Express Scripts Sues FTC, Demands Withdrawal of ‘False and Misleading’ PBM Report

 

Pharmacy benefit manager Express Scripts announced Tuesday it has filed a lawsuit in federal court in Missouri against the Federal Trade Commission for its “unfair, biased and erroneous” July report on the industry.

Express Scripts by Evernorth, a subsidiary of The Cigna Group, is demanding in a lawsuit that the Federal Trade Commission retract its recent “defamatory” report on the pharmacy benefit management sector.

The FTC’s interim report detailed the power and influence that pharmacy benefit managers (PBMs) like Express Scripts exert over patients and their ability to access affordable prescription drugs. The commission made allegations that PBMs are making agreements to keep lower-cost competitor drugs from the formularies in exchange for increased manufacturer rebates.

Specifically, the FTC alleged that the top three PBMs processed nearly 80% of the approximately 6.6 billion prescriptions dispensed by U.S. pharmacies in 2023, while the top six PBMs processed more than 90%. In addition, the report found that pharmacies affiliated with the three largest PBMs accounted for nearly 70% of all specialty drug revenue.

The three biggest players in the market are owned by insurers who own specialty, mail order, or retail pharmacies: Cigna owns Express Scripts, UnitedHealth owns OptumRx, and CVS Health owns CVS Caremark.

Just days after the report’s release in July, the FTC announced plans to file lawsuits against the three largest PBMs including Express Scripts.

The PBM on Tuesday slapped back with its own lawsuit, filed in Missouri federal court, accusing the FTC of an “unfair, biased, and erroneous” report. According to the lawsuit, the report is not based on data provided by the PBMs but rather “seventy-four pages of unsupported innuendo leveled against Express Scripts and other PBMs under a false and defamatory headline and accompanied by a false and defamatory press release.”

Andrew Nelson, chief legal officer for The Cigna Group called the FTC’s actions unconstitutional while advancing a narrative that could harm the healthcare system by removing checks and balances. Nelson suggests this would lead to higher drug prices for Americans.

“We don’t take this step lightly, but as advocates working to lower drug prices for millions of Americans and the employers, labor unions, and government agencies that provide their prescription drug benefits, we cannot let the FTC’s unlawful actions and false information stand,” Nelson said in a statement.

Express Scripts contends it achieved around $38 billion in savings for clients last year, emphasizing that drug manufacturers—not PBMs—set drug prices.

Congress is slated to review several bills that would require PBMs to declare how much of a profit they’re making while negotiating drug prices.

In its lawsuit, Express Scripts points a finger at FTC Chair Lina Khan, accusing her of anti-PBM bias since the time before she was appointed to the commission. The company is seeking a judgment declaring the FTC’s report to be defamatory and unlawful, that it be removed from all commission websites and Khan be recused from any actions related to Express Scripts.

https://www.biospace.com/business/express-scripts-sues-ftc-demands-withdrawal-of-false-and-misleading-pbm-report

Boehringer Aces Phase III Pulmonary Fibrosis Trial, Plans FDA Application

 

Boehringer Ingelheim’s investigational compound nerandomilast, which targets the PDE4B enzyme involved in fibrosis and inflammation in the lungs, met its primary endpoint in a late-stage study.

Boehringer Ingelheim on Monday released topline results from the Phase III FIBRONEER-IPF study, demonstrating that its investigational oral drug nerandomilast can significantly improve lung function in patients with idiopathic pulmonary fibrosis.

The German pharma did not provide specific data in its announcement, only that nerandomilast met its primary endpoint by eliciting a significant improvement in forced vital capacity at 52 weeks versus placebo. Boehringer Ingelheim will use the findings from FIBRONEER-IPF to support a drug application for nerandomilast with the FDA and other regulatory authorities worldwide.

The company expects to present full data and analyses from FIBRONEER-IPF in the first half of 2025.

Idiopathic pulmonary fibrosis (IPF) “has a high unmet need for patients,” Ioannis Sapountzis, Boehringer’s head of global therapeutic areas, said in a statement. The disease is one of the more common subtypes of interstitial lung disease, often manifesting as dry and persistent coughs, weakness, fatigue and chest discomfort. Patients also typically reach breathlessness during physical activity.

Nerandomilast addresses IPF by preferentially targeting and inhibiting the phosphodiesterase 4B enzyme, which is highly expressed in the lungs and is believed to be involved in fibrosis and the inflammatory process. The investigational compound works to disrupt these pathways, exerting anti-fibrotic and anti-inflammatory effects on the lungs, according to the pharma’s website.

