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Regenerative medicine development faces challenges in standardization, regulation and manufacturing the Government Accountability Office (GAO) determined in a recently released report. Read More
WHO and the International Council for Harmonisation (ICH) plan to establish a unified language that streamlines global regulatory decision making on the safety and efficacy of drugs, while offering insights into the scope, causes and consequences of diseases. Read More
Multiple clinical trial results from two manufacturers posted in the past several days in The Lancet show high levels of success of both weight loss in obese adults and in control of type 2 diabetes through weight loss. Read More
Addressing growing interest in the therapeutic potential of psychedelic drugs, the FDA has published a draft guidance noting multiple unique considerations for psychedelic drug development programs and challenges in designing trials. Read More
This month, our review of recent clinical trial results features Rinvoq’s sustained remission in almost half of Crohn’s disease patients, Novo Nordisk’s semaglutide showing significant patient weight loss, and improved insulin and fasting glucose levels in a phase 2B study of Akero Therapeutics’ human fusion protein efruxifermin.Read More
Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t wait for every question to be answered. Read More
Scientists have long been perceived and portrayed in film as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. The present-day reality is quite different. Scientists are increasingly data jockeys in hoodies sitting before monitors analyzing enormous amounts of data. Modern day labs are more likely composed of sterile rows of robots doing the manual handling of materials, and lab notebooks are now electronic in massive data centers holding vast quantities of information. Today, scientific input comes from data pulled from the cloud, with algorithms fueling scientific discovery the way bunsen burners once did. Read More
A potential cure for amyotrophic lateral sclerosis (ALS) remained elusive this week as two pharma companies shuttered trials that just barely missed the efficacy mark. Read More
The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and sometimes decades — to evaluate, adopt and fully implement new technologies and methods. Read More
This month, our review of recent clinical trial results features a drug for anemia due to chronic kidney disease that saw success after an FDA complete response letter, positive results for an ovarian cancer treatment and a hemophilia therapy as well as a lymphoma drug trial derailed by a serious adverse reaction.Read More
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be willing to offer training and support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More