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Regulatory approvals: oral PCSK9 inhibitor breaks into the pill market
The FDA has approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra), the first member of the class available as a pill in the U.S. The approval targets adults with hypercholesterolemia,...
M&A: Lilly takes control of psychedelics-focused AtaiBeckley
Eli Lilly agreed to acquire AtaiBeckley for $2.8 billion upfront, with potential total value rising to about $3.8 billion tied to development and regulatory milestones. The deal gives Lilly a...
Biotech financing: Chai jumps with a $400M Series C to scale AI drug discovery
Chai Discovery raised $400 million in Series C financing, pushing the company’s valuation to $3.8 billion and accelerating deployment of its AI platform for de novo molecular design. The San...
Immuno-oncology prevention: mKRAS-VAX shows durable T-cell response in phase 1
A first-in-human Phase 1 study of a mutant KRAS peptide vaccine (mKRAS-VAX) reported safety and durable immune activity in high-risk pancreatic cancer cohorts. Investigators enrolled 20...
Cell & gene therapy research: gene therapy restores fragile X deficits in mouse model
Researchers at Cincinnati Children’s Hospital Medical Center reported that an AAV-based gene therapy delivering human FMRP to a fragile X mouse model reversed multiple clinically relevant...
Oncology platform innovation: modular in vivo antibody–ADC click defeats resistance in mice
A WashU Medicine team reported a modular “click-to-assemble” strategy to improve antibody–drug conjugate performance in heterogeneous tumors, using engineered antibodies and sequential dosing to...
Oncology biology: ZBP1 review links genomic stress to innate tumor immunity
A new open-access review in Ferroptosis and Oxidative Stress argues that ZBP1 can function as an innate immune sensor linking genomic damage to antitumor immune activation. The authors propose...
Venture/financing: AdvanCell raises $315M to expand radiopharma capacity and drive late-stage testing
AdvanCell closed a $315 million Series D to advance its lead radiopharmaceutical into late-stage development while expanding U.S. manufacturing capability. The financing is described as a response...
Regulatory/oversight: CMS proposes restricting payment for third-party remote patient monitoring
The Centers for Medicare & Medicaid Services signaled it may restrict Medicare payment for remote patient monitoring (RPM) services when delivered by third-party vendors under its proposed 2027...
Diagnostics infrastructure: NIH expands All of Us into multiomics at ~750,000 people
The NIH’s All of Us Research Program expanded its database into multiomics, adding RNA sequencing and proteomics data for nearly 750,000 participants. The expansion broadens the precision-health...
Regulatory approvals
The FDA approved Merck’s oral PCSK9 inhibitor Lipfendra (enlicitide) to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The approval makes...
Big pharma dealmaking
Eli Lilly agreed to acquire AtaiBeckley, paying $2.8 billion upfront and up to $3.8 billion including milestone-based contingent value rights. The deal gives Lilly an entry point into...
Oncology immunoprevention and vaccines (KRAS/PDAC)
Early clinical data are emerging for mutant KRAS (mKRAS)-targeted peptide vaccination designed to intercept pancreatic ductal adenocarcinoma (PDAC) in high-risk cohorts. In a Phase I...
M&A: radiopharma growth via assets and financing
Dimerix acquired Mission Therapeutics’ stalled, Phase 2-ready kidney disease candidate in a $292 million transaction structured with a $5 million upfront payment and up to $287 million in...
Cell therapy platform operations (infrastructure and data)
Autolomous and Cellular Origins announced end-to-end integration of their cell therapy manufacturing platforms, aiming to deliver a fully automated and digitized workflow. The combined approach is...
Diagnostics and clinical operations: reimbursement and labs
CareDx said its stock rose after receiving a finalized Medicare Local Coverage Determination (LCD) that expands reimbursable surveillance testing for heart, lung, and kidney transplant patients....
Women’s health genomics and testing scale-up
Juno Bio raised $3.8 million and opened a CLIA-certified sequencing lab in Oakland to expand clinical testing for its vaginal microbiome assay. The company says the test analyzes roughly 10,000...
Investment and funding: radiopharma, venture selectivity, IPO queue
Biotech funding remained active in the first half of 2026 with capital concentrated in a smaller number of very large rounds, even as deal counts stayed lean. The data point to median round sizes...
AI in drug discovery and genome editing tooling
Researchers reported an AI-guided framework to design functional CRISPR-like, RNA-guided nucleases that can match or outperform natural variants in cell-based testing. Published in Science, the...
Payer and policy pressure on medical reimbursement systems
Germany’s lawmakers approved an act that will increase rebates on sales of patented drugs, with the rebate rate rising from 7% to 15.5%. The policy also sets a 9% rebate on patented vaccines and...