AnaptysBio (ANAB) stock dips as rival J&J's (JNJ) trial data for its anti-inflammatory agent similar to ANAB's lead asset disappoints
https://seekingalpha.com/news/4455583-jj-hurts-anaptysbio-anti-inflammatory-data
Wednesday, June 4, 2025
Judge rules against health insurers in price-fixing case filed by healthcare providers
Health insurers Cigna, UnitedHealth, and Aetna face lawsuits over alleged underpayment schemes.
Nutritional priorities to support GLP-1 therapy for obesity
A joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society
Abstract
Background
Glucagon-like peptide 1 receptor agonists and combination medications (hereafter collectively referred to as GLP-1s) are shifting the treatment landscape for obesity. However, real-world challenges and limited clinician and public knowledge on nutritional and lifestyle interventions can limit GLP-1 efficacy, equitable results, and cost-effectiveness.
Objectives
We aimed to identify pragmatic priorities for nutrition and other lifestyle interventions relevant to GLP-1 treatment of obesity for the practicing clinician.
Methods
An expert group comprising multiple clinical and research disciplines appraised the scientific literature, informed by expert knowledge and clinical experience, to identify and summarize relevant topics, priorities, and emerging directions.
Results
GLP-1s reduce body weight by 5% to 18% in trials, with modestly lower effects in real-world analyses, and multiple demonstrated clinical benefits. Challenges include side effects, especially gastrointestinal; nutritional deficiencies due to calorie reduction; muscle and bone loss; low long-term adherence with subsequent weight regain; and high costs with resulting low cost-effectiveness. Numerous practice guidelines recommend multicomponent, evidence-based nutritional and behavioral therapy for adults with obesity, but use of such therapies with GLP-1s is not widespread. Priorities to address this include: (a) patient-centered initiation of GLP-1s, including goals for weight reduction and health; (b) baseline screening, including usual dietary habits, emotional triggers, disordered eating, and relevant medical conditions; (c) comprehensive exam including muscle strength, function, and body composition assessment; (d) social determinants of health screening; (e) and lifestyle assessment including aerobic activity, strength training, sleep, mental stress, substance use, and social connections. During GLP-1 use, nutritional and medical management of gastrointestinal side effects is critical, as is navigating altered dietary preferences and intakes, preventing nutrient deficiencies, preserving muscle and bone mass through resistance training and appropriate diet, and complementary lifestyle interventions. Supportive strategies include group-based visits, registered dietitian nutritionist counseling, telehealth and digital platforms, and Food is Medicine interventions. Drug access, food and nutrition insecurity, and nutrition and culinary knowledge influence equitable obesity management with GLP-1s. Emerging areas for more study include dietary modulation of endogenous GLP-1, strategies to improve compliance, nutritional priorities for weight maintenance post-cessation, combination or staged intensive lifestyle management, and diagnostic criteria for clinical obesity.
Conclusions
Evidence-based nutritional and lifestyle strategies play a pivotal role to address key challenges around GLP-1 treatment of obesity, making clinicians more effective in advancing their patients' health.
Myeloma Trial Results Spark Talk of 'Potential Cure'
A single infusion of the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel (cilta-cel; Carvykti) improved long-term survival among patients with heavily pretreated relapsed/refractory multiple myeloma without any maintenance treatment, according to a post-hoc analysis of the CARTITUDE-1 trial.
Among 97 patients, 45 were still alive and in long-term follow-up, with a median overall survival (OS) of 60.7 months, reported Peter Voorhees, MD, of the Wake Forest University School of Medicine in Charlotte, North Carolina, during a session at the American Society of Clinical Oncology (ASCO) annual meeting.
Moreover, 32 patients were alive and progression-free without any further anti-myeloma treatment 5 or more years after treatment with cilta-cel.
Of these progression-free patients, 12 from a single center with serial minimal residual disease (MRD) assessments were all MRD-negative and imaging-negative at year 5 or later after cilta-cel without additional therapy, "suggesting a potential cure, or at bare minimum, unprecedented durability of complete response," Voorhees said.
Results from this updated analysis were also published in the Journal of Clinical Oncology.
