The FDA on Friday revoked the emergency use authorizations (EUAs) of four monoclonal antibodies for COVID-19.
The four drugs — bebtelovimab, sotrovimab, casirivimab/imdevimab (REGN-COV2), and tixagevimab/cilgavimab (Evusheld) — had been authorized for COVID-19 as treatments or as pre- or post-exposure prophylaxis for individuals at high risk of severe outcomes.
Casirivimab/imdevimab had famously been used in 2020 to treat Donald Trump during his bout with COVID-19, while bebtelovimab’s claim to fame may have been the degree of difficulty in pronouncing it.
“The four mAb [monoclonal antibody] products have not been authorized for administration to patients for more than a year due to the high frequency of circulating SARS-CoV-2 variants that are not susceptible to each particular mAb product,” the agency said.
At various points, the FDA had limited each product’s use since their initial authorizations, allowing healthcare facilities to hold on to the drugs in case circumstances changed and they became active against later COVID strains.
“However, the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to these particular mAb products has persisted. In addition, the shelf life for nearly all lots of these products has expired,” the FDA said.
Antivirals such as nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) remain approved or authorized for outpatients at high-risk for severe outcomes of COVID-19.
Currently, pemivibart (Pemgarda) is the only monoclonal antibody authorized for COVID-19, after gaining an EUA earlier this year as pre-exposure prophylaxis in immunocompromised individuals who are unlikely to mount a sufficient immune response following vaccination.
A long-acting monoclonal antibody, pemivibart is specifically authorized for people ages 12 years and older (and weighing 40 kg or more) with moderate-to-severe immune compromise either because of a medical condition or due to immunosuppressant medications. Pemivibart is not for use as post-exposure prophylaxis or in people currently infected with SARS-CoV-2.
The FDA recently expressed concern that newer COVID variants may no longer be susceptible to pemivibart, but quickly reversed course.
According to CDC’s Nowcast tracker, XEC is currently the most common circulating variant of SARS-CoV-2, accounting for an estimated 44% of cases, most closely followed by KP.3.1.1 (39%).
The EUAs for bebtelovimab, sotrovimab, casirivimab/imdevimab, and tixagevimab/cilgavimab were revoked at the request of their respective sponsors, the FDA noted.

Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.

