imaging device wins FDA premarket approval — intraoperative AI
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, its AI‑assisted wide‑field optical coherence tomography device designed to image surgical margins during breast‑conserving...
CAR‑astrocytes remove amyloid in mice — single‑dose proof of concept
Researchers at Washington University reported in Science that astrocytes engineered to express chimeric antigen receptors (CAR‑As) can target and clear amyloid‑β deposits in mouse models of...
Kestrel’s pan‑KRAS oral inhibitor cleared for IND — FIH trial to start
Kestrel Therapeutics received FDA investigational new drug clearance for KST‑6051, an oral pan‑KRAS inhibitor aimed at KRAS‑driven cancers, enabling a first‑in‑human phase I (FALCON) trial slated...
Study maps HIV‑1 lenacapavir resistance pathways — surveillance implications
A Nature Communications study traced recurrent and unique evolutionary routes by which HIV‑1 develops resistance to lenacapavir, a long‑acting capsid inhibitor. The research identified specific...
Japan clears first iPSC‑derived therapy for Parkinson’s — regulatory milestone
Japanese regulators approved the first therapy derived from induced pluripotent stem cells (iPSCs) for Parkinson’s disease, marking the world’s first authorization of an iPSC‑based clinical...
Scalable sample hashing boosts single‑cell multiomics for clinical samples
A new workflow introduces low‑cost, scalable sample hashing compatible with single‑cell multiomic platforms, enabling high‑throughput multiplexing of limited clinical specimens. The method builds...
FDA’s Vinay Prasad to depart in April — Replacement unclear
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will leave the agency at the end of April, the agency confirmed. Prasad’s tenure was marked by a string of...
Servier buys Day One for $2.5B — Gains pediatric glioma franchise
France’s Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, giving Servier ownership of Ojemda (tovorafenib), an FDA‑approved therapy for pediatric low‑grade...