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Friday, December 13, 2024

Mangione’s family operated nursing home empire cited for abuse and health violations

 Accused killer Luigi Mangione may have targeted UnitedHealthcare CEO Brian Thompson over hatred of his company’s policies — but the suspect’s own family made millions with a nursing home network that was rife with violations and complaints, according to the Department of Health and Human Services (HSS).

UnitedHealthcare CEO murder suspect Luigi Mangione hails from an affluent Maryland family that founded Lorien Health Services.
Lorien’s Bel Air nursing home has been flagged for incidents of abuse recorded in an April 2024 report.Lorien Health Services

The for-profit Lorien Health Services network, founded by Mangione’s affluent grandparents, touts its nine Maryland homes as idyllic places with the promise of top-class services and amenities that include restaurant-style dining, movie theaters and even beauty spas.  

But at least two of the homes have been hit with low ratings by Medicare.gov for health inspections and quality-of-life issues, with one slammed with a warning label over reports of abuse.

The Lorien Nursing and Rehab Center, in Bel Air, was accused of mistreating its patients in several incidents that occurred inside the home, according to an April 2024 inspection by HSS.

The report found that on August 24, 2023, a geriatric nursing assistant (GNA) flung a call bell at a resident who needed help using the bathroom, warning the patient “not to press the button again.”

That same day, the GNA was also accused of being too rough when assisting a resident who needed to be turned over in bed, with the staff later medicating the patient with Tylenol for the pain.

While the GNA was fired over the bell-flinging incident, the HHS inspection found that the company failed in its due diligence after reviewing the nurse’s file and finding that they had not completed their annual abuse training since 2020.

Lorien’s Columbia home faced steep fines over the summer for repeated incidents of mismanagement.Lorien Health Services

The report also cited several claims from residents that the nursing staff failed to respond to their calls for assistance in a timely manner, with some waiting nearly an hour to get help.

“Based on medical record review of a complaint and a facility reported incident, review of medical records and interview with staff, it was determined that the facility failed to ensure that a resident was free from mental and physical abuse,” the report concludes.

Overall, the Bel Air facility has been hit with 24 health citations over the last six years, nearly three times more than the national average of 9.6 citations.

Lorien Health Services was founded by the late Mary C. Mangione and her late husband, self-made millionaire Nick Mangione Sr.Loyola.edu

Lorien’s Columbia facility, meanwhile, had to pay a $24,680 fine in July following an HHS inspection that found a plethora of health and safety violations in the nursing home.

The July report also recorded a slew of incidents throughout the year in which staff regularly mismanaged patients’ health care needs and failed to communicate with each other, the residents or the families of the residents.

The mismanagement caused moments of distress for the patients, including one incident in which a resident who needed help getting dressed was left alone and naked on a bed when another patient of the opposite gender walked into the room.

Mary died in 2023 and left her estate to her family.Nino Mangione/X

In June, Lorien Health Services also agreed to pay the federal government $55,192 for allegedly violating the Civil Monetary Penalties Law by retaining the services of an unlicensed individual, the Daily Mail reports.

The Office of Inspector General for the HSS claimed Lorien “allegedly submitted claims for services provided by an individual impersonating licensed nursing staff, using stolen credentials.”

Officials also said that “after Lorien learned the employee was an imposter and unlicensed, Lorien failed to timely report and return to Medicare and Medicaid payments received for services furnished by the employee.”

A spokesman for the company told The Post that the status of abuse cited for the Bel Air location was being disputed and the fines paid by Lorien over the violations are but a tiny fraction of the millions paid by similar facilities across the state.

Mangione with his parents at his college graduation.Instagram / Kathy Mangione

“For 47 years, Lorien has excelled at providing unparalleled assisted living and nursing home care for our residents,” Lou Grimmel Sr., CEO for Lorien Health Services, said in a statement.

“We have been guided by our founders’ pride of ownership and their principal value that ‘we are family taking care of families, friends, and neighbors.’

“We embrace this mantra every day along with our CareForward approach, which grows from our team embracing innovation, new techniques, and professional care that set us apart from the pack,” Grimmel added.  

Mangione’s grandmother, Mary, who left the family some $30 million in a trust, was not named personally in any of the federal documents.

Despite the troubles faced at its Bel Air and Columbia locations, the company is still among the leaders in its industry, with Lorien named among the top 19% of nursing homes in US News & World Report’s 2025 list.

The company’s health care violations have received renewed public interest given Mangione’s alleged hatred of the industry flagged in his manifesto, according to police.

“These parasites simply had it coming,” Mangione wrote, according to law enforcement.

In his writings, Mangione railed against the “greed” of private insurers that he accused of putting their profits above the well-being of their clients.

Authorities also found engravings on the bullets used by the assassin, which appear to include the words “deny,” “depose” and “defend” — words eerily similar to a 2010 book condemning the insurance business, titled “Delay, Deny, Defend: Why insurance companies don’t pay claims and what you can do about it.”

