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.
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.
It appears that the expression no news is good news is especially applicable to intra-aortic balloon pumps (IABPs), thus the class I recall of Arrow International devices was bad news for patients.
Scientists spread across Europe and the U.S. filed for protection of an implantable electrode array including a plurality of microneedles, which may be implanted into the auditory nerve bundle and stimulate the auditory nerve in response to receiving electrical signals representative of observed sounds.
The U.S. CMS has floated an alternative payment model dubbed the Transforming Episode Accountability Model for Medicare beneficiaries in fee-for-service care, but some in industry have misgivings about the proposal.
Dexcom Inc. and Insulet Corp. both reported introductions of their products into new countries on the eve of the 2024 American Diabetes Association annual meeting in Orlando, Fla. The two firms also announced the U.S. launch of Insulet’s Omnipod 5 tubeless automated insulin delivery system with connectivity to Dexcom’s G7, the company’s latest generation continuous glucose monitor.
The recent licensing agreement that Alzpath Inc. signed with Roche AG for use of its pTau217 antibody to develop and commercialize an Alzheimer's disease diagnostic blood test will not only transform the company but also allow patients access to a more cost-effective test, Venkat Shastri, CEO of Alzpath told BioWorld.
After a rocky year, Akili Inc. received U.S. FDA clearance for use of its non-prescription product, Endeavorotc, for treatment of adults with attention deficit/hyperactivity disorder (ADHD). Endeavorotc employs a video game format to improve attention in individuals with inattentive or combined-type ADHD.
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