Inventiva: positive results in Phase II lanifibranor-empagliflozin combo for MASH/NASH, T2D

 

• LEGEND achieved its primary efficacy endpoint by significantly lowering HbA1c level in both the lanifibranor arm and in the lanifibranor with empagliflozin arm compared to placebo.
• Statistical significance was also achieved on several markers of liver injury, markers of glucose and lipid metabolism, as well as hepatic steatosis.
• Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.
• Treatment with lanifibranor alone and in combination with empagliflozin decreased the ratio of visceral abdominal fat to subcutaneous fat, reflecting a shift from pro-inflammatory visceral fat towards metabolically healthy adipose tissue.
• The treatment with lanifibranor 800mg/once daily alone or in combination with empagliflozin for 24 weeks was well tolerated, with no safety concerns reported.
• Inventiva will host an investor webcast Tuesday, March 19th at 8am ET (details below).

Inventiva will host a conference call and webcast with slide presentation on Tuesday, March 19, 2024 at 8:00 am ET (New York time) 1:00 pm CET (Paris time).
Introduced by Frederic Cren, Chairman, CEO and cofounder of Inventiva, this event will be as follow:

• Presentation of LEGEND Results - Michael Cooreman, M.D., CMO of Inventiva
• Metabolic and hepatic benefits of lanifibranor - Stephen Harrison, M.D., Pinnacle Clinical Research and principal investigator of the exploratory cohort of NATiV3, Phase III clinical trial
• Vascular benefits of lanifibranor - Sven Francque, M.D., University Hospital Antwerp, co-principal investigator of NATiV3, Phase III clinical trial
• Opportunity for lanifibranor - Frederic Cren, CEO and cofounder of Inventiva

The conference call and the slides of the presentation will be webcast live at: https://edge.media-server.com/mmc/p/hyuvxf9a  and will also be available on Inventiva’s website: Investor Presentations - Inventiva Pharma. In order to receive the conference access information necessary to participate to the conference call, it is required to register in advance using the following link: https://register.vevent.com/register/BI334d62953abb41cea27de99dc5da974c . Participants will need to use the conference access information provided in the e-mail received at the point of registering (dial-in number and access code).

https://www.globenewswire.com/news-release/2024/03/18/2848135/0/en/Inventiva-announces-positive-results-from-the-Phase-II-LEGEND-Proof-of-Concept-study-combining-lanifibranor-with-empagliflozin-in-patients-with-MASH-NASH-and-T2D.html

'Inconsistent Insurance Coverage For Weight Loss Drugs'

 The recent expansion of Novo Nordisk A/S’s 

NVO+0.66%

Get Free Report

 Wegovy’s (semaglutide) FDA approval has sparked a debate over insurance coverage for the drug. 

However, despite its potential health benefits, some employers and health plans remain hesitant to cover the drug due to its high monthly price of $1,350 and uncertainties regarding patient adherence.

This expansion allows for a cost cap or savings guarantee, fostering accessibility for deserving patients.

Citing John Crable, Senior Vice President of Corporate Synergies, CNBC noted that the growing benefits associated with weight loss drugs may increase pressure on insurers to include them in standard insurance plans. 

However, convincing insurers to do so may require more evidence of long-term efficacy and cost-effectiveness.

While approximately 50 million insured American adults have coverage for weight loss drugs, coverage for GLP-1s remains inconsistent across different insurance plans.

Despite potential long-term cost savings and improved health outcomes associated with covering weight loss drugs, some employers, like North Carolina’s state plan, are scaling back coverage due to financial concerns. 

North Carolina Treasurer Dale Folwell highlighted the state’s financial strain caused by covering Wegovy, which amounted to nearly $87 million last year.

CNBC noted that Novo Nordisk says its savings program can help patients without insurance coverage save up to $500 per 28-day supply of Wegovy. 

The company also said roughly 80% of Wegovy patients in the U.S. with commercial coverage for the drug are paying $25 per month or less.

