Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atricure, Cerapedics, Celltrion, Lumenis, Soliton, Sommetrics.
Urgency to meet the world's worsening load of COVID-19 cases appeared unflagging Thursday, with four new trials kicking off to evaluate treatments aimed at keeping people from progressing to worsened disease and reports on two new variant-focused efforts yielding signs of preclinical promise.
CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Fractyl Laboratories, Johnson & Johnson Vision.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Lucira Health, Neurolutions, Phoenix Cardiac, Speedx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Better Therapeutics, Diacarta, Elixir Medical, Solace Therapeutics.
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
