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China clears PacBio long‑read sequencer — Illumina export ban lifted
Pacific Biosciences said China’s National Medical Products Administration approved Berry Genomics’ Sequel II CNDx system — the world’s first regulatory clearance for a clinical‑grade long‑read...
SGLT2 inhibitors show kidney benefit across GFR and albuminuria
Large new analyses presented at recent nephrology forums and published in JAMA report that sodium‑glucose cotransporter‑2 (SGLT2) inhibitors provide kidney protection across a broad spectrum of...
MIT LNP cuts mRNA vaccine dose by 100x — new ionizable lipid
Researchers at MIT reported a next‑generation lipid nanoparticle (LNP) formulation that delivered an influenza mRNA vaccine at roughly 1/100th the dose required by current FDA‑approved LNP...
Qiagen buys Parse Biosciences — single‑cell tools consolidate
Qiagen agreed to acquire Seattle‑based Parse Biosciences for up to $280 million, folding a high‑throughput single‑cell library and automation platform into a larger public company. Parse...
Lilly’s amylin eloralintide posts strong weight‑loss; Phase 3 planned
Eli Lilly reported Phase 2 results showing its amylin receptor agonist eloralintide produced substantial weight loss, with some arms showing mean reductions comparable to leading GLP‑1 therapy and...
FDA clears DARZALEX Faspro for high‑risk smoldering myeloma
Johnson & Johnson’s DARZALEX Faspro received FDA approval for treatment of adult patients with high‑risk smoldering multiple myeloma, offering the first approved therapy for this earlier disease...
Biohub merges AI and biology — EvolutionaryScale team joins new initiative
Mark Zuckerberg and Priscilla Chan announced a new Biohub initiative that integrates EvolutionaryScale’s AI team and aligns frontier compute with experimental biology to accelerate disease...
Intellia CRISPR trial: patient death prompts FDA clinical hold
Intellia reported that an elderly patient dosed with its in‑vivo CRISPR candidate nexiguran ziclumeran (nex‑z) died after hospitalization for severe liver injury, and the FDA placed a clinical...
FDA expands priority voucher list: six more therapies win fast-track
The FDA added six additional drugs to its Commissioner’s National Priority Voucher (CNPV) pilot, expanding a program designed to accelerate review timelines for therapies deemed in the national...
Metsera takeover fight: Pfizer tops Novo with $10 billion offer
Pfizer upped its offer and moved to acquire obesity biotech Metsera, outbidding Novo Nordisk in a high‑stakes auction that valued the startup at close to $10 billion, according to company...
MIT particles slash mRNA dose: 100‑fold potency gain reported
MIT researchers published preclinical results showing a new class of degradable cyclic amino ionizable lipids and particle formulations that delivered influenza mRNA at roughly 1/100th the dose of...
PacBio Sequel II CNDx cleared: China approves first clinical long‑read sequencer
PacBio and clinical partner Berry Genomics received Class III medical device registration from China’s National Medical Products Administration (NMPA) for the Sequel II CNDx system, marking the...
Swiss Rockets scores CoolMPS license — eyes NGS instrument market
Swiss Rockets secured an exclusive license from MGI Tech and Complete Genomics for CoolMPS sequencing chemistry outside the Asia‑Pacific region, positioning the Basel‑based incubator to develop...
Qiagen buys Parse Biosciences — single‑cell consolidation accelerates
Qiagen agreed to acquire Parse Biosciences for up to $280 million, folding a high‑throughput single‑cell library prep and automation provider into a larger public company. Parse’s founders and...
SGLT2 benefit broad but nuanced: kidney protection spans subgroups
Large analyses presented at major nephrology meetings and published in JAMA reinforce that SGLT2 inhibitors provide kidney protection across a wide spectrum of patients, including people with and...
Eledon plots phase III despite Bestow miss — transplant candidate under review
Eledon Pharmaceuticals reported Phase 2 Bestow results for tegoprubart (tego), a CD40‑ligand targeting therapy for preventing rejection in de novo kidney transplant patients, and the study failed...
Biohub snaps up EvolutionaryScale: Zuckerberg backs frontier AI for biology
The Chan‑Zuckerberg Biohub absorbed EvolutionaryScale’s team and assets to create an integrated AI‑biology initiative that centralizes frontier compute, experimental platforms, and data...
Patient dies after Intellia CRISPR dose — Phase 3 trials paused
An elderly patient dosed with Intellia Therapeutics’ in vivo CRISPR candidate nexiguran ziclumeran (nex‑z) died after developing severe liver dysfunction, prompting the biotech to pause dosing and...
CMS launches ‘GENEROUS’ Medicaid drug-price pilot — manufacturers invited
The Centers for Medicare & Medicaid Services announced a five‑year voluntary drug payment model for state Medicaid programs that aims to tie Medicaid outpatient drug prices to selected...
FDA awards second round of priority vouchers — obesity drugs among winners
The U.S. Food and Drug Administration disclosed a second wave of Commissioner’s National Priority Vouchers (CNPVs), accelerating review for selected drug candidates aligned with administration...