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Introduction of biosimilars for the rheumatology drug adalimumab, whose original branded version Humira has long been a blockbuster, appears to have led to a dramatic drop in net spending for these products — even though biosimilars barely dented Humira prescription rates.
Analysis of prescriptions and sales figures for 2023 — the first year in which Humira faced biosimilar competition — showed the total number of adalimumab prescriptions remained nearly flat in the year’s fourth quarter (Q4) relative to the same quarter in 2022, but net spending on all adalimumab products fell 45% over this period, according to Benjamin Rome, MD, MPH, of Brigham and Women’s Hospital in Boston, and colleagues.
Net costs per prescription also declined precipitously, by 43%, the group reported in a JAMA Health Forum research letter. But Humira also retained its stranglehold on the market for adalimumab: biosimilar prescriptions in Q4 2023 were just 1.35% of the total.
The researchers pulled prescription data from the IQVIA National Prescription Audit, and sales figures from manufacturers’ published financial reports. (Because some biosimilar makers aren’t public companies, not all were included in the analysis; also, patients’ out-of-pocket costs were not available.)
While the net spending drop is clearly a good thing, Rome and colleagues warned that it may not be sustainable if biosimilar manufacturers can’t do better at selling their products.
“Lower health care spending is a goal of biosimilar introduction, but low uptake raises concerns that manufacturers may withdraw from the market or avoid developing future biosimilars,” they explained. “Compared with biosimilars, uptake of new generic drugs is often rapid, averaging 66% of the market share during the first year after brand-name market exclusivity ends.”
Adalimumab ought to be the most lucrative market there is for biosimilars: as Rome and colleagues noted, it’s “the best-selling drug in history, with more than $200 billion in global sales since its 2002 approval.” It now boasts approvals for nine indications including rheumatoid arthritis and related conditions, both major forms of inflammatory bowel disease, and plaque psoriasis. Biosimilars began to win FDA approval in 2016; but thanks to the patent thicket AbbVie had erected around adalimumab, actual biosimilar sales in the U.S. didn’t begin until 2023.
Prospects for cost savings didn’t look great initially: AbbVie started 2023 by actually raising Humira’s list price by 8%, Rome and colleagues indicated. The onset of biosimilar competition, however, apparently prompted the company also to hike its discounts and rebates paid to insurers and pharmacy benefit managers. That is how AbbVie was able to keep selling Humira at nearly the same rate as before, and also how its net sales plummeted despite the increased list price.
Thus, it turns out that both sides in an earlier debate about biosimilars’ impact on the biologic drug market were correct.
In 2017, at the American College of Rheumatology’s annual meeting, Roy Fleischmann, MD, of the University of Texas Southwestern Medical Center in Dallas, squared off against Jonathan Kay, MD, of the University of Massachusetts Medical School in Worcester, on the question of whether rheumatologists should switch their patients from original branded products to biosimilar equivalents. Kay took the “yes” position, arguing that prices would surely come down once competition began.
Fleischmann countered that costs hadn’t budged and probably wouldn’t, because of the many tricks that branded-drug makers have up their sleeves. “For my patients in the United States, there are no savings from biosimilars,” he said. (At the time, a biosimilar for infliximab had been on the market for a year.) “The savings, if there are any, go exclusively to pharmacy benefit managers and vertically integrated healthcare systems. There is no benefit in cost to patients and no improvement in access to biologic therapy to patients.” The latter, he added, was the key factor — if patients’ costs aren’t any lower, then there is no reason to move them from a branded biologic to a biosimilar.
So Kay seems to have been correct that biosimilars would bring total costs down, even as Fleischmann rightly predicted that branded manufacturers could dissuade most prescribers from switching.
Another example (and perhaps driver) of that latter success came in June, with a report showing that only about half of Medicare Part D plans pay for adalimumab biosimilars, whereas nearly all cover Humira.
On the other hand, hints are emerging that biosimilars could chip away at the Humira monolith. Rome and colleagues observed that the lone adalimumab biosimilar with “interchangeability” designation — meaning the FDA has approved back-and-forth switching with the originator product — had begun winning prescriptions.
Perhaps more important was a move earlier this year by one of the nation’s biggest insurers, CVS Health. In January, it said it would replace Humira with biosimilars as the preferred adalimumab versions in its commercial formularies.

John Gever was Managing Editor from 2014 to 2021; he is now a regular contributor.

Disclosures
Arnold Ventures supported the study.Rome and one co-author reported receiving grants from the National Academy for State Health Policy and from Elevance Health Public Policy Institute.One co-author disclosed he was an expert witness for the Federal Trade Commission in a case involving pharmacy benefit managers.

Primary Source
JAMA Health Forum
Source Reference: Rome BN, et al “Use, spending, and prices of adalimumab following biosimilar competition” JAMA Health Forum 2024; DOI: 10.1001/jamahealthforum.2024.3964.

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Diets higher in inflammatory foods were linked to increased dementia risk in older adults.Risks were higher for both all-cause dementia and Alzheimer’s dementia.The study tracked Dietary Inflammatory Index scores measured at three time points over 10 years.

Diets higher in inflammatory foods were tied to an increased incidence of dementia in older adults, longitudinal data from the Framingham Heart Study Offspring cohort showed.
Over 13 years of follow-up, higher Dietary Inflammatory Index (DII) scores averaged across three time points were linearly associated with an increased incidence of all-cause dementia (HR 1.21, 95% CI 1.10-1.33, P

Obstructive sleep apnea (OSA) was linked to a more than twofold risk of developing age-related macular degeneration (AMD) in a retrospective cohort study.
Among 58,700 matched pairs of patients with OSA and controls, a 5-year analysis found that the OSA group was more likely to develop nonexudative AMD (2.05% vs 0.76%; HR 2.64, 95% CI 2.37-2.96, P

