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ADC financing: Sidewinder raises for bispecific platform
Sidewinder Therapeutics, a San Diego biotech pursuing bispecific and dual-payload ADC designs, has raised a $137 million Series B led by blue-chip investors. The funding will support preparations...
Med-tech diagnostics: Grail integrates Galleri ordering into Epic EHR
Grail has partnered with Epic to broaden ordering access for its Galleri multi-cancer early detection test inside electronic health record workflows. The collaboration enables clinicians using...
Regulatory shift: Waters’ FDA clearance for at-home HPV self-collection
Waters said its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay received FDA 510(k) clearance, enabling at-home collection to improve access to cervical cancer screening. The test...
Clinical evidence: Duloxetine fails to prevent chemotherapy-induced neuropathy
A randomized clinical trial led through the Alliance for Clinical Trials in Oncology and supported by the National Cancer Institute found that duloxetine did not prevent chemotherapy-induced...
Diagnostics at scale: UCLA blood test targets cfDNA methylation for multiple diseases
UCLA researchers have developed a low-cost blood test, MethylScan, built on cell-free DNA (cfDNA) methylation sequencing to detect multiple cancers and liver-related conditions in a single assay...
Bio-processing and analytics: TriNetX buys Zetta Genomics assets
TriNetX has acquired Zetta Genomics assets, aiming to expand its genomics data management and analytics capabilities for healthcare providers and life science researchers. The move is intended to...
Regulatory modernization: FDA proposes faster US first-in-human pathways
The FDA used its 2027 budget proposal to outline steps intended to shorten the time to first-in-human trials, with an optional, risk-based Investigational New Drug pathway for certain candidates....
AI + clinical ops: CellCarta partners with Lunit for AI pathology in trials
CellCarta and Lunit have partnered to integrate Lunit’s Scope AI pathology tools into clinical trial pathology workflows. The collaboration is designed to help sponsors manage biomarker...
Gilead expands oncology ADC platform with Tubulis takeover
Gilead Sciences moved deeper into antibody-drug conjugates by agreeing to acquire German biotech Tubulis for $3.15 billion upfront and up to $1.85 billion in milestones, with the deal expected to...
Neurocrine buys Soleno for $2.9B to bolster rare disease and endocrinology portfolio
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion to expand its marketed endocrinology and rare-disease franchise. The deal would add Vykat XR (diazoxide choline), a...
Funding: Jeito closes €1B+ second fund for European independent biopharmas
Jeito Capital closed its second independent biopharma fund at $1.2 billion (more than €1 billion), saying it topped its target and will back 15 to 20 clinical-stage European companies. The...
Insmed abandons Brinsupri after mid-stage hidradenitis suppurativa setback
Insmed shelved Brinsupri as it faced a mid-stage trial failure in hidradenitis suppurativa, a painful chronic skin condition. The company’s decision follows a prior pivot late last year when it...
Regulatory and policy: FDA budget proposes faster domestic drug testing and trial entry
The FDA used the 2027 budget proposal to float policies aimed at encouraging domestic development and manufacturing of drugs, including a potential faster route to first-in-human studies. The...
Clinical and regulatory: FDA fast-track designation for TRI-611 in ALK-positive NSCLC
The FDA granted Fast Track designation to TRI-611 for ALK-positive non-small cell lung cancer, a development step for an oral “molecular glue degrader” of ALK fusion proteins. TRI-611 is being...
Oncology development: Sanofi bispecific lunsekimig posts mixed Phase 2 results in asthma/sinusitis but misses in eczema
Sanofi reported mixed Phase 2 outcomes for lunsekimig, a bispecific nanobody targeting TSLP and IL-13. In two respiratory studies, lunsekimig met endpoints: it reduced asthma flare-ups in the...
Trial enrollment stop: Amplia halts Phase 2 pancreatic cancer study after dose-limiting toxicities
Amplia Therapeutics halted recruitment in its Phase 2 Amplicity trial in advanced pancreatic cancer after three dose-limiting toxicities linked to a modified FOLFIRINOX regimen combined with...
Diagnostics and AI: Grail expands Galleri ordering into Epic EHR workflows
Grail partnered with Epic to broaden access to its Galleri multi-cancer early detection test inside electronic health record workflows. Under the collaboration, clinicians using Epic will be able...
M&A and deals: Biopharma legal leadership changes and compliance focus
Several biopharma companies reshuffled legal leadership, signaling ongoing emphasis on compliance, governance, and deal readiness. Aquestive Therapeutics appointed Thomas A. Zalewski as chief...
Oncology M&A: ADC platform snap-up by Gilead
Gilead Sciences moved deeper into antibody-drug conjugates by agreeing to buy privately held German firm Tubulis in a deal worth up to $5 billion, including $3.15 billion upfront and as much as...
Neuroscience rare disease: Neurocrine takes over Soleno
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion, a transaction aimed at scaling Vykat XR (diazoxide choline) and adding commercial endocrinology and rare-disease...