Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Arena, Avillion, Boehringer Ingelheim, Brickell, Bristol Myers Squibb, Eli Lilly, EMD Serona, Incyte, Janssen, Nicox, Novartis, Novavax, UCB, Verona.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biostable Science & Engineering, Cerus Endovascular, Empowered Diagnostics, Enzo Biochem, Johnson & Johnson Vision, Medtronic.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affirmxh, Atlas Genomics, Axonlab, Baxter, Cathmedical Cardiovascular, Delcath Systems, Endpoint Clinical, Labcorp, Lifeconnect, Movement Interactive, Opsens, Pixcell Medical, Prevencio, Qiagen, Quick Tube Medical, Red One Medical, Sherlock Biosciences, United PPE, Xphyto.
In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. That approval could be awhile in coming. On April 21, a day after completing its onsite inspection of Emergent’s Bayview plant in Baltimore, Md., the FDA released Form 483 from its inspection, revealing nine observations related to cross-contamination issues, lack of employee training and poorly designed and maintained facilities.