About Covid-19
More than 1 in 10 people have missed their second dose of Covid-19 vaccine: “As of June 16, about 88% of those who received one dose of vaccine and were eligible for their second -- recommended 21 days after the first Pfizer/BioNTech shot or 28 days after the first Moderna shot -- had completed their two dose series, according to data shared with CNN by the US Centers for Disease Control and Prevention.
That's down from a 92% completion rate earlier in the year.”
U.S. approves Roche drug for emergency use against severe COVID-19: “U.S. health regulators have approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19.”
Nearly all COVID deaths in US are now among unvaccinated: “An Associated Press analysis of available government data from May shows that “breakthrough” infections in fully vaccinated people accounted for fewer than 1,200 of more than 853,000 COVID-19 hospitalizations. That’s about 0.1%.
And only about 150 of the more than 18,000 COVID-19 deaths in May were in fully vaccinated people. That translates to about 0.8%, or five deaths per day on average.”
Lilly's COVID antibody combo halted nationwide, dealing huge blow to blockbuster program: “Eli Lilly's COVID-19 antibody cocktail has already been on the outs in several states over fears of reduced variant efficacy. Now, the U.S. has decided to extend that policy nationwide.
With a pair of troubling coronavirus variants on the rise, the U.S. is pausing the national distribution of Eli Lilly’s COVID-19 antibody combo of bamlanivimab and etesevimab until further notice, the HHS Assistant Secretary for Preparedness and Response said Friday.”
U.K. doubles down on Innova's rapid COVID-19 test, after FDA urged users to throw it away: “A week after the FDA urged anyone who had Innova Medical Group’s COVID-19 antigen test to stop using it and toss it in the trash, regulators across the pond have cleared the rapid diagnostic's use and extended its authorization.
The U.K. Medicines and Healthcare products Regulatory Agency said it found no problems in its own assessment of the test, which it carried out after the FDA delivered a warning letter to the company for pre-emptively delivering unreviewed products to a number of customers and making accuracy claims that did not match up with clinical data.”
Israel to reinstate indoor mask mandate next week as COVID-19 cases keep rising: “Coronavirus czar Nachman Ash announced Thursday that the indoor mask mandate, obligating people to cover their mouths and noses to prevent infections, will return early next week in an effort to stem the rise in COVID-19 cases.
In a briefing with journalists Thursday evening, Ash said the outbreak had spread to Kfar Saba, Ramla, Herzliya and other cities, as Health Ministry data showed 169 had been diagnosed Thursday by 6 p.m., the highest daily tally in months.
Ash recommended avoiding flights abroad, especially for people who have not been vaccinated.”
FDA greenlights its first saliva-based COVID-19 antibody test: ”Developed by Diabetomics, the rapid, lateral-flow diagnostic received an agency emergency authorization allowing it to be used at the point of care for adults and children. Designed to deliver a result within 15 minutes, the CovAb test also does not require any additional hardware or instruments.
When administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels, the test demonstrated a false-negative rate of less than 3% and a false-positive rate of nearly 1%…”
About pharma
Sanofi, Translate Bio start seasonal mRNA flu vaccine trial, gaining early lead over Moderna and Pfizer: “Sanofi and Translate Bio have started a phase 1 clinical trial of an mRNA vaccine for seasonal influenza. The initiation of the study puts the partners ahead of Moderna and Pfizer in the race to show mRNA vaccines are as good or better at preventing flu than existing technologies.
The validation of mRNA technology by vaccines against COVID-19 has ramped up interest in using the approach to protect against seasonal flu.”
Pfizer halts global distribution of smoking cessation pill as it tests for potential carcinogens: “After finding potential carcinogens in some lots of Chantix, Pfizer late last month halted worldwide distribution of its smoking cessation pill.
