‘Damning’ FDA inspection report undermines positive trial results of possible Alzheimer’s drug
This report extends a pattern of data that lack rigor and reliability, and further undermines my confidence in any clinical trial results from this program,” says neuroscientist Matthew Schrag. The Vanderbilt University professor, who previously identified what he said were problematic data from the company and Wang, reviewed the FDA report for Science , working independently of his institution. “As I’ve said before, I think that the simufilam clinical trials should be shut down,” he concluded. FDA would not say whether its inspection findings would affect the agency’s review of the phas...
Source: Science of Aging Knowledge Environment - March 11, 2024 Category: Geriatrics Source Type: research

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know
Ann Intern Med. 2024 Mar 12. doi: 10.7326/M23-3266. Online ahead of print.NO ABSTRACTPMID:38466998 | DOI:10.7326/M23-3266 (Source: Annals of Internal Medicine)
Source: Annals of Internal Medicine - March 11, 2024 Category: Internal Medicine Authors: Haider J Warraich Laura Carroll Robin A McKinnon Claudine Kavanaugh Robert M Califf Source Type: research

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects
We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred mor...
Source: Regulatory Toxicology and Pharmacology : RTP - March 11, 2024 Category: Toxicology Authors: Tsung-Jen Liao Lynn Crosby Kevin Cross Minjun Chen Rosalie Elespuru Source Type: research

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know
Ann Intern Med. 2024 Mar 12. doi: 10.7326/M23-3266. Online ahead of print.NO ABSTRACTPMID:38466998 | DOI:10.7326/M23-3266 (Source: Annals of Internal Medicine)
Source: Annals of Internal Medicine - March 11, 2024 Category: Internal Medicine Authors: Haider J Warraich Laura Carroll Robin A McKinnon Claudine Kavanaugh Robert M Califf Source Type: research

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects
We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred mor...
Source: Regulatory Toxicology and Pharmacology : RTP - March 11, 2024 Category: Toxicology Authors: Tsung-Jen Liao Lynn Crosby Kevin Cross Minjun Chen Rosalie Elespuru Source Type: research

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know
Ann Intern Med. 2024 Mar 12. doi: 10.7326/M23-3266. Online ahead of print.NO ABSTRACTPMID:38466998 | DOI:10.7326/M23-3266 (Source: Annals of Internal Medicine)
Source: Annals of Internal Medicine - March 11, 2024 Category: Internal Medicine Authors: Haider J Warraich Laura Carroll Robin A McKinnon Claudine Kavanaugh Robert M Califf Source Type: research

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects
We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred mor...
Source: Regulatory Toxicology and Pharmacology : RTP - March 11, 2024 Category: Toxicology Authors: Tsung-Jen Liao Lynn Crosby Kevin Cross Minjun Chen Rosalie Elespuru Source Type: research

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know
Ann Intern Med. 2024 Mar 12. doi: 10.7326/M23-3266. Online ahead of print.NO ABSTRACTPMID:38466998 | DOI:10.7326/M23-3266 (Source: Annals of Internal Medicine)
Source: Annals of Internal Medicine - March 11, 2024 Category: Internal Medicine Authors: Haider J Warraich Laura Carroll Robin A McKinnon Claudine Kavanaugh Robert M Califf Source Type: research

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know
Ann Intern Med. 2024 Mar 12. doi: 10.7326/M23-3266. Online ahead of print.NO ABSTRACTPMID:38466998 | DOI:10.7326/M23-3266 (Source: Annals of Internal Medicine)
Source: Annals of Internal Medicine - March 11, 2024 Category: Internal Medicine Authors: Haider J Warraich Laura Carroll Robin A McKinnon Claudine Kavanaugh Robert M Califf Source Type: research

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know
Ann Intern Med. 2024 Mar 12. doi: 10.7326/M23-3266. Online ahead of print.NO ABSTRACTPMID:38466998 | DOI:10.7326/M23-3266 (Source: Annals of Internal Medicine)
Source: Annals of Internal Medicine - March 11, 2024 Category: Internal Medicine Authors: Haider J Warraich Laura Carroll Robin A McKinnon Claudine Kavanaugh Robert M Califf Source Type: research

Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review
AbstractAdalimumab (ADL, Humira®, reference product), an anti-TNF- α biologic, has transformed the treatment of chronic, immune-mediated inflammatory diseases. However, the high cost of ADL therapy has driven the development of more affordable ADL biosimilars, agents with no clinically meaningful differences from the reference product. This review summarizes the p roduct attributes of reference ADL and the nine ADL biosimilars approved and available in the USA in relation to patient experience of injection-site pain (ISP). Product formulation, delivery volume and device features (e.g., type and needle gauge size) influen...
Source: Advances in Therapy - March 11, 2024 Category: Drugs & Pharmacology Source Type: research

Identifying eleven new ferroptosis inhibitors as neuroprotective agents from FDA-approved drugs
In this study, we identified ferroptosis inhibitors as neuroprotective agents from US Food and Drug Administration (FDA)-approved drugs. 1176 drugs have been screened against erastin-induced ferroptosis in HT22 cells, resulting in 89 ferroptosis inhibitors. Among them, 26 drugs showed significant activity with EC50 below10 μM. The most active ferroptosis inhibitor is lumateperone tosylate at nanomolar level. 11 drugs as ferroptosis inhibitors were not reported previously. Further mechanistic studies revealed that their mechanisms of actions involve free radical scavenging, Fe2+ chelation, and 15-lipoxygenase inhibition. N...
Source: Bioorganic Chemistry - March 9, 2024 Category: Chemistry Authors: Qingyun Tan Deyin Wu Yating Lin Haopeng Ai Jun Xu Huihao Zhou Qiong Gu Source Type: research

Identifying eleven new ferroptosis inhibitors as neuroprotective agents from FDA-approved drugs
In this study, we identified ferroptosis inhibitors as neuroprotective agents from US Food and Drug Administration (FDA)-approved drugs. 1176 drugs have been screened against erastin-induced ferroptosis in HT22 cells, resulting in 89 ferroptosis inhibitors. Among them, 26 drugs showed significant activity with EC50 below10 μM. The most active ferroptosis inhibitor is lumateperone tosylate at nanomolar level. 11 drugs as ferroptosis inhibitors were not reported previously. Further mechanistic studies revealed that their mechanisms of actions involve free radical scavenging, Fe2+ chelation, and 15-lipoxygenase inhibition. N...
Source: Bioorganic Chemistry - March 9, 2024 Category: Chemistry Authors: Qingyun Tan Deyin Wu Yating Lin Haopeng Ai Jun Xu Huihao Zhou Qiong Gu Source Type: research