The FDA gave nerandomilast its Breakthrough Therapy designation for IPF in 2022.

FIBRONEER-IPF is a double-blinded, randomized and placebo-controlled study with nearly 1,200 patients enrolled in more than 30 countries. Nerandomilast was given at high and low doses for 52 weeks, after which patients were assessed for lung function. Key secondary outcomes include the time to the first acute IPF exacerbation or death, and the time to first respiratory hospitalization or death.

FIBRONEER-IPF “is the first IPF Phase III trial in a decade to meet its primary endpoint,” Sapountzis said.

Aside from IPF, Boehringer is also assessing nerandomilast for progressive pulmonary fibrosis, for which it is running the Phase III FIBRONEER-ILD study.

Monday’s Phase III win positions nerandomilast as a potential successor to Boehringer’s Ofev (nintedanib), which is also indicated for IPF to slow disease progression. In 2023, Ofev was one of the pharma’s top-performing assets, growing 12.8% year-over-year and bringing in more than $3.9 billion.

https://www.biospace.com/drug-development/boehringer-aces-phase-iii-pulmonary-fibrosis-trial-plans-fda-application

Merck, Daiichi Score Late-Stage NSCLC Win for ADC, Flag Two Deaths

 

Despite meeting the primary endpoint in a Phase III study, two patients treated with Merck and Daiichi Sankyo’s experimental antibody-drug conjugate died in a Phase III non-small cell lung cancer study, though the deaths have not been linked to patritumab deruxtecan.

Merck and Daiichi Sankyo on Tuesday announced that their investigational antibody-drug conjugate patritumab deruxtecan hit the primary endpoint in the Phase III HERTHENA-Lung02 study in non-small cell lung cancer.

Patritumab deruxtecan’s safety profile in the trial was consistent with what had been established in prior studies, with no new signals, according to the companies. “The majority of interstitial lung disease (ILD) events were low grade” but there were two deaths—both from grade 5 ILD events, though Tuesday’s announcement provided no causal link to patritumab deruxtecan treatment.

Without providing specific HERTHENA-Lung02 data, Merck and Daiichi Sankyo revealed that patritumab deruxtecan treatment resulted in “statistically significant improvement” in progression-free survival, compared with platinum plus pemetrexed induction chemotherapy followed by maintenance with pemetrexed. However, at the time of the interim analysis, overall survival data were not yet mature with the study continuing to follow its participants for the analysis.

HERTHENA-Lung02, an open-label late-stage trial, enrolled patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. Patients underwent prior treatment with an EGFR tyrosine kinase inhibitor.

Merck and Daiichi will present full findings and analyses from the study at an upcoming medical meeting and will share its results with regulatory authorities “to discuss next steps,” Ken Takeshita, global head of R&D at Daiichi Sankyo, said in a statement.

“These results from HERTHENA-Lung02 demonstrate the potential of patritumab deruxtecan to become an important treatment option for certain patients with EGFR-mutated non-small cell lung cancer with prior tyrosine kinase inhibitor treatment,” Takeshita said.

Patritumab deruxtecan is an antibody-drug conjugate (ADC) composed of a fully human IgG1 monoclonal antibody that targets the HER3 protein on cancer cells, and an exatecan derivative payload, which is a topoisomerase I inhibitor that can trigger cell death. The ADC is the centerpiece of the $22 billion October 2023 agreement between the companies, which gave Merck the right to co-develop and co-commercialize three investigational ADCs for cancer.

In the Phase II HERTHENA-Lung01 study, patritumab deruxtecan elicited an overall response rate of nearly 30% in patients with EGFR-mutated locally advanced or metastatic NSCLC. This includes on complete response and 66 partial responses. At the time, median duration of response was over six months.

However, in June 2024, the FDA denied approval for patritumab deruxtecan, citing issues with a third-party manufacturing facility. The regulator did not flag problems with the ADC’s safety or efficacy data.

Tuesday’s readout comes soon after the end of the 2024 World Congress on Lung Cancer, where Daiichi Sankyo reported disappointing Phase III data for its AstraZeneca-partnered ADC datopotamab deruxtecan (Dato-DXd). In the late-stage TROPION-Lung01 study, Dato-DXd cut the risk of death by 6%, which fell short of statistical significance. Dato-DXd’s overall survival benefit in the study’s non-squamous population was likewise not statistically significant.

