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Early-stage cell and gene funding softens — biopharma financing normalizes
Venture financing for U.S. cell and gene therapy startups pulled back sharply in 2025, with seed and Series A activity falling notably while China remained a relative bright spot. The pullback...
In vivo HSPC editing and Dravet gene therapy — gene-editing milestone to pivotal path
Nature Biotechnology published work demonstrating in vivo gene editing of human hematopoietic stem and progenitor cells using envelope-engineered virus-like particles, marking a technical advance...
Pazdur resigns as CDER director — another leadership shake-up
Richard Pazdur filed paperwork to retire as director of the FDA’s Center for Drug Evaluation and Research, marking the latest in a year of rapid turnover at the agency. The move follows internal...
12 ex-FDA chiefs slam Prasad: vaccine-rule overhaul draws fire
Twelve former FDA commissioners publicly rebuked CBER head Vinay Prasad’s plan to tighten evidence requirements for updated vaccines, framing the proposal as a major regulatory shift. The New...
ACIP drops universal birth-dose: hepatitis B guidance flipped
The CDC’s Advisory Committee on Immunization Practices voted to remove the longstanding universal recommendation for a hepatitis B vaccine dose at birth, switching to a model that advises parental...
Freenome to go public via $330M SPAC — IPO route for liquid biopsy
Early-stage liquid-biopsy developer Freenome agreed to go public through a $330 million SPAC merger and a linked PIPE, positioning the company to fund commercialization of its multi-cancer and...
Vertex’s Casgevy meets pediatric goals — push to expand label
Vertex reported early pediatric results for its CRISPR-based exa-cel (Casgevy) showing clinical benefit in children with sickle cell disease and transfusion-dependent beta-thalassemia, outcomes...
Praxis halts pivotal epilepsy trial early — efficacy triggers run-up
Praxis Precision Medicines stopped its Phase 2/3 EMBOLD trial early after an interim analysis showed robust efficacy for relutrigine in developmental and epileptic encephalopathies, prompting a...
Natera buys Foresight to boost MRD sensitivity — phased-variant push
Natera agreed to acquire Foresight Diagnostics, integrating the firm’s PhaseED-Seq phased-variant technology to enhance Natera’s Signatera MRD platform and accelerate lymphoma and solid-tumor...
Crescent and Kelun tee up PD‑1/VEGF bispecific program — twin-data plan
Crescent Biopharma struck a two-way alliance with Sichuan Kelun-Biotech to generate parallel clinical data for CR‑001, a PD‑1/VEGF bispecific antibody, aiming for monotherapy and ADC-combination...
Ginkgo wins $47M DOE phenotyping contract; Avance opens potency center
Ginkgo Bioworks secured a four‑year, $47 million contract to design and integrate an automated phenotyping platform for Pacific Northwest National Laboratory, covering cultivation, imaging, flow...
Seed crash in cell & gene; financing normalizes across biopharma
Early-stage venture funding for U.S. cell and gene therapy start-ups has fallen sharply, with seed and Series A rounds contracting and China emerging as a rare bright spot for capital, according...
Casgevy shows early pediatric benefit: pediatric expansion moves into view
Vertex reported early pediatric results for its CRISPR-based sickle cell and beta-thalassemia therapy, Casgevy (exa‑cel), showing clinical improvements in children that meet initial study goals....
ACIP scraps universal birth-dose guidance – hepatitis B policy shaken
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to move away from a universal hepatitis B birth‑dose recommendation, replacing automatic newborn dosing with a framework that...
Freenome to go public: $330M SPAC backs liquid‑biopsy commercialization
Freenome agreed to a $330 million SPAC merger, including a roughly $240 million PIPE, to list publicly and fund the anticipated 2026 commercialization of its multi‑cancer blood test SimpleScreen....
FDA leadership churn deepens: Høeg named CDER head amid policy shifts
Tracey Beth Høeg was named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), marking another rapid leadership change at the agency and fueling industry concern about...
Praxis halts pivotal trial early – relutrigine posts efficacy signal
Praxis Precision Medicines stopped its pivotal EMBOLD study early after an interim analysis showed statistically significant efficacy for relutrigine in developmental and epileptic...
Natera expands MRD toolkit with Foresight buy: $275M upfront deal
Natera agreed to acquire Foresight Diagnostics for $275 million up front plus up to $175 million in earnouts to integrate PhasED‑Seq phased‑variant MRD technology into its Signatera platform....
Biomanufacturing and automation spend rises: Ginkgo wins DOE contract; BioNexus scales
Ginkgo Bioworks secured a four‑year, $47 million contract with Pacific Northwest National Laboratory to design and integrate a high‑throughput automated phenotyping platform for DOE microbial...
Crescent inks Kelun alliance – PD‑1/VEGF bispecific race heats up
Crescent Biopharma struck a two‑way agreement with Sichuan Kelun‑Biotech to generate parallel clinical data for its PD‑1/VEGF bispecific antibody CR‑001, with plans for monotherapy and...