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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

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

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

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

Pfizer’s rare heart disease med Vyndaqel, at $225,000 a year, is too pricey for many patients. To help Medicare participants afford the expensive drug—and maintain its hefty sticker price—the Big Pharma is going as far as to argue the U.S. government’s anti-kickback policy is unconstitutional...Pfizer questions two federal regulations that prohibit drugmakers from offering direct payments to help cover a drug’s cost or working with charity programs to direct their funding—and Medicare patients—to a particular medicine...If Pfizer's argument succeeds, essentially, it would open up federal insurance programs to the sort of copay assistance drugmakers often offer to privately insured patients, particularly for pricey medications and new launches...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 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

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

FDA enlists AstraZeneca as first cancer drugmaker in its program to publish patient-reported symptoms that came up in clinical trials...The FDA and AstraZeneca are going beyond the label with cancer drugs—literally. In a new pilot program, the FDA will publish patient-reported symptoms that are collected during clinical trials but typically go undisclosed...The additional information includes 28 different symptoms that patients reported during the trial, ranging from dry mouth and itchy skin to shaking chills and hair loss. The disclosure lists the percentage of patients on each regimen who experienced a given symptom...The FDA said its goal is to get more information into the hands of physicians and patients to help make decisions about cancer treatments...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