Risultati per: FDA approva un nuovo trattamento per l’emicrania

New England Journal of Medicine, Ahead of Print.

This study examines the frequency of drug patent invalidations based on inequitable conduct.

This case series study examines the clinical evidence cited for US Food and Drug Administration–approved clinical decision support devices for use in the critical care setting.

We are entering a new era of computerized clinical decision support (CDS) tools. Companies are increasingly using artificial intelligence and/or machine learning (AI/ML) to develop new CDS devices, which are defined by the US Food and Drug Administration (FDA) as software used in disease prevention, diagnosis, or treatment. Recognizing the potential implications for clinical practice, the 21st Century Cures Act enjoined the FDA to regulate these new devices.

Aiuta ciascuno a capire la terapia da usare 

The US Food and Drug Administration (FDA) agreed to review an application to allow eligible adult patients to self-administer FluMist, AstraZeneca’s nasal spray flu vaccine that uses a live, weakened version of the virus to prompt an immune response. Under the application, caregivers would also be able to administer the vaccine to people aged 2 to 49 years who are not immunocompromised.

La pagina ‘Viverla Tutta’ divenuta un luogo virtuale di incontro

Indagine Piepoli, per troppi è solo un comune mal di testa

A new committee focused on digital health technologies, including artificial intelligence, machine learning, and virtual reality, will advise the US Food and Drug Administration (FDA) on the risks, benefits, and clinical outcomes linked with these tools, the agency announced.

Si chiama Ixchiq ed è prodotto dall’europea Valneva. Il virus, trasmesso dalle zanzare, è diffuso soprattutto nelle regioni tropicali e subtropicali

Circulation, Volume 148, Issue Suppl_1, Page A13319-A13319, November 6, 2023. Introduction:BAROSTIM NEO® is a Baroreflex activation therapy (BAT) system which has been approved recently by FDA for patients with refractory heart failure. Post market experience of BAT related complications and performance issues have not been reported.Objective:To analyze the post-approval device failures and patient related adverse events (AE) associated with Barostim NEO® system using Manufacturer and User Facility Device Experience (MAUDE) database.Methods:A MAUDE database search was conducted on December 7, 2022, for reports received between Jan 1, 2019, to November 30, 2022. Manual search of the MAUDE database conducted using the term “Barostim” in the brand name section. The AE were adjudicated to various categories based on the review of the event description for each medical device report (MDR).Results:A total of 22 events were reported which included MDRs reported by physicians or manufacturer or both. Device related malfunction was reported in 45.5% (n=10) whereas patient related AE reported in 77.3% (n=17) cases. Of total device related AE, material split, cut or torn was most commonly reported problem (32%, n=7), followed by high impedance (13.6%, n=3) and low impedance (9.1%, n=2). Of the patient related AE, 32% (n=7) were related to clinical or subclinical infection, 18.2% (n=4) hematoma, 13.6% (n=3) heart failure or myocardial injury, 9.1% (n=2) stroke/CVA, 9.1% and 9.1% (n=2) twiddler’s syndrome. No carotid artery or jugular injury and procedure related death reported in the study period. The report is limited by the lack of information on the total number of BAT devices implanted across the country.Conclusions:This study provides a wide range of device malfunction and patient related post-approval adverse events for Barostim device which have not been reported in any clinical trial/study before. The reported complications seem to be in line with other cardiac implantable electronic devices and no BAT specific complications were noted.

Circulation, Volume 148, Issue Suppl_1, Page A18533-A18533, November 6, 2023. Introduction:Nivolumab and Ipilimumab are human monoclonal antibodies that target cell surface PD1 and anti-CTLA-4 receptors respectively. Nivolumab and ipilimumab combination is used for metastatic small cell lung carcinoma, advanced renal cell carcinoma and metastatic melanoma. The pre-approval CHECKMATE trials have underestimated the occurrence of cardiovascular adverse events (AEs). In contradiction, post-marketing studies have demonstrated a higher incidence of cardiac AEs, particularly myocarditis.Therefore, it is important to establish a post-marketing safety profile of these medications.Methods:We investigated the cardiovascular AEs of nivolumab and ipilimumab using U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Healthcare professionals (HCPs) reported 79.73% and 80.92% of AEs until March 2023 for nivolumab and ipilimumab respectively. We conducted further subgroup analysis of cardiovascular AEs in male, females as well as in three age groups: 18-64, 65-85 and >85 years.Results:Amongst the cardiovascular AEs reported by HCPs, myocarditis was reported in 905 (1.55 %) in nivolumab vs 445 (1.72%) in ipilimumab group. There were higher reports of other cardiovascular AEs including heart failure (1.15% vs 0.74%), pericarditis/pericardial effusion (1.19% vs 0.6% ), myocardial infarction (0.18% vs 0.71%), cardiomyopathy (0.36% vs 0.29%), cardiac arrest (0.41% vs 0.53%) and cardiac death (0.01% vs 0.02%) in nivolumab vs ipilimumab. On sub-group analysis, we observed higher incidence of myocarditis in females (1.54% vs 1.6%) males (1.73% vs. 1.84%) and in patient with age 18-65 years (1.17% vs 1.15%) in both nivolumab vs ipilimumab group as compared to previous studies.Conclusions:The reported events of myocarditis were significantly higher in FAERS reporting as compared to the CHECKMATE trials (