Archive for May 2023

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. Source: Drug Industry Daily

The FDA is hoping lawmakers will pass proposed legislation giving the agency regulatory authority for in vitro clinical tests (IVCT) — a new product category that includes both laboratory-developed tests (LDT) and in vitro diagnostic (IVD) tests. Source: Drug Industry Daily

Neuralink has succeeded in winning FDA authorization to conduct a first-in-human clinical trial of its implantable brain interface after being denied in 2022 over safety concerns. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Over the past week, the FDA issued a notice of Abbott’s withdrawal of Cylert NDA, draft guidance on generally accepted scientific knowledge and final guidance on covariates in randomized clinical trials. Source: Drug Industry Daily

The FDA issued four guidance documents on Thursday covering a variety of topics, including efficacy endpoints for antidiabetic drugs, adjusting for covariates in randomized clinical trials, electronic submission of study data and tissue containment systems used during power morcellation procedures. Source: Drug Industry Daily

A medical school research team and a digital therapeutics firm in South Korea used deep learning (DL) models to detect and assess autism in videos of children as young as 24 months of age by measuring a set of behaviors called “joint attention.” Source: Drug Industry Daily

The U.S. Patent and Trademark Office (PTO) has found against Longhorn Vaccines & Diagnostics for committing “egregious abuse” of the Patent Trial and Appeal Board (PTAB) process during its review of Longhorn patent claims filed against Spectrum Solutions’ COVID-19 test. Source: Drug Industry Daily

Integra LifeSciences has initiated a voluntary recall of all its products manufactured at its Boston facility for the past five years after discovering, through an internal investigation, that the products contained higher than acceptable levels of endotoxins. Source: Drug Industry Daily

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. Source: Drug Industry…