The results "are remarkable, given the historically dismal prognosis for this population with a [median OS] of approximately 1 year," Voorhees and co-authors wrote. "No therapies currently approved for the treatment of triple-class exposed/refractory [multiple myeloma] achieve similar outcomes; moreover, existing regimens typically require ongoing therapy and are often associated with relapse."
ASCO discussant Krina Patel, MD, MSc, of the University of Texas MD Anderson Cancer Center in Houston, noted that "ciltacabtagene autoleucel is the first potential functional cure for patients with modern-day relapsed/refractory multiple myeloma."
Patel said the study's progression-free survival (PFS) curve -- which seemed to have completely flattened out at about 60 months -- "is worth another look."
"This might be the first time we have a plateau," she explained. "I do hope this plateau continues forever for these 33% of patients where we can say it's a true cure. I won't hold my breath, because most of my patients do relapse at some point. But I was really excited about this curve when I saw it."
CARTITUDE-1 was a phase Ib/II, open-label, multicenter study of cilta-cel in patients with relapsed/refractory multiple myeloma. Enrolled patients had undergone three or more previous lines of therapy and were triple-class exposed.
Among 97 patients infused (median age 61, 58.5% men), 97% were refractory to daratumumab (Darzalex), 25.3% had high-risk cytogenetics, 13.4% had extramedullary plasmacytomas, and 87.6% were triple-class refractory. The median time from start of last line of therapy to progression was 4.2 months.
In the original study, median PFS was 34.9 months, and median OS was not reached.
Based on these results, cilta-cel was initially approved by the FDA for patients with relapsed/refractory multiple myeloma after four or more previous lines of therapy. Approval was subsequently expanded to relapsed, lenalidomide (Revlimid)-refractory multiple myeloma with one or more previous lines of therapy based on results from CARTITUDE-4.
Voorhees and colleagues reported that the baseline characteristics were similar between patients who were progression-free at 5 or more years and those who progressed. The median number of previous lines of therapy was 6.5 versus 5, 23.3% versus 26.7% had high-risk cytogenetics, and 12.5% versus 13% had extramedullary plasmacytomas.
"Importantly, long-term remission was not limited to standard-risk disease," Voorhees observed.
However, "there was a difference in the burden of disease between these two groups of patients," he added.
Specifically, the percentage of patients with high tumor burden was lower (6.3% vs 17.4%) among progression-free patients, who also had numerically lower median soluble B-cell maturation antigen levels (36.0 μg/L vs 58.5 μg/L) and median bone marrow plasma cells (5% vs 24%).
"This would suggest that a lower burden of disease going into cilta-cel infusions does predict for better long-term outcomes," Voorhees said.
He also reported that patients in long-term remission had more fit immune T-cell phenotypes, and a higher effector-to-target ratio at peak CAR T-cell expansion. "The bottom line is that it appeared there is a signal for more immune-fit CAR T-cell products leading to durable remissions," he said.
With the longer follow-up in progression-free patients, Voorhees reported that there were no new cases of parkinsonism or other cases of delayed neurotoxicities. There were two second primary malignancies (both solid tumors), two neurologic adverse events, and four grade ≥3 infections (not related to cilta-cel).
Disclosures
The study was supported by Johnson & Johnson and Legend Biotech.
Voorhees reported consulting or advisory roles with AbbVie/Genentech, Bristol Myers Squibb, Pfizer, Sanofi, Janssen, GSK, Regeneron, Ascentage Pharma, AstraZeneca, and Kite, and research funding from AbbVie, Janssen, GSK, TeneoBio, and Regeneron.
Patel reported relationships with Bristol Myers Squibb/Celgene, Kite, Oricell Therapeutics, AbbVie, AstraZeneca, Janssen, Legend Biotech, Merck, Novartis, Pfizer, Regeneron, Takeda, Indapta Therapeutics, and Nektar.
Primary Source
Journal of Clinical Oncology
Source Reference: Jagannath S, et al "Long-term (≥5-year) remission and survival after treatment with ciltacabtagene autoleucel in CARTITUDE-1 patients with relapsed/refractory multiple myeloma" J Clin Oncol 2025; DOI: 10.1200/JCO-25-00760.
