For people with type 1 or type 2 diabetes and the companies developing technologies to help them, the International Conference on Advanced Technologies & Treatments for Diabetes delivered an abundance of good news. On the type 1 diabetes front, Insulet Corp.’s RADIANT study demonstrated massive improvement in time in range as well as lower glycemic levels for patients switching from multiple injections to the Omnipod 5 automated insulin delivery system.
Biomérieux SA recently received U.S. FDA 510(k) clearance for its Vitek Compact Pro, a system for microorganism identification and Antibiotic Susceptibility Testing. The company hopes that the system will help clinical laboratories combat antimicrobial resistance and diagnose infectious diseases as well as support industrial laboratories in identifying contaminants to ensure consumer safety.
Mehmet Oz, the Trump administration’s pick to lead the U.S. Centers for Medicare & Medicaid Services (CMS), appeared for a second time in the Senate for the CMS administrator’s job.
The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
Shares of Unity Biotechnology Inc. (NASDAQ:UBX) sank 28.8% to close at $1.30 March 24 as a top-line readout of its phase IIb Aspire study testing UBX-1325 head-to-head against aflibercept in diabetic macular edema (DME) fell short of statistical noninferiority on the primary analysis endpoint. But that’s not the full story, according to company executives, who have plans for moving the senolytic Bcl-xL inhibitor into late-stage studies.
The U.S. Medicare program took several bites out of rates paid for radiation oncology services under the physician fee schedule, but stakeholders are again gaining traction on Capitol Hill with a plea for intervention.
Alcon AG plans to acquire Lensar Inc. for up to $430 million in a transaction expected to close in the latter half of the year. The acquisition will add Lensar’s Ally robotic cataract laser treatment system, Streamline software technology and Lensar legacy laser system to Alcon’s cataract surgery portfolio and expand global access to Lensar’s femtosecond laser technology.
Third-party litigation funding (TPLF) has a checkered reputation in the U.S. med-tech industry and the practice has now raised hackles in the European Union as well. The European Commission recently posted a document explaining how EU-wide legislation would map onto member state law, the results of which suggest that any pan-EU legislation would be at best a tricky exercise in policymaking.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
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