Search This Blog

Wednesday, July 2, 2025

HHS, Justice Department form False Claims Act task force

 The Justice Department and HHS have launched a joint False Claims Act Working Group to intensify efforts at combatting fraud and abuse in the federal healthcare system.

The group builds on a long-standing partnership between the agencies in enforcing the False Claims Act (FCA), a tool used to tackle healthcare fraud. Through enhanced collaboration, the DOJ-HHS Working Group aims to streamline and expedite investigations, identify new leads and leverage HHS resources, according to a July 2 news release. 

The group will be co-led by senior officials from the HHS Office of General Counsel, CMS’ Center for Program Integrity, the Office of Counsel to the HHS Office of Inspector General, the Justice Department’s Civil Division, and designees from U.S. attorney’s offices. HHS general counsel, chief counsel to HHS-OIG and the deputy assistant attorney general of the Commercial Litigation Branch will all jointly lead the group. 

New priorities will be added to the working group’s focus area. Among them are Medicare Advantage; device, biologics or drug pricing, along with discounts, rebates, service fees and formulary placement and price reporting arrangements; patient care access barriers like network adequacy requirement violations; kickbacks related to medical devices, durable medical equipment, drugs and other federal healthcare program-paid products; materially defective medical devices that affect patient safety; and intentional alteration of electronic health record workflows to drive unwarranted Medicare billing.

“The working group shall maximize cross-agency collaboration to expedite ongoing investigations in these priority areas and identify new leads, including by leveraging HHS resources through enhanced data mining and assessment of HHS and HHSOIG report findings,” the release said.

https://www.beckershospitalreview.com/legal-regulatory-issues/hhs-justice-department-launch-false-claims-act-working-group/

Gilead Eyes HIV Market Domination With Twice-Yearly Yeztugo as GSK Trails

 

Analysts believe that Gilead’s new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say about it.

Gilead is mounting a bid to tighten its grip on the HIV market. Having secured approval for twice-yearly HIV prevention product Yeztugo, the company has a shot at wresting more market share from GSK and generics manufacturers.

HIV products generated $19.6 billion for Gilead last year. Biktarvy, a once-daily pill for treating HIV, is the cornerstone of the portfolio, generating $13.4 billion in 2024. Descovy, a once-daily drug to treat and prevent HIV, is Gilead’s other main HIV product. The company reported $2.1 billion in Descovy sales last year, most of which came from its use in HIV prevention.

Descovy competes with GSK’s Apretude, an injectable preventive given every two months, in the pre-exposure prophylaxis (PrEP) market. Talking on an earnings call in April, Johanna Mercier, Gilead’s chief commercial officer, said Descovy maintained an “over 40% market share and grew more than 2% year-over-year.”

An HIV doctor told Mizuho analysts that 45% to 50% of their 125 PrEP patients are on Descovy. One-third of the doctor’s patients take Apretude, although the analysts said the average could be 20% to 25% in the northeast U.S. and varies with the commercial insurance rates of individual practices. Around 20% of patients take Truvada, Gilead’s old PrEP drug, or generic copies of the off-patent molecule.

Yeztugo’s Path to $4.5B Peak Sales

The analyst consensus is that Yeztugo will achieve peak sales of around $4.5 billion. Talking at a Goldman Sachs event in June, Gilead CEO Daniel O’Day outlined three pools of patients the big biotech will target as it seeks to grow Yeztugo sales.

First, the company will seek to convert the 400,000 to 450,000 current PrEP users in the U.S. to Yeztugo, O’Day said. The new drug could improve treatment compliance, which O’Day said is around 50% for daily pills.

The HIV doctor expects Yeztugo to be popular with current PrEP users, telling Mizuho analysts the “vast majority” of Apretude users and the “majority” of daily oral PrEP users could switch to the new drug. Up to 10% of the doctor’s patients may want to stay on an oral regimen because of needle aversion. Another doctor Mizuho spoke with, however, was more conservative, estimating that just 30 to 40% of their private practice PrEP patients will switch.

