- High Prices Forcing Americans to Buy Prescription Drugs From Overseas (newsmax.com)Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries (jamanetwork.com)
More than 2 million Americans buy prescription drugs from other countries as a way around rising prices in the United States, a new study finds...The analysis of nationwide survey data showed that 1.5% of adults got their prescription meds from outside the United States between 2015 and 2017...Immigrants and people who were older or who had inadequate health insurance coverage and tight budgets were more likely to do so. Those who use the internet for health care information were, as well, the findings showed...The number of Americans looking for cheaper prescription drugs is likely to rise due to the spike in unemployment stemming from the coronavirus pandemic and the loss of work-based health insurance...READ MORE
- U.S. demand outstripping supply of steroid treatment for COVID (reuters.com)Hospitals see shortages of a cheap steroid that one study says helps Covid-19 patients (statnews.com)FDA Drug Shortages (accessdata.fda.gov)
Soaring hospital demand for the steroid dexamethasone, which British researchers say significantly reduces mortality among severely ill COVID-19 patients, is outstripping supply of the drug, but hospitals have so far been able to treat patients out of their inventories, according to Vizient Inc, a drug buyer for about half of U.S. hospitals...Hospitals and other health-care customers advised by Vizient increased orders of the drug by more than 600% after the researchers announced their findings last week. Manufacturers were only able to fill around half of those orders...dexamethasone reduced death rates by nearly a third among COVID-19 patients requiring mechanical breathing assistance...The injectable version of dexamethasone has been in shortage in the U.S. since February of last year, according to the U.S. Food and Drug Administration...READ MORE
- New fair price for Gilead’s remdesivir? Below $2,800 if dexamethasone lives up to its COVID-19 promise (fiercepharma.com)
Gilead Sciences' remdesivir should be priced at no higher than $2,800 if peer-reviewed dexamethasone data support the steroid as the new COVID-19 standard of care, the Institute for Clinical and Economic Review says...Nearly two months ago, an influential drug cost watchdog pegged $4,460 as the fair price for Gilead Sciences’ authorized COVID-19 therapy remdesivir. But on coronavirus time, that's an eternity—and a lot has changed since then...In an updated assessment...the Institute for Clinical and Economic Review slightly dialed up its cost-effective price for remdesivir to a range of $4,580 to $5,080 based on detailed clinical data, updated cost estimates and interactions with Gilead...A recent announcement from U.K. researchers on the successful use of low-cost dexamethasone in a large COVID-19 clinical trial added another wrinkle to the price. That is, if the steroid’s benefits are confirmed in a peer-reviewed paper and therefore qualify it as the new standard of care, remdesivir’s cost should be cut to around $2,520 to $2,800, ICER said...READ MORE
- It’s the end of road for hydroxychloroquine in COVID-19 as Novartis, NIH and WHO pull out of trials (fiercepharma.com)
The road for hydroxychloroquine against COVID-19 is coming to an end. Three major clinical programs have been terminated after a U.K. trial found “no clinical benefit” for the malaria drug...the World Health Organization, generic hydroxychloroquine maker Novartis and the U.S. National Institutes of Health have all ended their HCQ COVID-19 studies in hospitalized patients in quick succession...The WHO and NIH cited lack of benefits for patients, while Novartis blamed “acute enrollment challenges.”...Numerous investigator-sponsored trials may still be underway, but none of them has the scale of these three to yield any convincing results...READ MORE
- Gilead’s long-awaited remdesivir price is $3,120, in line with watchdog estimates (fiercepharma.com)
Industry watchers and pharma critics have spent the past two months pitching their calculations on how Gilead Sciences would—and should—price remdesivir after the repurposed antiviral drug became the first to show benefits for COVID-19 patients in a large controlled study...the guessing is over...For private insurance plans, Gilead set a list price of $520 per vial...The cost for a five-day treatment course using six vials, which most patients are expected to receive, would add up to $3,120. For governments of developed countries, including the U.S., the price will be lower, at $390 per vial or $2,340 per course...The prices are roughly in line with those an influential U.S. drug cost watchdog pegged on the drug in its latest cost-effectiveness analysis, but came below the sticker Wall Street was expecting...READ MORE
- Vaccine makers face biggest medical manufacturing challenge in history (reuters.com)
Developing a COVID-19 vaccine in record time will be tough. Producing enough to end the pandemic will be the biggest medical manufacturing feat in history...From deploying experts amid global travel restrictions to managing extreme storage conditions, and even inventing new kinds of vials and syringes for billions of doses, the path is strewn with formidable hurdles, according to Reuters interviews with more than a dozen vaccine developers and their backers...Any hitch in an untested supply chain - which could stretch from Pune in India to England’s Oxford and Baltimore in the United States - could torpedo or delay the complex process...READ MORE
- NIH launches analytics platform to harness nationwide COVID-19 patient data to speed treatments (nih.gov)
The National Institutes of Health has launched a centralized, secure enclave to store and study vast amounts of medical record data from people diagnosed with coronavirus disease across the country. It is part of an effort, called the National COVID Cohort Collaborative (N3C), to help scientists analyze these data to understand the disease and develop treatments. This effort aims to transform clinical information into knowledge urgently needed to study COVID-19, including health risk factors that indicate better or worse outcomes of the disease, and identify potentially effective treatments...READ MORE
- Health agency: Data entry error caused bulge in case reports (apnews.com)
Nevada on Saturday reported a record daily increase of additional confirmed COVID-19 cases. But health officials later said the bulge largely resulted from laboratory data entry errors that delayed the posting of hundreds of cases from two previous days...The state Department of Health and Human Services reported an additional confirmed 1,099 cases, mostly from metro Las Vegas...The number of additional cases reported Saturday was more than double the previous record of 507 reported Thursday. Bur the Southern Nevada Health Agency said the reported daily increase included over 600 cases that should have been reported earlier in the week but were not...READ MORE
- Nevada’s already slim physician workforce may grow slimmer with patients slow to return to doctor’s offices (thenevadaindependent.com)
A majority of Nevada doctors believe they can only keep their doors open for another two to six months unless the volume of patients trickling back into their offices significantly increases, according to a new survey from the American Medical Association...Ten percent of physicians in Nevada reported layoffs, 15 percent reported pay cuts, 20 percent reported temporary furloughs and 30 percent reported a reduction in staff hours, while 55 percent reported none of those changes, according to preliminary results from the survey, which Dr. Ron Swanger, president of the Nevada State Medical Association, presented to the Patient Protection Commission...READ MORE
- FDA Publishes Guidance on CGMP Requirements During COVID-19 (pharmtech.com)
FDA published guidance on June 19, 2020 detailing the agency’s recommendations for current good manufacturing practices (CGMP) requirements for addressing COVID-19 infection in employees engaging in drug manufacturing. The guidance was issued to help mitigate and prevent effects on drug safety and quality by employees confirmed to be either infected with COVID-19 or potentially exposed to someone with COVID-19...READ MORE