Today's News and Commentary

About Covid-19

Coronavirus in the U.S.: Latest Map and Case Count: Latest data from The NY Times. Among the findings:
”With the Omicron variant spreading rapidly, the country is averaging more than 500,000 new cases a day, far more than at any previous point in the pandemic. Omicron appears to cause less severe illness than prior forms of the virus, but has contributed to upticks in hospitalizations…
Hospitalizations have increased more than 50 percent over the last two weeks, a steep incline but so far a much lower rate of increase than cases. More than 100,000 coronavirus patients are hospitalized nationwide. Deaths, which are a lagging indicator of virus activity, have not yet increased.”

FDA shortens timing of Moderna booster to 5 months: “U.S. regulators on Friday shortened the time that people who received Moderna’s COVID-19 vaccine have to wait for a booster — to five months rather than six.
The two-dose Moderna vaccine is open to Americans 18 and older. The Food and Drug Administration’s decision Friday means Moderna recipients are eligible for a booster after at least five months have passed since their last shot. The Centers for Disease Control and Prevention agreed.
That’s in line with new recommendations for recipients of the Pfizer vaccine. Initial Pfizer vaccinations are open to anyone 5 or older. But only Pfizer recipients 12 and older are eligible for boosters, and earlier this week U.S. health authorities said they can get one five months after their last shot.”

U.S. sends states monoclonal antibodies that may not work against omicron: “David Kessler, the chief scientific officer for the administration’s covid response, said the government has been responding to requests from state and local health officials in making all three monoclonal antibodies available. But the administration has made clear that the two that don’t work against the omicron variant should be used ‘only if the delta variant represents a significant proportion of infections in the region and then only with the explicit understanding that these treatments would be ineffective if the patients are infected with the omicron variant.’”

Vaccinated Women Pass COVID-19 Antibodies to Breastfeeding Babies: “Women vaccinated against COVID-19 transfer SARS-CoV-2 antibodies to their breastfed infants, potentially giving their babies passive immunity against the coronavirus, according to University of Massachusetts Amherst research.
The study, published in the journal Obstetrics & Gynecology, measured the immune response to the COVID-19 mRNA vaccine in both breast milk and the stools of breastfed infants.”

A guide to COVID tests: When to test, what kind to use and what your results mean: A good review from NPR.

Association of a Third Dose of BNT162b2 Vaccine With Incidence of SARS-CoV-2 Infection Among Health Care Workers in Israel: “In this cohort study of 1928 health care workers in Israel who were previously vaccinated with a 2-dose series of BNT162b2 [Pfizer/BioN Tech], administration of a booster dose compared with not receiving one was significantly associated with lower risk of SARS-CoV-2 infection during a median of 39 days of follow-up (adjusted hazard ratio, 0.07).”

Pfizer CEO says omicron vaccine will be ready in March: “Pfizer CEO Albert Bourla said an omicron vaccine will be ready in March, and the company is already manufacturing doses.
Bourla said the goal is to produce a vaccine that is much better at preventing infection from omicron.”

About healthcare IT

Teladoc projects $2.03B in 2021 revenue, up from previous guidance, after stock plummeted last year: “Teladoc expects its full-year 2021 revenue to hit $2.03 billion, up from previous guidance of $2.015 billion to $2.025 billion, nearly doubling its 2020 revenue.
The telehealth provider estimates it delivered more than 14.7 million virtual visits in 2021, up from 10.6 million visits in 2020. The company also anticipates between $260 million and $265 million in full-year adjusted EBITDA.
For 2022, Teladoc is projecting full-year revenue of around $2.6 billion.
Despite the company’s strong financial performance, Teladoc’s shares plummeted 54% in 2021, compared to the S&P 500’s strong gain of approximately 27%. The telehealth giant isn’t yet profitable…”

R1 RCM to Acquire Cloudmed, Creating the Strategic Revenue Partner for Healthcare Providers: “R1 RCM Inc. (“R1”), a leading provider of technology-driven solutions that transform the patient experience and financial performance of healthcare providers, today announced that it has entered into a definitive agreement to acquire Cloudmed, a leader in Revenue Intelligence™ solutions for healthcare providers, in an all-stock transaction. The transaction values Cloudmed at approximately $4.1 billion, including $857 million of net debt, based on R1’s closing stock price on January 7, 2022.”

ONC releases data standard for patient addresses: 4 things to know: “The Office of the National Coordinator for Health Information Technology on Jan. 7 issued Version 1.0 of Project US@, its healthcare specification for representing patient addresses to improve patient matching.”

