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Fda - Europe PMC

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Last Updated: 13 August 2022

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Repurposing FDA-approved sulphonamide carbonic anhydrase inhibitors for treatment of Neisseria gonorrhoeae .

In vitro, Ethoxzolamide demonstrated a MIC 50 against a panel of N. gonorrhoeae isolates, with 0. 125 g/mL, 16-fold more potent than acetazolamide, although both molecules had almost identical potency against the gonococcal carbonic anhydrase enzyme in vitro. Hence, the increased anti-gonococcal strength of ethoxzolamide in N. gonorrhoeae was attributed to its improved permeability in N. gonorrhoeae in comparison to that of acetazolamide. These findings, when taken together, suggest that acetazolamide and ethoxzolamide should be investigated further for translation into effective anti-N. gonorrhoeae agents.

Source link: https://europepmc.org/article/MED/34894972


FDA Approval Summary: Nivolumab for adjuvant treatment of adults with completely resected esophageal/gastroesophageal junction cancer and residual pathologic disease.

Following chemoradiotherapy, the Food and Drug Administration approved nivolumab for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients with persistent pathologic disease following chemoradiotherapy. Following CRT, the study findings and the risk of nivolumab are expected to change the treatment paradigm for patients with partially resected esophageal or gastroesophageal junction cancer with a persistent pathologic disease following CRT.

Source link: https://europepmc.org/article/MED/35960160


Qualitative content analysis of public responses to an FDA inquiry on the impact of scheduling changes to kratom.

The legal status of kratom in the United States is ambiguous and differs by region. The present research analyzed open-ended responses from the public to an FDA request for data regarding kratom with the intention of giving a complete analysis of kratom use's motives. The FDA sought information regarding kratom abuse potential, medical safety, and impact of scheduling reforms from July to August 2021 and posted them on the Federal Register website in order to inform decisions regarding kratom regulation. We analyzed comments submitted during the first six weeks of comment solicitation using an inductive approach by qualitative content analysis. Individuals use kratom for a variety of health-related uses, although it is not approved as a safe and effective therapy for any indication. Nonetheless, this report illustrates widespread misconceptions regarding the therapeutic uses of kratom and provides insight into potential individual-level consequences of regulating kratom in the United States.

Source link: https://europepmc.org/article/MED/35952436


Reported Pericardial Toxicities Associated with Acute Myelogenous Leukemia Treatments: A Pharmacovigilance Analysis of the FDA Adverse Reporting Database.

Acute myelogenous leukemia is one of the most common leukemias in adults, and it causes significant morbidity and mortality. Although AML's common anthracycline based therapies of anthracycline based therapies involve cytarabine, research in alternatives and targeted agents exist, though the current anthracycline-based therapies are still in use. Methods Used by the Food and Drug Administration Adverse Events Reporting System, we compiled a list of adverse events related to FDA-approved treatments for AML. venetoclax remained significantly associated with reduced incidence of reported pericardial events after adjusting for age and sex, Cladribine and Fludarabine, and Cladribine and Fludarabine. Conclusion Although cytarabine has traditionally been used/drug of choice for AML induction chemotherapy, alternatives such as cladribine may have a higher safety profile regarding pericardial toxicities. Future studies should be directed at investigating the cardiovascular safety profiles of AML induction therapy's cardiovascular health.

Source link: https://europepmc.org/article/MED/35948197


FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple Negative Breast Cancer.

Following a successful, early-stage triple negative breast cancer diagnosis, the Food and Drug Administration approved pepeolizumab in combination with chemotherapy for neoadjuvant therapy and then continued as a single agent for adjuvant therapy after surgery for patients with high-risk, early-stage triple negative breast cancer patients on July 26, 2021. In the peso arm, the trial showed an increase in pCR and EFS relative to the control arm. Patients in the petaluximab arm received EFS assistance despite tumor PD-L1 status.

