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Pharmaceutical companies Novartis and Rising Pharmaceuticals are taking action to support the latest clinical trials exploring hydroxychloroquine as a treatment for the coronavirus disease 2019...Novartis announced March 30 that it is donating 20,000 doses of hydroxychloroquine to the University of Washington for a COVID-19 PEP clinical trial, which is expected to provide approximately 2000 patients with a 14 post-exposure regimen...Earlier in March, Novartis committed to donating up to 130 million doses, or 200mg tablets, of generic hydroxychloroquine to support COVID-19 research...Rising Pharmaceuticals has announced a collaborative agreement with the Division of Infectious Disease and International Medicine at the University of Minnesota, Department of Infectious Disease on a clinical trial investigating hydroxychloroquine as a preventive treatment for COVID-19...READ MORE

As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.,,READ MORE

Associations representing generic drug makers, health insurers, pharmacy benefit managers and pharmacies have sent a letter to top administration and congressional leaders laying out how some policies and proposals to fight COVID-19 are making the situation worse...In an unusual display of coordinated frankness for the industry, a coalition representing generic drug makers, insurers, pharmacies and benefit managers told Vice President Mike Pence and congressional leaders that some policies in place or under consideration to fight COVID-19 are making it difficult and more expensive for patients to get some drugs...Signers of the letter are the Academy of Managed Care Pharmacy, America’s Health Insurance Plans, the Association for Accessible Medicines, the Blue Cross Blue Shield Association, the National Association of Chain Drug Stores, the National Association of Specialty Pharmacy, the Pharmaceutical Care Management Association and Pharmaceutical Research and Manufacturers of America...READ MORE

The specter of global drug shortages looms large amid the coronavirus pandemic. But so far, the supply chain is holding steady and prices are going up—in the generic drug business, at least. One analyst, in fact, figures COVID-19 could turn out to be a profitable time for the generics industry...After some "initial shocks" from COVID-19, the global generic drug supply chain is likely to rebound and deliver strong growth numbers despite some potential "spot shortages,"...A potent mixture of patient and channel stockpiling and manufacturer "allocation" measures will drive generics pricing upward in the short term...READ MORE

There are lots of numbers swirling around in the time of coronavirus: Confirmed cases of COVID-19, people tested, number of hospitalizations and, increasingly, new deaths...There are also other data points revealing the finer points of how the virus is affecting people, such as the age and gender of those who have tested positive and what pre-existing conditions people hospitalized after contracting the novel coronavirus have...But those numbers can be difficult to parse without context. Below, The Nevada Independent explores that data and puts it into context, walking through what we do and don’t know about coronavirus in Nevada, how Nevada stacks up against other states and projections for the future...READ MORE

During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products. The agency is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response. Here is a status update and details on some of the latest actions we have taken:...READ MORE

Medical Devices

Human Drugs & Biologics and Animal Drugs

Blood Supply

Human and Animal Food

Veterinary Medicine

Here are seven things you may have missed in the enormous $2 trillion economic stimulus package...includes major requirements for insurers to cover diagnostics and services associated with COVID-19 and gives some flexibility to hospitals...But the bill, which includes massive unemployment assistance and help to businesses, includes several other healthcare provisions...READ MORE

1. Requiring Medicare Part D and Medicare Advantage plans to allow for refills and fills for up to three months.
2. Extending healthcare programs through November.
3. Waiving site-neutral payment cuts, 50% rule for long-term care hospitals.
4. Eliminating Medicare sequester and boosting Medicare payments for COVID-19 payments.
5. Requiring payers to cover hospital-made tests.
6. Publishing the cash price for diagnostic testing.

Requiring group and individual health plans to cover preventive services.

The U.S. Food and Drug Administration said malaria drugs hydroxychloroquine and chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic...The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency's website that lists drug shortages on Tuesday...Studies are underway in a number of countries to see whether hydroxychloroquine and the related malaria drug chloroquine may be effective in controlling the spread of coronavirus, which has led to a surge in demand for the treatments...READ MORE

The Food & Drug Administration has authorized the use of two drugs championed by President Donald Trump as a means to fight coronavirus...On Sunday night the FDA issued an emergency authorization for the use of two anti-malaria drugs, hydroxychloroquine and chloroquine. Researchers in the United States have begun testing the drugs in some states, like New York, but the drug will now be more widely available...The FDA has allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” the department of Health and Human Services said in a statement...READ MORE

News about COVID-19 runs rampant on the internet and changes by the hour, or even by the minute. It’s difficult to stay on top of what’s happening, much less what’s important, in the life sciences industry without scrubbing the entire internet. That's what W2O Group and the California Life Sciences Association (CLSA) are looking to change with a new data-driven platform...Their jointly launched dashboard, called COR, uses W2O’s machine and artificial intelligence data engine to scrape its life science industry data set for news and posts mentioning COVID-19. It then serves up the top-ranked information across different sectors—life sciences, healthcare providers, media, California, and the scientific community—to reveal what’s trending in each one from that segment’s leading voices and sources in almost real time...READ MORE