Endogenex Inc. closed an oversubscribed $88 million series C financing round to support completion of its investigational device exemption trial for the Recet system. The Recet system uses non-thermal pulsed electric fields to remodel the duodenal tissue to treat adults with type 2 diabetes.
Roche Holding AG’s Genentech Inc. unit received U.S. FDA approval on June 20 of Piasky (crovalimab) to treat adults and children 13 and older with paroxysmal nocturnal hemoglobinuria and a body weight of at least 40 kg (88 pounds).
Any skepticism that might have been lingering in the wake of Alnylam Pharmaceuticals Inc.’s February decision to tweak the analysis plan for the Helios-B trial testing vutrisiran in transthyretin amyloidosis with cardiomyopathy appeared to dissipate as the company reported top-line data showing the study met the primary and all secondary endpoints.
Even though the U.S. FTC recently claimed a court victory in its campaign to shut down the listing of device patents for drugs in the FDA’s Orange Book, 80% of the listings targeted in the commission’s first round of warning letters remain in place more than seven months later.
Argenx SE gained U.S. FDA approval of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The company’s stock (NASDAQ:ARGX) was up 11.7% to $440.59 at the close of trading June 24. About 24,000 people in the U.S. are being treated for CIDP, and patients are generally diagnosed between 40 and 60 years of age.
Medtronic plc’s diabetes unit has not received the positive attention lavished on competitors in recent years, but that may be about to change, if its presentations and analysts’ views from the American Diabetes Association 84th Scientific Sessions this weekend provide a good measure. Perhaps most notably, Medtronic’s Mimimed 780G, a hybrid closed-loop automated insulin delivery system that received U.S. FDA clearance in April 2023, posted strong results and could be the catalyst for increased traction of the diabetes franchise.
Results presented at the American Diabetes Association’s 84th Scientific Sessions in Orlando this weekend demonstrated significant reductions in blood glucose and insulin requirements in people with type 2 diabetes using Insulet Corp.’s Omnipod 5 automated insulin delivery (AID) system, providing a solid base for the company’s expansion into a much larger market.
The recent conviction of Ontrak Inc. CEO Terren Peizer for insider trading was conspicuous on two counts, including that it was the first time such a conviction had been obtained solely for trading conducted under a government-approved insider trading policy. More worrisome for industry, generally, is the case is another example of federal prosecutors’ ever-growing use of data and analytics to root out violations of SEC law. This is a trend that seems destined to grow with advances in artificial intelligence.
The annual U.S. Medicare inpatient rule typically encodes a number of proposed reassignments of procedures between diagnostic-related groups , and the draft rule for fiscal year 2025 proposes several such changes in the area of orthopedic surgeries. The Medical Device Manufacturers Association lauded the proposed changes, arguing that the existing DRG code structure has failed to keep pace with the growing number of procedures for the lumbar spine, not to mention the significant cost differential associated with each.
Communication missteps, overreliance on a contract research organization and lack of clarity of U.S. FDA expectations for an expanded access protocol for emergency use resulted in a warning letter posted June 18 that highlights potential pitfalls for sponsor/investigators conducting the individualized studies.
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