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MIT LNP breakthrough: 100‑fold dose cut for influenza mRNA in mice
MIT researchers described a degradable cyclic amino ionizable lipid nanoparticle (LNP) that delivered an influenza mRNA vaccine in mice at roughly 1/100th the dose required by current FDA‑approved...
FDA expands fast‑track pilot: six more drugs gain national‑interest vouchers
The FDA added six additional therapies to its Commissioner’s National Priority Vouchers pilot, bringing the program total to 15 drugs selected for accelerated review under a national‑interest...
Thermo Fisher board OKs $5B buyback – capital returns after solid Q3
Thermo Fisher Scientific’s board authorized a $5 billion open‑market share repurchase with no expiration date, expanding a prior buyback and signaling confidence after reporting $11.12 billion in...
Intellia CRISPR trial death... dosing paused and FDA hits clinical hold
Intellia disclosed the death of an elderly participant in its Phase III MAGNITUDE program for nexiguran ziclumeran (nex‑z) and subsequently paused dosing and screening across two trials. The...
Pfizer wins Metsera: $10 billion takeover ends bidding war
Pfizer agreed to buy obesity‑drug developer Metsera for roughly $10 billion after upping its offer and outmaneuvering Novo Nordisk in a high‑profile bidding contest. The deal resolves a public...
Merck’s oral PCSK9 pill delivers injectable‑level LDL cuts – Phase 3 readout
Merck’s oral PCSK9 inhibitor, enlicitide, produced LDL cholesterol reductions up to 60% in a Phase 3 trial testing the pill on patients already taking statins, the company reported. The...
Early CRISPR editing shows deep lipid drops... but safety questions linger
Early clinical data from a CRISPR‑based in‑vivo therapy reduced LDL cholesterol and triglycerides dramatically in a small cohort, according to a preliminary report presented at a major cardiology...
SGLT2s broaden kidney care: benefits hold across GFR and albuminuria
A large analysis presented at Kidney Week and published in JAMA found sodium‑glucose cotransporter‑2 (SGLT2) inhibitors improve kidney outcomes across a wide range of glomerular filtration rates...
China clears PacBio long‑read sequencer for clinical use – first global regulatory win
PacBio announced that Berry Genomics obtained National Medical Products Administration (NMPA) Class III approval in China for the Sequel II CNDx system, marking the first regulatory clearance of a...
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 vendor into a larger molecular diagnostics and sample‑prep infrastructure....
Swiss Rockets licenses CoolMPS... aims to be western NGS instrument maker
Swiss Rockets secured an exclusive license from MGI Tech and Complete Genomics for CoolMPS sequencing chemistry outside Asia‑Pacific, positioning the Basel‑based incubator to enter next‑generation...
CMS launches Medicaid drug pricing model – voluntary international‑reference approach
The Centers for Medicare & Medicaid Services unveiled the GENEROUS payment model to lower outpatient drug spending in Medicaid by negotiating prices linked to selected international benchmarks....
Hi‑C lymphoma assay shows FISH‑replacement potential in clinical labs
Arima Genomics reported early clinical results for its Aventa Hi‑C lymphoma sequencing assay that identified clinically significant gene fusions and rearrangements in FFPE lymphoma samples where...
Patient dies in Intellia CRISPR study — Phase III programs paused
A patient treated with Intellia Therapeutics’ in vivo CRISPR base‑editing therapy nexiguran ziclumeran (nex‑z) for transthyretin amyloidosis with cardiomyopathy (ATTR‑CM) has died after...
Pfizer outbids Novo — $10 billion Metsera takeover sealed
Pfizer won a heated bidding war for obesity‑drug developer Metsera, raising its offer to about $10 billion and outmaneuvering Novo Nordisk. The transaction resolves an aggressive acquisition...
Merck’s oral PCSK9 pill matches injectables: Phase 3 shows deep LDL cuts
Merck presented Phase 3 data showing its once‑daily oral PCSK9 inhibitor produced LDL cholesterol reductions up to 60% in patients already on statins, matching reductions historically seen with...
CRISPR edit cuts LDL and triglycerides in early human study — safety questions remain
A small early‑phase study of a CRISPR‑based gene editing therapy significantly reduced LDL cholesterol and triglycerides in patients with heart disease, according to published data and AHA...
China clears PacBio long‑read sequencer — clinical HiFi sequencing approved
China’s National Medical Products Administration granted Class III medical‑device registration for Berry Genomics’ Sequel II CNDx system using PacBio HiFi long‑read sequencing, marking the first...
Swiss Rockets licenses CoolMPS — western push for MGI tech
Swiss Rockets secured an exclusive license to MGI/Complete Genomics’ CoolMPS sequencing chemistry for regions outside Asia‑Pacific and plans to launch CoolMPS‑based next‑generation sequencers as...
Qiagen to buy Parse Biosciences — single‑cell consolidation deepens
Qiagen agreed to acquire Parse Biosciences for up to $280 million, folding a high‑throughput single‑cell library‑prep platform into a larger corporate portfolio. Parse cofounders and key personnel...