Oral minoxidil promoted hair regrowth with no serious side effects in women who had hair loss related to breast cancer treatment. (NYU Langone Health, Journal of the American Academy of Dermatology)
The FDA issued a second, expanded recall of duloxetine after higher than acceptable levels of a cancer-causing chemical were found in some of the antidepressant tablets.
People who are prone to accelerated aging may benefit from early screening for colorectal cancer (CRC). (University of Miami Sylvester Comprehensive Cancer Center, Cancer Prevention Research)
Mixed results from adding immunotherapy to chemoradiation or radiotherapy for non-small cell lung cancer (NSCLC): Adding nivolumab (Opdivo) to concurrent chemoradiation followed by maintenance nivolumab failed to improve progression-free survival (PFS) and increased the risk of adverse events in patients with unresectable/metastatic disease. On the other hand, post-irradiation durvalumab (Imfinzi) appeared to improve PFS in older, frail patients with NSCLC. (European Society for Medical Oncology)
Bipartisan legislation introduced in the Senate would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies. (STAT)
Authors of a new report from the American Cancer Society call the recent surge in early-onset CRC a “global phenomenon.”
LAVA Therapeutics announced discontinuation of an early-stage trial of its bispecific antibody targeting prostate-specific membrane antigen for lack of efficacy in metastatic castration-resistant prostate cancer.
Adding retifanlimab (Zynyz) to platinum-based chemotherapy improved overall survival in previously treated NSCLC, Incyte announced.
An investigational blood test showed potential for identifying patients with advanced prostate cancer that is unlikely to respond to ongoing treatment, perhaps allowing an earlier switch to different therapy. (University of Minnesota, Nature Communications)
Adding the PLK1 inhibitor onvansertib to standard of care doubled the response rate in first-line treatment of RAS-mutated CRC, Cardiff Oncology announced.
The FDA has tweaked its accelerated approval program to require that confirmatory trials must be underway at the time of approval, with limited exceptions, and to include more succinct labeling regarding potential limitations of a therapy’s usefulness and benefits.

Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined MedPage Today in 2007. Follow

