In an effort to keep up with the advances being made in manufacturing technologies, the European Commission (EC) is updating its 2007 technical guidance on good manufacturing practices for sterile drugs.
The first randomized placebo-controlled trial assessing the effectiveness of the antiviral drug Tpoxx (tecovirimat) in treating monkeypox has begun in the U.K., with the first patients enrolled on Aug. 21.
A team of researchers from France has started subjecting e-health applications marketed in France to a new scoring tool. This involves rapidly assessing the relevance and potential of software solutions in the medical sector. The results of their study have been published this summer in the Journal of Medical Internet Research (JMIR).
Investors in Cathvision ApS are backing the company with an additional $7.2 million to accelerate U.S. commercialization of its electrophysiology (EP) recording system, Ecgenius. The ECG support technology is designed to detect cardiac electrograms with minimal baseline noise so electrophysiologists can accurately interpret complex arrhythmias, including atrial fibrillation (AF). In May, the U.S. FDA granted the Copenhagen-based company 510(k) clearance for the system.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
The link between the use of antipsychotic medications and the risk of sudden cardiac arrest may not have yet earned universal recognition among cardiologists, but the U.K. National Institute of Health and Care Excellence (NICE) has seen enough to believe the hypothesis has some merit. The agency recently proposed that the Kardiamobile 6L device by Alivecor Inc., of Mountain View, Calif., be covered for patients taking antipsychotic medications, a policy which if adopted would reflect what NICE sees as an unmet need for a population at grave risk.
Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, released its latest survey. This study analyses the availability of medical devices in 2022 in light of the Medical Devices Regulation (MDR) being implemented.
Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
Integrated Graphene Ltd. is partnering with a team of scientists at the University of Edinburgh to develop a point-of-care biomedical test for liver transplants. The Sensibile project team is working to develop a prototype electrochemical biosensor that can detect biliary complications’ biomarkers in donor livers. Sterling, Scotland-based Integrated Graphene’s 3D graphene foam electrode will help to assess the viability of the biliary compartment, and the quality of the donor liver prior to transplantation.
RSS
