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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...
Regulatory: FDA proposal to shorten time to first-in-human trials
The FDA proposed new steps intended to cut the time needed to start first-in-human trials, using a budget-driven regulatory pathway approach. The plan would introduce an optional, risk-based...
Regulatory risk: DOJ and OIG scrutiny targets patient support programs
Regulators’ enforcement focus on patient support programs (PAPs) intensified, with DOJ and OIG scrutiny centered on compliance gaps tied to program design, intent, and profit-driven outcomes. At...
Diagnostics: Grail expands Galleri ordering inside Epic EHR
Grail and Epic announced a collaboration that will integrate the Galleri multi-cancer early detection test directly into Epic electronic health record workflows. Clinicians using Epic will be able...
Clinical development: Amplia pauses Phase II pancreatic cancer enrollment
Amplia Therapeutics halted recruitment in its Phase II Amplicity trial in advanced pancreatic cancer after three dose-limiting toxicities linked to the chemotherapy backbone combined with...
Regulatory policy: South Korea streamlines biosimilar pathway
South Korea rolled out regulatory changes designed to speed biosimilar development, including shorter review timelines, eased Phase III trial requirements, and simplified oversight of...
M&A and exits: Blackstone and TPG complete Hologic acquisition
Blackstone and TPG completed their acquisition of Hologic, moving the molecular diagnostics and medical technology company to the private markets. The deal, valued at up to $18.3 billion, takes...
Women’s health diagnostics: Zymo and Stori take cfDNA early pregnancy test to market
Zymo Research partnered with Stori to commercialize a cfDNA-based early pregnancy test built around Zymo’s sample preservation and cfDNA extraction technologies. The companies said the test can...
Health policy and drug pricing: AbbVie places Humira on TrumpRx at steep discount
AbbVie agreed to offer Humira through the government direct-to-consumer platform TrumpRx at around $950 per month, alongside other discounted AbbVie products, in the context of tariff and...