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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

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

Fewer Americans were admitted to emergency departments with life-threatening conditions such as heart attacks during the initial months of the COVID-19 pandemic,..The study suggests that patients may be delaying or avoiding seeking care because of fear of COVID-19, researchers from the U.S. Centers for Disease Control and Prevention said...study...showed that the number of deaths in New York City from causes other than COVID-19 rose by more than 5,000 people above the seasonal norm during the first two months of the pandemic...Visits to the emergency department because of heart attacks fell 23%, ten weeks after the pandemic was declared a national emergency, compared with ten weeks before the emergency declaration...READ MORE

The Trump administration's quest for drug prices in TV ads just took another hit—and it might be a fatal blow. A U.S. appeals court agreed with a lower court ruling that found the U.S. Department of Health and Human Services didn't have the authority to require them...It was a big win for Merck & Co., Eli Lilly and Amgen along with the Association of National Advertisers, which sued last June to block the rule that would have forced drugmakers to include list prices in TV ads...Their argument? HHS has no statutory authority to create the rule in the first place, and even if it did, the rule violates the First Amendment...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

New York pharmacists can provide the coronavirus disease 2019 vaccine when it becomes available, according to new legislation...The Community Pharmacy Association of New York State and NACDS praised the new law, based on legislation (S. 8182-A / A. 10508-A) that adds COVID-19 to the list of illnesses for which pharmacists can vaccinate...The legislation was...was signed into law by New York Governor Andrew Cuomo...“Now is the time to make sure that people will be able to get their COVID-19 vaccination as soon as it becomes available. It is essential that all states continue to remove barriers for pharmacies to help meet the needs of patients during this phase of the pandemic,”...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

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

In the high-stakes patent fight between Biogen and Mylan over Tecfidera’s main remaining patent, Mylan has scored a major win in federal court...U.S. District Judge...said Mylan “demonstrated by clear and convincing evidence” that certain claims of Biogen’s '514 patent are invalid for “lack of written description.”...The decision threatens Biogen’s bestselling medicine with early generics; Tecfidera, a multiple sclerosis drug, generated $3.3 billion in the U.S. last year. The company's '514 patent is set to expire in 2028, meaning the decision, if upheld, could wipe out years of monopoly sales...Biogen is also facing patent challenges in Delaware federal court. That court's decision will also factor into the ongoing efforts by generics companies to launch copycats...READ MORE