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Congress paves path for Medicare coverage of FDA‑approved MCEDs
The federal appropriations bill approved by Congress and heading to the President includes a provision that would allow Medicare to reimburse FDA‑approved multi‑cancer early detection (MCED)...
PacBio exits short‑read tech to Illumina — long‑read push intensifies
Pacific Biosciences announced the sale of select short‑read sequencing intellectual property and assets to Illumina for roughly $48.1 million and said it will use proceeds to accelerate...
FDA launches PreCheck pilot to speed U.S. plant builds
The U.S. Food and Drug Administration opened submissions for its PreCheck pilot program, inviting drugmakers to apply for a streamlined review pathway aimed at accelerating domestic...
CIRM puts $100M behind platform gene‑therapy acceleration for rare diseases
The California Institute for Regenerative Medicine approved a $100 million RAPID initiative to fund platform‑based approaches for in‑vivo genetic therapies targeting rare diseases. The program...
Natera’s MRD portfolio advances — Latitude prognostic, Signatera seeks PMA
Natera published validation data showing its tissue‑free Latitude methylation MRD assay prognosticates disease‑free survival in colorectal cancer and reported high longitudinal sensitivity for...
FDA seeks withdrawal of Amgen’s Tavneos — company resists
The U.S. Food and Drug Administration requested Amgen withdraw Tavneos from the market following ongoing safety and efficacy questions, while Amgen publicly said it will not comply with the...
Pfizer’s monthly GLP‑1 meets efficacy target – $4.4B charge tempers gains
Pfizer reported positive phase 2b data for the once‑monthly GLP‑1 acquired from Metsera, showing statistically significant placebo‑adjusted weight loss at 28 weeks and supporting a broad Phase 3...
Congress preserves NIH funding: FY2026 rises to $48.7B
Congress passed the 2026 Consolidated Appropriations Act, increasing NIH funding by just under 1 percent to $48.7 billion for fiscal year 2026. The final bill reversed a proposed 40 percent cut...
Congress clears Medicare path for FDA‑approved MCED tests – reimbursement set for 2029
The federal appropriations bill includes a provision allowing Medicare coverage for multi‑cancer early detection (MCED) tests that have received FDA approval, bypassing the usual USPSTF...
PacBio exits short reads – Illumina picks up assets as PacBio doubles down on long reads
Pacific Biosciences sold select short‑read sequencing intellectual property and related assets to Illumina for approximately $48.1 million, a move PacBio said would sharpen its focus on...
CIRM commits $100M to platform gene‑therapy model – RAPID funds scalable rare‑disease approaches
The California Institute for Regenerative Medicine (CIRM) approved a $100 million Rare Disease Acceleration Platform and Innovation and Delivery (RAPID) program to fund platform approaches that...
Ultragenyx rolls out UX‑111 data – resubmission targets Sanfilippo type A approval
Ultragenyx disclosed new long‑term clinical data for UX‑111 (rebisufligene etisparvovec), an AAV9 gene therapy for Sanfilippo syndrome type A, showing durable biomarker improvements and meaningful...
Natera MRD assays validated in colorectal study — Signatera heads to FDA for bladder CDx
A validation study published using Natera’s methylation‑based Latitude assay showed that postsurgical ctDNA positivity strongly predicted recurrence in colorectal cancer, with a hazard ratio of...
Medtronic to acquire CathWorks for up to $585M – expands coronary physiology offerings
Medtronic announced plans to exercise its option to acquire CathWorks for up to $585 million, bringing the startup’s angiography‑derived coronary physiology platform into Medtronic’s portfolio....
Wistar reports single‑shot HIV vaccine neutralization in nonhuman primates
Researchers at The Wistar Institute published nonhuman primate data showing a vaccine candidate elicited neutralizing antibodies after a single immunization. The work, appearing in Nature...
AccurEdit raises $75M to push CRISPR therapies toward clinic
Suzhou‑based AccurEdit Therapeutics closed a $75 million Series A to advance a pipeline of CRISPR‑based in vivo and ex vivo gene‑editing candidates. The round ranks among the larger early‑stage...
Pfizer’s monthly GLP‑1 posts meaningful Phase 2b weight loss — $4.4B charge follows
Pfizer reported Phase 2b data for the once‑monthly GLP‑1 acquired in its $10 billion Metsera deal, showing clinically meaningful weight loss in obesity patients and supporting a broad Phase 3 plan...
Congress raises NIH funding in final spending bill — small uptick, big signal
Congress approved the 2026 consolidated appropriations act, lifting NIH funding by just under 1% to $48.7 billion for FY2026 and averting steep cuts proposed earlier. Lawmakers restored much of...
Natera MRD and Signatera move toward clinical utility and regulatory clearance
A study validating Natera’s methylation‑based Latitude tissue‑free MRD assay found postsurgical ctDNA positivity linked to markedly worse disease‑free survival and a median lead time of roughly...
Illumina to sequence Frozen Zoo; PacBio exits short‑read tech to refocus long reads
Illumina struck a partnership with the San Diego Zoo Wildlife Alliance to sequence up to 4,000 samples from the Frozen Zoo biobank, generating whole‑genome and multi‑omic data to accelerate...