CIENCIASMEDICASNEWS: enero 2022

COVID-19 Treatment Guidelines Dear International Colleague, As we have throughout the COVID-19 pandemic, the U.S. Food and Drug Administration has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency. In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we're making changes today. Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it's highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time. This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant. The NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) because of markedly reduced activity against the omicron variant and because real-time testing to identify rare, non-omicron variants is not routinely available. Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should consult the NIH panel's COVID-19 treatment guidelines and assess whether these treatments are right for their patients. While it's critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death. The FDA is committed to continuing to review emerging data on all COVID-19 therapies related to the potential impact of variants and revise the authorizations further as appropriate to ensure healthcare providers have an effective arsenal of treatments for patients.

Personal Information - 2021-2022 Principles of Pediatric Clinical Pharmacology and Therapeutics Course FDA Announces Upcoming Principles of Pediatric Clinical Pharmacology Lecture Series The 2021-2022 Principles of Pediatric Clinical Pharmacology lecture series offered by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) resumed on January 5, 2022. Two upcoming U.S. Food and Drug Administration (FDA) roundtable discussions will be presented as a part of this series: February 16, 2022: FDA Roundtable Discussion on Systems Pharmacology April 6, 2022: FDA Roundtable Discussion on Pharmacometrics and Clinical Trials Design This lecture series is designed to address the fundamentals of clinical pharmacology from a pediatric perspective. 1.00 AMA PRA Category 1 Credits™ are available for each lecture. Registration is free and open to the public. Lectures are given via live webinar in Adobe Connect on Wednesdays from 12:00 PM to 1:00 PM ET. Login details are emailed to course registrants before each webinar. You are welcome to attend these and all other webinars in the course, as well as to share the links below with any interested trainees or colleagues. To register, visit https://cvent.me/Vng9ve. To view the course schedule, visit https://cvent.me/OmbxdR. For additional information, please contact pharmcourse@infinityconferences.com.

lunes, 31 de enero de 2022

domingo, 30 de enero de 2022

sábado, 29 de enero de 2022

viernes, 28 de enero de 2022

jueves, 27 de enero de 2022

miércoles, 26 de enero de 2022

martes, 25 de enero de 2022

lunes, 24 de enero de 2022