The U.S. Food and Drug Administration on Thursday declined to approve a treatment from Y-mAbs Therapeutics for a rare form of nerve cancer in pediatric patients, dragging its shares 15% lower in extended trade.
Thursday, December 1, 2022
Cutera, Inc. Provides Response to FDA Inquiry
Cutera, Inc. (Nasdaq: CUTR) ("Cutera" or the "Company"), a leading provider of aesthetic and dermatology solutions, today disclosed that it has provided a response to a recent FDA inquiry.
In 2019, Cutera undertook remediation to remove all marketing materials related to gynecological indications, including vaginal rejuvenation, for a device designed and manufactured by a third party. This followed commitments that Cutera had made to the FDA to cease the promotion of MyJuliet for all vaginal rejuvenation and similar claims. As part of this remediation, Cutera requested that the 510(k) owner of MyJuliet, Asclepion, also stop promoting vaginal procedures on its US website. Moreover, Cutera offered all existing customers a replacement handpiece for skin revitalization along with a notification that vaginal procedures are not cleared by the FDA.
The FDA, however, recently issued a Warning Letter to Cutera identifying a vestigial piece of marketing material that had escaped Cutera’s attention. Regrettably, a website that was registered to Cutera, but hosted and managed by a non-U.S. third party on Cutera’s behalf, was mistakenly not taken down in 2019. Cutera believes that this was an isolated oversight and is taking action to prevent any such recurrence. The site identified by the FDA is no longer active.
Cutera takes the Warning Letter and compliance with all FDA laws and regulations very seriously. Accordingly, Cutera is undertaking a series of additional corrective and preventive actions to ensure that Cutera continues to operate in full compliance with FDA requirements and its own commitments. These actions are identified in Cutera’s response to the FDA. Cutera will continue to work with the FDA until all such actions are complete.
The MyJuliet system is a non-material segment of Cutera’s business. Cutera has not actively promoted this device since 2019. Furthermore, Cutera has not deployed any new devices in more than one year, with fewer than 150 total systems sold in the four years before the cessation of shipments. The revenue associated with servicing the devices with replacement handpieces is immaterial to Cutera.
Cutera intends to accelerate its full exit from this market segment in a manner that supports our customers while being fully compliant with FDA guidance. Cutera is also taking additional steps internally to ensure that similar lapses do not recur.
Nuvectis fast tracked for ovarian cancer therapy
Nuvectis Pharma, Inc (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian carcinoma.
“We are very pleased with the FDA’s decision to grant Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian carcinoma, which underscores the potential of NXP800 to address this serious condition of unmet medical need,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur added, “We remain focused on our mission of developing novel treatments for severe oncological conditions, and we believe that with our pipeline of targeted-therapy drug candidates and experienced development team we are well positioned to achieve our goals."
https://finance.yahoo.com/news/fda-grants-fast-track-designation-130000009.html
Simulated Driver Training May Reduce Accidents Among Teens With ADHD
A simulated driving program reduced inattention and risk of crashing among teens with attention deficit-hyperactivity disorder (ADHD) compared with conventional driver's training, according to a small study that used a program combining computer-based and driving simulator training.
During 15-minute simulated drives, teens in the training group had a mean of 16.5 long glances (>2 seconds) from the road per drive compared with 28.0 long glances per drive in those who did not undergo the training at 1 month (incidence rate ratio [IRR] 0.64, 95% CI 0.52-0.76, P<0.001), and 15.7 versus 27.0 long glances, respectively, at 6 months (IRR 0.64, 95% CI 0.52-0.76, P<0.001), reported Jeffery N. Epstein, PhD, of Cincinnati Children's Hospital Medical Center, and co-authors.
The standard deviation of lane position was 0.98 SD at 1 and 6 months in the intervention group compared with 1.20 SD at both points for the control group (P<0.001 for both), they noted in the New England Journal of Medicine.
During real-world driving over the year after training, the rate of long glances per g-force event was 18.3% in the intervention group versus 23.9% in the control group (relative risk [RR] 0.76, 95% CI 0.61-0.92), while the rate of collision or near-collision per g-force event was 3.4% and 5.6%, respectively (RR 0.60, 95% CI 0.41-0.89).
