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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...
CRISPR editing shows dramatic lipid drops in small human study
An early human study of a CRISPR‑based therapy from CRISPR Therapeutics produced pronounced reductions in LDL cholesterol and triglycerides in a small cohort, raising the prospect of durable,...
Long‑read sequencing cleared in China; CoolMPS license fuels global NGS push
PacBio and Berry Genomics reported that Berry’s Sequel II CNDx system—built on PacBio HiFi long‑read technology—received Class III medical device approval from China’s NMPA, marking the first...
CMS launches GENEROUS Medicaid pricing pilot — International benchmarks drive rebates
The Centers for Medicare & Medicaid Services unveiled the Generating Cost Reductions for U.S. Medicaid (GENEROUS) model, a five‑year voluntary pilot that will negotiate outpatient drug prices for...
FDA expands national priority review vouchers — Six more drugs added
The FDA added six therapies to its Commissioner’s National Priority Voucher pilot, expanding the pool of drugs eligible for accelerated review under a program tied to national priorities. The new...
Single‑cell market consolidates: Qiagen buys Parse; 10x posts mixed quarter
Qiagen agreed to acquire Parse Biosciences for up to $280 million, folding a high‑throughput single‑cell player into a larger public diagnostics firm. Parse’s founders will remain, the companies...
mRNA tech leap: new LNP and RNA elements could slash doses and costs
Two independent advances target core limitations of mRNA therapeutics: an MIT team designed degradable cyclic amino ionizable lipids that, in mice, delivered an influenza mRNA vaccine at roughly...
Kidney care updates: SGLT2s show benefits across subgroups; Takeda antibody sustains function
Large analyses and midstage data presented at nephrology meetings reinforced momentum in kidney therapeutics. A comprehensive study supports routine SGLT2 inhibitor use across a range of...
Intellia patient dies — Phase III CRISPR trials put on hold
An elderly patient dosed with Intellia and Regeneron’s in‑vivo CRISPR candidate nexiguran ziclumeran (nex‑z) died after developing severe liver dysfunction, prompting sponsors and the FDA to pause...
Amgen’s Repatha: 25% fewer first‑time cardiovascular events
Amgen reported top‑line results from the VESALIUS‑CV trial showing its PCSK9 inhibitor Repatha reduced first‑time major cardiovascular events by about 25% when added to standard therapy in...
PacBio HiFi wins clinical clearance in China — first long‑read sequencer cleared
China’s National Medical Products Administration granted Class III medical device approval to Berry Genomics’ Sequel II CNDx workflow built on PacBio HiFi sequencing, marking the first regulatory...
Pfizer outbids Novo — $10 billion Metsera takeover complete
Pfizer prevailed in a high‑stakes auction to acquire Metsera, the obesity‑drug developer, with a bid valued at up to $10 billion. The deal ends a public bidding tussle with Novo Nordisk and gives...
FDA expands Commissioner’s National Priority Vouchers — six more drugs added
The FDA announced six additional medicines will receive Commissioner’s National Priority Vouchers (CNPVs), expanding a pilot intended to shorten review timelines for therapies aligned with U.S....
Qiagen buys Parse Biosciences — single‑cell market consolidates
Qiagen agreed to acquire Seattle‑based Parse Biosciences for up to $280 million, folding a high‑throughput single‑cell library‑prep platform into a larger portfolio. Parse’s founders and key...
Swiss Rockets licenses CoolMPS — eyes global NGS platform launch
Swiss Rockets secured an exclusive global license (excluding Asia‑Pacific for now) to CoolMPS chemistry from MGI Tech and Complete Genomics, aiming to develop and commercialize CoolMPS‑based...