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The following is a transcript of the podcast episode:
Rachael Robertson: Hey everybody. Welcome to MedPod Today, the podcast series where MedPage Today reporters share deeper insight into the week’s biggest healthcare stories. I’m your host, Rachael Robertson.
Today, we are talking with Michael DePeau-Wilson about how the murder of United Healthcare’s CEO raised questions about the risks healthcare leadership faces. After that, Shannon Firth will tell us about health-related conspiracy theories that Robert F. Kennedy Jr. has spewed — and what the evidence actually says. Lastly, Joyce Frieden will share her reporting on “gold card” laws.
On to the show.
In the aftermath of the shooting of United Healthcare CEO Brian Thompson and the subsequent hunt for his alleged killer, the healthcare community started to reflect on the state of violence in the industry. There have been numerous studies and reports about violence against frontline healthcare workers, but these recent events expose something that is discussed far less: the dangers of serving in leadership positions in healthcare organizations. Michael DePeau-Wilson is here to talk about the very real threats of violence facing leaders in the health industry.
So Michael, what can you tell us about the concerns that leaders in the healthcare industry have about violence?
Michael DePeau-Wilson: Yeah, first, I should say that we didn’t get a chance to talk to very many leaders about this topic on the record. Most of the organizations we contacted referred us to existing reports about violence against all healthcare workers, especially those who are on the frontlines of healthcare, like emergency medicine physicians and nurses.
But we were able to speak to a few people about the challenges facing leaders in the industry.
Chris Van Gorder, who is the president and CEO of Scripps Health in San Diego, told us that this affects everyone in his organization. He said that they receive threats frequently and that they have even received manifestos written by individuals who were patients or unhappy family members of patients as well. And if you’ve been online or especially social media over the past couple of weeks, you would probably have seen that a lot of people share those feelings of frustration about the healthcare industry, and especially health insurance companies, and so some of that definitely gets directed towards the leaders of those companies.
So you know, and of course, obviously, we saw in the direct coverage of the shooting that Thompson had received threats prior and that the alleged shooter was holding a manifesto when arrested, so it sort of tracks along those lines with a lot of healthcare leaders.
Robertson: Got it. So this isn’t necessarily a new concern for people in healthcare leadership, then.
DePeau-Wilson: Right. You know, there’s not a lot of data or even general reporting about this issue as a trend, though. We were able to find some information about this being a very real threat of violence against healthcare leaders. For example, there was one high-profile case in New Jersey in 2014 where John Sheridan, the CEO of Cooper Health, and his wife were found dead in their home. And initially the medical examiner declared their deaths a murder-suicide, but that decision was eventually reversed, and now officials believe the couple was murdered. That case is actually still being investigated, so they haven’t really found any answers as to what happened and what the motivation of those murders might have been.
And not all of the dangers are external, either. There have been several examples that we found where healthcare leaders have died by suicide as well. So without a complete report, it’s impossible to know just how prevalent these dangers are, but it seems clear that people in these positions are receiving threats, and they are being targeted with violence in certain situations, and generally, there just seems to be a lot of risk around the job. And with Thompson’s death, that just seemed to really highlight these concerns in a very big and noticeable way.
Robertson: Has Thompson’s shooting changed anything for healthcare organizations and their leadership?
DePeau-Wilson: It’s hard to say definitively, but we did find some evidence of that. You know, for example, some of your reporting for this story actually revealed that there were several healthcare-related organizations — including United Healthcare, Blue Cross Blue Shield, CVS — that had actually removed personal information about the leaders of their organizations [from their websites].
They didn’t say for sure that that was out of precaution for their safety, but it was done in the immediate aftermath of this shooting. We also heard from Van Gorder that his team has met to kind of re-discuss their security plans moving forward. And then there was some reporting that we found in other sources, like the New York Times, that head security officials at a lot of organizations have actually come together to talk about best practices for security measures and sort of re-discuss whether or not things are being done in the best way possible.
Robertson: Well, thank you for these updates, Michael.
DePeau-Wilson: Thank you, Rachael.
Robertson: Robert F. Kennedy Jr. has been chosen by President-elect Trump to run the Department of Health and Human Services. When most people think of Kennedy, one of the first things that springs to mind are his anti-vaccine views. RFK Jr. is the former chair of the Children’s Health Defense, an anti-vaccine nonprofit known for spreading misinformation, including the entirely false claim that vaccines cause autism. Shannon Firth is here to tell us more about some of RFK Jr.’s views.
So as your story highlights, vaccine misinformation is not the only misinformation that RFK Jr. has been spreading. He’s also been a proponent of AIDS denialism.
Shannon Firth: That’s right, Rachael. RFK Jr. has tried to sow doubt around the idea that HIV left untreated causes AIDS — but the causal connection between the virus and AIDS was borne out decades ago in the 1980s. And in 2008, two French researchers won a Nobel Prize for this discovery.
Yet RFK Jr. has repeatedly, including in a video posted to social media just last year, claimed a link between AIDS and recreational drugs. He said that the first thousand people who died of AIDS were “addicted to poppers.” Poppers, or amyl nitrates, are a type of recreational drug, and they do not cause AIDS. As Carl Schmid, executive director for the HIV+Hepatitis Policy Institute here in Washington, told me, this type of misinformation can be “dangerous and clearly wrong.”
