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Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
NEW BRUNSWICK, N.J., December 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a ‘mix and match’ booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). “We are pleased with today’s Positiv...
Source: Johnson and Johnson - December 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
NEW BRUNSWICK, N.J., December 9, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and above. The WHO recommend the booster shot should be administered two to six months after the primary vaccination. SAGE advises WHO on global vaccine and immunization policies, and its recommendations provide guidance on the use of vaccines supplied through the COVAX Facility, a ...
Source: Johnson and Johnson - December 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

IJERPH, Vol. 18, Pages 12879: Identifying Targets for Interventions to Increase Earplug Use in Noisy Recreational Settings: A Qualitative Interview Study
rmitage Earplugs can reduce the risk of hearing loss and tinnitus. However, earplug use during noisy recreational activities is uncommon, and methods for increasing uptake and regular use have had limited efficacy. The aim of the present study was to examine barriers and enablers of ever-performers (e.g., people who have used earplugs) and never-performers (e.g., people who have not used earplugs) to identify targets to inform the content of interventions to increase uptake and regular use of earplugs in recreational settings. The Capabilities, Opportunities, and Motivations model of Behaviour (COM-B) informed the outl...
Source: International Journal of Environmental Research and Public Health - December 7, 2021 Category: Environmental Health Authors: Michael T. Loughran Samuel Couth Christopher J. Plack Christopher J. Armitage Tags: Article Source Type: research

Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., October 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend 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 initial vaccination with the single-shot vaccine. The vote was based on findings from two Company clinical trials, including the Phase 3 ENSEMBLE 2 study, which evaluated a booster dose of the Johnson & Johnso...
Source: Johnson and Johnson - October 15, 2021 Category: Pharmaceuticals Tags: Innovation 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

Characterization of VigiBase reports on tinnitus associated with bisoprolol —An exploratory and descriptive study
AbstractThe aim of this descriptive and explorative study was to assess individual case safety reports of bisoprolol associated with tinnitus and investigate their added value in information about adverse drug reactions (ADRs) in relation to information provided in medicine labels. The global reports from VigiBase, the WHO database of individual case safety reports, as of May 3, 2020, were analyzed for information about bisoprolol associated with tinnitus as an ADR affecting the quality of life of the patients. There were 123 reports of the ADR tinnitus reported with intake of bisoprolol in VigiBase. These described experi...
Source: Pharmacology Research and Perspectives - May 6, 2021 Category: Drugs & Pharmacology Authors: Sarah Watson, Henric Taavola, Marian Attalla, Elenor Kaminsky, Quin ‐Ying Yue Tags: ORIGINAL ARTICLE Source Type: research

Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
SAN DIEGO, Oct. 5, 2015 -- (Healthcare Sales & Marketing Network) -- Otonomy, Inc. (OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today a... Biopharmaceuticals, FDAOtonomy, OTO-311, tinnitus
Source: HSMN NewsFeed - October 5, 2015 Category: Pharmaceuticals Source Type: news

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