State of pneumococcal vaccine immunity
Volume 20, Issue 1, December 2024 . (Source: Human Vaccines and Immunotherapeutics)
Source: Human Vaccines and Immunotherapeutics - April 3, 2024 Category: Allergy & Immunology Authors: Mustafa AkkoyunluDivision of Bacterial Allergenic and Parasitic Diseases, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA Source Type: research

Aortic Regurgitation, Time to Aortic Valve Reintervention, and Mortality in Degenerated Trifecta Versus Non-Trifecta Bioprosthesis
The first Trifecta valve (Abbott, St Paul, Minnesota) was introduced in 2007, CE marked in 2010, and received US Food and Drug Administration (FDA) approval in 2011. An “improved” first-generation valve was introduced in 2015, with a second-generation Trifecta Glide Technology (GT) valve introduced in 2016 that received FDA approval the same year and with a new holder introduced with the later model in 2020. These stented valves touted a single bovine pericardi al tissue, externally mounted on a titanium stent that was designed for supra-annular placement. (Source: The American Journal of Cardiology)
Source: The American Journal of Cardiology - April 3, 2024 Category: Cardiology Authors: Amr E. Abbas, Luai Madanat, Houman Khalili, Ramy Mando, Mazhed Kheyrbek, Rohit Chandra, Shailesh Niroula, Ivan Hanson, Simon Dixon, Brian Renard, Richard Bloomingdale, Elvis Cami, Brittany Pridham, Jeffrey Altshuler, Bogdan Kindzelski, Franco Fazzalari, F Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Utah flouts FDA with law greenlighting placental stem cell therapies
The state of Utah is challenging the authority of the U.S. Food and Drug Administration (FDA) with a new, unusually bold law that allows patients to receive unapproved placental stem cell “therapies.” Observers predict that the law, which takes effect on 1 May, could significantly undermine FDA’s authority to regulate drugs and other treatments. The new statute , passed almost unanimously by both houses of the Utah legislature in February and signed by Governor Spencer Cox (R) last month, declares that Utah health care providers “may perform a [placental] stem cell therapy that is not approved by [F...
Source: Science of Aging Knowledge Environment - April 1, 2024 Category: Geriatrics Source Type: research

High systemic inflammation as a novel cardiovascular risk factor and target for anti-cytokine therapy: comment regarding the triglyceride glucose index
Int J Cardiovasc Imaging. 2024 Apr 1. doi: 10.1007/s10554-024-03046-6. Online ahead of print.ABSTRACTIn the last century, there has been more than enough research that proved the association of high lipid and glucose levels with cardiovascular disease, thus establishing the current well-known traditional cardiovascular risk factors such as dyslipidemia, diabetes, and metabolic syndrome. Hence, these cardiovascular risk factors are target therapy for glucose and lipid-lowering agents to prevent adverse cardiovascular events. However, despite controlling the lipid and glucose levels, some studies demonstrated the subclinical...
Source: Atherosclerosis - April 1, 2024 Category: Cardiology Authors: Artemio Garc ía-Escobar Rosa L ázaro-García Jos é-Ángel Cabrera Alfonso Jurado-Rom án Ra úl Moreno Source Type: research