Robertson: Yikes. What other kinds of fringe theories has RFK Jr. supported?
Firth: Well, RFK Jr. has also given voice to the completely false claim that pesticides make children gay. Here, Kennedy has conflated studies of frogs with potential impact on actual human children.
In studies involving male African clawed frogs that are exposed to the pesticide atrazine, which is an endocrine disruptor, the exposure leads to chemical castration and feminizes the frogs as adults. RFK Jr. claims that these chemicals could similarly affect children. Meanwhile, the author of the study, Tyrone Hayes, PhD, of the University of California at Berkeley, has said that while he’d like to see more research on atrazine, “there are NO data to really make that link.” That’s according to a conversation Hayes had with fact-checkers at Politifact.
Robertson: Are there any other wild conspiracy theories backed by RFK Jr. that our listeners should know about?
Firth: Lots! But the other claims that I focused on in my story are his belief that antidepressants are to blame for mass shootings — they are not — and that Wi-fi causes cancer – it does not.
As recently as last year, RFK Jr. suggested in a conversation with Elon Musk over social media that before Prozac came on the market, there were “almost none of these events in our country.” And by events, he’s talking about mass shootings. For the record, according to Ragy Girgis, MD, a professor of clinical psychiatry at Columbia University in New York City who studies mass shootings, a causal link between mass shootings and antidepressants, including SSRIs or selective serotonin reuptake inhibitors, has never been established — and other experts agree.
As for Kennedy’s beliefs about Wi-fi causing cancer, according to the Globe and Mail, RFK Jr. recently shared claims that 5G “damages human DNA, causes cancer, and is being installed in order to carry out mass surveillance.” And in a 2023 interview with the podcaster Joe Rogan, Kennedy said that “Wi-fi radiation opens up your blood-brain barrier, so all these toxins that are in your body can now go into your brain.”
The American Cancer Society (ACS), on its website, is clear in stating that there is no evidence of a causal link between wireless device use and cancer or other illnesses. However, the ACS stressed that there is a need for more and longer-term research of wireless devices.
Robertson: Thank you for doing this research for us, Shannon. This is really helpful.
Firth: My pleasure, Rachael, thank you.
Robertson: As physicians and other providers continue to struggle with administrative burdens like prior authorization, some states have passed “gold card” laws that aim to exempt clinicians from prior authorization in some circumstances. Joyce Frieden is here to tell us more.
Joyce, what are you hearing about how these laws are working out?
Joyce Frieden: Hi, Rachael. Well, so far six states have passed these gold card laws, which generally require insurers and in some cases pharmacy benefit managers, too, to give providers a gold card that exempts them from having to seek prior authorization for a particular service, procedure, or drug if they meet certain criteria, such as having at least 90% of prior authorizations for that service approved in the past 6 months.
However, in at least one state, Texas, the law there, which was passed in 2021, is not working out as well as its backers had hoped. According to the Texas Department of Insurance, only 3% of healthcare providers had received a gold card as of a survey taken in January 2023.
Zeke Silva, MD, chair of the Council on Legislation for the Texas Medical Association, told me the reason for that is likely because even though the law only requires providers to have gotten approval for a minimum of five instances of a particular procedure or service in the prior 6 months, that actually turns out to be a high bar, because CPT [Current Procedural Terminology] codes are very specific. So if the doctor gets approval for a CT scan with contrast and then gets approval for one without contrast — those are two different CPT codes and can’t be grouped together toward that five procedure minimum.
The same is true for prescribing a particular drug at different dosages or in different therapeutic regimens.
Robertson: Are there any efforts being made to change the Texas law so that more providers can take advantage of it?
Frieden: Yes, Dr. Silva said he and his colleagues are seeking several changes to the law. One is to lower the minimum number of required approvals for a particular service from five to as few as one. Another request is to increase the amount of time a gold card is good for, currently set at 6 months to 1 year, “so that physicians aren’t constantly having to engage or think about this process.”
And finally, the association would like to see more transparency from health insurers about the exact criteria used to grant the gold cards, which are supposed to be given without any effort on the provider’s part, and about their processes.
Robertson: What are experts predicting for the future of these types of laws?
Frieden: Well, here’s what Emily Donaldson, a principal at the healthcare consulting firm Avalere, told me: “When we first saw gold carding legislation being discussed, it was more on the medical services side, and as the legislation has evolved, we have now seen states also apply gold carding to prior authorization for medicines, or subsets of medicines.”
She also said she wasn’t surprised at the results of the Texas law, because the law gives insurers a lot of latitude in designing their gold card programs. She said there has been an uptick in interest from state legislatures in gold card laws, and that she expects they will look at the lessons learned from the Texas law when writing their own gold card laws.
Robertson: Thanks, Joyce. We’ll turn to you for future updates.
Frieden: Thanks, Rachael.
Robertson: And that is it for today. If you like what you heard, please leave us a review wherever you listen to podcasts, and hit subscribe if you haven’t already. We’ll see you again soon.
This episode was hosted and produced by me, Rachael Robertson. Sound engineering by Greg Laub. Our guests were MedPage Today reporters Michael DePeau-Wilson, Shannon Firth, and Joyce Frieden. Links to their stories are in the show notes.
MedPod Today is a production of MedPage Today. For more information about the show, check out medpagetoday.com/podcasts.