To address concerns over rising costs, some insurers are implementing cost control measures, such as spending caps and limits on annual spending increases for weight loss drugs. 

Earlier this month, Evernorth Health Services, a subsidiary of Cigna Group 

CI+0.22%

+ Free Alerts

, introduced a financial guarantee in its EncircleRx program.

The move aims to provide clients with predictability when covering GLP-1s, ultimately empowering companies and health plans to exercise better control over their expenditures.

According to a report in October 2023, coverage for obesity medications, including Wegovy, is expected to expand among U.S. employers. 

The survey indicates a growing willingness among employers to include GLP-1 drugs like Wegovy in their health coverage plans amid rising healthcare costs associated with the increased popularity of such weight-loss treatments.

https://www.benzinga.com/general/biotech/24/03/37793319/inconsistent-insurance-coverage-for-weight-loss-drugs-novo-nordisks-glp-1s-face-hurdles-despite-h

Alito extends order barring Texas from detaining migrants under SB4 immigration law for now

 Supreme Court Justice Samuel Alito on Monday extended an order barring Texas officials from detaining and jailing migrants suspected of crossing the U.S. southern border without authorization under a new state immigration law known as SB4 that the Biden administration has called unconstitutional.

Minutes after a self-imposed deadline passed, Alito issued an order continuing to pause enforcement of the controversial Texas law, one of Gov. Greg Abbott's signature immigration policies, on an administrative basis.

The U.S. Court of Appeals for the 5th Circuit is considering the measure's legality, and the Justice Department asked the Supreme Court to put the law on hold as the court challenge plays out. The full court has not yet acted on that request.

Passed by the Texas legislature last year, SB4 criminalizes unauthorized migration at the state level, making the act of entering the U.S. outside of a port of entry — already a federal offense — into a state crime. It also creates a felony charge for illegal reentry at the state level.

At the request of the Biden administration, a federal judge last month blocked SB4, finding that the state measure is at odds with federal immigration laws. That ruling was then suspended by the 5th Circuit until Alito paused the appeals court's order on administrative grounds. Alito's administrative stay maintains the status quo while the court considers the Justice Department's request for emergency relief.

SB4 empowers Texas law enforcement officials, at the state and local levels, to stop, jail and prosecute migrants on illegal entry and reentry charges. It also allows Texas judges to order migrants to return to Mexico as an alternative to continuing their prosecution, effectively creating a de facto state deportation system.

The Justice Department has said SB4 conflicts with federal law and the Constitution, noting that immigration enforcement, including arrests and deportations, have long been a federal responsibility. It has also argued the measure harms relations with the Mexican government, which has denounced SB4 as "anti-immigrant" and vowed to reject migrants returned by the state of Texas.

Abbott, who has positioned himself as the leading state critic of President Biden's border policies, has portrayed SB4 as a necessary measure to discourage migrants from crossing the Rio Grande, arguing the federal government has not done enough to deter illegal immigration.

Over the past three years, Texas has mounted the most aggressive state effort yet to challenge the federal government's power over immigration policy, busing tens of thousands of migrants to major, Democratic-led cities, assembling razor wire and buoys along stretches of the border to deter migrant crossings and filing multiple lawsuits against federal immigration programs. 

https://www.cbsnews.com/news/supreme-court-texas-immigration-law-sb4/

"Like The Wild West": Crime And Violence On NYC Transit Underreported: NYPD Source

 by Matthew Lysiak via The Epoch Times (emphasis ours),

Crime and violence in New York City’s subway system have spiraled out of control and are “significantly higher” than the agency’s official numbers have publicly indicated, according to a New York Police Department (NYPD) source.

The official number of arrests made in the city’s subway system rose by 45 percent this year, with more than 3,000 arrests made underground in the first two months of the year, many of them of repeat offenders, according to figures released by the NYPD Transit Bureau. However, the publicly released data only scratch the surface of the amount of crime in the nation’s largest transit system, a law enforcement source told The Epoch Times.

