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Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinicaltrial operator.
After years of disappointing malaria vaccinetrials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.
As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinicaltrials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinicaltrials. A 2018 NIH survey found that patients felt clinicaltrial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.
There has been increasing awareness around the need for improving inclusion and diversity in clinicaltrials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies.
The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus. Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body.
Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price rise considerably on the Hong Kong stock exchange. But Reuters reported that the doctor identified as its principal clinicaltrial investigator has said he is not in charge of the trial.
The trial has enrolled 1,900 high-risk non-hospitalized and 84% of patients were vaccinated to some extent, from July 2021-Feb 2022. It was a big treatment effect observed in a predominantly vaccinated population. Glenn, MD, PhD) appeared first on Rethinking ClinicalTrials.
Clinicaltrials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.
Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinicaltrials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.
SUMMARY: Even though the Delta variant of COVID is highly contagious, people are still choosing not to get vaccinated. Concerns about safety, fear of unknown side effects, and misinformation about COVID-19 are some reasons why people may not accept the vaccine. The media stories about the FDA.
The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinicaltrial development as of November 2022.
Covid-19 Drugmakers Take On Your Favorite TV Shows to Tackle Vaccine Hesitancy ( WSJ ).
Regeneron resumes enrollment in lymphoma drugtrials ( Reuters ).
Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ).
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Now they fear an increase.
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