'Inside the Spectacular Downfall of UnitedHealth and Its CEO'
On Feb. 5, top executives of UnitedHealth Group gathered in a conference center on the company’s suburban Minneapolis campus. Chief Executive Officer Andrew Witty stood up in the front and offered an encouraging message: Business was good. He was optimistic about the company’s prospects in the coming year.
A trio of other executives extolled the recent insurance season, when people start their new coverage, including a large number of Medicare enrollees. They were happy with how smoothly things were going.
Two months later, those same Medicare patients would be at the center of a financial meltdown that has wiped out more than $250 billion in market capitalization at the healthcare giant.
On April 17, Witty announced disappointing profits and cut UnitedHealth’s earnings projection for the rest of 2025. Weeks later, the company withdrew its financial guidance altogether, saying costs were accelerating. With that, Witty was out, replaced by UnitedHealth’s chairman and former longtime chief, Stephen Hemsley. Today, UnitedHealth’s shares are worth about half of their value before the April announcement.
It is a plunge that has left investors asking how UnitedHealth—a company with earnings and shares that rose steadily for decades—could have reversed fortunes so rapidly.
Aggressive business practices left the company vulnerable to regulatory change and scrutiny, including three investigations from the Justice Department. Higher costs for Medicare patients slammed a key sector. And Witty, a British executive whose background wasn’t in the U.S. insurance industry, didn’t delve deeply into operational details, striking an optimistic tone with investors and employees even as problems stacked up, according to interviews with current and former employees, industry officials and analysts and internal documents viewed by The Wall Street Journal.
During the company’s annual shareholder meeting Monday, Hemsley apologized for UnitedHealth’s recent performance and said it was working to recast many of its processes, and has incorporated its recent results into its bids for next year’s Medicare business.
Hemsley said he has a “fresh perspective on some of the most publicly discussed matters,” and UnitedHealth will bring in independent experts for a comprehensive review of some of the company’s more controversial practices, including in Medicare billing, an area highlighted by a Wall Street Journal investigation last year.
A UnitedHealth spokesman said Witty’s departure was for personal reasons, and that he “led UnitedHealth Group with compassion and dignity through some of the most challenging times any company has ever faced.” He said Witty, who is now a company adviser, wasn’t available for comment.
Witty, who was earlier CEO of the drugmaker GlaxoSmithKline (now known as GSK), took over UnitedHealth in 2021. The sprawling company is parent of the largest health insurer in the country, UnitedHealthcare, as well as a health-services arm, Optum, which includes doctor groups, a pharmacy benefit manager and other assets.
From the start, he presided over the Minnesota-based healthcare giant while living across the Atlantic in Buckinghamshire, outside London, according to property records and UnitedHealth’s proxy documents. The proxies said the company helped with his taxes because he lived in the U.K.
When he was in the U.S., he generally worked out of a UnitedHealth office in Washington, D.C., where he has an apartment. For meetings such as the February gathering, which happened quarterly, he typically flew in using a corporate Gulfstream jet. The jet also went back and forth to London.
Witty never moved into the window-lined CEO office at the Minnesota headquarters once occupied by Hemsley, which was given to a local executive, operating chief Dirk McMahon. Monthly executive meetings—which had been in-person under Hemsley and were so intense some executives called them “colonoscopies”—were often presided over virtually under Witty, according to former executives. He generally left the detailed grilling to McMahon, who retired in April 2024.
The UnitedHealth spokesman said that when Witty was in the U.S., he split time between Minnesota and Washington, and that he had offices in both places and an apartment in Minnesota. In 2024, the company began saying in its financial filings that it had headquarters in both places.
As CEO, Witty brought a different style to a company that had been led for 15 years by accountants who wore suits to work. He sported zippered tracksuit-style tops and a signature collection of brightly colored sneakers. Witty enhanced some educational and child-care benefits and changed some of UnitedHealth’s hiring practices to add to the workforce’s diversity.
Some of his top hires were former colleagues from GSK who hadn’t spent their careers in the U.S. insurance or healthcare-provider industries. Roger Connor, a longtime pharmaceutical executive, was put in charge of Optum Insight, the technology and data unit. Starting in 2022, UnitedHealth’s general counsel was Rupert Bondy, a British attorney who had worked at GlaxoSmithKline and BP, but not in the heavily regulated U.S. insurance sector.
