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FDA rethinks rejected cell therapy pathway for EBV+PTLD
The FDA agreed to reconsider its approach to Pierre Fabre and Atara Biotherapeutics’ EBV-specific cytotoxic T-cell therapy Ebvallo (tabelecleucel) after a prior shock rejection. The companies said...
Roche buys PathAI to scale AI-driven digital pathology and companion diagnostics
Roche agreed to acquire PathAI for up to $1.05 billion to strengthen digital pathology capabilities used in biopharma workflows. The deal structure includes a $750 million upfront payment plus up...
Large-cap pharma builds ophthalmology pipeline with Bayer’s PER-001 purchase
Bayer expanded its ophthalmology portfolio by acquiring Perfuse Therapeutics for $2.45 billion, gaining full rights to PER-001 for glaucoma and diabetic retinopathy. The transaction includes a...
Commercial genomics accelerates in multiple myeloma as fast WGS enters market
TGen (City of Hope) launched JAYseq™, a clinical whole-genome sequencing test tailored for multiple myeloma with results delivered in about three days. The offering is positioned as a fast,...
Caris targets New York access for Assure genomic profiling assay
Caris Life Sciences submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program for authorization to run its Caris Assure blood-based...
Oncology diagnostics lit up as Guardant raises full-year outlook on Q1 growth
Guardant Health reported Q1 2026 revenue growth of 48% year over year and raised its full-year 2026 guidance after gains in minimal residual disease and screening. The company posted $301.7...
IPO window opens again for autoimmune and inflammatory pipeline with Odyssey
Odyssey Therapeutics upsized its IPO and raised $304 million total gross proceeds to fund clinical development in ulcerative colitis and lupus. The company priced 15.5 million shares at $18 each...
Prostate cancer monitoring gets a non-invasive boost with urine test vs MRI
A new study reported that a urine-based diagnostic test can outperform MRI for monitoring low-risk prostate cancer in patients on active surveillance. The results were published in The Journal of...
Regulatory decisions: FDA gene therapy approval
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning it as the first gene therapy designed to restore a neurosensory function to normal levels....
FDA reconsideration for rejected cell therapy
The FDA agreed to reconsider approval of Pierre Fabre and Atara Biotherapeutics’ twice-rejected Ebvallo (tabelecleucel) after a new meeting with regulators. The companies said the agency accepted...
Corporate IPOs and funding: Odyssey’s public-market debut
Odyssey Therapeutics completed an upsized IPO, raising $304 million gross proceeds to fund autoimmune and inflammatory programs. The company priced 15.5 million shares at $18 and also entered a...
Digital pathology consolidation: Roche to acquire PathAI
Roche agreed to acquire PathAI in a deal valued at up to $1.05 billion to expand its AI-powered diagnostic platform. Roche will pay $750 million upfront and make additional milestone payments of...
Major pharma M&A: Angelini buys Catalyst for rare neurology portfolio
Angelini Pharma will acquire Catalyst Pharmaceuticals in an all-cash deal valued at $4.1 billion, adding a portfolio of FDA-approved rare neurology drugs. The transaction includes Catalyst’s...
Diagnostics and liquid biopsy: Guardant raises guidance on oncology momentum
Guardant Health raised its full-year 2026 guidance after Q1 revenue grew 48% year over year, driven by continued strength in oncology testing and screening. The company reported $301.7 million...
Cell therapy manufacturing innovation: In vivo mRNA LNP platform reprograms T cells
Researchers at the University of Pennsylvania reported an in vivo mRNA-LNP platform capable of selectively reprogramming cytotoxic effector T cells (Teff) by targeting the CX3CR1 marker. The...
Biotech finance: Seed round for manufactured red blood cells
Scarlet Therapeutics closed a $4 million seed round to advance its manufactured red blood cell platform toward a first clinical application. The company said its manufactured RBCs behave similarly...
Diagnostics IP and litigation: 10x Genomics sues Element over spatial patents
10x Genomics sued Element Biosciences, alleging that Element’s Aviti24 multiomic spatial platform infringes multiple 10x spatial technology patents licensed from Harvard University. The complaint...
Biopharma deals: Cell therapy and diagnostics partnerships
Circle Biosciences (Immatics) and Cellular Origins agreed to use Cellular Origins’ automated mobile robotic platform, Constellation, across parts of Immatics’ cell therapy manufacturing workflows....
FDA accelerates gene therapy with first-in-class hearing-loss approval
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning the therapy as the first gene treatment designed to restore neurosensory function in...
FDA reconsiders Ebvallo after initial shock rejection
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics said the FDA agreed to reconsider Ebvallo (tabelecleucel/tab-cel) after the agency previously rejected the therapy for relapsed or refractory...