Neuros Medical Inc.’s Altius direct electrical nerve stimulation system significantly reduced pain in 30 minutes and continued to reduce pain for a year, a study published Sept. 24, 2024, in Neuromodulation: Technology at the Neural Interface found.
The U.S. FDA’s inspection of two facilities run by San Francisco-based Irhythm Technologies Inc., illuminated some of the usual problems with corrective and preventive action. The agency indicated that problems with skin irritation associated with the company’s Zio device should have been handled as medical device reports, a view the company apparently did not share.
Given the demand for Ozempic and Wegovy and the revenue the GLP-1 drugs are generating for Novo Nordisk A/S in the U.S., a lot of generic companies are clamoring to cash in on the drugs’ current popularity. And there are some U.S. lawmakers more than willing to oblige.
As Eli Lilly and Co. launches its recently approved Ebglyss (lebrikizumab) in an atopic dermatitis market already dominated by established biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), investors tuned into an Amgen Inc. investor call disclosing positive top-line phase III results for rocatinlimab, a monoclonal antibody that could potentially offer patients a new mechanism of action. While data from the Rocket Horizon study showed rocatinlimab hit all co-primary and secondary endpoints, the early findings fell below expectations in a highly competitive market.
The U.S. FDA announced a class I recall declared by Baxter Healthcare Corp., of Deerfield, Ill., for the automated compounding inlets used with the company’s Exactomix compounding systems due to the risk of particulate matter in the inlets.
Joe Kiani’s reign at Masimo Corp. abruptly ended following a vote at the annual shareholders meeting on Sept. 19 that saw Kiani, Masimo’s founder and CEO, ousted from the board as part of a hard-fought battle with activist investor Politan Capital Management. Michelle Brennan, a Politan nominee and former Johnson & Johnson senior executive who won her board seat last year, was named interim CEO.
The U.S. Court of Appeals for the Federal Circuit remanded a patent case to district court after finding that a patent applicant need not invoke identical terminology when describing a central feature of a catheter technology across multiple patents.
With two drugs cleared by the U.S. FDA for Niemann-Pick disease type C (NPC) in less than seven days, Wall Street was pondering the differences between the compounds, given what’s known so far about each. Most recently, the FDA approved Intrabio Inc.’s Aqneursa (levacetylleucine) on its PDUFA date for the treatment of neurological manifestations of NPC in adults and pediatric patients weighing at least 15 kg, making Aqneursa the only approved stand-alone therapy indicated for NPC. On Sept. 20, Zevra Therapeutics Inc. won FDA clearance for Miplyffa (arimoclomol) as the first treatment for NPC.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) on Sept. 26 will take up a controversy that’s hardly new: whether approval of immune checkpoint inhibitor drugs should be restricted in accordance with PD-L1 expression.
While in the hot seat at a Sept. 24 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing, Novo Nordisk A/S President and CEO Lars Fruergaard Jørgensen said he would sit down with Sen. Bernie Sanders (I-Vt.) and the three largest pharmacy benefit managers to discuss lowering the list prices for the company’s popular diabetes and weight-loss drugs, Ozempic and Wegovy.
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