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Total 48 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
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 Nasal Spray for Migraines Approved by FDA
MONDAY, March 13, 2023 – Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke.
The U.S. Food and Drug Administration has approved Pfizer Inc.’s zavegepant...
Source: Drugs.com - Daily MedNews - March 13, 2023 Category: General Medicine Source Type: news
New Nasal Spray for Migraines, Zavzpret, Approved by FDA
MONDAY, March 13, 2023– Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke.
The U.S. Food and Drug Administration has approved Pfizer Inc.’s...
Source: Drugs.com - Daily MedNews - March 13, 2023 Category: General Medicine Source Type: news
F.D.A. Approves New Nasal Spray for Migraines
Pfizer ’s treatment applies an approach that is different from some other products, which doctors say may make it safer for people at risk of heart attacks or stroke.
Source: NYT Health - March 10, 2023 Category: Consumer Health News Authors: Christina Jewett Tags: Migraine Headaches Drugs (Pharmaceuticals) Nerves and Nervous System Clinical Trials Food and Drug Administration Lancet Neurology, The (Journal) Pfizer Inc Source Type: news
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
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
U.S. FDA Approves TECVAYLI ™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., October 25, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.1 TECVAYLI™ is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.1 This off-the-shelf (or ready to use) therapy uses innovative science to ac...
Source: Johnson and Johnson - October 25, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Evidence-Based Contraception: Common Questions and Answers
Am Fam Physician. 2022 Sep;106(3):251-259.ABSTRACTPrimary care clinicians are uniquely situated to reduce unintended pregnancy in the context of a patient's medical comorbidities, social circumstance, and gender identity. New evidence regarding contraception use has emerged in recent years. The copper intrauterine device is the most effective option for emergency contraception, with similar effectiveness found for the levonorgestrel-releasing intrauterine system, 52 mg, and both offer extended future contraception. Ulipristal given within 120 hours after unprotected intercourse is the most effective oral emergency contrace...
Source: American Family Physician - September 20, 2022 Category: Primary Care Authors: Scott L Paradise Corinne A Landis David A Klein Source Type: research
