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Regulatory: FDA real-time trial review + pilot AI safety monitoring
The FDA announced it will begin a pilot effort to let reviewers access clinical trial data in real time as it flows in. The initiative is intended to accelerate benefit-risk assessment during...
UK clinical trials overhaul: Combined Review to shorten timelines
The UK implemented the biggest overhaul of clinical trials rules in about 20 years, with new regulations taking effect April 28. The update aims to reduce approval timelines and introduces a...
Oncology licensing and partnerships: AbbVie eyes pan-RAS via Kestrel option deal
AbbVie agreed to secure an exclusive option to acquire Kestrel Therapeutics for up to $1.45 billion tied to milestones for KST-6051, its oral pan-KRAS inhibitor in solid tumors. Kestrel disclosed...
FDA enforcement: proposed withdrawal of Amgen’s Tavneos
The FDA proposed withdrawing Amgen’s Tavneos (avacopan) after alleging “untrue statements” in the drug’s approval application. The agency’s Center for Drug Evaluation and Research put forward...
Clinical setback: Erasca’s pan-RAS molecular glue faces scrutiny after interim patient death
Erasca’s shares plunged after a phase I interim update for ERAS-0015, a pan-RAS molecular glue tested in RAS-mutant solid tumors including non-small-cell lung cancer and pancreatic ductal...
Big deal: CareDx to acquire Naveris to expand HPV liquid biopsy testing
CareDx agreed to acquire Naveris for up to $260 million in a deal designed to add HPV-driven cancer liquid biopsy testing to its portfolio. The transaction includes $160 million upfront in cash...
Gene editing breakthrough: Intellia’s lonvo-z hits primary endpoint in Phase 3
Intellia reported that its in vivo CRISPR therapy lonvoguran ziclumeran (lonvo-z) met the primary endpoint in the Phase 3 HAELO study for hereditary angioedema. The company said the treatment...
M&A: Sun Pharma to acquire Organon for $11.75B to build women’s health footprint
Sun Pharma agreed to acquire Organon & Co. for $11.75 billion in an all-cash transaction expected to close in early 2027. The acquisition adds Organon’s women’s health products, legacy brands, and...
FDA/biomarkers: Laguna Diagnostics gets Breakthrough Device for mRNA test to distinguish psychosis subtypes
Laguna Diagnostics’ blood-based mRNA Gene Biomarker test for schizophrenia and bipolar I disorder received FDA Breakthrough Device designation. The assay is designed to differentiate schizophrenia...
Immunology drug build-out: Coultreon raises $125M for oral SIK3 inhibitor after Galapagos acquisition
Coultreon Biopharma, formerly a Galapagos-linked asset platform focused on an oral immunology strategy, raised a $125 million Series A to advance its lead pill designed to selectively inhibit...
FDA moves to speed oncology and other trials with real-time data review
The FDA launched a pilot program to collect and review clinical trial data in real time, aiming to give reviewers earlier visibility into safety signals and other critical information as studies...
New KRAS G12D targeted therapy posts early human signals
A first-in-human trial testing setidegrasib against KRAS G12D–driven lung and pancreatic cancers reported early clinical success, published by an international consortium in the New England...
AbbVie enters pan-RAS with option to buy Kestrel for up to $1.45B
AbbVie agreed to a staged transaction that gives it an exclusive right to acquire Kestrel Therapeutics for up to $1.45 billion, contingent on milestones tied to Kestrel’s oral pan-RAS inhibitor,...
Eli Lilly expands genetic medicine with Profluent recombinase deal
Eli Lilly struck a deal with Profluent to develop new forms of gene editors that could, in principle, insert entire genes into patients, as reported by STAT+. The collaboration is described as...
Incyte’s povorcitinib scores twin Phase 3 vitiligo wins; plans to file
Incyte said its JAK1 inhibitor povorcitinib delivered success in two Phase 3 trials in nonsegmental vitiligo, and the company plans to file for approval. The readouts position the oral therapy as...
FDA action targeting Tavneos approval undermines Amgen’s rare disease drug
The FDA proposed withdrawing Amgen’s Tavneos (avacopan) approval after alleging untrue statements of material fact in the approval application. The agency’s Center for Drug Evaluation and Research...
Sun Pharma buys Organon for $11.75B to accelerate women’s health growth
Sun Pharmaceuticals agreed to acquire Merck spinoff Organon & Co for $11.75 billion in cash, a deal expected to close in early 2027. Sun said the acquisition expands its women’s health portfolio,...
Thermo Fisher sells microbiology business to Astorg for about $1.08B
Thermo Fisher Scientific agreed to sell its microbiology business to Astorg for about $1.075 billion, consisting of cash and a $50 million seller note. The unit provides antimicrobial...
Coultreon raises $125M to move SIK3 inhibition in autoimmune disease (oral pill vs injectables)
Coultreon Biopharma, a Galapagos-acquired spinout focused on immunology, raised $125 million in a Series A to advance a small-molecule SIK3 inhibitor program. The company plans Phase 2 studies in...
Coultreon identity update: rebranded Galapagos asset vehicle moves forward as a $125M Series A story
On the heels of its financing and clinical plans, the rebranded entity previously launched as Onco3R Therapeutics is now operating as Coultreon Biopharma, according to reporting on the $125...