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The Trump administration announced it will cover a vaccine for COVID-19 at no cost to Medicare beneficiaries...The Centers for Medicare & Medicaid Services released an interim rule on Wednesday that aims to remove regulatory barriers for seniors to get the vaccine, which is expected to be approved by early next year...READ MORE

...Purdue Pharma has signed a massive settlement to walk away from federal civil and criminal charges. But as the company wades throught court-supervised bankruptcy, will the government—or individuals hurt by Purdue's bad behavior—see anywhere close to that amount in damages?...Purdue has reached an $8 billion-plus deal with the U.S. Department of Justice to plead guilty and settle federal criminal and civil claims for its role in fueling the nation's opioid epidemic...Purdue has been assessed a $3.54 billion criminal penalty and will forfeit an additional $2 billion, the government said. The company has also agreed to pay $2.8 billion to settle the government's civil claims. In addition, the company's founding Sackler family will forfeit $225 million in civil damages...READ MORE

Food and Drug Administration advisory committee meetings tend to be staid, albeit important, events typically watched by a few dozen company representatives, scientists, investors and patient advocates...But next week's hearing on coronavirus vaccine studies will be set against the backdrop of a presidential election 12 days later that could turn on the White House's response to the pandemic, likely making it a closely-watched affair of historic proportions...In the meantime, here are five important questions that could feature at next week's meeting...READ MORE

• How will vaccine safety be monitored following an emergency clearance? After a full approval?
• How long will immunity last and how would it be measured?
• How will vaccine-induced enhanced respiratory disease be monitored?
• Has enough data been collected on vulnerable groups?
• Will future vaccine trials need to measure COVID-19 cases, or will immune response data be enough?

Pfizer’s fast-growing and costly heart meds Vyndaqel and Vyndamax have been the subject of drug pricing scrutiny since their launch in 2018. Now, they’re at the center of a Medicare copay lawsuit that could reverberate around the industry...meds list with prices of $225,000 per year, the company is suing the U.S. Department of Health and Human Services in an attempt to help with Medicare patients with their copays...kickbacks laws prohibit drugmakers from assisting with Medicare patient copays; companies can financially help patients on commercial insurance. The laws are designed to keep a check on drug prices, and one expert told Barron’s a ruling in Pfizer's favor “would be a major earthquake” for the industry...READ MORE

Walmart has filed suit against the United States Department of Justice and the Drug Enforcement Administration, asking a US District Court judge to clarify the roles and responsibilities of pharmacists and pharmacies under the Controlled Substances Act...Although Walmart’s pharmacies have blocked “thousands” of questionable physicians from having their opioids scripts filled by its pharmacists, “certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis,” the retailer said. “They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions.”...READ MORE

Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir). Previously authorized only for emergency use (EUA) in the U.S., the drug can now be prescribed to adults and children 12 and older weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization...READ MORE

After AstraZeneca’s move to stop selling discounted drugs to safety net providers through contract pharmacies, patient advocates took the drugmaker to task...protestors blasted the company’s recent decision to restrict the sale of discounted meds through contract pharmacies under the federally mandated 340B Drug Pricing Program. The program requires companies to discount medicines to hospitals and clinics that serve disadvantaged communities...But AstraZeneca isn’t alone in cracking down on drugs sold under the 340B program. Eli Lilly, Sanofi, Novartis and Merck & Co. have also implemented new restrictions or initiatives...seven hospital and pharmacy groups asked U.S. Department of Health and Human Services...to enforce the 340B rules following new moves from the companies...READ MORE

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections...COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections...The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products...READ MORE

A California panel of experts will independently review the safety of new coronavirus vaccines and initial plans for distribution, Governor Gavin Newsom said...The 11-person panel specializing in topics such as epidemiology, biostatistics, and infectious disease will review any vaccine approved by the Food and Drug Administration before it is distributed to state residents, Newsom told a news conference...The U.S. government’s efforts to speed development of a COVID-19 vaccine - and promises by U.S. President Donald Trump that one could be available prior to the Nov. 3 presidential election - has led to concerns of political interference in the regulatory process at the expense of safety. The FDA has vowed to ensure the safety of COVID-19 vaccines before approving them...READ MORE

Americans living or working in long-term care facilities, including nursing homes and assisted care living centers, will receive COVID-19 vaccinations for free if and when they become available, the Trump administration said...The administration announced a partnership with the nation's two largest drug store chains, CVS and Walgreens, "to provide and administer" the vaccines with "no out-of-pocket costs" for the recipients...READ MORE