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Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet
NEW BRUNSWICK, NJ, May 5, 2022 - Our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine. Johnson & Johnson, in close coordination with the U.S. Food and Drug Administration (FDA), has updated its U.S. COVID-19 Vaccine Fact Sheet to increase awareness about the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition. Language about the risk of TTS has been added to the first page of the Fact Sheet to increase its prominence. Following the update to the Fact Sheet, the Johnson & Johnson COVID-19 vaccine is now...
Source: Johnson and Johnson - May 5, 2022 Category: Pharmaceuticals Source Type: news

Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
NEW BRUNSWICK, N.J., October 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot. The EUA follows a unanimous recommendat...
Source: Johnson and Johnson - October 20, 2021 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
NEW BRUNSWICK, N.J., October 05, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.The submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) again...
Source: Johnson and Johnson - October 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
This study compared approximately 390,000 people who received the Company’s single-shot COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity.This study is a longitudinal cohort design, using robust propensity matching methods to create a comparator cohort to assess real-world VE. All analyses were performed using the Aetion Evidence Platform, which is a scientifically validated software that is also used by regulators, payers, and health technology assessment bodies to assess the safety, eff...
Source: Johnson and Johnson - September 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

FDA Panel Greenlights First Single-Shot COVID-19 Vaccine, from Johnson & Johnson
The U.S. Food and Drug Administration’s (FDA) vaccine advisory committee earlier today (Feb. 26) voted unanimously to recommend Johnson & Johnson’s COVID-19 vaccine for emergency use authorization. While the FDA isn’t obligated to follow the committee’s advice, it generally does. At the end of a full day of review and discussion of the company’s shot, all 22 voting members of the committee agreed that the vaccine was safe and effective enough to be used by the public. It’s the third vaccine that the group of independent experts has recommended, following Pfizer-BioNTech and Moderna. ...
Source: TIME: Health - February 27, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news

Pharmacologic Treatments for Tinnitus —Reply
In Reply Dr Asnis emphasizes the importance of pharmacological treatments for tinnitus, which were not addressed in our Clinical Update. Although we disagree with his assertion that nonpharmacological treatments are ineffective in many, his letter does raise several good points about the comorbid conditions of insomnia and depression and the role that pharmacotherapy, especially hypnotics and antidepressants, may play. Unfortunately, no drug has “demonstrated replicable, long-term reduction of tinnitus impact in excess of placebo effects,” and there is no drug approved by the US Food and Drug Administration for tinnitus.
Source: JAMA - September 15, 2020 Category: General Medicine Source Type: research

Auditory and Vestibular Side Effects of FDA-Approved Drugs for Diabetes
This article isolates the auditory and vestibular side effects of those drugs as reported by the drug's manufacturer as well as those side effects that could interfere with a balance assessment. Twenty of the 75 approved medications (26%) could have an auditory-related side effect. Hearing loss and tinnitus are not on the list. Only two, or just 3%, have vertigo and spinning as reported side effects (one each). More than 50% of the drugs will have some effect on a balance assessment. Audiologists who evaluate a patient with diabetes (PWD) are presented with symptoms that could be related to their diabetes medication. Altho...
Source: Seminars in Hearing - October 8, 2019 Category: Audiology Authors: DiSogra, Robert M. Meece, Jerry Tags: Review Article Source Type: research

Avoiding Severe Cutaneous Adverse Drug Events
Progress in drug development has brought a host of novel agents for the treatment of neurological disorders ranging from multiple sclerosis to chronic pain. However, the treatment of most neurological disorders is still dependent on older medications. This includes medications, such as carbamazepine, with clinical activity across a broad number of disorders. Carbamazepine was first approved in 1963 for the treatment of epilepsy but has been used for treating types of schizophrenia, bipolar disorder, neuropathic pain, tinnitus, and trigeminal neuralgia. Although this agent is safe and effective for many patients, there is a...
Source: JAMA Neurology - April 2, 2018 Category: Neurology Source Type: research

Personalized Medicine: The Way Forward?
This article will look at some of the strategies already available to help healthcare professionals meet individual patient needs, in the multifaceted field of personalized medicine. Personalizing drug therapy for depression Research suggests that around 50 percent of patients with depression do not respond to first-line antidepressants. What can explain this, and how can it be solved? Current treatment is often a case of trial and error. A patient may take one medication after another, often for 12 weeks or more each time, while symptoms remain the same, or worsen. A team from King's College London in the United Kingd...
Source: Healthy Living - The Huffington Post - July 6, 2016 Category: Consumer Health News Source Type: news

Tinnitus and its current treatment–Still an enigma in medicine
Publication date: Available online 30 December 2015 Source:Journal of the Formosan Medical Association Author(s): Santosh Kumar Swain, Saumyadarshan Nayak, Jayprakash Russel Ravan, Mahesh Chandra Sahu Tinnitus is a phantom auditory perception that occurs in humans. Tinnitus, which is a distressing problem affecting many people around the world, is commonly referred to as ringing in the ears. No effective drug therapy is available for this elusive disease, although much research work into mechanism and possible treatment is underway. As yet, there are no Food and Drug Administration approved drugs available and the qu...
Source: Journal of the Formosan Medical Association - January 12, 2016 Category: Journals (General) Source Type: research

Tinnitus and its current treatment-Still an enigma in medicine.
Abstract Tinnitus is a phantom auditory perception that occurs in humans. Tinnitus, which is a distressing problem affecting many people around the world, is commonly referred to as ringing in the ears. No effective drug therapy is available for this elusive disease, although much research work into mechanism and possible treatment is underway. As yet, there are no Food and Drug Administration approved drugs available and the quest for a new treatment option for tinnitus focus on important challenges in tinnitus management. A number of options have been used to treat patients with tinnitus, but outcomes have been ...
Source: J Formos Med Assoc - December 30, 2015 Category: Journals (General) Authors: Swain SK, Nayak S, Ravan JR, Sahu MC Tags: J Formos Med Assoc Source Type: research

This Device Can Zap Your Brain Into A State Of Zen. Is That A Good Thing?
What if you could zap your brain into a state of calm or energy with only the push of a button? It may sound like the stuff of sci-fi, but it's now the promise of a new class of tech wearables created by teams of Silicon Valley entrepreneurs and neuroscientists. Several devices have come onto the market claiming to use brain stimulation to alter an individual's mental state. One of the latest is Thync Vibes ($299), a stick-on device that delivers low-grade electrical pulses ("vibes") into the scalp to cause a change in automatic nervous system activity.  How does it actually work? Those who are brave en...
Source: Science - The Huffington Post - July 30, 2015 Category: Science Source Type: news

Cochlear implantation and single-sided deafness
Purpose of reviewRecently, more patients with single-sided deafness (SSD) have been undergoing cochlear implantation. We review recent studies and case reports to provide an overview of the efficacy of cochlear implants to rehabilitate patients with SSD with regards to sound localization, speech discrimination, and tinnitus suppression. Recent findingsThere are a growing number of studies evaluating the effect of cochlear implantation for rehabilitation of the deficits associated with SSD over the past several years as more centers offer this treatment modality to patients with SSD. Although individual studies have few pat...
Source: Current Opinion in Otolaryngology and Head and Neck Surgery - September 11, 2014 Category: ENT & OMF Tags: OTOLOGY AND NEURO-OTOLOGY: Edited by Ravi N. Samy Source Type: research