Rachael Robertson is a writer on the MedPage Today enterprise and investigative team, also covering OB/GYN news. Her print, data, and audio stories have appeared in Everyday Health, Gizmodo, the Bronx Times, and multiple podcasts. Follow

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A senior partner has also pleaded to obstruction of justice after destroying company documents.McKinsey & Company has agreed to pay $650 million to settle a Justice Department investigation of its work with the opioid maker Purdue Pharma. A former senior partner, Martin Elling, has also agreed to plead guilty to obstruction of justice for destroying internal company records in connection with that work.At the center of the government’s case was McKinsey’s advice that Purdue Pharma should “turbocharge” sales of Purdue’s flagship OxyContin painkiller in the midst of an opioid addiction epidemic that was killing hundreds of thousands of Americans. More than two dozen McKinsey partners consulted for Purdue over roughly 15 years, earning the firm $93 million.The settlement stemmed from charges brought by the U.S. attorney’s offices in Massachusetts and the Western District of Virginia.McKinsey has in recent years settled government investigations in this country and overseas by paying hundreds of millions of dollars while not admitting any wrongdoing. That is no longer true.McKinsey issued a statement on Friday apologizing for its work with the opioid maker“We are deeply sorry for our past client service to Purdue Pharma and the actions of a former partner who deleted documents related to his work for that client,” the consulting firm wrote. “We should have appreciated the harm opioids were causing in our society and we should not have undertaken sales and marketing work for Purdue Pharma. This terrible public health crisis and our past work for opioid manufacturers will always be a source of profound regret for our firm.”Mr. Elling’s decision to plead guilty to destroying internal company records follows an announcement this month by federal prosecutors that another former McKinsey senior partner, Vikas Sagar, pleaded guilty to conspiring to violate the Foreign Corrupt Practices Act in connection with paying bribes to secure South African government contracts for the firm. McKinsey had earlier fired Mr. Sagar.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Former House Speaker Nancy Pelosi has been hospitalized after she “sustained an injury” during an official engagement in Luxembourg, according to a spokesman.
Pelosi, 84, was in Europe to mark the 80th anniversary of the Battle of the Bulge in World War II. Her spokesman, Ian Krager, said in a statement that she is “currently receiving excellent treatment from doctors and medical professionals” and is unable to attend the remainder of events on her trip.
He did not describe the nature of her injury or give any additional details.
Pelosi “looks forward to returning home to the U.S. soon,” Krager said.
Pelosi, who was first elected in 1987 and served as speaker twice, stepped down from her leadership post 2 years ago but remained in Congress and was re-elected to represent her San Francisco district in November.

She has remained active in the 2 years since she left the top job, working with Democrats behind the scenes and in public and attending official events. She attended the Kennedy Center Honors in Washington last weekend and was on the Senate floor Monday to attend the swearing in of her former Democratic House colleagues, Adam Schiff of California and Andy Kim of New Jersey.
The former speaker’s unspecified injury comes days after Senate Republican Leader Mitch McConnell (R-Ky.) tripped and fell in the Senate, spraining his wrist and cutting his face. McConnell, who is stepping down from his leadership post at the end of the year, missed Senate votes on Thursday after experiencing some stiffness in his leg from the fall, his office said.

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