The COVID-19 pandemic may have been largely responsible for the lower volume of enforcement activities against device makers in 2020, but the volume of these activities seems to be ramping up in 2021. Recently, the FDA posted a large batch of warning letters to device makers while the U.S. Department of Justice (DoJ) announced two new enforcement actions, including a $27 million fine to the operators of durable medical equipment distributorships for kickbacks, part of a growing set of signals that enforcement is back in vogue in the U.S.
TORONTO – Spino Modulation Inc., a subsidiary of Montreal-based med-tech company Spinologics Inc., has received breakthrough device designation for a vertebral body tethering (VBT) device to treat adolescent idiopathic scoliosis, one of three types of scoliosis that cause the spine to develop an abnormal curve.
Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease.
The FDA’s draft guidance for the form and content of unique device identifiers (UDIs) may have lacked the controversy of some other policies, but the 2016 draft languished for five years even though only 10 comments appear in the docket. While the agency made some concessions regarding substantial edits of the draft, the final retains a need for data delimiters in the definition of “easily readable” plain text in UDIs, despite industry’s argument that this was not required in the agency’s UDI rulemaking.
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
The FDA granted breakthrough device designation for the Hyalex Cartilage System, a biomimetic materials platform designed to restore function and repair cartilage defects in the knee. The system, developed by Hyalex Orthopaedics Inc., combines two polymers that improve adhesion on one side and create a low-friction surface that protects the cartilage counterface on the other.
Officials at Sigilon Therapeutics Inc. declined to comment beyond a press release on the FDA’s clinical hold for the phase I/II study with encapsulated cell therapy SIG-001 for severe or moderately severe hemophilia A. Shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX) closed at $6.90 on July 9, down $2.34, or 25% after Wall Street learned of the regulatory move, which came because one of three patients treated has developed inhibitors to factor VIII (FVIII).
As rumblings continued about possible skulduggery between Biogen Inc. and the FDA related to Aduhelm (aducanumab), an already precedent-setting case took yet another turn: Acting FDA Commissioner Janet Woodcock asked acting U.S. Inspector General Christi Grimm’s office to conduct an independent review of goings-on that led to approval of the amyloid-beta-targeting drug in Alzheimer’s disease.
Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.
DUBLIN – Shares in Oncopeptides AB dropped 26% July 8 on news that the FDA had placed a partial clinical hold on a raft of trials involving its newly approved multiple myeloma drug Pepaxto (melphalan flufenamide; melflufen), following a bizarre incident involving the incomplete handover to an independent review committee of data from a phase III head-to-head trial in myeloma, which had pitted melflufen against Pomalyst (pomalidomide).
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