A large group of researchers from Indian and Malaysian academic medical centers, led by Mainul Haque, Pharmacology Unit, Faculty of Medicine and Defense Health, National Defense University of Malaysia, recently sought to study the World Health Organization (WHO)...
Safety
Category
IQVIA Building Remote COVID-19 Vaccine Safety Monitoring Operation in Ireland Creating 170 Jobs
The world’s largest combined contract research organization (CRO) and biomedical research information services company, IQVIA will form 170 new remote jobs in Ireland as the CRO establishes a COVID-19 vaccine safety monitoring unit in that nation. Targeting...
Genpact wins £1.5m Deal to Develop AI System to Detect & Learn from High Volume Safety Signals from COVID-19 Vaccines
New York City and India-based Genpact secured a £1.5 million (US $1.9m) strategic contact with the UK Medicines and Healthcare Regulatory Authority (MHRA) to develop an artificial intelligence (AI) -based software tool to sift through the “high volume” of reports...
IDMC Observes Some Safety Signals in Regeneron’s Study of REGN-COV2 in Hospitalized Patients: Recommendations Made to Modify
Regeneron’s monoclonal antibody investigational product known as REGN-COV2 has been touted by trial site’s all over the United States, almost in a marketing like manner due to the explicit promotion of the drug by POTUS during the stay at Walter Reed Medical Center....
AstraZeneca and Johnson & Johnson COVID-19 Vaccine Trials to Resume in the United States
According to recent reports, the U.S. Food and Drug Administration (FDA) gave the green light to AstraZeneca and Johnson & Johnson to resume their respective clinical trials testing Covid-19 vaccines. Both drugmakers received the go-ahead on Friday. The...
Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials
Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan) regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets), a...
A Second Safety Incident Report Associated with COVID-19 Vaccine AZD1222
AstraZeneca followed Moderna and Pfizer to release specifics about the vaccine trial protocol to help alleviate public concern. TrialSite has noticed more chatter throughout the media about general public concerns in regards to the COVID-19 vaccines. A growing sense...
Yale University Meta Analyses Finds Type 2 Diabetes Drug Avandia Boosts Cardiovascular Risk by Up to 33%
A new study conducted by Yale School of Public Health finds that Rosiglitazone (Avandia), a drug developed to treat type 2 diabetes, increases the risk of heart attack, heart failure, cardiovascular deaths, and non-cardiovascular-related deaths by 33%. The Study The...
FDA-Lead Research Effort to Compare Clinical Trial Results vs. Medicare Beneficiaries Receiving Idelalisib
A research team, including the Food and Drug Administration (FDA) Stanford and a boutique data analysis firm called Acumen, set up a study comparing outcomes between relapsed follicular lymphoma and relapsed chronic lymphocytic leukemia patients treated with...
A Wake-up Call: Vancouver Study Reveals Harmful Medication Re-Exposure Could be Avoided with New Approaches
The Vancouver Coastal Health Research Institute-led study reports that a key finding of a recent study reveals adverse drug events could be avoided by sharing patients’ medication histories and previous harmful medication exposures among various health care...
Beth Israel Deaconess Observational Study Reveals Some Biologic Psoriasis Treatments Superior
Beth Israel Deaconess Medical Center conducted an observational cohort study, finding less risk of serious infection in patients taking newer targeted systemic medications for psoriasis as recently reported in EurekAlert! A common chronic skin condition...
Is NIH Obstructing a Clinical Trial Safety Investigation?
Science Magazine offers a disturbing report that our taxpayer funded National Institute’s of Health (NIH) is obstructing two of its critical care physicians from speaking to government investigators in regard to a large NIH-funded trial. The Wall Street Journal ...
ICON Introduces New Global Safety Platform Built on Pega 7
Leading Irish CRO ICON has introduced a new global safety reporting system. This product space has long been dominated by a couple of vendors and is ripe for disruption. Argus Safety (Oracle) maintains the largest market position and Aris G is second. Now with...
FDA Seek to Approve Febuxostat for Gout Despite Potential CV Risks
Medscape reports that the FDA’s Arthritis Advisory Committee (AAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee voted by a large margin (19 yes, 2 no 1 abstention) to still recommend febuxostat (Uloric, Takeda) for some patients with gout-related...
Why have up to 150 Deaths at Heart Unit of St. George’s Hospital South London occurred in the past 5 years?
Site Watch—Concerns: Why have up to 150 Deaths at Heart Unit of St. George’s Hospital South London occurred in the past 5 years? This is a horrifying number of deaths in today’s day and age. TrialSite News notes that St. George’s Hospital is a research site for dozens...
A “Substantial Proportion” of Hospital MRSA Infections Occur Post-Discharge, Study Concludes
Brian Dunleavy of Contagion Live reports on Methicillin-resistant Staphylococcus aureus (MRSA)—and old enemy. However, the findings of a study published on August 11 in Clinical Infectious Diseases (CID) suggests infectious disease and public health specialists may...
Two Consumer Baby Monitors Show Worrisome Results in Measuring Vital Signs
A reported in EurekAlert!, CHOP researchers test pulse oximetry monitors in hospitalized infants. Researchers who tested two commercially available baby monitors are raising serious concerns about the accuracy of these products, which are marketed to parents, but are...
More on China: Laboratory Errors Could Lead to Cancer in Europeans EMA Warns
As reported in ConnexionFrance The European Medicines Agency (EMA) has said that impurities were found in valsartan, an active ingredient in many medicines taken by people all over the world - including in Europe - with heart conditions or high blood pressure. In...
Ultra News Report India: 1,104 Deaths During Clinical Trials Over Past Three Years
According to writer Trisha Thomas of Ultra News, a total of 1,104 people have died during clinical trials of various drugs and procedures in India in the last three years, according to the ministry of health and family welfare. However, not everyone who died during...
More on Unsafe Cancer Treatment Recommendations from Watson AI
Shannon Jennings writes that IBM may inadvertently have put the lives of thousand cancer afflicted people in danger by providing dangerous recommendations for their treatment. Their supercomputer ‘Watson’ has been continuously providing erroneous recommendations to...