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China clears first clinical long‑read sequencer: PacBio/Berry get NMPA nod
PacBio and partner Berry Genomics announced that the Sequel II CNDx system received Class III medical device registration from China’s NMPA—the first regulatory clearance for a clinical‑grade...
MIT particles boost mRNA potency — same response at 1/100th dose
Two complementary MIT papers reported design and screening of novel ionizable lipids and degradable LNP formulations that delivered influenza mRNA vaccines in mice at roughly 1/100th the dose...
Qiagen buys Parse Biosciences — single‑cell consolidation accelerates
Qiagen announced it will acquire Parse Biosciences for up to $280 million, folding a high‑throughput single‑cell library prep provider into a larger public company. Parse’s founders will remain,...
Swiss Rockets to commercialize CoolMPS—new Western NGS entrant readies platform
Swiss Rockets secured an exclusive global license (ex‑Asia‑Pacific) to MGI/Complete Genomics’ CoolMPS technology and announced plans to launch CoolMPS‑based sequencers next year. The Basel‑based...
Chronic kidney disease doubles since 1990 — nearly 800 million affected
Two large analyses published this week quantified a sharp rise in chronic kidney disease (CKD) burden: prevalence has more than doubled since 1990, with nearly 788 million adults showing...
CMS launches GENEROUS drug‑pricing model — states invited to opt in
The Centers for Medicare & Medicaid Services unveiled a voluntary five‑year pilot called GENEROUS that will negotiate outpatient Medicaid drug prices based on selected international benchmarks....
Sana suspends allogeneic CAR‑T programs — company trims cell therapy pipeline
Sana Biotechnology said it will suspend work on its allogeneic CAR‑T programs and trim its cell‑therapy pipeline, shifting resources amid broader challenges in allogeneic cell‑therapy development....
Patient dies after Intellia CRISPR dose: Phase 3 trials halted
Intellia Therapeutics reported the death of an elderly patient who was hospitalized with severe liver dysfunction after receiving nexiguran ziclumeran (nex-z) in a Phase III ATTR‑CM study. The...
Pfizer wins Metsera... $10 billion deal ends bidding war
Pfizer prevailed in a heated acquisition battle for obesity biotech Metsera, submitting a roughly $10 billion proposal that the startup accepted. The deal ended public disputes and litigation...
MIT LNP breakthrough: same immunity at 1/100th the dose
MIT researchers published a preclinical advance in Nature Nanotechnology showing a novel lipid nanoparticle (LNP) formulation that delivered an influenza mRNA vaccine at roughly 1/100th the dose...
SGLT2 inhibitors: kidney benefit spans GFR and albuminuria levels
A large analysis presented at Kidney Week and published in JAMA found that sodium‑glucose cotransporter‑2 (SGLT2) inhibitors provide kidney and heart protection across a broad range of glomerular...
Amgen’s Repatha reduces first‑time events: 25% fewer deaths and MIs
Amgen presented VESALIUS‑CV Phase 3 data showing its PCSK9 monoclonal antibody Repatha reduced major cardiovascular events by 25% when added to standard therapy in high‑risk patients without prior...
Swiss Rockets licenses CoolMPS — enters NGS hardware race
Swiss Rockets secured an exclusive license to MGI/Complete Genomics’ CoolMPS sequencing chemistry and plans to develop and commercialize CoolMPS‑based next‑generation sequencing (NGS) instruments...
Qiagen buys Parse Biosciences — single‑cell consolidation continues
Qiagen agreed to acquire Parse Biosciences for up to $280 million, signaling further consolidation in single‑cell sequencing technologies. Parse’s founders and leadership will remain in place, and...
PacBio‑Berry NMPA nod: China clears clinical long‑read sequencer
The National Medical Products Administration granted Class III medical device registration in China for Berry Genomics’ Sequel II CNDx system based on PacBio HiFi long‑read sequencing. PacBio said...
FDA expands national‑priority voucher pilot: six more drugs added
The FDA added six drugs to its Commissioner’s National Priority Voucher pilot, bringing the total number of therapies in the program to 15. The pilot is intended to accelerate reviews for...
Regulatory U‑turns create mixed messaging in rare‑disease approvals
A BioCentury analysis identified a pattern of recent reversals and shifting positions by the FDA that have generated uncertainty for developers of rare‑disease therapies. The report cites multiple...
Intellia CRISPR trial death — Phase 3 studies paused
An elderly patient treated with Intellia Therapeutics’ in vivo CRISPR therapy nexiguran ziclumeran (nex‑z) died after severe liver injury, triggering FDA clinical holds on the company’s Phase 3...
Pfizer tops Novo Nordisk in Metsera bidding war — $10 billion deal
Pfizer won the auction for obesity biotech Metsera with a $10 billion offer, outbidding Novo Nordisk and ending a high‑profile dispute that produced lawsuits and multiple revised bids. The deal...
Cholesterol care pivots: Merck’s oral PCSK9 matches injectables; Repatha prevents first events
Two major cardiovascular updates presented at late‑stage meetings signal changes in LDL management. Merck reported Phase 3 data showing its oral PCSK9 inhibitor reduced LDL by up to 60% and halved...