Daiichi Sankyo and AstraZeneca are seeking approval for Dato-DXd in non-squamous NSCLC, with a target action date of Dec. 20, 2024.

https://www.biospace.com/drug-development/merck-daiichi-score-late-stage-nsclc-win-for-adc-flag-two-deaths

US Secret Service says it is aware of Musk post about Biden, Harris

 The U.S. Secret Service said on Monday it was aware of a post by billionaire Elon Musk on the X social media platform musing about an absence of assassination attempts on President Joe Biden and Vice President Kamala Harris.

Musk, who owns the platform, formerly known as Twitter, put up the post after a man suspected of planning to assassinate Republican former President Donald Trump at his golf course in West Palm Beach was arrested on Sunday.

A Trump supporter and the CEO of Tesla, Musk wrote on Sunday: "And no one is even trying to assassinate Biden/Kamala," a post he ended with an emoji of a face with a raised eyebrow.

He was quickly criticized by X users from the left and right, who said they were concerned his words to nearly 200 million followers could incite violence against Biden and Harris.

Musk deleted the post but the Secret Service, tasked with protecting current and former presidents, vice presidents and other notable officials, took notice.

"The Secret Service is aware of the social media post made by Elon Musk and as a matter of practice, we do not comment on matters involving protective intelligence," a spokesperson told Reuters in an email. "We can say, however, that the Secret Service investigates all threats related to our protectees."

The spokesperson declined to specify whether the agency had reached out to Musk, who seemed to suggest in follow-up posts that he had been making a joke.

"Well, one lesson I've learned is that just because I say something to a group and they laugh doesn't mean it's going to be all that hilarious as a post on X," he wrote. "Turns out that jokes are WAY less funny if people don't know the context and the delivery is plain text."

Harris, a Democrat running against Trump in the Nov. 5 presidential election, issued a statement on Sunday night as did Biden expressing relief and gratitude that Trump had not been harmed and condemning political violence.

The White House criticized Musk for his post.

"Violence should only be condemned, never encouraged or joked about. This rhetoric is irresponsible," White House spokesperson Andrew Bates said on Monday.

https://www.yahoo.com/news/us-secret-says-aware-musk-192156536.html

US strategy for anti-ship weapons to counter China: plentiful, mobile, deadly

 The United States is amassing an arsenal of abundant and easily made anti-ship weapons as part of American efforts to deter China in the Indo-Pacific region and gear up U.S. forces there.

Russia's invasion of Ukraine has pushed U.S. thinking toward a new philosophy - "affordable mass," as one missile industry CEO put it, speaking on condition of anonymity, referring to having plenty of relatively cheap weapons at the ready.

"It's a natural counter to what China has been doing," said Euan Graham, a senior analyst with the Australian Strategic Policy Institute think tank, referring to the Chinese arsenal of ships and conventional ballistic missiles including those designed to attack vessels.

The Pentagon and China's Ministry of Defence did not immediately respond to requests for comment.

The United States has ramped up testing of its QUICKSINK weapon, an inexpensive and potentially plentiful bomb equipped with a low-cost GPS guidance kit and a seeker that can track moving objects. The U.S. Air Force used a B-2 stealth bomber during a test last month in the Gulf of Mexico to strike a target ship with QUICKSINK.

China will still have a large advantage in sheer numbers of anti-ship missiles, according to experts, and can base them on its home territory. But increasing U.S. production of QUICKSINK would narrow that gap by putting China's 370 or so warships at more risk during any future conflict than they have faced since before Beijing leaned into modernizing its military in the 1990s.

QUICKSINK, still in development, is made by Boeing, with a seeker from BAE Systems. QUICKSINK can be used with the hundreds of thousands of Joint-Direct Attack Munition tail kits - systems that can be dropped from U.S. or allied warplanes and cheaply turn "dumb" 2,000-pound (900-kg) bombs into guided weapons.

The U.S. military's Indo-Pacific Command wants thousands of the QUICKSINK weapons - and has for years - according to an industry executive, who declined to reveal the precise figure because it is classified.

With enough "affordable mass" weapons aimed at them, Chinese ship defences would be overwhelmed, according to this executive, speaking on condition of anonymity.

In such a scenario, the U.S. military would use Long Range Anti-Ship Missiles (LRASM) or SM-6 missiles to damage a Chinese warship and its radars, then bombard the vessel with lower-cost weapons such as QUICKSINK.