Thompson was notably the head of the insurance division for the UnitedHealth Group, the largest private insurer in the nation with a long and controversial history of rejecting customers’ claims. 

https://nypost.com/2024/12/13/us-news/luigi-mangiones-family-operated-nursing-home-empire-that-was-cited-for-abuse-and-health-violations/

FDA Committee Calls For More Research After Moderna’s RSV Vaccine Safety Issues

 

Following news of RSV lower respiratory tract infections in infants immunized with Moderna’s investigational RNA vaccines, FDA advisors said the trial investigators should continue the study, while keeping an eye out for further safety signals.

An FDA advisory committee reviewing an imbalance in severe respiratory syncytial virus cases in a trial of Moderna’s vaccine has urged the FDA and companies to continue the research—albeit carefully.

The Vaccines and Related Biological Products Advisory Committee met Thursday to discuss safety findings for mRNA-1345 and mRNA-1365. The FDA flagged an imbalance in severe cases of RSV in infants who received the shot and a possible “blunting” effect of antiviral treatment in those who had received the vaccine. The committee did not vote on a course of action but discussed the implications of the safety findings.

During the meeting, experts said there was not enough information and that more investigation is needed to determine if the safety signal is indeed real. Companies should therefore proceed—cautiously—with clinical trials in infants rather than halting research and never finding an answer.

Original story published Dec. 11:

Moderna’s RSV Vaccines Run Into Safety Roadblock

The FDA on Tuesday revealed that it has detected severe side effects in two of Moderna’s experimental mRNA-based respiratory syncytial vaccine candidates, which the biotech is advancing for the immunization of infants.

In a briefing document released ahead of an advisory committee meeting later this week, the regulator’s staffers flagged “an imbalance in severe RSV [lower respiratory tract infection (LRTI)]” in infants given Moderna’s investigational mRNA-1345 and mRNA-1365 shots. Additionally, the report noted that the responses to prophylactic antibody Beyfortus (nirsevimab) were “blunted” after vaccination with the mRNA shots.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene on Thursday to discuss these safety findings for mRNA-1345 and mRNA-1365—though no vote will be held. The panelists will determine “the implications of these findings for ongoing and future pediatric development of other non-live attenuated RSV vaccines,” as well as the potential interactions between RSV prophylactic antibodies and vaccines.

Moderna’s mRNA-1345 won the FDA’s approval in May for use in adults aged 60 years and above, and is being marketed under the brand name mRESVIA. The company was also previously developing the shot for use in infants, but dropped this program in September, according to reporting by Endpoints News. According to the biotech’s website, mRNA-1345 continues to move forward in high-risk adults aged 18 to 59 years, and in a pediatric population.

Meanwhile, mRNA-1365 is being developed as a combination vaccine for RSV and the human metapneumovirus. The candidate is currently in a Phase I study in this indication.

In its briefing document, the FDA revealed that in one study, inoculation with mRNA-1365 led to a case of severe or very severe RSV LRTI in the subgroup of participants aged 8 months to less than 24 months. In a younger subpopulation—aged 5 months to less than 8 months—five such side effects were reported after mRNA-1635 administration.

Moderna was made aware that there were at least two positive RSV LRTI tests in the study by July 17, triggering one of the study’s pause criterion. A few days later, Moderna enacted a “study-wide pause,” according to the briefing document, amid its ongoing safety investigation.

These new safety data come as a blow to Moderna, which was already struggling to find its footing in the RSV vaccine space, where it is in third place. GSK became the frontrunner in this field when it won the FDA’s first approval in May 2023 for Arexvy, which has since gone on to corner around two-thirds of all retail RSV vaccinations in the U.S.

Pfizer has fallen to second place with its Abrysvo, though recent approvals in a broader adult population and in immunocompromised adults could help the pharma shore up sales for its shot.

https://www.biospace.com/drug-development/modernas-rsv-vaccines-run-into-safety-roadblock

2 Private Equity Firms Near Potential $3B+ Deal for Mitsubishi’s Pharma Unit

 

Blackstone and Bain Capital are said to be among the final bidders for the Japanese company’s Mitsubishi Tanabe Pharma, sources told Reuters Friday.

Two major global private equity firms are in play to bid for Mitsubishi’s pharma unit, with the deal potentially valued between $3 billion an $3.5 billion, Reuters reported Friday.

Sources told the publication that Blackstone and Bain Capital are among the final bidders for the Japanese company’s Mitsubishi Tanabe Pharma. Parent company Mitsubishi Chemical has reportedly engaged Goldman Sachs for the sale process. Bids are due December 24, Reuters wrote.

The potential for a deal came to light in September, when Mitsubishi Chemical responded to a news report by saying that it is continuously reviewing its business portfolio and exploring options for divestiture.

