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Gilead doubles down on ADC platform with Tubulis deal
Gilead Sciences agreed to acquire German antibody-drug conjugate specialist Tubulis in a deal valued at up to $5 billion, with $3.15 billion upfront and as much as $1.85 billion in milestones. The...
Neurocrine seals $2.9B Soleno buyout to add Vykat XR
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion to bolster its foothold in endocrinology and rare disease. The companies said Neurocrine will pay $53 per share in...
FDA pushes domestic development incentives in 2027 budget
The FDA outlined proposals in its 2027 budget to encourage domestic drug development and manufacturing, including a plan to make it easier for companies to start early clinical testing in the U.S....
U.S. FDA proposes pathway to speed up first-in-human trials
The FDA is seeking to cut time to first-in-human studies through a new regulatory pathway described as optional and risk-based. The proposal is intended for experimental drugs with existing...
South Korea streamlines biosimilar review and trial requirements
South Korea announced regulatory changes designed to shorten biosimilar review timelines and streamline oversight of manufacturing changes. The reforms also aim to reduce the phase III trial...
Grail and Epic integrate Galleri ordering into EHR workflows
Grail and Epic announced a collaboration to integrate the Galleri multi-cancer early detection test into Epic electronic health record platforms. Clinicians using Epic will be able to access the...
CellCarta and Lunit partner to bring AI pathology into trials
CellCarta and Lunit entered a partnership to integrate Lunit’s AI pathology tools (Scope) with CellCarta’s clinical trial pathology services. The companies said the combined offering will support...
Bristol Myers Squibb adopts AI-driven structured protocol design with Faro
Bristol Myers Squibb said it will use AI with Faro Health to streamline clinical trial protocol development using structured design tools. Under the multiyear agreement, Faro’s technology converts...
DOJ scrutiny tightens around patient support program compliance
Regulators increased focus on compliance gaps in patient support programs (PAPs), with DOJ and OIG scrutiny tied to program design intent and profit orientation. Coverage from Access USA...
Biopharma legal leadership shuffle signals compliance scaling
Multiple biopharma companies announced leadership changes in legal and compliance functions, reflecting continued emphasis on governance as commercial footprints expand. Aquestive Therapeutics...
Oncology M&A accelerates with ADC platform buy
Gilead Sciences agreed to acquire German biotech Tubulis in a deal valued at up to $5 billion, expanding Gilead’s antibody–drug conjugate (ADC) pipeline with new linker and payload technologies....
Rare disease deal: Neurocrine buys Soleno to scale hyperphagia franchise
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion, adding Soleno’s marketed Prader-Willi syndrome therapy Vykat XR to Neurocrine’s endocrinology and rare disease...
Regulatory reform proposal targets speed to first-in-human trials
The FDA proposed a new risk-based pathway that would cut time to first-in-human trials, aiming to reduce regulatory burden and accelerate clinical development in the U.S. The plan would create an...
Cancer screening meets EHR integration as Galleri expands ordering routes
Grail partnered with Epic to integrate its Galleri multi-cancer early detection test into Epic’s electronic health record platforms. The collaboration would allow clinicians to access Galleri...
Diagnostics M&A: Blackstone/TPG complete Hologic buyout
Blackstone and TPG completed their acquisition of Hologic, moving the molecular diagnostics company off public markets at a valuation described as up to $18.3 billion. Under the deal, Hologic...
Regulatory pricing and access: Humira discounted on TrumpRx
AbbVie will offer Humira on the White House’s TrumpRx direct-to-consumer platform at a reported $950-per-month price, as the administration pairs discounted biosimilars with a tariff-avoidance...
Oncology M&A and pipeline cleanup: Terns sells to Merck after lower revised bid
Terns Pharmaceuticals accepted a deal with Merck that values the leukemia specialist at a level about 15% below an earlier bid, according to regulatory filings. The revised outcome comes amid...
Enforcement and compliance: DOJ scrutiny tightens on patient support program design
Regulators and DOJ enforcement trends are increasingly focused on compliance gaps in patient support programs (PAPs), with scrutiny tied to program design, profit intent, and how federal dollars...
Biomarker and trial operations: CellCarta and Lunit partner for AI pathology in trials
CellCarta partnered with AI developer Lunit to integrate Lunit’s Scope AI pathology platform into CellCarta’s clinical trial pathology services. The collaboration targets biomarker development,...
Liquid biopsy innovation: UCLA teams advance low-cost DNA methylation assay for multiple diseases
UCLA researchers developed MethylScan, a low-cost, single-sample blood test using targeted DNA methylation sequencing of cell-free DNA to detect multiple cancers and other conditions. In early...