About pharma
Most People Are Unlikely to See Drug Cost Savings From President Trump’s “Most Favored Nation” Proposal:”If a “most favored nation” approach was limited to setting prices for prescription drugs covered by Medicare Part B only, it could lower drug costs for approximately 4 million Medicare beneficiaries, based on the number of people who used Part B drugs in 2018 (just 7% of all 60 million beneficiaries covered by Medicare). However, it would have no direct impact on the lion’s share of drug spending under Medicare for prescriptions filled by the 45 million beneficiaries covered under Medicare Part D, nor would it lower drug costs for the 157 million people with employer coverage or for millions more with other insurance coverage or no coverage whatsoever.”
US government’s Darpa probes Moderna’s vaccine patents: In a report published last week, “researchers at Knowledge Ecology International (KEI), a patient advocacy group, said Moderna failed to disclose in its vaccine patents that it had received about $25m in grants from the DoD’s Defense Advanced Research Projects Agency, or Darpa, to develop its vaccine technology.” The disclosure will impact royalties due to the US government.
One shot of coronavirus vaccine likely won't be enough : The headline speaks for itself. The article is a nice update on the leading vaccine research companies.
FDA expands emergency use of Gilead's remdesivir in hospitalized COVID-19 patients: “U.S. Food and Drug Administration expanded the emergency use authorization of its experimental antiviral COVID-19 treatment, remdesivir, to allow its use in all hospitalized COVID-19 patients.” It had previously been authorized only in severe cases.
Researchers Eye Potential 'Broad-Spectrum' Antiviral Discovery for Covid-19: “Dubbed a ‘broad-spectrum antiviral strategy’ for Covid-19 and other viral infections, the finding by a team of microbiologists at the University of Hong Kong could eventually lead to a medicine that could stop a half-dozen known respiratory viruses as well as new threats the world has yet to encounter.
The discovery centers on a broad-spectrum antiviral peptide known as P9R that the researchers hope will lead to a possible defense against the novel coronavirus -- officially called SARS-CoV-2 -- as well as the viruses that cause MERS, SARS and the H1N1 flu. So far, the research has been limited to mice in the lab, but if effective, it could change the "one bug, one drug," approach to viral outbreaks, say the scientists…”
The research was published in the Journal Nature Communications.
Eli Lilly, Boehringer's Jardiance slices CV events by 25% in Farxiga-matching heart failure trial: “AstraZeneca put the rest of the SGLT2 inhibitor class on notice when its Farxiga scored an FDA heart failure nod in patients with or without diabetes. One of its competitors, Eli Lilly and Boehringer Ingelheim's Jardiance, is fast on Farxiga's heels, though, and it's ready to bring its pivotal trial win in front of physicians. Jardiance, added to standard of care therapy, sliced the risk of cardiovascular hospitalizations or death by 25% over placebo in heart failure patients with or without Type 2 diabetes, according to late-breaking science set to be presented Saturday at the European Society of Cardiology virtual annual meeting.”
Also, see: AstraZeneca's Farxiga cuts kidney disease risks by 39% in trial that could 'rewrite' the treatment textbook.
Walgreens names former Rite Aid CEO as its new president:”Walgreens has named former Rite Aid CEO John Standley as its new president, effective immediately.
Mr. Standley will lead all Walgreens operations and be responsible for the development, growth and management of the business. He previously served as president, CEO and chair of Rite Aid as well as CEO of the Pathmark supermarket chain and has held leadership roles in several other grocery and retail companies.
Mr. Standley was also a former chair of the National Association of Chain Drug Stores.”
The top 10 global R&D institutes:”We ranked the top institutes using the Nature journal’s Index, rather than direct funding amounts, given that all these institutes have investments beyond life sciences.
The Index tots up the largest contributors to papers published by a subset of 55 journals among the 82 journals tracked by the Nature Index from January 2015 to December 2018.”
Harvard and the NIH top this global list.
About the public’s health
FDA commissioner says willing to fast-track COVID-19 vaccine: “The head of the U.S. Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on Sunday.
Dr. Stephen Hahn, the FDA Commissioner, said his agency was prepared to authorize a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks…” And in a related article: UK to Allow Emergency Use of Any Effective COVID-19 Vaccine: “The UK has unveiled a proposal that would empower the Medicines and Healthcare Products Regulatory Agency (MHRA) to temporarily authorize effective COVID-19 vaccines while they are still under review.”
However: Covid vaccine rush could make pandemic worse, say scientists: “The experts say the world would be better served by waiting until comprehensive results showed vaccines with at least 30% to 50% effectiveness…”
U.S. coronavirus cases top six million as Midwest, schools face outbreaks: “U.S. cases of the novel coronavirus surpassed six million on Sunday as many states in the Midwest reported increasing infections, according to a Reuters tally.”
HHS cancels remainder of Philips' contract for 43K ventilators: This news goes along with the easing of COVID-19 related hospitalizations.
