The Biden administration released its full budget proposal for fiscal year 2022, increasing the FDA’s budget authority to nearly $3.6 billion, up 10% over 2021. The Alliance for a Stronger FDA said that though analysis is needed to parse out the details, the proposal will be supported.
Medical devices have had to deal with a large body of uncertainty where patent protection is concerned, thanks principally to jurisprudence arising out of the Supreme Court. However, Mark Mansour, a regulatory attorney with the D.C. office of Dykema Gossett PLLC, said on a recent webinar that even in the absence of a patent, de novo devices can gain some market exclusivity with smart use of labeling, a practice that can help ensure that the developer can achieve the needed return on investment.
In an effort to address the longstanding issues with medical device manufacturers failing to comply with Section 522 postmarket surveillance studies, the FDA is looking to revamp 2016 policies in new draft guidance issued on Wednesday. A separate FDA draft document seeks to update guidance on post-approval study requirements for high-risk devices with new policies on procedures and submissions.
Woebot Labs Inc. got a bit of a pick-me-up with the FDA's decision to grant breakthrough device designation to the company's digital therapeutic for postpartum depression. The WB001 app combines cognitive behavioral therapy with interpersonal psychotherapy and an understanding of how postpartum depression affects interactions and daily life. The investigational treatment is designed as an eight-week, prescription-only intervention for women under a physician’s care.
Digital therapeutics startup Akili Interactive Inc. has secured $160 million in a combined equity and debt financing to accelerate commercialization of its Endeavorrx platform for cognitive disorders. The company won FDA clearance and the CE mark in June 2020 for its video game-based treatment, Endeavorrx ALK-T01, for children with attention deficit hyperactivity disorder (ADHD).
Originally intended as a way to help provide health care to uninsured and underinsured Americans, the 340B program has mutated into a revenue stream that’s benefiting large U.S. hospital systems, contract pharmacies and even pharmacy benefit managers (PBMs) while contributing to higher drug prices for patients, according to stakeholders speaking at a May 26 Air 340B summit on the federal program.
With a number of Medicare coverage policies in flux, the U.S. Senate has confirmed Chiquita Brooks-LaSure as the next CMS administrator, closing out one more critical remaining position for the Biden administration at the Department of Health and Human Services. Still unannounced is the administration’s nominee to lead the FDA, an omission that becomes more conspicuous with each passing day.
A new study by Laboratory Corp. of America Holdings (Labcorp) has found that nearly 9 in 10 COVID-19 patients continue to have antibodies to SARS-CoV-2 proteins 10 months after infection. Published in The Lancet-affiliated Eclinicalmedicine, the study provides real-world evidence of the persistence of SARS-CoV-2 antibodies in infected individuals, though the authors said more research is needed to determine if, and to what degree, protection against reinfection persists.
The May 25 appearance of Francis Collins, director of the U.S. National Institutes of Health, before a congressional committee revolved in large part around the Biden administration’s so-called ARPA-H proposal, but the administration’s proposal to waive intellectual property rights for vaccines was also on tap.
RSS
