MEXICO CITY – Merck Sharp & Dohme's MK-8591, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), impressed in both treatment and prevention studies at the 2019 International AIDS Society (IAS) Conference on HIV Science.

Drug "re-innovation" specialist Bioxcel Therapeutics Inc. is gearing up to discuss a pivotal phase III trial for BXCL-501 with the FDA after top-line results of a phase Ib study showed it reduced schizophrenia-associated agitation while calming trial participants without excessive sedation. H.C. Wainwright & Co. analyst Raghuram Selvaraju called the results "highly favorable" and suggested the drug, a sublingual-formulated version of dexmedetomidine, could reach market as soon as 2021.

The FDA placed a clinical hold Wednesday on a phase I trial by Unum Therapeutics Inc. after a patient experienced serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection, and grade 4 respiratory distress.

The artificial pancreas represents a dramatic improvement over existing approaches to management of diabetes, but Sernova Corp. of London, Ontario, is intent on going one better on conventional device technology. The company recently presented the results from an early phase study of its Cell Pouch device with pancreatic islet cells to a major medical conference, and the results suggest that the Cell Pouch with islets will pass the safety bar and may prove efficacious for several measures, including glycemic control.

As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The condition isn’t treatable with drugs – not yet, at least – but it’s nonetheless disabling, prompting researchers at several centers in North America and Europe to work collaboratively and seek to help patients carry on with their lives. Clinical studies of prosopagnosia have, so far, informed researchers more about the causes and structural manifestations of the disease than about potential...

This week, researchers are presenting their latest and greatest at the annual meeting of the American Association of Cancer Research. The excitement of all those novel findings, though, received something of an advance puncturing last week by a commentary in Nature that reported a successful replication rate of just over 10 percent for roughly 50 landmark studies in cancer research. From my perspective, the study makes it even more difficult to figure out which of the many research findings that (briefly) come to my attention every day to write about, and which to ignore. Is this study more interesting, or...

How old is our clinical trial system? The first randomized clinical trial was conducted in 1946. British epidemiologist Sir Austin Bradford Hill used randomization to test a pertussis vaccine and a tuberculosis treatment. But according to an article in the British Medical Journal, the concept of randomization was used even earlier, in agriculture experiments in the 1920s. And even before randomization, controlled clinical trials were taking place as early as 1747, when James Lind conducted an experiment in which groups of sailors with scurvy were given various supplements, including citrus fruits. Yet at the recent Foley & Lardner Life Sciences...

Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine. The reason? As the authors put it, “cosmopolitan cities now include many individuals whose genetic heritage is drawn from multiple continental origins.” In other words, there’s no such thing as racial purity. In their paper, which was published in PLoS ONE and which you can find here (http://ow.ly/4YxK6) the team genotyped nearly 1,000 participants of Biobank, a program that collects DNA and plasma samples to aid in genomic and...