U.S. Will Revive Global Virus-Hunting Effort Ended Last Year: “The government agency that let Predict die last October has quietly created a $100 million program with a similar purpose as Predict, but it has a different name. The new program, set to begin in October, will be called Stop Spillover.
Predict, which was started in 2009 as part of the Obama administration’s Emerging Pandemic Threats program, was inspired by then 2005 H1N1 bird flu scare. Predict was run by the United States Agency for International Development, which is an independent foreign-aid agency overseen by the State Department.
Predict was an odd fit for USAID, experts said. Unlike the Centers for Disease Control and Prevention or the National Institutes of Health, the agency is not normally a home to cutting-edge science.
The American response to pandemics is strangely fragmented. The C.D.C. investigates outbreaks, while the National Institute of Allergy and Infectious Diseases pursues vaccines. Much research into tropical diseases and bioweapons is done by the military, legacies of the Spanish-American War and the Cold War, while the State Department coordinates global campaigns against AIDS.”
Empiric Antibacterial Therapy and Community-onset Bacterial Co-infection in Patients Hospitalized with COVID-19: A Multi-Hospital Cohort Study: “The prevalence of confirmed community-onset bacterial co-infections was low. Despite this, half of patients received early empiric antibacterial therapy. Antibacterial use varied widely by hospital. Reducing COVID-19 test turnaround time and supporting stewardship could improve antibacterial use.”
COVID-19 Not Likely to Be Transmitted by Breast Milk: Study:”No cases of an infant contracting COVID-19 from breast milk have been documented, but questions about the potential risk remain.
Researchers examined 64 samples of breast milk collected from 18 women across the United States who were infected with the new coronavirus (SARS-CoV-2) that causes COVID-19.
One sample tested positive for coronavirus RNA, but follow-up tests showed that the virus couldn't replicate and therefore, couldn't infect the breastfed infant…”
Clinical Characteristics and Viral RNA Detection in Children With Coronavirus Disease 2019 in the Republic of Korea: “In this case series of 91 children with COVID-19 in Korea, 22.0% were asymptomatic. Only 8.5% of symptomatic cases were diagnosed at the time of symptom onset, while 66.2% had unrecognized symptoms before diagnosis and 25.4% developed symptoms after diagnosis; SARS-CoV-2 RNA was detected for a mean of 17.6 days overall and 14.1 days in asymptomatic cases.” In other words, asymptomatic children can harbor the virus and be infectious for two weeks.
COVID-19 reinfection reported in Nevada patient, researchers say: First documented case of reinfection in the US. “The case involves a 25-year-old man living in Reno, Nevada, who first tested positive for COVID-19 in mid-April. He recovered, but got sick again in late May. The second time around, his illness was more severe, the case report said.”
About health insurance
Trump Program to Cover Uninsured Covid-19 Patients Falls Short of Promise: The headline speaks for itself and the article gives examples.
COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing: Latest update from CMS.
CMS rule aims to reduce lag time between FDA approval and Medicare coverage of new devices: “For devices approved under the new process, Medicare would give national coverage simultaneously with FDA approval. The coverage would extend for four years.” Other countries approve technology and pricing at the same time. But the process is not necessarily shorter, since costs need to be determined for Medicare passthrough payment purposes.
About healthcare IT
Vast majority of specialists increased use of telehealth tech during COVID-19 pandemic: ”Nearly 80% of cardiology, gastroenterology, pulmonology and respiratory physicians polled for a new survey said their use of virtual care technology has increased.”
Children’s National Study Ties Telehealth to Better Antibiotic Stewardship: “The study, published this week in the Journal of General Internal Medicine, found that providers using a virtual care platform with real-time access to their own prescribing statistics as well as practice-wide statistics reduced their prescribing rates. That would help reduce the estimated 2.8 million antibiotic resistant infections that occur each year in the US.”
Amazon unveils Halo to battle Apple Watch and Fitbit — tracks activity, body fat, emotions: More information on this new technology. One particularly interesting feature is “Tone.”
“Tone is an optional feature that listens to the user’s voice throughout the day and analyzes that information to present a picture of how they felt -- for instance, showing times they were feeling energetic, hopeful, or hesitant. For instance, the device might pick up on an argument, or a tense conversation at work, and indicate that the user felt elated at 10 a.m. but hesitant 30 minutes later. Amazon says none of the voice-based snippets are stored in the cloud and they’re automatically deleted once they’re processed. The company also said it won’t use the voice recordings for targeted advertising.”
About healthcare quality
Medical Errors Climb After Daylight Saving Time Switch: “Sleep medicine academy calls for DST to be abolished.
Medical errors increased the week after the spring switch to daylight saving time (DST) in a large healthcare system, an observational study showed.
Safety-related incidents stemming from human errors increased by 18.7% (95% CI 5.6%-33.6%, P=0.004) in the week after the spring time change, reported Bhanu Prakash Kolla, MD, of the Mayo Clinic in Rochester, Minnesota, and co-authors, at the virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and Sleep Research Society.”