Janssen Announces U.S. FDA Approval of INVEGA HAFYERA ™(6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia

TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.1 The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. The results showed non-inferiority of INVEGA HAFYERA™ compared to INVEGA TRINZA® on the primary endpoint of time to first relapse at the end of the 12-month period. Results found that 92.5 percent of patients treated with INVEGA HAFYERA™ and 95 percent treated with INVEGA TRINZA® were relapse-free at 12 months.1 Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale [PANSS] total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation. The safety profile observed in the trial was consistent with previous studies of INVEGA SUST...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Every-other-day fasting is effective for a variety of major human diseases, but the safety of these interventions is uncertain for patients with spinal cord injury. A randomized controlled study was conducted to investigate the safety of every-other-day fasting in patients with spinal cord injury. Participants who met the diagnostic inclusion and exclusion criteria were randomly divided into the control and every-other-day fasting groups. In the every-other-day fasting group, fasting lasted from 09:00 p.m. on day 1 to 06:00 p.m. on the following day (day 2). Dinner on day 2 was restricted to approximately 30% of the averag...
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: Original Research Articles Source Type: research
In response to increasing dependence on US Medical Licensing Examination Step 1 scores for resident selection, and to improve medical student well-being and education, the Federation of State Medical Boards and the National Board of Medical Examiners announced that no sooner than 2022, Step 1 score reporting would change from numeric to pass/fail. To gauge the impact that this change will have on the residency application process in physical medicine and rehabilitation, an anonymous survey was electronically distributed to program directors of all accredited physical medicine and rehabilitation residency programs in the Un...
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: Education & Administration Source Type: research
No abstract available
Source: American Journal of Physical Medicine and Rehabilitation - Category: Rehabilitation Tags: Letters to the Editor Source Type: research
Hi everyone, I'm currently active duty and working on a plan to go to medical school after I get out. My ETS is May 2023. As of now, I'm not sure if I will stay in or not; if I do, I'd be in for another 4 years doing a software development program. I only recently learned about VR&E and I'm not sure if I will even qualify but I hope so. I don't know what my disability rating will be. I have a bad knee, sleep problems, and possible mild PTSD from a sexual assault on deployment but it's not... Read more
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Veterans' Benefits Source Type: forums
Conclusions: Two-way messaging and standardized documentation increased rates. Declinations persisted despite education. Reasons included fear of side effects, and rarely leaving home due to the COVID-19 pandemic. Nursing interventions can increase influenza vaccination quality measures for primary care home telehealth patients.
Source: Journal of Nursing Care Quality - Category: Nursing Tags: Articles Source Type: research
Conclusions: Changes could be due to individual state practices.
Source: Journal of Nursing Care Quality - Category: Nursing Tags: Articles Source Type: research
France has just made boosters available for everyone over 18, as long as it has been 5 months since their second dose. Those who are not vaccinated by mid-January risk losing their pass sanitaire.Medscape Medical News
Source: Medscape Infectious Diseases Headlines - Category: Infectious Diseases Tags: Infectious Diseases News Source Type: news
AbstractMore than 12 months have passed since the World Health Organization (WHO) declared Coronavirus Disease 19 (COVID-19), caused by the SARS-CoV2 virus, to be a pandemic on 11 March 2020. The entire world scientific community agrees that at this time vaccine is the most promising weapon to combat the infection and the severity of the disease. According to the document “Draft landscape of COVID-19 candidate vaccines” by WHO, 272 vaccines against SARS-CoV-2 virus are in development, although only four of these, produced by Pfizer-BioNTech (Pfizer, Inc. and BioNTech), Moderna, AstraZeneca, and Janssen companie...
Source: Dermatology and Therapy - Category: Dermatology Source Type: research
Background: Whether American College of Cardiology (ACC) Chest Pain Center (CPC) accreditation alters guidelines adherence rates is unclear. Methods: We analyzed patient-level, hospital-reported, quality metrics for myocardial infarction (MI) patients from 644 hospitals collected in the ACC’s Chest Pain-MI Registry from January 1, 2019, to December 31, 2020, stratified by CPC accreditation for>1 year. Results: Of 192,374 MI patients, 67,462 (35.1%) received care at an accredited hospital. In general, differences in guideline adherence rates between accredited and nonaccredited hospitals were nume...
Source: Critical Pathways in Cardiology - Category: Cardiology Tags: Original Study Source Type: research
In this study, we aimed to assess the utility of structuring chest pain pathway (CPP) with the instantaneous case-by-case feedback protocol using WhatsApp and its impact on improving 2 major key performance indicators—the impact on initial emergency room (ER) door-to-electrocardiogram (ECG) time, and door-to-balloon time—in a predefined 6-month corrective action period. Methods: A prospective, quality improvement plan was set to reduce door-to-first-ECG and door-to-balloon times to less than 10 and 90 minutes, respectively, in all acute coronary syndrome cases (including STEMI cases), from August 2020 to...
Source: Critical Pathways in Cardiology - Category: Cardiology Tags: Original Study Source Type: research
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