Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
The latest global regulatory news, changes and updates affecting biopharma, including: Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FBI, FDA, Glaxosmithkline, National Institute for Health and Care Excellence, NIH, U.K. National Cyber Security Agency, U.S. Department of Justice.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Athos KT, Blue Flame Medical, Glaxosmithkline, Harsco, Lymol Medical, Pfizer, Stericycle, Vir Biotechnology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Archerdx, Bio-Rad, Cochlear, Invivoscribe, Ortho, Quidel, Theradiag, Thermedical.
Responding to COVID-19’s wakeup call as it exposes the risks of relying heavily on foreign biopharma supply chains, the U.S. Department of Health and Human Services (HHS) signed a four-year, $354 million agreement with a team of private industry partners, led by Phlow Corp., to expand U.S. manufacturing of essential medicines at risk of shortage during the pandemic and in future public health emergencies.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kempharm, Novartis, Organicell, Theralase, Tolero.
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.
Balt USA LLC, of Irvine, Calif., has received a thumbs up from the FDA to begin an IDE trial of its Squid liquid embolic device for the treatment of chronic subdural hematoma (cSDH). The nonadhesive agent offers a minimally invasive option for a disabling neurological condition that often requires brain surgery to correct.
The FDA has granted an emergency use authorization (EUA) for the home sample collection kit made by Austin, Texas-based Everlywell Inc., which can be run on two lab-developed tests. However, the agency has also shut down a Gates Foundation-backed effort in Seattle to develop another home sample collection kit even though the organization behind the effort has been authorized by state health authorities. The FDA announced the news about the Everlywell EUA with the stipulation that the user of the kit has completed an online questionnaire that is subsequently reviewed by a health care professional.
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