“The numbers they are putting out are a complete joke and everyone knows it,” the source, who requested anonymity out of fear of retribution, said. “The sense of lawlessness (on the subway) is so bad that unless you have personal experience in the system, especially at night, it is impossible to understand.

“It’s like the Wild West.”

NYPD officers have also been incentivized to not report minor offenses in an effort to keep the numbers as low as possible, according to the source, who said pressure has come from higher-ups to maintain the narrative that crime has plateaued or is going down.

However, not even the city’s own agencies can agree on how much crime is occurring in the subway system. After Transit released figures showing that violent subway crimes went up by 13 percent this year, the mayor’s office quickly pushed back, disputing the numbers released by the agency and claiming that crime actually dropped last month.

New York City Mayor Eric Adams, a former police chief, said that “overall crime is down.”

However, a “significant majority” of the crimes that do occur on the subway go unreported by the victims, according to the source.

“People understand that the majority of those who commit larceny or assaults are never going to be apprehended, so why go through the trouble of making a report?” the source said.

The mayor’s office did not respond to a request for comment by press time.

The topic of commuter safety has risen to the forefront of the national dialogue after several recent high-profile crimes in New York’s subway system, including a shooting caught on film at the Hoyt-Schermerhorn station in Brooklyn on March 14 during a rush-hour commute.

The crime spree provoked New York Gov. Kathy Hochul to order 750 New York National Guard troops and 250 New York State Police troopers be deployed into the subway system to conduct bag searches and combat the surge in crime. The new deployment is in addition to the 1,000 New York City police officers who were ordered to patrol subway lines and do security checks on bags.

“Since taking office, I have been laser-focused on driving down subway crime and protecting New Yorkers,” Mrs. Hochul told reporters at the March 6 news conference. “I am sending a message to all New Yorkers: I will not stop working to keep you safe and restore your peace of mind whenever you walk through those turnstiles.”

“No one heading to their job, or to visit family, or to go to a doctor’s appointment should worry that the person sitting next to them possesses a deadly weapon.”

Morale among NYPD officers is at an all-time low as crime and police resignations have been on the upswing, according to officials.

In recent years, an increasing number of New Yorkers, including police, have been assaulted. From Jan. 1 to March 31, 2023, citywide, 1,251 on- and off-duty police were assaulted, compared with 949 in the first quarter of 2022, according to NYPD crime statistics.

A total of 2,516 officers resigned from the department in 2023, according to police pension data previously obtained by The Epoch Times. It is the fourth most in the past decade and 43 percent more than the 1,750 who resigned their positions in 2018. Further, the data show that the number of officers quitting before they reach the 20 years required to receive their full pensions has increased by 104 percent since 2020.

In January, officers’ jobs became more difficult after the New York City Council pushed through controversial legislation dubbed the “How Many Stops Act,” which requires police to officially document any encounter they have with the public, including logging the race, gender, and age of any person to whom they speak.

The recent exodus comes on top of years of officer attrition, eroding the ability of the nation’s largest police force to serve and protect to dangerous levels, according to Police Benevolent Association President Patrick Hendry.

“This is truly a disaster for every New Yorker who cares about safe streets,” Mr. Hendry previously told The Epoch Times. “Cops are already stretched to our breaking point, and these cuts will return us to staffing levels we haven’t seen since the crime epidemic of the ’80s and ’90s.”

https://www.zerohedge.com/political/its-wild-west-crime-and-violence-nyc-transit-underreported-according-nypd-source

Israeli Official Accuses US Of 'Slow-Walking' Arms & Ammo Deliveries

 An Israeli official has told ABC News that the pace of military aid from Washington to Israel has noticeably slowed, but stopped just short of accusing the Biden administration of intentionally throttling weapons deliveries, though the implication is there.

The unnamed senior Israeli official described that in the weeks and initial months following the Oct.7 Hamas terror attack supply shipments from the United States "were coming very fast" but that now "we are now finding that it’s very slow."

The official specified that after more than five months of the major Gaza offensive, the Israeli military is running out of 155 mm artillery shells and 120 mm tank shells.

