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Russia..became the first country to approve a coronavirus vaccine, a move that was met with international skepticism and unease because the shots have only been studied in dozens of people...President Vladimir Putin announced the Health Ministry’s approval and said one of his two adult daughters already was inoculated. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness...READ MORE

Hospital executive minds have understandably been distracted since the start of 2020, but the impact of the emergence of SarsCoV2 has not been limited to its physical toll. It has also torn into data security defenses and exposed patient privacy...The word ‘unprecedented’ seems to have been used on a daily basis during the COVID-19 pandemic, particularly when it comes to the impact of the virus on patients, clinicians, resources and care delivery. But it has resonated equally strongly with hospital chief information security officers, with its power to either stiffen resolve or ratchet up already stretched nervous tension as data security faces a whole new scale and level of cyber threats...READ MORE

President Donald Trump...signed an executive order aimed at boosting U.S. production of medicines and medical equipment, lowering drug prices and protecting the United States against shortfalls in a future pandemic...Trump said the order would also support advanced manufacturing processes that would benefit U.S. pharmaceutical companies...The long-awaited measure includes a “Buy America” provision mandating federal purchases of certain medical supplies and equipment deemed essential and moves to remove regulatory hurdles to approval of new U.S. drugs...READ MORE

A recent study suggests that fewer patients sought camcer(sic)-related care as a result of the coronavirus disease 2019 pandemic...Published in JCO Clinical Care Informatics...the study...measure(d) the effects of the pandemic on normal cancer care activities, including cancer screening efforts...the most significant findings...relate to cancer screening...declines in mammograms and colorectal cancer screenings...According to the investigators, the data indicate underlying trends observed using diagnosis data and suggest a potential increase in the presentation of later-stage disease for newly diagnosed patients in future months...READ MORE

India's Wockhardt and the Serum Institute of India have lined up new deals to help ramp up the production of two coronavirus vaccines advancing quickly through clinical testing...Wockhardt's 18-month agreement with the U.K. government covers fill/finish work for a vaccine under development by the University of Oxford and AstraZeneca. The Serum Institute, meanwhile, entered a wide-ranging pact with Maryland-based Novavax, covering development, production and commercial licensing of its experimental shot...India is already a key supplier to the global drug industry, producing pharmaceutical ingredients, vaccines and other medicines. The two agreements boost the country's role in making the likely billions of needed doses of coronavirus vaccines, a task being shouldered by nations around the world...READ MORE

Washington, Oregon, Nevada and Colorado will share best practices for telehealth and remote patient monitoring, and follow their own state policies while also adhering to seven key principles, their governors say...Given their states' "significant individual and collective experience with telehealth," the governors say they'll work together to help "ensure that the nation benefits from our knowledge as changes to federal regulations are contemplated, to support continued application and availability of telehealth in our states, and to ensure that we address the inequities faced in particular by tribal communities and communities of color."...READ MORE
Access
Confidentiality
Equity
Standard-of-care requirements
Stewardship
Patient choice
Payment and reimbursement

As Covid-19 drives many patients away from in-person care and toward virtual visits, experts warn that the nation’s most vulnerable members may be shut out of the booming telehealth business...Federal policymakers temporarily relaxed regulations to make it easier to provide virtual care during the pandemic, fueling a shift toward telemedicine that has become so popular among patients and providers that there are now a number of proposals to make the changes permanent. Just this week, President Trump signed an executive order that would permanently extend some of those policies...But a pair of new studies published this week show that there are barriers to virtual visits that regulatory changes alone can’t fix...READ MORE

Johnson & Johnson has agreed to supply the U.S. government with 100 million doses of its experimental coronavirus vaccine, a stockpile that could be used either in clinical trials or, if cleared by the Food and Drug Administration, a widespread inoculation campaign...If necessary, the U.S. government can negotiate to buy up to 200 million additional doses of the shot, which would be available at no cost in any U.S. vaccination program, excepting charges from doctors for administration...READ MORE

The Trump administration’s surprising $765 million deal that would enable former photography giant Kodak to start making drug ingredients has yet to be finalized, and it’s already attracted plenty of controversy. First, insider trading allegations from the U.S. Senate—and now, an investigation by House Democrats...The lawmakers are questioning why the government picked Kodak, which has little experience in pharma manufacturing, for such a major pact, as well as suspicious stock transactions by company executives...READ MORE

Unhappy with the price and availability of Gilead’s remdesivir—the only drug with FDA clearance to treat COVID-19—dozens of state attorney generals have called for the federal government to exercise march-in rights to allow for broader production of the medicine...In a letter to the heads of the FDA, HHS and NIH, 34 attorneys general wrote that Gilead has been unable to ensure “sufficient” supply and has priced the medicine out of reach for many patients who need it. Gilead is charging $3,120 per treatment course for patients with commercial insurance, Medicare or Medicaid, and $2,340 for patients on certain smaller federal programs...READ MORE