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MGI and Geneseeq expand national genomics and CDx infrastructure
MGI Tech inked an MoU with South African agencies to launch a 110,000‑genome sequencing initiative aimed at creating the country’s first national genomic reference database. The program installs...
AI tools for single‑cell work: parts lists and chat‑based analysis arrive
Nature Biotechnology published two papers advancing computational tooling for single‑cell research: a comprehensive 'parts list' of promoters and gRNA scaffolds to improve mammalian prime editing...
FDA moves to strip boxed warnings from menopause HRTs
The FDA announced it will work with manufacturers to remove longstanding boxed warnings from hormone replacement therapies used for menopause, following review of evidence that earlier labels...
Pfizer wins Metsera bidding war: $10B deal sealed
Pfizer reached an amended agreement to acquire Metsera for about $10 billion after a week-long competitive auction with Novo Nordisk. The deal gives Pfizer access to Metsera’s obesity and...
Merck’s PCSK9 pill mimics injectables: 59% LDL reduction
Late-stage results presented at a major cardiology meeting show Merck’s oral PCSK9 inhibitor produced LDL‑C reductions on par with existing injectable PCSK9 antibodies. In the CORALreef program...
CRISPR’s mixed week: fatal trial event — gene edit halves lipids
The CRISPR field faced sharp contrasts this week: Intellia disclosed a death in its MAGNITUDE Phase III program and is awaiting FDA communication on the event, while CRISPR Therapeutics reported...
FDA taps Richard Pazdur as CDER director — leadership pivot
The FDA named veteran regulator Richard Pazdur director of the Center for Drug Evaluation and Research following George Tidmarsh’s abrupt resignation. Pazdur, a 26‑year agency veteran known for...
Lilly bulks up genetic meds: buys MeiraGTx eye therapy, inks $1.2B RNAi pact
Eli Lilly expanded its genetic‑medicine footprint with two strategic transactions: the company acquired global rights to MeiraGTx’s AAV‑AIPL1 retinal program and signed a $1.2 billion...
Iambic nets $100M-plus — AI drug discovery attracts big backers
Iambic Therapeutics closed an oversubscribed financing of over $100 million to accelerate its AI‑discovered therapeutic pipeline and platform development. The round drew strategic and...
Scaling genomics: MGI launches 110K South Africa program — Geneseeq wins China CDx nod
Two developments signal expanding genomic infrastructure globally. MGI Tech signed an MoU with South African agencies to launch the 110K Human Genome Program, installing a high‑throughput...
Engene posts pivotal bladder gene‑therapy data — BLA plan intact
Engene/EnGene reported additional preliminary pivotal‑cohort data for its nonviral gene therapy, detalimogene voraplasmid, in high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer with...
Cogent’s bezuclastinib halves progression risk — two NDAs coming
Cogent Biosciences’ bezuclastinib met primary endpoints in two late‑stage trials: the Peak study in imatinib‑resistant GIST showed a ~50% reduction in progression or death versus sunitinib, and...
Medicare covers Personalis MRD assay for breast‑cancer surveillance
The U.S. Centers for Medicare and Medicaid Services has granted coverage for Personalis’ NeXT Personal minimal residual disease (MRD) assay for recurrence monitoring in Medicare beneficiaries with...
Pfizer wins Metsera bidding war: $10 billion deal closes
Pfizer reached an amended agreement to acquire obesity drug developer Metsera for about $10 billion after a week-long auction that saw Novo Nordisk withdraw its competing offer. The deal gives...
Lilly doubles down on genetic and RNA bets — $1.2B Sanegene pact; retinal gene therapy buy
Eli Lilly expanded its genetic-medicine footprint with two high-value deals announced this week. Lilly agreed a potential $1.2 billion collaboration with Sanegene to access the company’s...
Merck’s oral PCSK9 pill posts near-injectable LDL cuts — market race intensifies
Merck reported pivotal data showing its oral PCSK9 inhibitor produced LDL-C reductions comparable to injectables, with trial reanalysis citing a 59.7% drop at week 24 in high-risk patients. The...
CRISPR programs face a split week: fatality at Intellia — cholesterol edits succeed
The CRISPR field recorded sharply divergent clinical outcomes this week: Intellia disclosed a patient death tied to acute liver injury in its MAGNITUDE Phase III trial and reported it is awaiting...
Neurocrine’s Takeda‑licensed depression candidate fails Phase II — company issues update
Neurocrine Biosciences announced that NBI‑1070770, an NR2B negative allosteric modulator licensed from Takeda, did not meet its primary endpoint in a Phase II major depressive disorder trial. The...
Cogent’s bezuclastinib clears pivotal hurdle — NDA timing accelerated
Cogent Biosciences reported Phase III success for bezuclastinib in imatinib‑resistant gastrointestinal stromal tumors, showing a 50% reduction in risk of progression or death versus sunitinib and...
FDA to ease HRT boxed warnings — labeling shift announced
Federal health officials announced a policy shift: the FDA is working with manufacturers to remove or narrow longstanding black‑box warnings on menopausal hormone replacement therapies. Agency...