Forget location. It’s timing, timing, timing when it comes to escaping the first round of U.S. Medicare price negotiations due to pending biosimilar competition. Under the Inflation Reduction Act (IRA), only single-source drugs that have been approved for a specific length of time are subject to the forced negotiations, which focus on drugs with the biggest Medicare spend, not necessarily the highest price tag. Since the IRA gives biologics a 12-year safe harbor from negotiations, which aligns with the biologic exclusivity provided by the Biologic Price Competition and Innovation Act, it creates a scenario in which the innovator could be facing negotiations just as its first biosimilar competition prepares to launch. That creates a lot of what-ifs.
Now that the U.S. FDA has nearly 15 years of experience with developing and implementing a biosimilar pathway, it’s time for that regulatory path to catch up with the science, according to experts that have been involved in biosimilar development even before Congress passed the Biologics Price Competition and Innovation Act that created the framework for the U.S. biosimilar market.
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing.
Abbott Laboratories took the next step in its years-long collaboration with Bigfoot Biomedical Inc. with the announcement after the market close on September 6 that it signed a definitive agreement to acquire the connected insulin cap maker. The financial terms of the transaction, which is expected to close this month, were not disclosed.
Neurochase Ltd. filed a patent for a septum-sealed transcutaneous, fluid-transferring device through which repeated access for the removal or delivery of fluid to the central nervous system (CNS) can be gained.
The queue of lawsuits challenging the constitutionality of the U.S. Inflation Reduction Act’s (IRA) prescription drug price negotiations continues to grow. Novartis AG is the latest drug company, but probably not the last, to join the line. It filed its challenge in federal court in New Jersey Sept. 1, a few days after the Centers for Medicare & Medicaid Services included the company’s heart failure drug, Entresto (sacubitril and valsartan), on its list of the 10 drugs subject to the first round of IRA negotiations.
The U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Corp., advising users to make sure they have a backup unit at the ready in the case of device failure. However, the agency noted that “alternative treatments are limited,” a clear sign that this market lacks competition, most likely due to a lack of incentives for the private sector to invest in this class of devices.
The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.
When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
Stimlabs LLC has taken a new view of wound healing by developing a fenestrated dehydrated complete human placental membrane allograft for chronic and acute wounds. The fenestration in the Release product allows fluids to drain away from the wound, promoting faster healing, while the tissue provides protection.
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