If the first doctor is right, Yeztugo will rapidly reshape the PrEP market. That doctor said “most” patients who want to switch to Yeztugo will be able to do so within 12 months. O’Day has predicted Yeztugo will have 70% to 75% payer coverage after six months, rising to 90% by the end of the drug’s first year on the HIV market.

Gilead’s second group of target patients is the 750,000 to 800,000 people in the U.S. who could benefit from PrEP but do not currently take a drug to prevent HIV. O’Day said most PrEP users are men who have sex with men who live in large urban areas. Gilead has been less successful at reaching other groups of at-risk individuals, O’Day said.

The company will target the current and potential U.S. PrEP patients from the start of the Yeztugo launch. The HIV doctor said some patients, mainly men who have sex with men, who do not currently take a PrEP drug have contacted them about Yeztugo. O’Day said it will take time to raise awareness and drive demand among underserved communities.

Gilead’s third group of patients is a longer-term play. PrEP is largely a U.S. phenomenon today, O’Day said, but Gilead believes Yeztugo represents good value to payers in other countries. Preventing a case of HIV in the U.S. saves about $1.1 million in eventual lifetime healthcare costs, according to the CEO. Gilead plans to talk to health ministries about programs where Yeztugo could serve targeted populations.

GSK Gears Up for Market Share Fight

The anticipated reshaping of the PrEP market is a threat to one of GSK’s growth drivers. Developed by the U.K. pharma’s HIV joint venture ViiV Healthcare, Apretude sales rose around 90% last year to hit 279 million pounds ($383 million). A wholesale switch to Yeztugo, as the HIV doctor foresees, could cause Apretude sales to contract.

GSK sees things differently. ViiV Chairman David Redfern said on an earnings call in February that the company “certainly [expects] Apretude to continue to grow this year,” arguing that the market is still “significantly underdeveloped” and that the launch of another long-acting PrEP drug will “help grow the market for all of us.” Redfern also expects some patients to prefer Apretude to Yeztugo.

“The competitive product definitely won’t be for everyone,” Redfern said. “We now know that there’s quite a high frequency of nodules that people experience in their abdomen, where the two injections are given. For potential PrEP users who are body image conscious, which will be quite a proportion of them, I think that potentially is an issue.”

Given the relative size of the HIV treatment and prevention markets, GSK could still have a big franchise even if Gilead starts dominating the PrEP sector. Redfern has valued the total HIV market at 22 billion pounds ($30.2 billion), with treatments accounting for 90% of all sales. Gilead’s Mercier said Biktarvy has a 51% share of the U.S. treatment market but GSK is advancing molecules to challenge the incumbent.

GSK’s pipeline includes VH184, an integrase strand transfer inhibitor the company said has the best resistance profile seen to date, and broadly neutralizing antibody N6LS. Those drug candidates, plus the capsid inhibitor VH499, are part of GSK’s plans to launch a twice-yearly HIV treatment between 2028 and 2030. GSK is aiming to launch a twice-yearly PrEP drug, matching the Yeztugo regimen, in the same timeframe.

While GSK is seeking to use its long-acting injectable capabilities to win market share, Gilead is also moving next-generation candidates through the clinic. Gilead has 12 clinical programs in HIV lined up to help defend its empire through potential launches including a once-yearly version of the active ingredient in Yeztugo.

https://www.biospace.com/business/gilead-eyes-hiv-market-domination-with-twice-yearly-yeztugo-as-gsk-trails

Iranian nuclear program degraded by up to two years, Pentagon says

 The U.S. military’s unprecedented strikes on Iran’s nuclear facilities last month set back the country’s nuclear program by one to two years, according to top Defense Department spokesman Sean Parnell.

Parnell maintained during Wednesday’s Pentagon briefing that the U.S. strikes resulted in the “total obliteration of Iran’s nuclear ambitions,” which has been the Pentagon’s stance on the strikes since they occurred, though he added, “We have degraded their program by one to two years at least.”

