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Pharma’s pursuit of innovative oncology drugs has hit a fever pitch like the industry has never felt. On the heels of a treatment revolution that has fundamentally changed how we understand, fight and, in some cases, can cure cancer, pharma is mobilizing at a dazzling speed to develop the next holy grail in oncology...The current generation of cancer treatments is also still stymied by a number of challenges including manufacturing issues, limited therapeutic benefits for many patients and sky-high prices that have drawn public ire...All told, oncology has become a segment of the industry that is both bursting at the seams and begging for further innovations. Recognizing the potential to help both patients and business, pharma has become obsessed with oncology...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

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

The coronavirus has upended the globe...Many companies have sent their employees home...Much attention, and rightly so, is focused on the drugs the biopharma industry is developing to treat COVID-19. But those efforts could disguise a cost to public health, too, in the form of stalled progress on experimental medicines for other diseases...Since the start of March, at least nine companies have reported some sort of disruption to a clinical trial as a result of the coronavirus pandemic. Such news is becoming more common, as medical centers across the world focus their precious resources on treating people infected with the coronavirus...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 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

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

Anthem faces a federal lawsuit for submitting inaccurate diagnostic data to get a higher Medicare reimbursement...The U.S. Attorney for the Southern District of New York said in the lawsuit...that Anthem failed to find and delete inaccurate diagnosis codes from 2014 to early 2018 through its “chart review program,”...“By ignoring its duty to delete thousands of inaccurate diagnoses, Anthem unlawfully obtained and retained from [Centers for Medicare & Medicaid Services] millions of dollars in payments under the risk adjustment payment system for Medicare Part C,” the lawsuit said...READ MORE

340B Health today asked the federal government to extend regulatory flexibility and financial support to safety-net hospitals participating in the 340B drug pricing program. In a pair of letters to leaders of the U.S. Dept. of Health & Human Services, 340B Health requested a series of policy changes under the public health emergency caused by the Coronavirus disease 19 pandemic...In a letter to HHS Secretary Alex Azar, 340B Health asked that the department take five key actions:

1. Delay implementation of a proposed survey of 340B hospitals on their drug acquisition costs so hospitals can focus on combating the pandemic;
2. Suspend the nearly 30 percent Medicare Part B payment reduction to 340B hospitals so these providers have the resources they need during this crisis;
3. Allow hospitals subject to the group purchasing organization (GPO) prohibition to purchase covered outpatient drugs through a GPO without the usual documentation requirements so hospitals can access drugs during the public health emergency that are subject to shortages;
4. Waive the Medicare disproportionate share (DSH) adjustment percentage requirements so hospitals currently participating in 340B won’t lose program eligibility due to their treatment of COVID-19 patients; and
5. Waive the quarterly enrollment periods to allow open registration for 340B-eligible covered entities, child sites, and contract pharmacies so safety-net providers can access the resources they need for their pandemic response.

“These steps would provide safety-net hospitals with much-needed assistance and flexibility to focus their attention on the growing patient treatment needs presented by COVID-19,”...READ MORE