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Latest Biotech News

Jackson Laboratory acquires NYSCF to scale stem‑cell research and therapies

October 21, 2025

The Jackson Laboratory completed acquisition of the New York Stem Cell Foundation to create an integrated research and translational platform, the institutions said. The deal combines JAX’s...

CBO revises orphan‑drug cost estimates upward after new law; industry windfalls flagged

October 21, 2025

The Congressional Budget Office (CBO) reported unexpected fiscal impacts from the Orphan Cures Act, raising a ten‑year cost estimate as three drugs drove larger‑than‑expected effects on price...

FDA Accepts Replimune Resubmission: April 10 Review Set

October 21, 2025

Replimune resubmitted its biologics license application for RP1, an engineered oncolytic herpes simplex virus combined with PD-1 blockade, and the FDA has accepted the filing with a target...

Grail Raises $325M; Galleri Shows Sevenfold Detection Gain

October 21, 2025

Grail entered a securities purchase agreement to raise approximately $325 million to fund commercial expansion and reimbursement efforts for its Galleri multi-cancer early-detection test. New and...

Exelixis Readies NDA After OS Win: Zanzalintinib Data Revealed

October 21, 2025

Exelixis said it will pursue a New Drug Application following Phase 3 STELLAR-303 results showing its oral TKI zanzalintinib plus atezolizumab reduced risk of death by about 20% versus regorafenib...

FDA Expands Gazyva Label: New Biologic Option for Lupus Nephritis

October 21, 2025

The FDA granted Roche an additional indication for Gazyva (obinutuzumab), approving the CD20-targeting antibody for treatment of lupus nephritis. The approval expands the agent's use beyond...

Anthropic Debuts Claude for Life Sciences: Industry Partnerships Signed

October 21, 2025

Anthropic launched Claude for Life Sciences, a domain-specialized large language model designed to assist researchers with tasks ranging from literature synthesis to querying complex datasets. The...

AI Reprograms Cancer Stem Cells: UCSD’s CANDiT Triggers Self‑Destruct

October 21, 2025

UC San Diego researchers described CANDiT, a machine‑learning systems biology framework that identifies targets to reprogram cancer stem cells toward differentiation and cell death. Applied to...

Jackson Laboratory Acquires NYSCF: Scale for Precision Therapies

October 21, 2025

The Jackson Laboratory completed its acquisition of the New York Stem Cell Foundation, combining JAX’s genetics infrastructure with NYSCF’s human stem cell platforms. The transaction creates an...

Chugai Licenses Rani’s Ranipill in $1B Pact: Oral Biologics Advance

October 21, 2025

Chugai Pharmaceutical signed a global collaboration and license with Rani Therapeutics to develop an oral product that pairs Rani’s Ranipill robotic delivery platform with a Chugai rare‑disease...

FDA Staffing Crunch: Nearly 1,000 Net Departures in FY2025 Quarter

October 21, 2025

New FDA hiring data show the agency’s drug and biologics centers recorded nearly 1,000 net departures in the last quarter of fiscal 2025, marking a historic outflow that offsets hundreds of hires....

AI Builds the Brain: CellTransformer Produces 1,300‑Region Mouse Atlas

October 21, 2025

Researchers at the Allen Institute and UCSF developed CellTransformer, an AI neural network that classified 3.9 million mouse brain cells across >5,000 neuron types to produce a data‑driven brain...

Grail secures $325M: Financing backs Galleri commercialization

October 20, 2025

Grail said Monday it has agreed a private placement expected to raise roughly $325 million to fund commercial expansion and reimbursement efforts for its Galleri circulating tumor DNA (ctDNA)...

Exelixis to file NDA: Zanzalintinib survival data spur regulatory push

October 20, 2025

Exelixis presented detailed STELLAR-303 Phase 3 data showing its oral TKI zanzalintinib plus Roche’s Tecentriq reduced the risk of death by about 20% versus Stivarga in previously treated...

Datroway, Trodelvy contest: ESMO elevates ADCs in first‑line and hard cases

October 20, 2025

ESMO presentations sharpened a head‑to‑head narrative between AstraZeneca/Daiichi Sankyo’s Datroway and Gilead’s Trodelvy in triple‑negative breast cancer and other difficult indications. At the...

Replimune resubmits RP1: FDA sets second review after resubmission

October 20, 2025

Replimune said it has resubmitted data for RP1, its oncolytic therapy for melanoma, prompting the FDA to grant a second review with a new decision date set for April 10. The company’s resubmission...

Anthropic debuts Claude for life sciences – partners with 10x, Benchling

October 20, 2025

Anthropic launched 'Claude for Life Sciences,' a large‑language model (LLM) tailored to research workflows, and announced collaborations with 10x Genomics and Benchling to integrate the model into...

ctDNA guides adjuvant decisions: Tecentriq, DYNAMIC‑III highlight precision uses

October 20, 2025

Roche presented Phase 3 data showing ctDNA‑guided adjuvant Tecentriq prolonged survival for a subset of bladder cancer patients identified as high risk by a circulating tumor DNA test. The data,...

mRNA vaccines augment immunotherapy: MD Anderson and UF findings converge

October 20, 2025

Researchers reported at ESMO and in accompanying analyses that mRNA COVID‑19 vaccines can enhance the efficacy of immune checkpoint inhibitors. MD Anderson presented retrospective data showing...

Chugai licenses Rani Ranipill: $1B collaboration targets oral delivery of biologics

October 20, 2025

Chugai Pharmaceutical struck a global license and collaboration with Rani Therapeutics to develop an oral product combining Rani’s Ranipill robotic oral delivery technology with a Chugai...