Microsoft warns of continued Log4j exploitation attempts: “Microsoft urges companies to remain vigilant and use scanning systems to detect unusual activity as Log4j's continued exploitation attempts occur.
Microsoft warned organizations in a Jan. 3 blog post that the attempts against Log4j, a highly-utilized open-source code, are extremely threatening and could pose security risks to the healthcare sector.“

About hospitals and health systems

19% of US hospitals critically understaffed, 21% anticipate shortages: An update of a previous post: “Just over 19 percent — or 1,168 of 6,089 — of all hospitals in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 9.
A critical staffing shortage is based on a facility's needs and internal policies for staffing ratios, according to HHS. Hospitals using temporary staff to meet staffing ratios are not counted among those experiencing a shortage.
Meanwhile, more than 21 percent — or 1,287 of 6,089 — of all hospitals in the U.S. are anticipating shortages in the next week.”

About health insurance

New Hampshire reaches $21.1 million settlement with Centene: “New Hampshire has reached a $21.1 million settlement with a Missouri company over the inaccurate reporting of pharmacy benefit services cost, the attorney general's office said Friday…
In recent months, the company has settled with several other states following a two-year investigation into whether the firm had overcharged Medicaid for prescriptions. Kansas in December reached a $27.6 million settlement and Mississippi and Ohio in June settled lawsuits against Centene for a total of nearly $144 million.”

About the public’s health

Association of Cigarette Sales With Comprehensive Menthol Flavor Ban in Massachusetts: “The comprehensive flavor ban in Massachusetts was associated with a statistically significant decrease in state-level menthol and all cigarette sales…
Nonflavored cigarette sales in Massachusetts vs the comparison states increased after the ban, suggesting the potential substitution of nonflavored cigarettes for menthol cigarettes.”

U.S. emissions surged in 2021, putting the nation further off track from its climate targets: “A 17 percent surge in coal-fired electricity helped drive an overall increase of 6.2 percent in greenhouse gas emissions compared with the previous year, according to an analysis published Monday by the Rhodium Group. While emissions remained below pre-pandemic levels, it marked the first annual increase in reliance on the nation’s dirtiest fossil fuel since 2014, the independent research firm said.”

10 Percent of U.S. Adults Meet Vegetable Intake Recommendations: “Only 12.3 and 10.0 percent of U.S. adults met the fruit and vegetable intake recommendations, respectively, in 2019, according to research published in the Jan. 7 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report
The researchers found that 12.3 and 10.0 percent of adults met fruit and vegetable recommendations, respectively, ranging from 8.4 to 16.1 percent in West Virginia and Connecticut and from 5.6 to 16.0 percent in Kentucky and Vermont, respectively.”

About pharma

Pfizer pays Beam $300 million upfront as part of base editing deal: “Pfizer entered into a four-year research deal with Beam Therapeutics potentially worth over $1.3 billion focused on in vivo base editing programmes for three targets for rare genetic diseases of the liver, muscle and central nervous system, the companies announced Monday…
The three programmes will leverage Beam's in vivo delivery technologies, which use mRNA and lipid nanoparticles (LNP) to deliver base editors to target organs. Under the agreed terms, Beam will conduct all research activities through development candidate selection. Pfizer will then be able to option exclusive, worldwide licenses to each of them, at which point it will take on all development activities.”

23andMe Initiates Phase 1 Clinical Trial for First Wholly-Owned Immuno-oncology Antibody for Patients with Solid Tumors: The headline is the story.
And in a related story: 23andMe snags 3rd FDA nod for cancer risk test, this time for prostate cancer

New York Plans to Install ‘Vending Machines’ With Anti-Overdose Drugs: “New York City health officials have announced a plan to install 10 “public health vending machines” that would dispense sterile syringes, an anti-overdose medication and other “harm reduction” supplies to help neighborhoods that have been hit hard by drug overdoses.”

JPM22, Day 1: The annual JP Morgan Healthcare Conference is being held virtually. “Fierce Pharma will be covering the day's biggest news at it happens. Check back here for updates, and catch Fierce Biotech's coverage here.” Among the announcements: New Johnson & Johnson CEO Duato points out 5 pipeline meds that can generate $5B+: “Among the healthcare giant's pipeline, Duato highlighted five programs that could generate $5 billion or more in peak sales. Those are the Legend Biotech-partnered CAR-T medicine Carvykti, the potential “pipeline in a product” drug nipocalimab, Rybrevant in lung cancer, a potential first-in-class oral Factor XIa inhibitor milvexian and a potential bladder cancer platform called Taris.”

About healthcare technology

In a First, Man Receives a Heart From a Genetically Altered Pig: “A 57-year-old man with life-threatening heart disease has received a heart from a genetically modified pig, a groundbreaking procedure that offers hope to hundreds of thousands of patients with failing organs.
It is the first successful transplant of a pig’s heart into a human being. The eight-hour operation took place in Baltimore on Friday, and the patient, David Bennett Sr. of Maryland, was doing well on Monday, according to surgeons at the University of Maryland Medical Center.”

Fierce Healthcare's Fierce 15 of 2022: “Virtual care, home health and health equity remain key trending topics within healthcare. Our list touches on those in a number of ways, including platforms to address the social determinants of health, ways to treat behavioral health needs digitally, and offer better care in the home.” The article has links to each of the 15 winners.