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Servier buys Day One for $2.5B — pediatric glioma drug in hand
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 access to Day One’s...
FDA’s Vinay Prasad to leave in April — tenure marked by controversy
Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), will depart the agency at the end of April after a turbulent tenure that included stricter review stances on...
FDA doubles down on sham control for uniQure Huntington’s trial — agency rebuffs company
A senior FDA official defended the agency’s decision to require a randomized sham‑controlled trial for uniQure’s AMT‑130 gene therapy for Huntington’s disease, saying reviewers stand by the need...
FDA speeds Tecvayli‑Darzalex approval via priority pilot — myeloma label widened
The U.S. FDA granted rapid approval to Johnson & Johnson’s combo of Tecvayli and Darzalex Faspro for early relapsed or refractory multiple myeloma under the Commissioner’s National Priority...
Zealand’s amylin candidate falls short — ambivalent Phase II readout dents hopes
Zealand Pharma and partner Roche reported Phase II results for petrelintide showing mean weight loss of about 10.7% at 42 weeks versus 1.7% for placebo — a tolerable safety profile but efficacy...
Lilly targets employers to expand GLP‑1 access — insurers bypassed
Eli Lilly unveiled employer‑focused programs designed to broaden access to its GLP‑1 obesity medicines by offering alternative payment channels and subsidies for workforce insurance plans. The...
Japan approves first iPSC‑derived therapy for Parkinson’s — regenerative milestone
Japan’s regulators approved the world’s first therapy derived from induced pluripotent stem cells (iPSCs) to treat Parkinson’s disease, marking a regulatory milestone for regenerative medicine....
Cell therapies for neurodegeneration advance — CAR astrocytes and boosted brain phagocytes
Two preclinical advances illustrated novel cell‑based strategies against neurodegeneration. Researchers engineered astrocytes to express chimeric antigen receptors (CARs) that target and clear...
FDA policy friction grows — industry seeks clarity on single‑trial rule and advisory panels
Contract research organization group ACRO urged the FDA to issue formal guidance and open notice‑and‑comment rulemaking before expanding a new default that a single adequate trial plus...
Genomics meets proteomics and AI imaging clears margins — diagnostics scale up
Illumina announced plans to add 50,000 genomes with paired proteomic data to its Alliance for Genomic Discovery (AGD), expanding multi‑omic datasets available to pharma members and aiming to...
FDA turmoil: Vinay Prasad set to leave CBER in April
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will depart the agency at the end of April, officials confirmed. Prasad’s tenure was marked by a string of...
Servier buys Day One for $2.5B – gains pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, a deal that transfers marketed pediatric glioma drug Ojemda (tovorafenib) and Day One’s development programs...
FDA doubles down: agency demands sham‑controlled trial for uniQure’s Huntington’s gene therapy
The FDA reaffirmed its reviewers’ decision requiring a randomized, sham‑controlled study for uniQure’s AMT‑130 Huntington’s gene therapy, rejecting the company’s objections that such a trial would...
Amylin setback: Roche‑Zealand obesity drug falls short of expectations
Mid‑stage data for petrelintide, an amylin analogue developed by Zealand Pharma with Roche, produced a mean placebo‑controlled weight loss of about 9.0% (10.7% absolute at 42 weeks), below...
FDA speeds Tecvayli‑Darzalex approval: rare fast‑track nod for myeloma combo
The FDA granted rapid clearance to Johnson & Johnson’s Tecvayli (pirtobrutinib) combined with Darzalex Faspro (daratumumab) for relapsed or refractory multiple myeloma under a priority‑review...
Kestrel lands IND for oral pan‑KRAS candidate – first‑in‑human study planned
Kestrel Therapeutics received IND clearance from the FDA for KST‑6051, an oral small‑molecule pan‑KRAS inhibitor targeting KRAS‑driven cancers, clearing the way for a first‑in‑human Phase I FALCON...
Tenaya and Alnylam strike $1B+ deal to mine genetic heart‑disease targets
Tenaya Therapeutics and Alnylam Pharmaceuticals entered a research collaboration in which Tenaya will deliver up to 15 novel genetic targets for cardiovascular disease discovery. The agreement...
FDA places partial hold on PepGen’s DM1 mid‑stage trial over preclinical signal
The FDA issued a partial clinical hold on PepGen’s Freedom2‑DM1 Phase II multiple‑ascending‑dose trial in myotonic dystrophy type 1 (DM1), citing concerns in previously submitted preclinical...
Illumina expands Alliance for Genomic Discovery with proteomics add‑on
Illumina announced it will add 50,000 genomes with paired proteomic data to the Alliance for Genomic Discovery (AGD), expanding the consortium’s multi‑omics resource for drug discovery. DeCode...
Perimeter’s Claire wins FDA PMA: AI imaging cleared for breast‑conserving surgery
Perimeter Medical Imaging AI secured FDA premarket approval for Claire, an AI‑enabled wide‑field optical coherence tomography device that provides real‑time imaging of tumor margins during...