“I think we’re thinking probably closer to two years, like degraded their program by two years,” he said. He added that when factoring the totality of the strikes from a “psychological” perspective, “We believe that Iran’s nuclear capability has been severely degraded, perhaps even their ambition to build a bomb.”

His comments on how far the United States set back Iran’s nuclear program marked the first detailed assessment from the Pentagon.

A preliminary analysis from the Defense Intelligence Agency that was leaked to the media after the strikes suggested, with low confidence, that Iran’s nuclear program had only been delayed by months. The leak of the report prompted an FBI investigation.

Defense Secretary Pete Hegseth and President Donald Trump disagreed with the assessment’s conclusions and argued the strikes had a devastating effect.

The U.S. targeted three of Iran’s facilities: Fordow, Natanz, and Isfahan. The Fordow facility was considered the most impenetrable, given it was built under a mountain. The U.S. had to deploy its most powerful nonnuclear bomb, which it had never used before in battle, to target it.

The U.S. began planning the operation targeting the Fordow facility about 15 years ago.

The head of the International Atomic Energy Agency, Rafael Grossi, said last week the damage to Iran’s nuclear program was “severe” but not “total,” and he added that they could restart producing enriched uranium “in a matter of months.”

Following the U.S. attack on Iran’s nuclear facilities, Iran carried out what was largely a symbolic retaliatory attack on the U.S.’s Al Udeid Air Base in Qatar.

https://www.washingtonexaminer.com/policy/defense/3461215/iran-nuclear-program-set-back-one-to-two-years-pentagon/

Moderna To Ask For Clearance For Combination COVID-Influenza Vaccine

 by Zachary Stieber via The Epoch Times (emphasis ours),

Moderna is going to ask regulators to approve its combination vaccine against COVID-19 and influenza, the company said on June 30.

The company said a phase 3 study evaluating its influenza vaccine candidate, mRNA-1010—which utilizes the same messenger ribonucleic acid (mRNA) platform as its COVID-19 vaccine—showed positive effectiveness.

In the trial, which featured 40,805 participants and compared mRNA-1010 to an existing seasonal flu vaccine in adults aged 50 and up, the relative protection from the candidate was 26.6 percent better. In a subgroup analysis among participants aged at least 65, the relative efficacy was 27.4 percent.

Today’s strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults,” Stéphane Bancel, Moderna’s CEO, said in a statement.

Several companies, including Moderna, have been planning to introduce combination shots against COVID-19 and influenza.

Moderna, however, in May withdrew its application for approval for its combination vaccine, a move the company said came after consulting with the Food and Drug Administration.

Moderna at the time said it planned to resubmit the application before the end of 2025 after it received efficacy data from the phase 3 trial for mRNA 1010.

“An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines,” Bancel said on Monday.

The trial results have been fully published or peer reviewed. Moderna said it plans to submit the results to a peer-reviewed journal.

Moderna said that the phase 3, randomized trial results showed safety results similar to those reported from a different phase 3 trial in March in the journal Vaccine. In that paper, researchers reported similar numbers of adverse events between Moderna vaccine recipients and volunteers who received existing flu vaccines. There were also fewer severe, serious, and medically attended adverse events among the Moderna recipients, with no deaths reported in that group.

“The majority of solicited adverse reactions (SARs) were mild,” Moderna said in a statement about the new study. “Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported.

“There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.”

There are currently no mRNA flu vaccines in the United States.

The FDA did not return a request for comment by publication time.

Regulators in May approved a new COVID-19 vaccine from Moderna for adults aged 65 and older, as well as other individuals aged at least 12 who have one or more conditions that officials say put them at higher risk for severe COVID-19.

https://www.zerohedge.com/medical/moderna-ask-clearance-combination-covid-influenza-vaccine

'Iranian Hackers Say They Have 100GB Of Trump Emails'

 by José Niño via Headline USA,

Hackers claiming ties to Iran say they possess 100GB of emails from President Donald Trump’s inner circle and may soon leak or sell the trove, after previously distributing a batch to the media before the 2024 U.S. election.