Under Witty, UnitedHealth grew in ways that brought outsize profits, but also exposed it to greater downside when costs rose and Medicare payment rules changed.
The company is dominant in Medicare Advantage, the business of privately managed Medicare plans, in which enrollment continued to grow. And Witty scaled up the role of its Optum doctor practices. With UnitedHealthcare getting taxpayer-funded payments to cover Medicare patients, while also using a share of those premiums to pay its Optum doctors to treat them, Medicare was a booming business for UnitedHealth. The company was reaping profits on both the doctor and insurance sides.
UnitedHealth’s total margins on Medicare enrollees could be double what traditional Medicare insurers made, former employees said—partly because federal rules limit how much premium revenue health insurers can retain, constraining the margins for pure insurance companies.
In addition, the government pays Medicare insurers more for sicker patients with certain diagnoses, and UnitedHealth gathered those lucrative diagnoses for Medicare customers at high rates, the Journal investigation showed last year.
At the start of 2025, Witty set a typically optimistic tone, after a difficult year that included both a devastating hack of a technology unit and the killing of the leader of UnitedHealthcare. Witty told analysts in January that the company always found a way to deliver on its commitments, and “we’re invigorated by the path ahead.”
But the roots of the financial downfall were already growing.
The Medicare agency in 2023 made big changes to the system that had worked so well for UnitedHealth, eliminating or limiting those lucrative payments for many diagnoses. The new phased-in rules first affected payments in 2024.
UnitedHealth had long known the Medicare payment change would be challenging. An internal Optum analysis of around 900,000 patients from the end of 2023, viewed by the Journal, projected that the new billing rules would cut back sharply on diagnoses of chronic health conditions that led to the higher payments.
UnitedHealth also bet on Medicare growth for 2025, including in plans that target high-risk patients, even as competitors were retrenching, after high costs across the industry in 2024 hurt profits and share prices.
On April 17, disclosing the earnings miss, Witty spoke with far less of his trademark ebullience. He called the results “frankly unusual and unacceptable.” The company was seeing higher-than-expected costs for its Medicare plan enrollees, among other issues. Because of UnitedHealth’s model, profits were squeezed at both its insurance unit and its Optum doctor groups.
“The margin has shrunk, and they can’t double dip” in both the insurance and doctor businesses, said John Ransom, an analyst with Raymond James.
Witty also acknowledged that UnitedHealth was struggling with the new Medicare payment system.
In the weeks following the April earnings announcement, Hemsley was in the Minnesota offices nearly every day, meeting with executives, asking questions and delving into the company’s issues, according to people familiar with the matter.
Witty told people he was considering his alternatives, including whether he should step down, a person familiar with the matter said. The board met in early May, and Witty’s departure was announced May 13.
On Monday, Hemsley pointed to some of the specific issues that surfaced in the company’s Medicare business during Witty’s tenure. “Clearly, we have gotten things wrong,” he said, saying that UnitedHealth underestimated medical costs and “generated outsized growth.” The company is improving its forecasting and management discipline, he said, with a particular focus on the part of Optum that includes its doctor groups.
The areas that Hemsley flagged for UnitedHealth’s planned comprehensive review included its work around the documentation of patients’ health conditions and diagnoses, which is primarily a Medicare billing issue. He also mentioned pharmacy services and managed care practices, an area that can include prior authorization, or requirements for doctors and patients to get insurer approval before rendering a medical service. Such processes have generated backlash from doctors and patients.
https://www.wsj.com/health/healthcare/unitedhealth-ceo-andrew-witty-medicare-dde1964c
'Young People Lead New Wave of Americans Unaware of Their Hypertension'
- A national study assessed changes in the proportion of adults unaware of their hypertension, diabetes, or high cholesterol level in the last decade.
- Awareness of diabetes and high cholesterol was stable, but the proportion of Americans not realizing they had high blood pressure rose.
- Adults ages 20 to 44 who were unaware of having hypertension surpassed one in three as recently as 2023.
High blood pressure (BP) awareness increasingly slipped under the radar since the COVID-19 pandemic, according to nationally representative health data.
