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Servier boosts rare-cancer push: $2.5B Day One buyout
Servier agreed to acquire Day One Biopharmaceuticals for about $2.5 billion, adding the FDA‑approved pediatric glioma drug Ojemda and an early-to-late stage oncology pipeline to its portfolio. The...
Vinay Prasad to depart FDA again — exit set for end of April
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will leave the agency at the end of April after a turbulent tenure marked by high‑profile rejections and reversals...
FDA doubles down: uniQure must run sham‑controlled Huntington’s trial
The FDA reaffirmed its requirement that uniQure perform a sham‑controlled randomized trial before accepting a Biologics License Application for AMT‑130, the company’s gene therapy for Huntington’s...
Petrelintide misses lofty bar—Roche/Zealand readout disappoints investors
Roche and Zealand Pharma reported Phase 2 data for petrelintide showing roughly 10.7% mean placebo‑controlled weight loss at 42 weeks, falling short of investor expectations and triggering a sharp...
High‑throughput DnD assay: new tool to unmask hidden antibiotic resistance
Researchers published a scalable dilution‑and‑delay (DnD) susceptibility assay that resolves low‑frequency and inducible antibiotic resistance phenotypes missed by standard tests. The Nature...
New study maps lenacapavir resistance — HIV finds recurrent and unique escape routes
A Nature Communications paper by Orris, Siddiqui, Tang and colleagues delineates evolutionary pathways HIV‑1 uses to escape lenacapavir, an extended‑release capsid inhibitor. The team identified...
CAR‑astrocytes prevent and reduce amyloid plaques in mice — single injection effect
A team at Washington University engineered astrocytes expressing chimeric antigen receptors (CAR‑As) that target amyloid‑β and demonstrated prevention and partial reversal of plaque pathology in...
FDA clears Claire: Perimeter wins approval for intraoperative AI margin imaging
Perimeter Medical Imaging AI received FDA premarket approval for Claire, an AI‑driven wide‑field optical coherence tomography system designed to image excised breast tissue margins during surgery....
Japan approves first iPSC‑derived therapy for Parkinson’s — regulatory milestone
Japanese regulators approved the first therapy derived from induced pluripotent stem cells (iPSCs) to treat Parkinson’s disease, marking a world first for iPSC‑based regenerative medicine. The...
Penn unveils microscopic robot — sub‑millimeter machines pack sensors and solar power
Researchers at the University of Pennsylvania described a microscopic robot under one millimeter long that integrates sensors, an onboard computer, a motor and tiny solar cells to convert light...
Prasad to leave FDA: departure caps tumultuous term
Vinay Prasad will depart the Food and Drug Administration at the end of April, concluding a turbulent tenure that saw heightened scrutiny of vaccine and rare-disease reviews. Reports from AP and...
FDA stands by sham-control demand: uniQure fight intensifies
The FDA defended its decision to require a sham-controlled trial for uniQure’s AMT-130 gene therapy for Huntington’s disease, telling reporters that the agency asked the company to randomize...
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...