The guidance calls for a median two months' worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.
While the White House and doctors at Walter Reed have sought to reassure the public that Trump's condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
The company, which also published Phase I data from its Phase I/II study earlier this month, is enrolling 10,000 volunteers aged 18 to 84 for the placebo-controlled trial of the vaccine against SARS-CoV-2, NVX-COV2373.
The agency's Covid-19 Treatment Guidelines Panel stated there was insufficient evidence for or against the treatment and pointed out that in certain groups, such as intubated patients, no benefit in seven-day overall survival was observed.
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
The NIAID create the Covid-19 Prevention Trials Network by combining four existing ones, primarily focused on HIV and AIDS, which will continue that work in addition to their new focus on Covid-19.
The company is running a Phase I/II study that started in May in Australia and plans to open a Phase III study of its vaccine candidate, NVX-CoV2373, that will enroll up to 30,000 participants starting in the fall.
The agency issued a guidance for industry laying out its various recommendations for vaccine development. The announcement preceded the release of data from Pfizer and BioNTech's Phase I/II clinical trial of their messenger RNA vaccine.
UnitedHealthcare plans to offer individual marketplace plans in Maryland in 2021. The insurer is taking a second look at the ACA exchanges after it had largely exited them.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
While not necessarily faulting the FDA for granting a limited emergency use authorization to hydroxychloroquine and chloroquine despite little data to support their use in the pandemic disease, some interviewed experts said it risked politicizing the agency.
The agency said it had redeployed some staff and streamlined processes to enable it to review clinical trial protocols faster and respond faster to companies and scientists developing new drugs for the disease.
HelpAround raised $6 million in funding from IQVIA and Windham Ventures. The company’s software is designed to make it easier for patients to navigate specialty prescriptions.
The company is developing phage-based therapies designed to target specific bacteria strains, as contrasted with antibiotics, which target multiple types of bacteria.
The researchers wrote that RWE could complement trials, but that observational methods are unlikely to take away the need for traditional clinical studies.