In online conversations with Reuters on Sunday and Monday, the hackers—who use the pseudonym “Robert”—claimed to possess about 100 gigabytes of emails from the accounts of “White House Chief of Staff Susie Wiles, Trump lawyer Lindsey Halligan, Trump adviser Roger Stone and porn star-turned-Trump antagonist Stormy Daniels.”

Robert mentioned the potential of selling the material but did not provide further details about their plans or the content of the emails.

U.S. Attorney General Pam Bondi described the breach as “an unconscionable cyber-attack.”

The White House and FBI responded with a statement from FBI Director Kash Patel, who said:

“Anyone associated with any kind of breach of national security will be fully investigated and prosecuted to the fullest extent of the law.”

The Cybersecurity and Infrastructure Security Agency (CISA) posted on X that “This so-called cyber ‘attack’ is nothing more than digital propaganda, and the targets are no coincidence. This is a calculated smear campaign meant to damage President Trump and discredit honorable public servants who serve our country with distinction”

Robert first appeared during the final months of the 2024 presidential campaign, claiming to have breached the email accounts of several Trump allies, including Wiles, and subsequently distributed emails to journalists.

Reuters authenticated some of the leaked material, including an email that appeared to show a financial arrangement between Trump and lawyers for Robert F. Kennedy Jr., now Trump’s health secretary.

Other documents included Trump campaign communications about Republican candidates and discussions of settlement negotiations with Daniels. Although the leaks received some media attention, they did not fundamentally alter the outcome of the presidential race, which Trump won.

A September 2024 indictment from the U.S. Justice Department alleged that Iran’s Revolutionary Guards ran the Robert hacking operation.

After Trump’s election, Robert told Reuters that no more leaks were planned. As recently as May, the hackers said, “I am retired, man.” However, the group resumed communication after the recent 12-day air war between Israel and Iran, which ended with U.S. bombing of Iran’s nuclear sites. In recent messages, Robert said they were organizing a sale of the stolen emails and wanted Reuters to “broadcast this matter.”

Frederick Kagan, a scholar at the American Enterprise Institute, commented that Iranian spies may be seeking retaliation through means unlikely to provoke further U.S. or Israeli military action, stating, “A default explanation is that everyone’s been ordered to use all the asymmetric stuff that they can that’s not likely to trigger a resumption of major Israeli/U.S. military activity. Leaking a bunch more emails is not likely to do that.”

Despite concerns about potential digital attacks, Iran’s hackers maintained a low profile during the conflict, though U.S. cyber officials warned that American companies and critical infrastructure operators might still be at risk from Iranian operations.

Over the last year, American-Iranian relations has reached new lows. Headline USA has reported on multiple instances of alleged Iranian plots to assassinate Trump, all in an effort to get the United States into a direct confrontation with Iran.

https://www.zerohedge.com/political/iranian-hackers-say-they-have-100gb-trump-emails

Wall Street Dealers Shred Treasury Auction Size Forecasts After Bessent Remarks

 


Wall Street dealers — until recently expecting US government debt auction sizes to resume growing next year — are going back to the drawing board after comments by Treasury Secretary Scott Bessent this week.

Interest-rate strategists at Bank of America Corp. scrapped their earlier forecast for note and bond auction size increases beginning in February, predicting levels will remain unchanged into 2027. Any increase in the borrowing need — which is expected based on federal deficit trends — will be met with more issuance of bills, which mature within a year, they said in a note Wednesday.

https://www.bloomberg.com/news/articles/2025-07-02/heeding-bessent-dealers-shred-treasury-auction-size-forecasts

Mamdani’s grocery scheme is foolish — but there’s method to the madness

 Democratic mayoral nominee Zohran Mamdani has a lot of dumb ideas. Of course, these days that’s pretty much assumed when you hear the words “Democratic mayoral nominee.”