A VARIETY OF WEAPONS

The United States has been amassing a variety of anti-ship weapons in Asia. In April, the U.S. Army deployed its new Typhon mobile missile batteries, which were developed cheaply from existing components and can fire SM-6 and Tomahawk missiles against sea targets, to the Philippines during an exercise.

Such weapons are relatively easy to produce - drawing on large stockpiles and designs that have been around for a decade or more - and could help the United States and its allies catch up quickly in an Indo-Pacific missile race in which China has a big lead.

Although the U.S. military has declined to say how many will be deployed in the Indo-Pacific region, more than 800 SM-6 missiles are due to be bought in the next five years, according to government documents outlining military purchases. Several thousand Tomahawks and hundreds of thousands of JDAMs are already in U.S. inventories, the documents showed.

"China's game is to restrict the movement of U.S. Navy assets in the Western Pacific and First Island Chain," Graham said, referring to the closest major archipelagos from the coast of East Asia. "This is a sort of like-minded response to make life difficult for the PLAN." PLAN is short for the People's Liberation Army Navy, China's maritime service branch.

Placing anti-ship weapons in locations such as the Philippines would put them within reach of much of the South China Sea. China claims 90% of the South China Sea as its sovereign territory, but is opposed by five Southeast Asian states and Taiwan.

Collin Koh, a scholar at the S. Rajaratnam School of International Studies in Singapore, said, "In a way it is like levelling the playing field."

Koh cited the example of Iran-aligned Houthi forces using low-tech anti-ship weapons against civilian traffic in the Red Sea, which forced the United States and others to deploy costly weapons to defend against them.

"If you look at the case of the Red Sea, clearly the cost equation (of anti-ship missiles) doesn't fall on the side of the defender," Koh said. "Even if you have a smaller arsenal of such offensive missile systems, you can still project some deterrence."

https://www.yahoo.com/news/analysis-us-strategy-anti-ship-050348349.html

Watch: Resident Of PA Manufacturing Town Exposes Reality Of Haitian 'Great Job Replacement'

 While Americans were hyper-fixated on the 20,000 Haitians the Biden-Harris administration dumped into Springfield, Ohio, through an expanded Temporary Protected Status program for migrants from the collapsed Caribbean nation, former President Trump shifted the conversation during a campaign rally last week to Charleroi, Pennsylvania. 

Ahead of Trump spotlighting the Haitian surge in the tiny blue-collar town of Charleroi during a rally last week in Arizona, we cited the think tank America 2100, which first revealed that the town's population of Haitian migrants exploded by 2,000% over the past two years.

Several downtown residents spoke with us about the ongoing migrant surge. They said when the national media began covering the situation in Springfield — they thought, "Wait a minute"—the same migrant influx orchestrated by the Biden-Harris administration was happening across their town. 

We spoke with one employee at a local shop, and we will keep his name anonymous for fear of retribution by local officials or the federal government. He provided us with helpful insight into the Haitian crisis in Charleroi. 

He said at least half of the town's population is now Haitian, noting the influx began to become noticeable under the Biden-Harris' first term, adding there was just a recent surge in new Haitians. Many of these migrants are beneficiaries of Temporary Protected Status. 

As far as what is visible by residents, they explained the primary reason the Haitians were dumped into the town was because of Fourth Street Foods, a food manufacturer that produces quality frozen food products for the processed foods industrial complex. These foods end up being sold in major retail stores throughout the US. 

Let's remind readers in March, we penned a note titled "How Shadowy Network Of NGOs Supplies Mega-Corporations With Migrants To Exploit Cheap Labor," which is possibly how this entire scheme is being operated. The federal government alone can't possibly plan shelter and transportation arrangements for the migrants. 

The consequence of importing third-world migrants to replace blue-collar workers in the town crushes native households. Many residents complained that rents are out of control because the migrants exacerbated a housing shortage. Some have left the town for cheaper housing outside city limits.

The picture being painted in Charleroi is part of a much broader labor theme:

• Great Replacement Job Shock: 1.3 Million Native-Born Americans Just Lost Their Jobs, Replaced By 635,000 Immigrants

The individual said Haitians are being shuttled to and from the food packaging plants via a complex network of vans. There must be dozens and dozens of these vans, easily spotted while driving down city streets. Several of the vans had a logo with a sign that read  'The Wellington Agency,' a staffing company. 

