About Covid-19
FDA panel backs half-dose Moderna booster for the elderly and others at high risk: “An FDA advisory committee voted unanimously Thursday to recommend Moderna's COVID-19 vaccine as a booster for people 65 and older and others at high risk.
The Vaccines and Related Biological Products Advisory Committee backed emergency authorization for booster doses at least six months after completion of the original two-shot Moderna series.
The booster won't be identical to the first two shots, though. The committee signed off on Moderna’s plan for a 50-microgram, or half-dose, for the booster compared to the 100-microgram dose used in the original two-shot series.”
Johnson & Johnson wins FDA panel backing for a second dose of its COVID shot but don’t call it a ‘booster’: “Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended unanimously for an emergency use approval for a second dose of the J&J vaccine, provided the first shot came at least two months ago. While the recommendation covered all adults, there was much discussion as to whether the second dose should be called a booster or not.”
Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results: The headline is the story.
About the public’s health
US reaches record high of more than 96,000 drug overdose deaths in a 12-month period, CDC data show: “Reported drug overdose deaths in the United States hit a new high of more than 96,000 in the 12-month period ending March 2021, according to data released Wednesday by the US Centers for Disease Control and Prevention's National Center for Health Statistics.”
About pharma
6 drug shortage predictions for 2022 and beyond: A good summary of how regulatory and financial trends may shape the future of drug shortages in healthcare.
Biden set to pick former FDA head Robert Califf to lead agency: reports: “US President Joe Biden is close to nominating former FDA Commissioner Robert Califf to lead the agency once again, according to reports Thursday citing anonymous sources. If nominated and subsequently confirmed by the US Senate, Califf would replace acting Commissioner Janet Woodcock who stepped into the role, from her position as long-time director of the FDA's Center for Drug Evaluation and Review (CDER), when Biden took office in January.
It would also mark Califf's second run at heading the agency, after the cardiologist served as FDA Commissioner for about a year between 2016-2017, at the end of former President Barack Obama's time in office.”
About healthcare professionals
Nursing schools see applications rise, despite COVID burnout: “Nationally, enrollment in bachelor’s, master’s and doctoral nursing programs increased 5.6% in 2020 from the year before to just over 250,000 students, according to the American Association of Colleges of Nursing.
Figures for the current 2021-22 school year won’t be available until January, but administrators say they have continued to see a spike in interest.”
Biden admin to invest $100M to address health care worker shortage: “The Biden administration announced Thursday that it will direct $100 million to the National Health Service Corps to help address the health care worker shortage.
Pulled from funding in the American Rescue Plan, the $100 million represents one of the nation’s biggest investments in a program that helps place primary care doctors in communities that have difficulty recruiting and retaining them. It's a five-fold increase from previous years, the Department of Health and Human Services said.”
About health insurance
US News names best Medicare Advantage plans for 2022: “The report uses data from the CMS' annual star rankings, which were released Oct. 8. The U.S. News report defines its best plans as those that have at least three out of five stars by CMS and average 4.5 or more stars in the state.”
Medicare Open Enrollment Period Kicks Off Today: From CMS: “The Medicare Open Enrollment period occurs every year from October 15 through December 7, with coverage changes taking effect January 1. During this time, people can find a plan that better meets their needs, saves money, or both.”
About hospitals and health systems
CMS requests corrective action plan from 32 hospitals over undisclosed prices: “Of the 32 hospitals that received corrective action plan requests, which is the second step in CMS' compliance process, six hospitals are now in compliance with the rule after addressing citations outlined in warning letters, according to CMS. In April 2021, CMS began sending warning letters to hospitals not in compliance with the regulation. As of late September, CMS has sent 316 warning notices to hospitals out of compliance with the rule.”
Goldman Sachs Asset Management and Charlesbank Capital Partners Complete Acquisition of MDVIP Primary Care Network: Change in ownership for this concierge medicine network: “ MDVIP, the national leader in personalized membership-based healthcare, today announced that the Private Equity business within Goldman Sachs Asset Management ("Goldman Sachs") and funds affiliated with Charlesbank Capital Partners ("Charlesbank") have completed the acquisition of MDVIP from Leonard Green & Partners and Summit Partners. The transaction gives Goldman Sachs and Charlesbank majority ownership of the company. Financial terms were not disclosed.
MDVIP leads the market in membership-based medicine with a national network of approximately 1,100 primary care physicians serving 362,000 patients.”
Fitch: Hospital credit downgrades outpace upgrades in Q3: “As of the end of the third quarter, 88.5 percent of the nonprofit hospital and health system sector had stable rating outlooks, while 6.5 percent had positive rating outlooks and 4.2 percent had negative rating outlooks, an Oct. 11 Fitch Ratings report showed.
Fitch upgraded six hospital ratings and downgraded seven in the third quarter.”
About diagnostics
Quanterix’s Alzheimer’s Blood Test Designated a Breakthrough Device: “The FDA has granted a Breakthrough Device designation to Quanterix’s Simoa phospho-Tau 181 (pTau-181) blood test for Alzheimer’s disease.
The assay measures the concentration of the pTau-181 protein in human serum and plasma using the company’s HD-X immunoassay system. The protein is a biomarker that suggests brain changes from Alzheimer’s, according to the National Institutes of Health.”