Results from National Health and Nutrition Examination Survey (NHANES) cycles, spanning the years 2013 to 2023, showed no improvement in the proportion of adults having hypertension, diabetes, and high cholesterol who self-reported being unaware and never diagnosed. In fact, hypertension awareness stood out for trending significantly in the wrong direction:
- Adults with hypertension not realizing it: 14.6% in 2013-2014 to 17.8% in 2021-2023
- Adults with diabetes not realizing it: 27.5% to 28.9%
- Adults with high total cholesterol not realizing it: 11.5% to 11.9%
"Given declining cardiometabolic health in young adults, it is concerning that approximately one in three with hypertension, two in five with diabetes, and one in four with a high cholesterol level are unaware of having these conditions. Policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events," wrote Rishi Wadhera, MD, MPP, MPhil, of Beth Israel Deaconess Medical Center and Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Cardiology.
Such results support the idea that the COVID-19 pandemic has had wide-ranging health effects, including indirect ones through disrupted medical care, increased sedentary behavior, and worsening psychosocial stressors.
Notably, the researchers reported it was the large jump in adults 20-44 years old unaware of their hypertension (from 21.9% in 2013-2014 to 37.1% in 2023-2024) that drove part of the population-wide increase since COVID-19. For those 45 years or older, there was no discernible increase in hypertension awareness.
Along the same lines, prior work had shown that young adults with diabetes had a sharp decrease in glycemic control comparing NHANES before and after the pandemic.
There was also a disproportionate increase in women, in particular, being unaware of their high BP (from 11.3% to 16.5%) in the present study.
NHANES is a well-known cross-sectional survey of the noninstitutionalized general population in the U.S. Selected participants undergo household interviews, physical assessments, and lab tests. Researchers generally use survey weights from NHANES to generate nationally representative estimates.
Wadhera and colleagues based their study on NHANES cycles from 2013-2014 and August 2021-August 2023. Included were over 15,000 adults age 20 or older with cardiovascular risk factors (mean age 56.8 years, 45.6% women).
For the study, hypertension was defined as elevated systolic BP (≥140mm Hg) or diastolic BP (≥90 mm Hg) or a prescription for antihypertensive therapy. The threshold for diabetes was hemoglobin A1c 6.5% or more, fasting plasma glucose 126 mg/dL or more, or a self-reported clinician's diagnosis. High total cholesterol level was defined as 240 mg/dL or more, or a self-reported clinician's diagnosis.
A major limitation of the analysis, study authors acknowledged, was the reliance on self-reported awareness and medication data.
Disclosures
The study was supported by the Sarnoff Cardiovascular Research Foundation, an American Heart Association Established Investigator award, and a grant from the National Heart, Lung, and Blood Institute.
Wadhera disclosed no relevant ties to industry. A co-author reported relationships with Chamber Cardio and Abbott Vascular.
Primary Source
JAMA Cardiology
Source Reference: Johnson DY, et al "Hypertension, diabetes, and high cholesterol awareness among US adults" JAMA Cardiol 2025; DOI: 10.1001/jamacardio.2025.1536.
CrowdStrike Cooperating With Federal Probes Into July 2024 Software Outage -- Update
CrowdStrike said it is cooperating with federal authorities in connection with an incident last July, in which a bug in the company's software knocked millions of computers offline.
The cybersecurity firm said the Justice Department and the Securities and Exchange Commission have requested information related to the incident and other matters, according to a Wednesday filing with the SEC.
The agencies are also seeking details about the company's revenue-recognition practices and the reporting of annual recurring revenue for transactions with certain customers, according to the filing.
CrowdStrike said it has additionally received inquiries from other government agencies and third parties regarding the July 19 outage. Some customers and third parties have also asserted claims or publicly threatened litigation, the company said.
The Austin, Texas, company said it is cooperating and providing information in response to these requests.
The disclosure came as part of CrowdStrike's fiscal first-quarter report, during which the company swung to a loss and issued a weaker-than-expected outlook. It noted that costs stemming from the outage have continued to weigh on results.
The July outage caused by the bug in the company's Falcon software delayed thousands of flights, broke back-end systems and rendered laptops temporarily unusable.
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