The vast bulk of Israel's arsenal has long been US-made and supplied, and the Jewish state has for decades been the single largest US foreign aid recipient, though much of these billions go straight back into the pockets of major American defense firms.

But the official said it's as yet unclear what is causing the weapons delivery slowdown. The word choice in the original ABC report strongly suggests the decision is intentional and could be in response to the soaring Palestinian death toll and ongoing humanitarian disaster: 

A senior Israeli official says the United States has begun slow-walking some military aid to Israel -- an assertion senior U.S. officials denied was the case, in what's perhaps more evidence that the relationship between the two allies is growing increasingly strained.

Famine looms and the IDF is poised for a ground assault on the refugee-packed southern city of Rafah. Gaza's health ministry has cited well over 30,000 deaths. Israel says the majority of those killed includes Hamas and that the numbers are inflated, while the Palestinian side says the overwhelming majority of deaths are civilians, especially women and children.

Biden admin officials have rejected that the US is slow-walking defense aid, per ABC:

When asked about the allegation, several U.S. officials said there was no change in U.S. policy or any deliberate delay in delivering previously promised aid or weapons sales to Israel.

Under a 10-year agreement negotiated by then-President Barack Obama, the U.S. provides about $3.8 billion in military and missile defense systems every year.

White House national security spokesman John Kirby said when asked about the issue, "I’m not gonna get into the timeline for every individual system that’s being provided." He added: "We continue to support Israel with their self-defense needs. That’s not going to change, and we have been very, very direct about that."

Gaza Strip destroyed, via AP

Some recent reports have said the opposite - that the White House is actually mulling increased arms and ammo deliveries while simultaneously ramping up pressure on Israel to more carefully select targets and mitigate the humanitarian fallout.

Things shifted in US-Israel relations when last week Senate majority leader Chuck Schumer (D-NY) blasted Israeli Prime Minister Benjamin Netanyahu, saying that the Jewish state risks becoming a "pariah" because of him. President Biden later said it was a "good speech" in yet another firm signal of strained and fraying relations.

https://www.zerohedge.com/geopolitical/israeli-official-accuses-us-slow-walking-arms-ammo-deliveries

NVIDIA Healthcare Launches Generative AI Microservices to Drug Discovery, MedTech, Digital Health

 NVIDIA today launched more than two dozen new microservices that allow healthcare enterprises worldwide to take advantage of the latest advances in generative AI from anywhere and on any cloud.

The new suite of NVIDIA healthcare microservices includes optimized NVIDIA NIM™ AI models and workflows with industry-standard APIs, or application programming interfaces, to serve as building blocks for creating and deploying cloud-native applications. They offer advanced imaging, natural language and speech recognition, and digital biology generation, prediction and simulation.

Additionally, NVIDIA accelerated software development kits and tools, including Parabricks®, MONAI, NeMo™, Riva and Metropolis, can now be accessed as NVIDIA CUDA-X™ microservices to accelerate healthcare workflows for drug discovery, medical imaging and genomics analysis.

The microservices, 25 of which launched today, can accelerate transformation for healthcare companies as generative AI introduces numerous opportunities for pharmaceutical companies, doctors and hospitals. These include screening for trillions of drug compounds to advance medicine, gathering better patient data to aid early disease detection and implementing smarter digital assistants.

Researchers, developers and practitioners can use the microservices to easily integrate AI into new and existing applications and run them anywhere — from the cloud to on premises — equipping them with copilot capabilities to enhance their life-saving work.

https://www.globenewswire.com/news-release/2024/03/18/2848209/0/en/NVIDIA-Healthcare-Launches-Generative-AI-Microservices-to-Advance-Drug-Discovery-MedTech-and-Digital-Health.html

Kroger to sell specialty pharmacy business to CarelonRx

  Kroger said on Monday it has entered into a definitive agreement for the sale of its specialty pharmacy business to CarelonRx, a subsidiary of Elevance Health.

https://finance.yahoo.com/news/kroger-announces-sale-specialty-pharmacy-201945307.html