The U.S. FDA has made it easier for people who want to get tested for COVID-19, granting emergency use authorization (EUA) for direct-to-consumer sales of Laboratory Corp. of America Holdings’ (Labcorp) Pixel COVID-19 test home collection kit. With this latest EUA, any individual 18 years and older can purchase the Pixel test system without a prescription. Read More
Roche Holding AG has revealed a partnership with Moderna Inc. involving the use of the Elecsys Anti-SARS-CoV-2 S antibody test in the latter’s mRNA-1273 vaccine research trials. The news comes shortly after Roche received emergency use authorization from the U.S. FDA for the antibody test. Read More
The COVID-19 pandemic has been more than just a distraction for the U.S. FDA, which started 2020 with a number of ambitions regarding digital health regulation. Despite having unveiled the Digital Health Center of Excellence to great fanfare, the agency is struggling to wrap up major digital health programs, such as the precertification program for software as a medical device, leaving the FDA with a daunting agenda for digital health in the coming year. Read More
Researchers at the Georgia Institute of Technology see a future where long-lasting hydrogel injections replace eye drops and surgery in the management of glaucoma, the most common cause of irreversible blindness in the world. The treatment would be delivered every six months, in line with glaucoma patients’ regularly scheduled visits to the ophthalmologist. Read More
HONG KONG – Partnerships are reshaping the pharmaceutical industry across Asia, said speakers during day two of the Phar-East 2020 virtual conference. While industry has “tended to have a go-at-it-alone approach,” doing all its discovery, development and commercialization work in-house, “nothing ever came in or out. I think that’s really changed in recent years,” said Kazia Therapeutics Ltd. CEO James Garner. Read More
Rayzebio Inc. has swiftly followed up its recent $45 million series A round with a $105 million series B round that attracted several top-tier crossover investors. Read More
The FDA’s vaccine advisory committee voted 17-4 with one abstention Dec. 10 to recommend an emergency use authorization (EUA) for the Pfizer Inc./Biontech SE mRNA vaccine BNT-162b2 to prevent COVID-19 in individuals 16 and older. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Senate passes counterfeit device destruction bill; MHRA posts device compliance dates for Brexit. Read More
Med-tech firms raising money in public or private financings, including: Dcn Dx, Printerprezz, Nanobitix, Rani Therapeutics, Resolve Biosciences. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aspivix, Biocept, Masimo, Menarini Silicon Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Bionics, Advanced Medtech, Laboratory Corporation of America, Oxford Immunotec Global, Recor Medical, Virocule. Read More
Keeping you up to date on recent developments in diagnostics, including: Predicting breast cancer recurrence, Comparing SARS-CoV-2 PCR tests, Paying attention to the little guy in proteomics, Increasing biomarker reproducibility Read More