Several times during the ride-along with the individual, Haitian drivers nearly hit the vehicle. He noted that one local DMV worker posted on the town's Facebook page about licenses being handed out to migrants like candy. He said migrants are sparking accidents all over town, which has led to a surge in insurance rates. 

One of the biggest takeaways is that open southern borders and other ways to import migrants from third-world countries have not just been done for election purposes that favor Democrats but as a source of low-cost labor to mega-corporations as the great replacement of native-born workers with foreign-born workers plays out. Basically, the federal gov't and corporate America are selling out blue-collar workers for cheap migrants.

Residents of Charleroi had no say in their beloved town, sold out by local, state, and federal politicians and possibly a network of taxpayer-funded NGOs who facilitated the migrant invasion. Corporate profits are certainly being prioritized over the native residents. 

There was no mention of the Haitians eating dogs and cats, but there were numerous sightings of goat carcasses on a backroad that many in the town joked in a Facebook group: "Hide your goats." 

Here's what the Charleroi residents are talking about on their private Facebook group:

The ride-along in Charleroi occurred on Sunday while factories were shuttered and the town was quiet. 

The biggest takeaway is that great replacement is ravaging American blue-collar households while the federal gov't and their corporate overlords import the third world to the first world just to make more profits.

https://www.zerohedge.com/political/watch-haitian-invasion-charleroi-exposed-resident-shows-great-replacement-us-factory

India Won't Capitulate To American Demands To Ban RT & Sputnik's National Hubs

 by Andrew Korybko via Substack,

Compliance would amount to damaging its own soft power and grand strategic interests...

The Hindu cited unnamed government sources to report that “U.S. officials have spoken to the Ministry of External Affairs about joining their actions against what they call ‘Russian disinformation’, by revoking accreditations and designating their journalists under the ‘Foreign Missions Act’. However, while the Ministry has been silent on the issue, government officials said that the debate on sanctions is not relevant to India.” The US should have known that India wouldn’t ever capitulate to its demands.

The decades-long Russian-Indian Strategic Partnership has been rejuvenated over the past two and a half years since the special operation began after India stepped up to preemptively avert Russia’s potentially disproportionate dependence on China. Time and again, India has responded to American pressure to distance itself from Russia by redoubling their relations, which is predicated on accelerating tri-multipolarity processes with a view towards jointly midwifing complex multipolarity (“multiplexity”).

On the soft power front, a survey carried out by India’s prestigious Observer Research Foundation in late 2022 showed that their country’s youth regarded Russia as their most reliable partner. Meanwhile, a US-based global business intel company confirmed two months later that adults view Russia as the country most allied to their own. This backdrop explains why so many were confused over the summer when it was discovered that RT and Sputnik had shared inconsistent depictions of India’s territorial integrity.

That scandal was analyzed here, which drew attention to how both publicly financed international media flagships are editorially autonomous but were influenced in those examples by what can be described as Russia’s pro-BRI policymaking faction. This incident discredits the US’ subsequent allegation that those two operate as instruments of Russian intelligence since Moscow would never order them to doubt its Indian strategic partner’s territorial integrity and had nothing to do with those inconsistent depictions.

Prime Minister Modi’s trip to Moscow soon thereafter presumably addressed this “rogue” activity and will likely ensure that it’s not repeated now that Russian officials are probably aware of this scandal. RT and Sputnik are publicly financed, after all, and must therefore abide by their patron’s guidelines. This doesn’t mean that they’re “state-run”, let alone intelligence fronts, but just that they have an obligation to ensure that this doesn’t happen again considering that they’re supposed to advance state interests.

About those, not only do they concern full support for the entirety of India’s territorial claims, but they also involve analyzing and articulating a multipolar perspective on International Relations. It was explained here in spring 2022 that this worldview isn’t the product of “Russian propaganda” since the Global Majority’s interests align naturally align with it. This includes India’s, which appreciates the role that RT and Sputnik play in promoting their country’s geostrategic balancing act (“multi-alignment”).

Banning their national hubs like the US demanded would therefore have amounted to damaging its own interests, both in the soft power realm as was explained as well as in the grand strategic one by backstabbing Russia and thus forcing it more into China’s arms at India’s possible expense. As the self-declared Voice of the Global South, the world’s most populous country, and its fifth-largest economy, India is now a trendsetter, so others might be emboldened by its defiance of the US to follow its lead.

https://www.zerohedge.com/geopolitical/india-wont-capitulate-american-demands-ban-rt-sputniks-national-hubs