This research provides some hope for a possible intervention that could help teens with ADHD drive more, while reducing the risk for accidents, Epstein told MedPage Today.
"I can tell you that anybody that treats teens with ADHD, when they come in for those visits, whether it be a pediatrician, whether it be a psychiatrist, or a psychologist, their parent is telling that care provider, I'm worried as all heck about my kid having a driver's license," he said. "And they should be, because the risk of having ADHD and driving is pretty bad."
Epstein explained that the main goal of the study was to train teens with ADHD not to look away from the road. This was an important finding, he noted, because teens are four times more likely to be in a crash versus adult drivers, and teens with ADHD are twice as likely as their neurotypical peers to be in a crash.
"What do parents do? They usually refuse to give their kid a license, or they delay licensure, or they get their kid a license and then they're just incredibly anxious about it," Epstein said. "That's really what we have today. There's really no options out there for parents."
Anish Dube, MD, MPH, chair of the American Psychiatric Association's Council on Children, Adolescents, and their Families, said this intervention holds a lot of promise for young people with ADHD, who otherwise would not have any help with reducing their risks while driving.
"When you take an activity that is both pervasive and common but also high risk, like driving, it's really important that we make sure that our young folks are safe, and that we can try to minimize the risk of any adverse outcomes happening, like accidents or injuries," Dube told MedPage Today. "Any kind of interventions that you have that are reducing or minimizing that risk of adverse events, I think these are steps in the right direction."
"The importance of the research is that if we know these kinds of interventions may be helpful, then you can take a public health systems approach, where you can start incorporating these kinds of interventions, especially in standard instruction like driver's education either in school or through the DMV," he added.
Dube said the next step would be working to make this kind of training more accessible for teens with ADHD.
Epstein noted that they are interested in developing a virtual reality-based version of the training to help make this program more accessible to teens, but these efforts are still in the early stages.
This study included a total of 152 teens with ADHD who were recruited from December 2016 to March 2020 in Kentucky, Ohio, or Indiana. At baseline, mean age was 17.4, 62% were boys, and 88% were white. Mean number of months with driving experience was 9.4, and 68% were taking stimulant medication for ADHD.
The teens were randomly assigned 1:1 to the intervention group, consisting of five sessions using both computer-based training and a console-based driving simulator, or the control group, consisting of more conventional driver's education involving desktop-based learning modules.
The teens in the intervention group were first asked to participate in tasks designed to train them to multitask during a simulated drive while limiting long glances away from a simulated road. Next, they used the driving simulator console with a steering wheel and pedals. The participants also wore specialized glasses that tracked eye and head movements. During this simulated driving training, the teens were asked to identify random symbols on the dashboard, which required them to take their eyes off the simulated road momentarily. If they looked away for longer than 2 seconds, an alarm sounded.
Epstein and colleagues noted that they could not determine the influence of ADHD medication on accidents or near-accidents, which was a limitation to their study. They also could not determine whether the intervention would be effective if the participants had not already completed state driver training.
Disclosures
The study was supported by grants from the National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences.
Epstein reported no conflicts of interest. One co-author reported consulting for LifeSpeak.
Dube reported no conflicts of interest.
Primary Source
New England Journal of Medicine
Source Reference: Epstein JN, et al "Trial of training to reduce driver inattention in teens with ADHD" N Engl J Med 2022; DOI: 10.1056/NEJMoa2204783.
Citius: FDA OKs Biologics License Application for Lymphoma Candidate
Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).
https://finance.yahoo.com/news/citius-pharmaceuticals-inc-announces-u-123000919.html
Aldeyra Therapeutics to Seek FDA Priority Review
Aldeyra Therapeutics Inc. on Thursday said it plans to seek speedy U.S. Food and Drug Administration approval of its ADX-2191 drug candidate for the treatment of primary vitreoretinal lymphoma, a rare but potentially fatal retinal cancer.
The Lexington, Mass., biotechnology company said the decision follows a pre-application meeting with the FDA, adding that it could submit its application as soon as the end of the year and that it will request priority review, which would shorten the agency's review period.
Aldeyra said ADX-2191 could be the first FDA-approved therapy for primary vitreoretinal lymphoma, which has a median survival of less than five years.
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