But — though the competition is stiff — the dumbest of his ideas may be his plan for government-run grocery stores. In fact, it’s so obviously a terrible idea that even Democrats seem to know it. 

So there must be another agenda, and I think I know what it is.

Business owners across New York City and the nation have denounced Mamdani’s plan as a Soviet-style disaster.

“You can’t force us to pay taxes and then be our adversary,” said Bronx bodega owner Rafael Garcia.

He’s on to something.

In the old Soviet Union, the government did in fact run the grocery stores. 

Shelves were often empty. Lines were absurdly long. Product quality and service were, to put it mildly, horrible.

In fact, things were so bad in the government-run grocery stores (and department stores, and clothing stores) that there were separate stores for the big shots, the nomenklatura as Soviet citizens resentfully called them. 

(The term arose because the leaders of the Workers’ Paradise were those with the right names — in essence, the Communist aristocracy.)

Imagine a supermarket with the sluggish, low-grade service of the Department of Motor Vehicles. 

And unlike the DMV’s standardized product line (there aren’t quality distinctions to be made with driver’s licenses and tags), you can bet the products offered in government-run grocery stores will be subpar.

Not, of course, in any city-run markets located in neighborhoods occupied by the influential and well-off. Who don’t need help buying groceries. 

It’s such a bad idea that the wildly unpopular Chicago Mayor Brandon Johnson considered it, too — and gave it a pass. 

Johnson conducted a feasibility study that he never made public, but the idea was apparently such a disaster that he never even tried to claim subsidies that the state of Illinois had made available for the purpose. 

The feasibility study likely concluded, as any bodega owner could attest, that the grocery business is notoriously low-margin — and, even in so-called “food deserts,” fiercely competitive.

As Seth Barron observed in City Journal, “Mamdani’s quaint suggestion that the lack of a profit motive will make it easier to run a successful business sounds a lot like what public-housing enthusiasts said about New York’s experiment with being a landlord a century ago.”

We know how that worked out.

Several American towns and smaller cities have tried to launch publicly owned grocery stores, usually when the last local market closed in the face of big-box competition. All have met with uniformly dreadful results.

Some point to the 17 states that successfully run state liquor stores to contend that a state-run grocer can work, too. 

But that’s a terrible argument: State-run liquor stores derive from a post-Prohibition decision to limit alcohol consumption by making it inconvenient and expensive. 

Nobody would argue that state liquor stores fail at doing that — but do we want to make food “inconvenient and expensive” too?

Who actually thinks this is a good idea?

And if it’s a bad idea, why are Democratic politicians in favor of it?

For the same reason they favor a lot of bad ideas, from rent control to defunding the police: They’re ideas that may be awful for a city but are good for them, or for their constituencies.

Once I wondered why so many politicians support commuter rail — until it dawned on me that politicians covet graft from developers, and commuter stations boost new developments. 

Bus stops? Not worth it, because politicians can always renege on the deal and move a bus stop. It’s much harder to move a train station, not to mention tracks. 

I suspect government-run grocery stores would work the same way:  A well-located city grocery is worth big bucks from a developer. A grocery store in a neighborhood full of your supporters helps keep them sweet. 

A neighborhood or developer that doesn’t support you can be punished by closing a store, or limiting its stock, or letting it run down.

A city-run grocer wouldn’t have Stalin’s power to starve out Ukraine — but it sure is interesting how hard-core leftists always want to control people’s access to food.

Of course, there are risks to the politicians, too. 

If the service and quality in city-run groceries is awful — and it likely will be, at least after an initial honeymoon period — voters will blame them. 

And while voters may tolerate corruption and inefficiency, the in-your-face misery created by lousy grocery stores may be enough to spark a New York City voter revolt.

Which, come to think of it, is exactly what the city needs.

Glenn Harlan Reynolds is a professor of law at the University of Tennessee and founder of the InstaPundit.com blog.

https://nypost.com/2025/07/02/opinion/nyc-mamdanis-grocery-scheme-theres-method-to-the-madness/