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FDA accelerates first gene therapy for neurosensory hearing loss
The FDA granted accelerated approval to Regeneron’s in vivo gene therapy Otarmeni (lunsotogene parvec-cwha), positioning it as the first gene therapy intended to restore neurosensory hearing in...
Company IPOs reshape fundraising for autoimmune pipelines
Odyssey Therapeutics returned to the public markets with an upsized IPO, raising $304 million to fund its autoimmune and inflammatory development plans. The company priced 15.5 million shares at...
Genomics and spatial diagnostics patent litigation escalates
10x Genomics filed suit against Element Biosciences, alleging the Aviti24 multiomic platform infringes multiple spatial technology patents licensed from Harvard University. The complaint, filed in...
Cell therapy rejection reversal signals FDA path change
The FDA agreed to reconsider its shock rejection of Pierre Fabre and Atara Biotherapeutics’ EBV-specific T-cell therapy Ebvallo (tabelecleucel/tab-cel), opening a potential route to approval using...
Company seed funding targets durable mRNA expression
ParcelBio raised $13 million in seed funding to develop its APEXm platform, aimed at producing higher and more durable protein expression from mRNA. The round was led by Breyer Capital with...
FDA/clinical pipeline: IND clearance accelerates new bispecific ADC concept
Harbour Biomed received IND clearance from the FDA for HBM-7004, enabling initiation of a first-in-human Phase I trial in advanced solid tumors. HBM-7004 is described as a B7H4 x CD3 bispecific...
FDA approval and pipeline churn in neuro and rare disease
Daiichi Sankyo disclosed an “extraordinary loss” of 149.4 billion yen (about $950 million) and moved to scrap plans for antibody-drug conjugate manufacturing capacity. The loss was linked to...
Regenerative medicine financing signals expansion of engineered cell therapies
Scarlet Therapeutics closed a $4 million seed round to move manufactured red blood cells into the clinic. The company says its RBCs behave in vivo like native cells and can be used as...
Public health signal: hantavirus cluster prompts surveillance escalation
A cruise ship hantavirus cluster continued to drive new surveillance actions after multiple reported infections and deaths. Singapore’s Communicable Diseases Agency isolated two residents for...
Oncology diagnostics commercialization: clinical whole-genome test for myeloma
TGen (City of Hope) launched JAYseq™, a clinical whole-genome sequencing test tailored for multiple myeloma, designed to deliver comprehensive analysis in about three days. The test is positioned...
FDA accelerates first-in-class gene therapy in neurosensory hearing loss
The FDA granted accelerated approval to Regeneron’s in vivo gene therapy Otarmeni (lunsotogene parvec-cwha), marking the first gene therapy intended to restore neurosensory function to normal...
Biotech’s supply chain meets regulation as digital orchestration becomes mission-critical
A new industry focus is emerging on how digital infrastructure should be designed for cell and gene therapy—especially around chain-of-identity and chain-of-custody controls across clinical,...
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...