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CIRM launches $100M RAPID program to scale platform gene‑therapy approaches
The California Institute for Regenerative Medicine approved a $100 million, two‑year Rare Disease Acceleration Platform and Innovation and Delivery (RAPID) program to fund platform‑level...
Ultragenyx presents new UX‑111 data as BLA resubmission targets FDA review
Ultragenyx released additional long‑term clinical and biomarker data for UX‑111 (rebisufligene etisparvovec), its AAV9 gene therapy for Sanfilippo syndrome type A, reporting consistent and...
DeepMind rolls out AlphaGenome tools to decode noncoding DNA and RNA splicing
DeepMind released new AI models designed to interpret regulatory and splicing‑related DNA variation across the noncoding genome. The Alphagenome/AlphaGenome suite applies advanced embeddings and...
FDA signals cautious, tailored pathway for CAR‑T in autoimmune disease — calls for long follow‑up
FDA leaders signaled a willingness to support CAR‑T development for autoimmune disorders under a flexible regulatory framework while emphasizing patient safety and long‑term monitoring. The agency...
China’s AccurEdit raises $75M to scale CRISPR therapeutics
AccurEdit Therapeutics, a Suzhou‑based CRISPR gene‑editing startup, closed a $75 million financing to advance its pipeline of in‑vivo and ex‑vivo gene editing candidates. The Series A positions...
Medtronic to acquire Cathworks for up to $585M to expand coronary physiology offerings
Medtronic is exercising its option to acquire Cathworks for up to $585 million, incorporating the company’s angiography‑derived physiology and coronary assessment technology into Medtronic’s...
Pfizer ramps phase 3 plan – Monthly GLP‑1 to anchor obesity push
Pfizer disclosed clinical data and a broad development strategy for the ultra‑long‑acting GLP‑1 agent it acquired from Metsera. The company reported Phase 2 results showing meaningful...
WHO endorses long-term GLP‑1 care: obesity reclassified as chronic disease
The World Health Organization released its first guidelines on medical treatment for obesity, explicitly recommending long‑term use of GLP‑1 receptor agonists as part of chronic disease...
Congress raises NIH budget – FY2026 gets $48.7B, $415M boost
Congress approved the final FY2026 spending package that raises the National Institutes of Health budget by about $415 million to $48.7 billion. The increase reverses earlier proposals for steep...
Congress paves path for Medicare coverage: FDA‑approved MCEDs eligible under new spending bill
The recent federal spending bill includes a provision that allows Medicare to cover multi‑cancer early detection (MCED) tests following FDA approval, sidestepping the traditionally lengthy USPSTF...
PacBio sheds short‑read tech: sale funds long‑read push
Pacific Biosciences completed a strategic shift by selling short‑read sequencing IP and assets to Illumina and signaling an intensified focus on high‑throughput long‑read platforms. PacBio’s...
Natera’s MRD assays show prognostic power – company seeks expanded regulatory use
Natera published validation data showing its tissue‑free MRD methylation assay (Latitude) correlates with disease‑free survival in colorectal cancer, reporting high specificity and clinically...
CIRM launches $100M RAPID: platform approach to rare genetic therapies
The California Institute for Regenerative Medicine approved a $100 million RAPID initiative to accelerate platform‑based in vivo gene therapies for rare diseases. The program funds scalable...
Genentech pays $200M upfront in RNAi tie‑up with Sanegene – up to $1.7B total
Genentech (Roche) struck a global licensing deal with SanegeneBio for an RNAi program, paying $200 million upfront and up to $1.5 billion in milestones plus tiered royalties. Sanegene will...
FDA signals tailored CAR‑T oversight for autoimmune use – long‑term surveillance urged
FDA officials signaled support for a flexible, cautious regulatory approach to CAR‑T development for autoimmune diseases, urging long‑term follow‑up similar to genetic therapies used in oncology....
AI milestones: Insilico and studies show AI trimming drug discovery timelines
Insilico Medicine announced a $5 million milestone payment from Menarini after first‑in‑patient dosing of MEN2501, an oncology candidate discovered with generative AI methods under a license to...
Pfizer’s monthly GLP-1 shows real-world momentum — mixed market reaction
Pfizer reported Phase 2b data for the ultra‑long‑acting GLP‑1 therapy it acquired with Metsera, showing clinically meaningful weight loss with a once‑monthly maintenance regimen. The company...
Novo’s CagriSema upends semaglutide in diabetes trial — obesity implications loom
Novo Nordisk’s combination GLP‑1/amylin candidate CagriSema delivered superior glycemic and weight‑loss outcomes versus semaglutide in a Phase 3 diabetes study, the company reported. In a trial of...
Congress paves Medicare path for FDA‑cleared MCED tests: reimbursement starts 2029
Congress approved an appropriations bill that makes FDA‑approved multi‑cancer early detection (MCED) tests eligible for Medicare reimbursement, a major policy shift for early‑detection...
CIRM launches $100M RAPID program to scale rare‑disease genetic platforms
The California Institute for Regenerative Medicine (CIRM) approved a $100 million initiative—RAPID—to fund platform‑based in vivo genetic therapies for rare diseases, shifting from single‑asset...