Get the Daily Brief
Latest Biotech News
FDA accelerates trial review via real-time data
The FDA launched a pilot effort to collect and review clinical trial data in real time, starting with oncology studies from AstraZeneca and Amgen. The agency said reviewers will access information...
Drug deals and M&A reshape oncology and specialty pipelines
AbbVie struck a right-to-buy option with Kestrel Therapeutics that could reach $1.45 billion to fund and potentially acquire the company’s investigational oral pan-KRAS inhibitor KST-6051. The...
Regulatory approvals and breakthrough designations move precision medicine forward
Health Canada approved the first generic version of Novo Nordisk’s Ozempic (semaglutide) based on Dr. Reddy’s Laboratories’ submission. The regulator said the generic meets safety, efficacy, and...
GLP-1 and obesity program updates intensify competition and scrutiny
Boehringer Ingelheim reported Phase 3 success for survodutide, a dual-acting obesity shot designed to stimulate GLP-1 and glucagon signaling. In the Synchronize-1 trial, Boehringer said treatment...
A new preclinical design principle emerges for mRNA vaccine targeting
Researchers at the Icahn School of Medicine at Mount Sinai reported that detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma models. In Nature...
Targeted oncology signals and early clinical setbacks reshape R&D priorities
A first-in-human trial generated early evidence for setidegrasib, a KRAS G12D-targeted therapy, in patients with advanced pancreatic ductal adenocarcinoma and non–small-cell lung cancer. The New...
Company guidance and financial updates track momentum and headwinds in diagnostics
NeoGenomics raised full-year 2026 revenue guidance after reporting strong Q1 results, citing momentum in its NGS testing business. The company said NGS testing products contributed about one third...
Biotech funding and investment continues with immunology and precision diagnostics
Coultreon Biopharma, formerly Onco3R Therapeutics, raised a $125 million Series A to advance its oral SIK3 inhibitor COL-5671 through clinical development. The seed for the program traces back to...
New clinical trial rules and oversight models raise execution standards in the UK
The UK implemented the biggest overhaul of clinical trials rules in 20 years, with new regulations taking effect April 28. The changes aim to reduce timelines for approvals and introduce a...
Precision diagnostics and imaging platforms expand in oncology care management
Precision oncology testing continues to expand as CareDx prepares to acquire Naveris for its NavDx HPV liquid biopsy MRD test, which is designed to detect HPV-driven cancer fragments in blood. The...
Regulators move to accelerate clinical trial oversight using real-time data and AI
The FDA announced a pilot approach to review clinical trial data in real time, starting with datasets from AstraZeneca and Amgen. The agency said it will also solicit feedback on a potential...
FDA pulls Tavneos approval, citing manipulated trial data
The FDA moved to withdraw Amgen’s Tavneos (avacopan) after alleging that information used to support approval included untrue statements of material fact and that trial results were manipulated....
Obesity drug pipeline steps forward in Phase 3 with Boehringer’s survodutide
Boehringer Ingelheim reported Phase 3 topline results for survodutide, its dual-acting obesity drug that targets GLP-1 and glucagon. In the Synchronize-1 trial of 725 participants, the company...
Precision oncology diagnostics: CareDx to acquire Naveris for NavDx and HPV MRD access
CareDx agreed to buy Naveris in a deal valued at up to $260 million, including $160 million upfront and as much as $100 million tied to revenue milestones. The acquisition is designed to expand...
M&A dealmaking heats up in KRAS and immunology: AbbVie options Kestrel for pan-RAS inhibitor
AbbVie signed an agreement to acquire Kestrel Therapeutics under an option structure valued at up to $1.45 billion, contingent on milestones tied to Kestrel’s oral pan-KRAS inhibitor KST-6051. The...
Clinical trial shift toward earlier evidence in solid tumor KRAS targeting: Erasca reports new data
Erasca reported preliminary clinical updates for ERAS-0015, its pan-RAS-targeting therapy, after a period of volatility tied to patient-reported and competitive readouts in the RAS space. The...
Immunology in the clinic: Coultreon launches Phase 1 SIK3 inhibitor package after $125 million Series A
Coultreon Biopharma (rebranded from an Onco3R Therapeutics spinout) raised a $125 million Series A to advance COL-5671, an oral SIK3 inhibitor designed for autoimmune indications. The round was...
Gene editing commercial benchmark: Intellia’s lonvo-z reaches Phase 3 endpoint in hereditary angioedema
Intellia reported Phase 3 success for lonvo-z (lonvoguran ziclumeran) in hereditary angioedema, positioning the treatment toward regulatory filing for an in vivo CRISPR approach. The company said...
Automation and agentic AI for clinical trial operations: Suvoda expands RTSM with agentic AI
Suvoda launched an updated randomization and clinical trial supply management (RTSM) system that incorporates agentic AI, aiming to compress trial startup timelines and reduce manual configuration...
Regulatory and market access in diabetes care: Health Canada approves first semaglutide generic for Ozempic
Health Canada approved the first generic version of Novo Nordisk’s Ozempic, clearing Dr. Reddy’s Laboratories’ semaglutide injection submission. The decision follows a review that Health Canada...