Metagenomics offers advances for infectious disease diagnostics by providing the diagnostic technology to detect a potentially unlimited numbers of known and novel microbes from a single sample in one test.
The two companies are working together to detect instances of the more contagious B.1.1.7 variant in the U.S. After Colorado identified the first case in the U.S. on Dec. 28, more than 60 cases have since been found across the country.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.
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 company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
The company emphasized that the partial hold was due to "additional questions" about the study, including the delivery device being used, and was not related to any adverse events. As such, the Phase I study of the vaccine, INO-4800, is proceeding.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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 placebo-controlled trial, ENSEMBLE, will enroll up to 60,000 healthy volunteers on three continents. The trial will test the vaccine JNJ-78436735, also known as Ad26.COV2.S.
The New York Times reported that in a memo, Alex Azar stated that the power to sign new rules is "reserved" for him, a move that one expert called a "power grab." It is unclear how it will affect authorizations of vaccines against the coronavirus.
Actemra reduced the percentage of patients with Covid-19 pneumonia who progressed to requiring mechanical ventilation, but did not show an improvement in mortality, time to discharge or improvement on an ordinal scale of clinical status. Results of the Phase III COVACTA study, announced in July, were negative.
Protocols - essentially the blueprints for clinical trials - are typically kept under wraps until studies are complete, but Pfizer and Moderna have made the ones for their SARS-CoV-2 trials public in a transparency push.