Get the Daily Brief
Latest Biotech News
FDA approvals for rare disease therapeutics
Mirum Pharmaceuticals’ Atebrioz won FDA approval for fibrodysplasia ossificans progressiva (FOP), adding a third approved option for the ultra-rare condition characterized by progressive bone...
Oncology treatment modeling and AI clinical guidance
A new AI approach is designed to flag when it is uncertain about whether metastatic non-small cell lung cancer patients will respond to first-line chemoimmunotherapy. By incorporating confidence...
Regulatory fallout for oncology antibody-drug conjugates
A BLA filing for ifinatamab deruxtecan was voluntarily withdrawn in previously treated extensive-stage small cell lung cancer. The decision reshapes the near-term regulatory path for the ADC in a...
Court ruling reshapes Nektar’s dispute with Eli Lilly
A jury found that Eli Lilly breached an implied covenant of good faith and fair dealing in a collaboration covering Nektar Therapeutics’ lead immuno-oncology candidate rezpegaldesleukin. Nektar...
Clinical monitoring automation and trial cost efficiency
Medable said an independent analysis with Tufts Center for the Study of Drug Development (CSDD) found its Clinical Monitoring Agent can improve the efficiency of clinical research monitoring and...
CRISPR platform engineering delivers major performance gains
Researchers reported a 60-fold boost in the performance of a compact CRISPR nuclease after engineering changes to the enzyme and guide RNA design. The work, published in Molecular Systems Biology,...
New radiotherapy evidence in metastatic colorectal cancer
The LAVA-CRLM randomized trial reported a head-to-head comparison of radiation and heat-based ablation for colorectal liver metastases. The study addresses a longstanding evidence gap by directly...
Cell therapy monitoring finds hidden cardiovascular risk
A large investigation reported that more than half of patients receiving cellular therapies develop orthostatic hypotension, a dangerous blood pressure drop on standing, within the first month...
CAR-T/immune-cell engineering advances for solid tumors
A review highlighted how metabolism-focused re-engineering could address CAR-T’s performance limitations in solid tumors, where nutrient and microenvironment constraints can blunt T-cell function....
Protein biomarker and screening tools to improve cancer risk stratification
New work proposes a modeling approach that uses AI combined with a clinical signal framework to predict colorectal cancer risk, aiming to standardize how risk is stratified earlier in the disease...
Regulatory approval in rare disease
Mirum Pharmaceuticals’ Atebrioz (atebrioz) has won FDA approval for fibrodysplasia ossificans progressiva (FOP), adding a third approved therapy for the ultra-rare condition. Mirum acquired...
Biotech litigation and partnership fallout
Nektar Therapeutics’ legal dispute with Eli Lilly took another turn as investors digested a $90 million jury award in Nektar’s favor over Lilly’s termination of a co-development collaboration. The...
Oncology trial data in colorectal liver metastases
The LAVA-CRLM trial has delivered a first direct comparison of two curative-intent options for colorectal liver metastases, with radiation matching heat-based ablation. In the randomized study...
Oncology trial data: endometrial cancer after immunotherapy
A dose-expansion phase study in advanced endometrial cancer reported durable tumor shrinkage when an oral Wnt-blocking agent was combined with lenvatinib after prior immunotherapy failure. The...
Drug pipeline: BLA withdrawal in SCLC
Boehringer Ingelheim’s ifinatamab deruxtecan development hit a setback as the company voluntarily withdrew its biologics license application in previously treated extensive-stage small cell lung...
Cell therapy safety signals in real-world cohorts
A large investigation has found that most patients receiving lifesaving cellular therapies develop hidden blood pressure drops upon standing within their first month. The study links a majority...
Clinical oncology support tool: switching treatment milestone
Researchers built a standardized rulebook for a key clinical milestone—time to subsequent therapy (TTST)—aimed at helping oncology trials and clinicians decide when patients should move off a...
Cell engineering review for solid tumors and metabolic rewiring
A review in the Journal of Translational Medicine argues that metabolism-focused engineering could be a path to make CAR-T cells work better in solid tumors. It outlines how tumor nutrient...
Bioengineering and platform validation: engineered CRISPR nuclease
A compact CRISPR nuclease, CgCas12n, has been engineered into a higher-performance genome-editing platform with a reported 60-fold power boost. In a study published in Molecular Systems Biology,...
AI-enabled oncology decision support
An AI model is helping identify when clinicians should be cautious about predicting cancer treatment success. For metastatic non-small cell lung cancer treated with first-line chemoimmunotherapy,...