The drug maker, which is now running tests, took this step after finding nitrosamine levels that were above an ‘acceptable’ daily intake, according to the company. “
About the public’s health
Trends in Prevalence of Diabetes and Control of Risk Factors in Diabetes Among US Adults, 1999-2018: “In this serial, cross-sectional study of nationally representative data from 28 143 participants in the National Health and Nutrition Examination Survey (NHANES), the estimated age-standardized prevalence of diabetes increased significantly, from 9.8% in 1999-2000 to 14.3% in 2017-2018. Only 21.2% of adults with diagnosed diabetes achieved all 3 risk factor control goals in 2015-2018, including individualized hemoglobin A1c targets, blood pressure less than 130/80 mm Hg, and low-density lipoprotein cholesterol level less than 100 mg/dL.”
Estimated Cost-effectiveness of Solar-Powered Oxygen Delivery for Pneumonia in Young Children in Low-Resource Settings: Often low-cost solutions are first employed in other countries and then find their way to the US. This invention is one such innovation to watch. “The results of this economic evaluation suggest that solar-powered O2 is a cost-effective intervention for pediatric patients with hypoxemia in low-resource settings.”
About health insurance
Missouri judge strikes down state's Medicaid expansion, dealing blow to Centene and Biden admin: “State Judge Jon Beetem issued an opinion Wednesday that the ballot initiative to approve the expansion in August 2020 did not include any requirement for the state to appropriate funds for the expansion…
A federal court ruled in June 2020 before the Aug. 4 vote that the initiative didn’t create a revenue source nor direct the state’s legislature to appropriate funds, according to a release from the governor’s office.
[Gov. MIke] Parsons asked the legislature for $1.9 billion to fund the expansion but was denied.”
About healthcare IT
Startups using AI to tackle malaria, mental health and human trafficking take top awards, and cash, from IBM XPrize: “An Israeli startup that uses artificial intelligence and other tech tools to wipe out malaria took the top prize in IBM Watson's AI competition, nabbing $3 million to expand its operations.
ZzappMalaria, a subsidiary of Sight Diagnostics, developed an AI-powered mobile app and dashboard to tackle malaria on the eradication level, specifically in developing countries…
Aifred Health, a digital health company focused on clinical decision support in mental health, took second place in the AI competition, banking $1 million. The startup uses AI to learn from thousands of patients to help tailor treatment, reducing the time it takes for a patient to reach remission.”
States’ Actions to Expand Telemedicine Access During COVID-19 and Future Policy Considerations: A really good review of this topic from the Commonwealth Fund.
About medical devices
Boston Scientific shells out a hearty $295M for Farapulse's electric-field-generating afib treatment: “Boston Scientific has exercised an option to acquire Farapulse in full, per [a] September 2020 agreement. The company already holds a 27% stake in Farapulse and will put down about $295 million to pick up the remainder…
With Boston Scientific’s support, Farapulse will be able to accelerate its work toward FDA clearance for its ablation system for atrial fibrillation and other cardiac arrhythmias..”
About diagnostics
Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set: Evidence is growing that demonstrates the utility of cancer diagnosis from blood samples (so-called liquid biopsies): “A multi-cancer early detection (MCED) test used to complement existing screening could increase the number of cancers detected through population screening, potentially improving clinical outcomes. The Circulating Cell-free Genome Atlas study (CCGA; NCT02889978) was a prospective, case-controlled, observational study and demonstrated that a blood-based MCED test utilizing cell-free DNA (cfDNA) sequencing in combination with machine learning could detect cancer signals across multiple cancer types and predict cancer signal origin (CSO) with high accuracy. The objective of this third and final CCGA substudy was to validate an MCED test version further refined for use as a screening tool.”
The study concluded:
”In a validation study, an MCED test identified a diversity of cancer signals with high specificity.
The MCED test predicted the origin of the cancer signal with high accuracy across multiple cancer types.
Results support the use of this MCED test on a population scale as a complement [emphasis added] to existing single-cancer screening tests.”