Tanabe Pharma’s pipeline includes therapies for the central nervous system, immune-inflammation and oncology. The unit recently reported sales revenue of 232.5 billion yen ($1.51 billion) at the halfway point of its fiscal year.

https://www.biospace.com/deals/two-private-equity-firms-near-potential-3b-deal-for-mitsubishis-pharma-unit-reuters

Cancer Pipelines Shrink as Incyte, iTeos Cut Candidates Following Disappointing Data

 

Incyte is abandoning its ALK2 blocker zilurgisertib, which it was trialing for myelofibrosis-associated anemia, while iTeos will deprioritize the development of inupadenant after it failed to meet the biotech’s clinical bar in a Phase II study of metastatic non-small cell lung cancer.

The oncology space on Thursday lost two pipeline treatments after Incyte and iTeos Therapeutics announced that they were discontinuing the development of respective drug candidates following underwhelming readouts.

Incyte revealed in an investor conference call on Thursday that it would no longer advance zilurgisertib, an investigational ALK2 inhibitor that the biotech was testing for myelofibrosis-associated anemia and fibrodysplasia ossificans progressiva, according to investor notes from William Blair and BMO Capital Markets.

The drug candidate was in very early stages of development for both indications, with the company still working on clinical proof-of-concept studies for the candidate before deciding to discontinue it. By blocking ALK2, zilurgisertib is designed to boost the production of the liver hormone hepcidin, in turn increasing plasma iron levels, promoting the production of red blood cells and suppressing ossification. The decision to discontinue zilurgisertib comes after the candidate’s “limited efficacy” in a Phase I trial, according to William Blair.

Meanwhile, BMO Capital Markets noted that the move “adds to growing list of pipeline misses,” though the firm ultimately did not find this development surprising. In its third-quarter report in October, Incyte leadership had indicated that “zilurgisertib needed to be dosed higher than initially expected to see signs of more promising efficacy,” which could indicate weak overall activity, BMO analysts wrote.

Zilurgisertib joins the MRGPRX4 antagonist INCB000547 in Incyte’s scrap pile. The biotech announced last month that Phase II data for the candidate fell short of expectations and thus do not support further investment into its development. Incyte was developing INCB000547 for chronic pruritus.

Joining Incyte’s cancer cut is iTeos, which on Thursday announced that it has “deprioritized” the development of its small molecule A2AR blocker inupadenant in metastatic non-small cell lung cancer (NSCLC) because the candidate “does not meet sufficient level of clinical activity to warrant further investment,” CEO Michel Detheux said in a statement.

The decision was based on Phase II data showing that a combination regimen of inupadenant with carboplatin and pemetrexed yielded a 63.9% overall response rate in post-immunotherapy patients. Median progression-free survival (PFS) across all doses was 7.7 months. An exploratory analysis of the mid-stage trial also showed that inupadenant treatment restored normal levels of the CXCL3 chemokine, a biomarker known to be associated with clinical activity.

Still, iTeos is funneling resources away from inupadenant and instead prioritizing the development of its other “differentiated, first- or best-in-class therapies,” Detheux said. It is not yet clear which candidates the biotech plans to focus on, though Detheux noted that the company will provide more details regarding its pipeline in 2025.

https://www.biospace.com/drug-development/cancer-pipelines-shrink-as-incyte-iteos-cut-candidates-following-disappointing-data

Bicycle Data Update, Strategy Leveraging NECTIN4 Gene Amplification

 Topline combination data for zelenectide pevedotin plus pembrolizumab in first-line metastatic urothelial cancer demonstrated a 60% overall response rate, in line with existing therapies

Dose selection and topline data from Phase 2/3 Duravelo-2 trial planned for 2H 2025

Heavily pretreated breast cancer and non-small cell lung cancer patients with NECTIN4 gene amplification and/or polysomy demonstrated an enhanced response to zelenectide pevedotin

Company to advance development strategy leveraging NECTIN4 gene amplification, with Phase 1/2 trials in breast cancer, lung cancer and multi-tumor planned for 2025

Bicycle Therapeutics to host conference call and webcast with management and oncology experts on Friday, Dec. 13, at 8 a.m. ET

Bicycle Therapeutics will host a conference call and webcast on Friday, Dec. 13, at 8 a.m. ET to review the data updates for zelenectide pevedotin. The company’s management team will be joined by Sherene Loi, M.D., Ph.D., Peter MacCallum Cancer Centre, and Niklas Klümper, M.D., University Hospital Bonn.

To access the call, please dial +1-833-816-1408 (U.S.) or +1-412-317-0501 (international) and ask to join the Bicycle Therapeutics call. A live webcast and replay of the conference call will be accessible in the Investor section of the Company’s website at www.bicycletherapeutics.com.

https://www.biospace.com/press-releases/bicycle-therapeutics-announces-data-updates-across-zelenectide-pevedotin-program-and-development-strategy-leveraging-nectin4-gene-amplification