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CIRM bets $100M on platform gene therapy — RAPID program launches
The California Institute for Regenerative Medicine approved a new $100 million program aimed at accelerating platform-based in vivo genetic therapies for rare diseases. The Rare Disease...
Ultragenyx publishes UX‑111 data as FDA resubmission advances
Ultragenyx released long‑term clinical data for UX‑111 (rebisufligene etisparvovec), its AAV9 gene therapy for Sanfilippo syndrome type A, pairing biomarker improvements with measurable functional...
AccurEdit raises $75M to advance CRISPR pipeline from China
AccurEdit Therapeutics closed a $75 million Series A to develop its CRISPR-based medicine portfolio from Suzhou, one of the largest early rounds for a Chinese gene‑editing startup. The financing...
Congress restores NIH funding: FY2026 rises to $48.7B
Congress approved the final spending bill that lifted the National Institutes of Health budget by just under 1 percent, adding $415 million for FY2026 and setting NIH funding at $48.7 billion. The...
Pfizer’s monthly GLP‑1 hits efficacy mark — Phase 3 program expands
Pfizer reported positive Phase 2b data for the ultra‑long‑acting GLP‑1 acquired with Metsera and said the readouts underpin a broad Phase 3 program. The company disclosed statistically significant...
WHO endorses long‑term GLP‑1 use: obesity reframed as chronic disease
The World Health Organization released its first‑ever guidelines recommending long‑term treatment of obesity with GLP‑1 receptor agonists, signaling a formal shift to treating obesity as a chronic...
Novo’s combo shot outperforms semaglutide — diabetes and obesity win
Novo Nordisk reported Phase 3 data showing its combination candidate CagriSema improved glycemic control and drove larger mean weight loss than semaglutide in people with type 2 diabetes. The...
Pfizer posts $4.4B impairment — CEO signals pipeline focus
Pfizer recorded a $4.4 billion non‑cash charge tied in part to underperforming recent acquisitions and said it removed several early‑stage programs from development. Management said the company...
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...