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News
CMO Location Drives Site Selection for Parkinsonian Imaging Trial
4+ hour, 12+ min ago (171+ words) clinicaltrialvanguard.com CMO Location Drives Site Selection for Parkinsonian Imaging Trial When a radiopharmaceutical expires within hours of manufacture, the drug’s chemistry, not the disease’s prevalence, decides where a trial can run. That constraint shaped every decision in a site…...
DYNAMIKA™: The Operating System for Imaging Clinical Trials
3+ day, 21+ hour ago (542+ words) Six trials. Six imaging platforms. Six disconnected databases. This is not a hypothetical scenario. It is the default operating model for most biotech sponsors running concurrent imaging programs today. And it is why, when something goes wrong, whether in site…...
A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
4+ day, 3+ hour ago (790+ words) The Clinical Trial Vanguard A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue A clinical operations lead gets the news from her biostatistics team: the new digitally enhanced composite endpoint just cut the required sample…...
Nektar to Release 24-Week Off-Treatment Data for Rezpegaldesleukin in Alopecia Areata
4+ day, 4+ hour ago (323+ words) The Clinical Trial Vanguard Nektar to Release 24-Week Off-Treatment Data for Rezpegaldesleukin in Alopecia Areata Nektar Therapeutics went quiet on September 8, 2026, and will stay that way until it releases the 24-week off-treatment follow-up data from its Phase 2b REZOLVE-AA study of…...
JST-018 Orthopoxvirus Antibody Enters Phase 1 Trial Under $123.9M Defense Contract
4+ day, 4+ hour ago (351+ words) The Clinical Trial Vanguard JST-018 Orthopoxvirus Antibody Enters Phase 1 Trial Under $123.9M Defense Contract A first-in-human trial of JST-018, a monoclonal antibody cocktail targeting orthopoxviruses, started this month under a 2023 contract worth up to $123.9 million combined across two biodefense programs that…...
The 400-Member Protein Family That Neuroscience Has Almost Entirely Ignored
6+ day, 3+ hour ago (986+ words) The Clinical Trial Vanguard The 400-Member Protein Family That Neuroscience Has Almost Entirely Ignored Pull up the target list from any major neuroscience pipeline review and you will see the same architecture repeated: GPCR agonists, ion channel modulators, monoamine reuptake…...
FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models
1+ week, 4+ hour ago (383+ words) The Clinical Trial Vanguard FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models Forty percent of Phase III cancer trials explicitly barred patients with an ECOG performance status of 2 or higher, and among trials that allowed those patients, they made…...
Early Termination No Longer Means Failure. It Means the Trial Was Working.
1+ week, 1+ day ago (616+ words) The Clinical Trial Vanguard Early Termination No Longer Means Failure. It Means the Trial Was Working. The CheckMate 057 trial was supposed to run longer. Bristol Myers Squibb had enrolled hundreds of patients with non-small cell lung cancer, randomized them between…...
NSABP B-59 Failed. The Real Question Is Why We Keep Designing Trials That Can’t Detect the Signal.
1+ week, 3+ day ago (198+ words) That failure carries weight far beyond the TNBC space. Every immuno-oncology sponsor running a Phase 3 program with a PD-L1 inhibitor, in any indication, should be reading the B-59 readout and asking a harder question than “did it work?” The harder question…...
The EMA Just Opened a Door That Animal Testing Has Kept Closed for Decades
1+ week, 4+ day ago (749+ words) The Clinical Trial Vanguard The EMA Just Opened a Door That Animal Testing Has Kept Closed for Decades Picture a toxicologist at a mid-size European biotech, staring at a dataset from a human Liver-Chip that correctly flagged drug-induced liver injury…...