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A new computer algorithm might be the next step toward accurate prediction of adverse drug reactions..Researchers from Harvard Medical School and the Novartis Institutes for BioMedical Research announced the creation of an open-source machine learning tool capable of predicting drug adverse effects (Aes)...The study, published in The Lancet journal EBioMedicine, examined 2 databases: 1 that reported adverse drug reactions and another with 184 proteins that specific drugs are known to interact with. Investigators constructed a computer algorithm to develop associations between the drug reactions and the 184 individual proteins...The algorithm discovered 221 associations, some known and some new. These associations indicated which proteins contribute to certain AEs and which may not...The new algorithm could help predict these AEs before the drug goes to human clinical trials, as well as before and after it enters the market...READ MORE

Bayer said...that it will pay up to $10.9 billion to settle litigation over the weedkiller Roundup, which has faced thousands of lawsuits over claims it causes cancer...The company said the settlement over Roundup, which is made by its Monsanto subsidiary, involves about 125,000 filed and unfiled claims. Under the agreement, Bayer will make a payment of $8.8 billion to $9.6 billion to resolve current litigation, and $1.25 billion to address potential future litigation, even as the company continues to maintain that Roundup is safe...READ MORE

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

Fast progress by several companies has spurred hopes that a vaccine is coming soon, spurring jockeying among governments to secure supplies…Scientists, drugmakers and governments are moving with unprecedented speed to deliver a vaccine to protect against the new coronavirus…The fastest of them have already delivered preliminary data from human studies, and further results from others should come quickly as the year progresses…The goal, at least in the U.S., is to have a vaccine ready for use in some fashion by the end of the year, or early next. Doing so would be a scientific feat with few parallels. No vaccine has ever been developed so quickly, never mind manufactured for the world…Vaccine frontrunners plan for fast development…READ MORE

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

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

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

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

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

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