Coronavirus
FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization
Adam Cancryn, Politico
The FDA is resisting Trump administration pressure to rebrand the emergency authorization of a Covid-19 vaccine as a “pre-licensure,” over worries that it would appear the agency is politicizing its scientific determinations, according to four senior administration officials with knowledge of the debate.
Trump again attacks Fauci’s guidance as coronavirus infections tick upward
David Nakamura, The Washington Post
President Trump’s long-fraught relationship with Anthony S. Fauci, the nation’s top infectious-disease specialist, ruptured again this week in an ugly public dispute just as U.S. coronavirus cases have ticked past 50,000 per day and with three weeks left in a campaign dominated by the government’s response to the pandemic.
Fauci: Trump’s rapid recovery from Covid-19, while welcome, ‘amplifies’ public misunderstanding of disease
Helen Branswell, Stat News
Health officials have struggled to convey the seriousness of Covid-19 to many Americans.
Coronavirus Reinfections Are Real but Very, Very Rare
Apoorva Mandavilli, The New York Times
Reports of reinfection with the coronavirus evoke a nightmarish future: Repeat bouts of illness, impotent vaccines, unrelenting lockdowns — a pandemic without an end.
Lilly CEO Says Covid Will Be ‘Endemic,’ Even With Vaccines: Q&A
Erik Schatzker, Bloomberg
Was it a blessing or a curse for Eli Lilly & Co. that President Donald Trump was treated with coronavirus antibodies made by rival Regeneron Pharmaceuticals Inc.? Neither, according to David Ricks, Lilly’s chief executive officer.
J&J Vaccine Pause Shows Challenges Still Ahead for Covid-19 Shots
Jenny Strasburg and Drew Hinshaw, The Wall Street Journal
The pause of Johnson & Johnson’s Covid-19 vaccine trials poses another setback for global efforts to develop a shot to protect lives and jump-start economies battered by the pandemic, as well as a reminder of the challenges of fast-tracking vaccine development.
Medicare Preparing Rule to Ensure Swift Access to Covid Vaccine
Tony Pugh, Bloomberg Law
The Centers for Medicare & Medicaid Services has a plan to ensure full payment for and speedy access to new Covid-19 vaccines and treatments for Medicare beneficiaries, agency Administrator Seema Verma said Tuesday at a virtual conference.
Deep freezers and dry ice for Pfizer vaccine may face shortages
Emily Kopp, Roll Call
States are getting little federal assistance as they scramble to find medical-grade deep freezers or dry ice for one of the COVID-19 vaccines furthest along in development, which requires storage at much colder temperatures than found on an average winter day on the South Pole.
Cytiva to Manufacture Covid Vaccine Supplies Under HHS Contract
Cheryl Bolen, Bloomberg Law
Massachusetts-based Cytiva will expand its manufacturing capacity for products essential to producing Covid-19 vaccines under an agreement announced Tuesday by the Department of Health and Human Services.
Gilead’s remdesivir shaved five days off COVID-19 recovery time, reduced risk of death in some
Julie Steenhuysen, Reuters
Final data from Gilead Sciences Inc’s antiviral drug remdesivir showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo, one day faster than indicated in preliminary data, the company and researchers said on Thursday.
Ezekiel Emanuel on vaccines, Trump’s Covid-19 treatment, and what went wrong on the U.S. response
Ed Silverman, Stat News
The controversy surrounding the Trump administration response to the Covid-19 pandemic grew still thornier after President Trump contracted the virus himself 11 days ago.
Coronavirus Vaccine Makers Are Not Mass-Slaughtering Sharks
Katherine J. Wu, The New York Times
Several companies in the race for a coronavirus vaccine have stumbled upon a new and unexpected hurdle: activists protesting the use of a substance that comes from sharks in their products.
Payers
Trump’s Drug-Discount Cards Expected to Reach Medicare Recipients After Election
Stephanie Armour, The Wall Street Journal
President Trump’s plan to send 33 million Medicare beneficiaries a card that can be used to help pay for as much as $200 in prescription drug costs won’t be completed until after the election, according to a person familiar with the plan.
A $52,112 Air Ambulance Ride: Coronavirus Patients Battle Surprise Bills
Sarah Kliff, The New York Times
Bills submitted to The New York Times show that patients often face surprise charges from out-of-network doctors, ambulances and medical laboratories they did not pick or even realize were involved in their care.
Providers
Kaiser CEO promises strategic shift to stronger focus on equity: HLTH 2020
Rebecca Pifer, Healthcare Dive
The Oakland, California-based nonprofit plans to bring ethnicity and race factors into how it evaluates quality and care across the organization, Adams said Monday at the HLTH virtual conference.
Pharma, Biotech and Devices
FDA faults quality control at Lilly plant making Trump-touted COVID drug
Dan Levine, Marisa Taylor, Reuters
Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.
J&J to contribute up to $5 billion to potential U.S. opioid settlement
Nate Raymond, Reuters
Johnson & Johnson said on Tuesday it will contribute up to $1 billion more to a potential settlement of lawsuits alleging it and other companies fueled the U.S. opioid epidemic, bringing its total payment to $5 billion.
Elizabeth Holmes Loses Request to Throw Out Criminal Charges
Peter Blumberg, Bloomberg
Elizabeth Holmes lost her latest long-shot challenge to U.S. criminal charges that she was engaged in a massive fraud while running Theranos Inc.
Johnson & Johnson beats third-quarter earnings expectations, raises guidance
Berkeley Lovelace Jr., CNBC
Johnson & Johnson on Tuesday reported third-quarter earnings and revenue that beat Wall Street’s expectations, led by higher sales in its medical-device unit and higher demand for some of its drugs.
Health Technology
Teladoc Sues Rival Over Hospital Robot Patents
Sarah Krouse, The Wall Street Journal
Teladoc Health Inc., the country’s largest publicly traded telemedicine provider, has sued rival American Well Corp. for alleged patent violations related to technology behind robot-like carts that connect hospitalized patients with specialists in real time via video.
Facebook Bans Ads Discouraging Vaccines, In Latest Misinformation Crackdown
Shannon Bond, NPR News
Facebook said on Tuesday it will ban anti-vaccination ads, following widespread pressure on the social network to curb harmful content.
Results are coming in on the AI systems built at the height of New York City’s spring Covid-19 outbreak
Rebecca Robbins, Stat News
At the peak of the Covid-19 wave that swept through New York City in the spring, with hospitals overwhelmed and more than 700 new virus deaths being reported each day, researchers there scrambled to build artificial intelligence models that could help doctors get a handle on the crisis.
Opinions, Editorials and Perspectives
New California law should serve as a national model for mental health care reform
Darrell Steinberg and Patrick J. Kennedy, Stat News
As our nation continues to confront the ramifications of a global pandemic, the stigma around mental health and addiction seems to be dissipating.
Research Reports
Family and Friend Perceptions of Quality of End-of-Life Care in Medicare Advantage vs Traditional Medicare
Claire K. Ankuda et al., JAMA Network Open
In this cross-sectional study of people who died while enrolled in Medicare, friends and family of those in Medicare Advantage reported lower-quality end-of-life care compared with friends and family of those enrolled in traditional Medicare. These findings suggest that, given the rapid growth of MA, Medicare should take steps to ensure that MA plans are held accountable for quality of care at the end of life.
General
Women voters say health care is on the line this year — and they aren’t hearing enough about it
Shefali Luthra, The 19th
Women “health care voters” fueled Democrats’ midterm election gains in 2018. Those voters want to hear more about how presidential candidates would change a system they say still isn’t working.
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