Despite some of the really important news today, the lead healthcare story is that tomorrow the Supreme Court will hear California v. Texas, deciding the fate of the ACA.
About the public’s health
PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY: This messenger RNA vaccine is the first of its kind. Here is what Pfizer reported today:
“Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints”
The Health 202: Biden is expected to unwind dozens of Trump-era health-care changes: A really good summary of these projected policy changes as well as who may serve in healthcare posts in the new government.
President-elect Joe Biden announces Covid task force: Read the article for the listing and also, see: President-Elect Biden Has A Plan To Combat COVID-19. Here's What's In It for the agenda go the task force.
United States nears 10 million coronavirus cases: Sadly, the headline speaks for itself.
Biden team held COVID-19 talks with Operation Warp Speed drugmakers before election: “In their talks, Biden’s advisers indicated to drug company officials that his administration would not be interested in making changes to Warp Speed that would disrupt work in getting new drugs and vaccines to market, Bloomberg reported, adding his administration will want to assist the companies’ efforts when Biden assumes office.”
FDA authorizes first test that screens for Covid-neutralizing antibodies:
“The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection.
Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long antibodies against Covid-19 last and how much protection they provide.
Patients and health providers should not interpret the positive results of the test to mean that patients are protected against Covid-19, the FDA said.”
An Explanation for Some Covid-19 Deaths May Not Be Holding Up: “Recent studies have created doubts about an agent in cytokine storms, and suggest that treatments for it may not help.”
About pharma
Biogen Alzheimer’s drug in doubt after criticism from expert panel: “The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator.
The panel voted that the company’s main trial data did not provide enough evidence that the drug, aducanumab, really worked.”
Sandoz ships first medicine in collaboration with Civica Rx to supply US hospitals: Sandoz Inc. “announced that it has shipped pantoprazole sodium for injection, 40 mg to Civica Rx to supply the hospitals it serves as part of a multiyear collaboration to help reduce supply shortages, with several other medicines on the way before the end of the year.
Pantoprazole is the first Sandoz medicine to ship to Civica since entering into the agreement in July… Sandoz previously announced it will supply six injectable medicines under the Civica private label to its 1,200 US hospitals.”
The 2020 Fierce Pharma Marketing Awards: See who won and what their ad campaigns looked like.
About health insurance
A battle of Blue Cross plans is brewing: “A tentative $2.7 billion settlement of an antitrust case would free Blue Cross plans to invade each other's markets. Under the deal, the Blue Cross Blue Shield Association agreed to loosen a rule that barred such competition.”
Medicare’s ‘Part B’ outpatient premium to rise by $3.90: “Medicare’s ‘Part B’ monthly premium for outpatient care will go up by $3.90 next year to $148.50, officials announced late Friday afternoon.
For most retirees, the health care cost increase will claim a significant slice of their Social Security cost-of-living adjustment, or COLA. It works out to nearly 20% of the average retired worker’s COLA of $20 a month next year.”
About healthcare IT
Pear Therapeutics Announces Publication of Real-World Data Demonstrating Impact of reSET-O for Patients with Opioid Use Disorder: “Data from more than 3000 patients prescribed and using reSET-O across the U.S. supports high real-world engagement and a positive association between product use and outcomes of reduced illicit opioid use and retention in treatment.”
reSET-O is an FDA-approved app that is used with buprenorphine.
Digital stethoscope maker Eko nets $65M to develop home telehealth offerings: “The company’s Duo stethoscope captures both heart sounds and electrocardiogram readings, and is connected to an AI program that received an FDA clearance at the top of this year to detect the signs of atrial fibrillation and heart murmurs.”