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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...
NGS and cancer diagnostics: Sophia Genetics partnerships and Medicare MRD coverage expand access
Sophia Genetics announced partnerships with Complete Genomics and Element Biosciences to integrate its AI analytics into their sequencing platforms for cancer profiling and rare disease workflows,...
AI biotech Iambic raises $100M+ — investors pile into AI‑discovered therapeutics
Iambic announced an oversubscribed financing topping $100 million to advance its AI‑discovered drug pipeline and platform technologies. The round drew strategic and financial investors, including...
Roche’s BTK inhibitor posts two Phase III wins — multiple sclerosis filings loom
Roche reported two Phase III victories for its BTK inhibitor in different multiple sclerosis populations, with the drug meeting primary endpoints and showing efficacy across relapsing and primary...
Pfizer Wins Metsera: $10 Billion Deal Closes the Bidding War
Pfizer agreed to acquire obesity biotech Metsera in a deal valued at up to $10 billion, outbidding Novo Nordisk and securing the company’s next-generation obesity and metabolic pipeline. The...
FDA Strips HRT Black Box: Warning Labels Narrowed
The U.S. Food and Drug Administration announced it will remove or narrow boxed warnings on hormone replacement therapy (HRT) products for menopause after concluding earlier label risks were...
Merck’s Oral PCSK9 Pill Posts Pivotal Wins — Oral Rival to Injectables
Merck reported positive pivotal data for its oral PCSK9 inhibitor, enlicitide, showing LDL‑C reductions similar to injectable PCSK9 blockers in two phase 3 trials presented at AHA 2025. In...