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Regulatory approval — cell therapy for transplant complications
The FDA cleared Orca Bio’s personalized Tregzi (T cell therapy) to reduce transplant-related complications in blood cancer patients undergoing stem cell transplants, the companies said. The...
Late-stage trial failure — social anxiety disorder
Vistagen’s intranasal fasedienol failed to beat placebo in a Phase 3 program for acute social anxiety disorder, with results presented from PALISADE-4. In the trial of nearly 240 patients,...
M&A — Ipsen expands rare-disease portfolio with Memo Therapeutics
Ipsen agreed to acquire Switzerland-based Memo Therapeutics in a deal valued at up to roughly $800 million, adding potravitug, an investigational antibody for BK polyomavirus–associated kidney...
M&A — BridgeBio adds preferred equity to fund upcoming launches
BridgeBio Pharma raised about $1 billion through a preferred equity deal as it prepares for three potential drug launches over the next year. The funding is designed to bolster the company’s cash...
Funding — Beeline Medicines extends Series A amid autoimmune development
Beeline Medicines secured an additional $126.3 million in a Series A extension, bringing total funding to $426.3 million as the company advances autoimmune programs. The financing supports ongoing...
Regulatory — FDA grants IDE for MRD use in CAR T trial
FDA granted an investigational device exemption for the use of Adaptive Biotechnologies’ ClonoSeq assay in a clinical trial sponsored by Imviva Biotech. The IDE covers TENACITY-01, evaluating...
Diagnostics — SkylineDx melanoma test earns FDA breakthrough designation
SkylineDx received FDA breakthrough device designation for Merlin CP-GEP, a clinicopathologic gene expression profiling assay designed to support risk assessment and clinical decision-making in...
FDA/ethics — leadership transition in cell and gene therapy regulation
Vijay Kumar, acting director of the FDA’s Office of Therapeutic Products within CBER, is stepping down from the role after a year, according to reports citing an email statement. FDA leadership...
Clinical integrity — NEJM retracts Tavneos pivotal data
Authors of a pivotal NEJM paper describing Amgen’s Tavneos (avacopan) trial outcomes retracted the study after primary endpoint assessments for nine patients were “re-adjudicated” after database...
Cell biology platform — genome-scale CRISPRi atlas for human pluripotent cells
Researchers constructed a genome-scale CRISPRi perturbation atlas in human induced pluripotent stem cells, pairing large-scale CRISPR interference with single-cell transcriptomics to map gene...
FDA approvals: next-gen cellular therapy expands options for transplant patients
FDA has approved Orca Bio’s personalized T-cell therapy Tregzi for blood cancer patients undergoing stem cell transplants, with the agency targeting reduction in graft-versus-host disease risk....
U.S. regulatory overhaul for COVID-era devices: EUAs set to end
HHS has moved to discontinue U.S. COVID-19 Emergency Use Authorization declarations for medical devices, with termination scheduled in 180 days for the device-specific determinations. HHS also...
Gene therapy regulatory leadership shakeup: top cell and gene official exits
Vijay Kumar has announced he is stepping down as acting FDA acting director of the agency’s Office of Therapeutic Products overseeing cell and gene therapies within CBER. The exit follows a...
Oncology M&A: Ipsen snaps up Kartos for late-stage p53-pathway myelofibrosis asset
Ipsen agreed to acquire Kartos Therapeutics in a deal valued at up to $1.75 billion, centered on navtemadlin, an investigational oral MDM2 inhibitor designed to restore p53 function. Ipsen will...
Renal transplant infection pipeline: Ipsen expands with Memo Therapeutics’ BK virus antibody
Ipsen has signed a $228 million upfront acquisition of Memo Therapeutics, betting on potravitug, a clinical-stage monoclonal antibody candidate aimed at BK polyomavirus-associated nephropathy...
Trial integrity and retractions: NEJM removes Tavneos pivotal data
Academic authors have retracted the pivotal phase 3 study article for Amgen’s Tavneos (avacopan) from The New England Journal of Medicine after primary endpoint assessments for nine patients were...
China clinical regulatory shift: updated GCP rules with new data governance emphasis
China’s NMPA has published revised Good Clinical Practice regulations that enter into force in September, updating clinical trial governance requirements with specific emphasis on data governance...
Biotech funding: Beeline raises additional Series A capital for oral immune drug programs
Beeline Medicines has secured a Series A extension adding $126.3 million to its existing funding, bringing total raised to $426.3 million. The company is advancing afimetoran for lupus, alongside...
Cell therapy trial enablement: FDA IDE clears ClonoSeq MRD assay for Imviva study
FDA has granted an investigational device exemption for Adaptive Biotechnologies’ ClonoSeq assay to be used in a clinical trial sponsored by Imviva Biotech. The TENACITY-01 open-arm Phase Ib/II...
Diagnostics: SkylineDx melanoma gene-expression test wins FDA Breakthrough Device designation
SkylineDx received FDA Breakthrough Device Designation for its Merlin CP-GEP assay, a clinicopathologic gene expression profiling test for early-stage cutaneous melanoma risk assessment. The test...