Source link: https://europepmc.org/article/MED/35925043


Biomonitoring and assessment of toxic element contamination in floodplain sediments and soils using fluorescein diacetate (FDA) enzymatic activity measurements: evaluation of possibilities and limitations through the case study of the Drava River floodplain.

Based on the identification of threat posed by contamination on the biotic receptors, the EU Water Framework Directive requires the monitoring and evaluation of surface water sediment quality. This study investigates the effect of PTE contamination in floodplain sediments and soils using the fast, cheap, and effective fluorescein diacetate method in order to determine its suitability for sediment quality monitoring and preliminary toxicity risk assessment. Some microbe species appear to be able to adapt to the elevated PTE concentrations in contaminated soil micro-environments with time, according to some. Despite the observed heterogeneity of microbial growth, the findings revealed a breakpoint in the FDA dataset around the FDA = 3 FC level, meaning that microbial growth is controlled by thresholds.

Source link: https://europepmc.org/article/MED/35922719


FDA MAUDE database reported adverse events on noninvasive body contouring, cellulite treatment, and muscle stimulation from 2015 to 2021.

The coronavirus disease 2019 pandemic observed increased interest in all surgical procedures, possibly as social distancing and stay-at-home orders allotted time and space for postop recovery. Providers must better advise their patients on risks and expectations when receiving informed consent as the market for these procedures expands. Products and methods We used the Food and Drug Administration Manufacturer and User Facility Experience database, which compiles medical device reports for suspected injuries from device use or failure submitted by manufacturers and operators, as well as product usage data. We narrowed our search to three main areas: noninvasive body contouring, cellulite treatments, and muscle stimulation strategies that use electromagnetic energy. Insight from the MAUDE database can be clinically translated when discussing patient care recommendations, ensuring patient safety and satisfaction.

Source link: https://europepmc.org/article/MED/35916105


Characteristics Of Key Patents Covering Recent FDA-Approved Drugs.

To determine the breadth and characteristics of the key patents covering recently approved brand-name drugs, we extracted patents from the Food and Drug Administration's database and assessed patent filings, characteristics of patents, and whether similar patents were sought in other countries to determine the breadth and characteristics of the recently licensed brand-name drugs. Among seventy-eight qualifying drug approvals in 2019 and 2020, ten had zero patents, and the remaining sixty-eight drugs had 322 different patents. On our date of data collection, the median time from originator drug approval to the end date of the final patent listed on our date of data collection was 10. 3 years. One out of every five patents in other world nations had no counterparts, indicating either a different manufacturer strategy or a different application of patent regulations in the United States than in other comparable countries.

Source link: https://europepmc.org/article/MED/35914209


Recent FDA Approvals in the Treatment of Graft-Versus-Host Disease.

For many years, there have been no effective treatment options for patients with GVHD. Corticosteroids account for up to 50% of patients's onset of steroid-refractory GVHD, but the prognosis for these patients is poor. Ruxolitinib, an oral selective JAK1/2 inhibitor, received FDA clearance for the treatment of steroid-refractory acute GVHD in 2019 and remains the only agent approved for acute GVHD. There are currently three FDA-approved treatments for chronic GVHD, belumosudil, an oral selective inhibitor of ROCK2, for patients with persistent GVHD who have received at least two lines of therapy, and ruxolitinib for chronic GVHD following failure of one or two lines of systemic therapy.

Source link: https://europepmc.org/article/MED/35443042


Clinical Pharmacology of Entacapone (Comtan) From the FDA Reviewer.

The Orion Corporation of Finland's first drug application was first submitted to the U. S. Food and Drug Administration by the Orion Corporation from Finland on January 2, 1998. When given to Parkinson's disease and end-of-dose deterioration in the reaction to levodopa, it has been shown to extend the clinical benefits of levodopa plus, an aromatic L-amino acid decarboxylase inhibitor. The clinical pharmacology analysis of the drug is presented in this paper from the perspective of a clinical pharmacologist who analyzed this new drug application at the FDA.

Source link: https://europepmc.org/article/MED/35302623

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions