Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA).
With the world heading straight into a "very tough" stretch of the COVID-19 pandemic in which "too many countries are seeing an exponential increase in cases," according to World Health Organization Director-General Tedros Adhanom Ghebreyesus, two lucrative deals announced Oct. 28 showed little slack in efforts to confront the virus, even as evidence is still developing.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers spill Purdue documents on heels of settlement; Western states join forces to review vaccines; FDA finalizes nicotine drug guidance; CBER tackling guidance agenda; Innovation Alliance voices support for PTAB changes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprinoia, Astellas, Astrazeneca, Daiichi Sankyo, Insmed, Passage, Qualigen, Revision, Taysha Gene Therapies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Allergan, Alx, Ampio, Aurinia, Boehringer, Castle Creek, Clinuvel, Finch, Galera, Gyroscope, Highlight, Orasis, Mediwound, Regentree, Therapeutics Solutions.
The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
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