Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Firstkind, Implicity, Roche, Sky Medical Technology.
Fist Assist Devices LLC received a breakthrough device designation from the FDA for its Fist Assist Model FA-1 device for patients with end-stage renal disease (ESRD). The pre-surgical dilation device promotes arteriovenous (AV) fistula creation in renal failure patients with inadequate vein size for creation of an AV fistula for hemodialysis. An AV fistula is a surgical connection between an artery and a vein used as an access point for dialysis.
The FDA’s regulation of medical technology may be assumed to have a number of unintended consequences, and one of those seems to be the lawsuit between Johnson & Johnson (J&J) and Auris Health Inc. Due to a 2018 FDA policy change regarding 510(k) devices, a robotic surgery system acquired by a J&J subsidiary from Auris was forced into the lengthier de novo premarket channel. This change ultimately helped derail the development effort for the Auris Iplatform surgical system and thus played a role in the $2.35 billion lawsuit alleging that J&J had engaged in fraud in its deal with Auris over the acquisition.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Fist Assist, Mdoloris, Mindray.
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.
Calliditas Therapeutics AB expects its oral version of budesonide to be available early in the first quarter of 2022, following FDA approval for treating patients with progressive kidney disease primary immunoglobulin A nephropathy (IgAN). Branded Tarpeyo, the delayed-release capsules were cleared for use in reducing proteinuria in adults with primary IgAN at risk of rapid disease progression, usually determined as a protein-to-creatinine ration (UPCR) of 1.5 g/g or less.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Boehringer, CSL, Everest, Fate, I-Mab, Incyte, J&J, Laurent, Merck, Nuvation, Sapience, Sobi.
With the U.S. Securities and Exchange Commission (SEC) and Cyberspace Administration of China (CAC) imposing stricter regulatory requirements on listing companies, more Chinese companies are likely to decide to list on stock exchanges closer to home.
Clinical trial fraud has not been on the radar screen for drug and device makers in recent years, but there have been several episodes in which the operators of clinical trial sites had fabricated data for clinical trials. U.S. deputy assistant attorney general Arun Rao said recently that clinical trial fraud is now front and center for federal attorneys, raising the risk that any documentation errors for clinical trials will create a massive liability for the sponsor.