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Total 151 results found since Jan 2013.

Will unpredictable side effects dim the promise of new Alzheimer ’s drugs?
A sea change is underway in the treatment of Alzheimer’s disease, where for the first time a drug that targets the disease’s pathology and clearly slows cognitive decline has hit the U.S. market. A related therapy will likely be approved in the coming months. As many neurologists, patients, and brain scientists celebrate, they’re also nervously eyeing complications from treatment: brain swelling and bleeding, which in clinical trials affected up to about one-third of patients and ranged from asymptomatic to fatal. The side effect—amyloid-related imaging abnormalities, or ARIA—remains mysterious. “We don’...
Source: Science of Aging Knowledge Environment - August 2, 2023 Category: Geriatrics Source Type: research

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
RARITAN, NJ, May 25, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical...
Source: Johnson and Johnson - May 25, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Clinical trial participant ’s autopsy and brain exam stoke Alzheimer’s drug fears
A full autopsy and detailed examination of the brain of a 79-year-old Florida woman who died after receiving lecanemab, an experimental Alzheimer’s therapy, in a pivotal clinical trial has deepened some researchers’ concerns that it poses serious risks for patients who share the woman’s hard-to-diagnose, preexisting condition. The patient’s history and autopsy “strongly suggests that lecanemab infusions were a catalyst leading to the events resulting in her death,” says Vanderbilt University pathologist Hannah Harmsen, co-author of a recently completed case report, which Science has obtained. The aut...
Source: Science of Aging Knowledge Environment - April 13, 2023 Category: Geriatrics Source Type: research

New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO ® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)
TITUSVILLE, NJ, March 5, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of ...
Source: Johnson and Johnson - March 5, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

FDA Approves Lecanemab, a New Alzheimer ’s Drug
On Jan. 6, the U.S. Food and Drug Administration (FDA) approved a new drug to treat Alzheimer’s disease in its early stages. Lecanemab, which will be available under the name Leqembi, can slow the cognitive decline associated with Alzheimer’s disease by 27%, according to data submitted to the FDA by the drug’s developers, Eisai and Biogen. It’s only the second medication to show any improvement in neurodegeneration, a key criterion in the FDA’s consideration for approval. “For a long time, this is what we have been looking for,” says Dr. Sam Gandy, professor of neurology and psychi...
Source: TIME: Health - January 6, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Drugs healthscienceclimate Source Type: news

Scientists tie third clinical trial death to experimental Alzheimer ’s drug
As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety. Science has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at Science ’s request believe her death was likely caused by the antibody, lecanemab. “The brain swelling and t...
Source: ScienceNOW - December 21, 2022 Category: Science Source Type: news

As some hail new antibody treatment for Alzheimer ’s, safety and benefit questions persist
In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration (FDA). Yet other researchers warn of potential risks, including brain swelling and brain hemorrhages that were linked to the recently disclosed deaths of two trial participants wh...
Source: Science of Aging Knowledge Environment - December 1, 2022 Category: Geriatrics Source Type: research

Andexanet Alfa and its Clinical Application
Heart Int. 2020 Jun 19;14(1):20-23. doi: 10.17925/HI.2020.14.1.20. eCollection 2020.ABSTRACTFactor Xa (FXa) inhibitors are widely used for stroke prevention in patients with nonvalvular atrial fibrillation, and for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Compared with warfarin, individual FXa inhibitors are associated with a lower risk of major bleeding. Nevertheless, bleeding remains a feared complication of any anticoagulant therapy. Despite their demonstrated safety, implementation of FXa inhibitors in clinical practice may have been limited by the lack of a specific antidote. Rece...
Source: Heart International - October 24, 2022 Category: Cardiology Authors: Fauve A Noordergraaf Marco Alings Source Type: research