Obesity Shot Frenzy Makes Lilly World’s Most Valuable Drugmaker

 Eli Lilly & Co.’s (LLY) third straight month of gains has helped it become the largest pharmaceutical company in the world by market value, surpassing Johnson & Johnson.

An 8.5% gain in May for Lilly lifted its shares to a record high and pushed its market capitalization to about $408 billion. J&J, meanwhile, slumped 5.3% during the month, dragging its value down to $403 billion. The Lilly rally was fueled in large part by two major announcements. The first was that its new diabetes drug worked for obesity, followed shortly by news that its experimental treatment for Alzheimer’s succeeded in a final-stage trial.

“Lilly is participating in arguably the two areas of therapeutics that investors are kind of most interested in,” Jared Holz, a managing director at Mizuho Securities, said in an interview. “The street is essentially saying that they’re willing to ascribe very significant value for the large market opportunities and then very little for what they believe are more niche.”

In late April, Lilly said that diabetes drug Mounjaro had succeeded in a second final-stage trial in obesity. Approval would open up an vast new market for the drug, allowing it to go head-to-head with Novo Nordisk A/S’s Wegovy, the leading GLP-1 drug approved for weight loss.

Read More: Obesity Drug Hit Makes Novo Nordisk More Valuable Than Nestle

Meanwhile, Novo Nordisk’s market value has more than doubled since the start of 2021 amid the popularity of its new GLP-1 drugs for diabetes and obesity. In March, it became the second-most valuable company in Europe, knocking Swiss food conglomerate Nestle SA into third place.

One trial showed that patients who take the highest dose of Mounjaro lost an average of 50 pounds. Analysts estimate its annual sales will approach $18 billion by 2029, according to figures compiled by Bloomberg.

Lilly also plans to apply this quarter for approval of its Alzheimer’s drug donanemab, after a late-stage trial showed it was capable of modifying the disease course of the most common form of dementia — only the second drug to to so. The therapy removes an abnormal protein, called amyloid, from the brains of Alzheimer’s patients and would compete with Eisai Co.’s Leqembi.

“Over the past like five to 10 years, when people talk about pharma, they kind of always lead with Pfizer, J&J, Merck,” Holz said. “Lilly is like fourth or fifth maybe, and now it’s first. So a reassortment of the standings I think, is meaningful.”

J&J’s spinoff of its consumer health unit into a new company earlier this year has been the biggest hit to its shares, according to Holz, which have fallen 12% this year. The company could regain at least some of its value with purchases, he said.

Losing its leading position “could put a little bit more pressure or urgency on the part of J&J to augment both its medical device and pharmaceuticals businesses over time,” Holz said.

https://finance.yahoo.com/news/obesity-shot-frenzy-makes-eli-202643499.html

US issues sanctions against Iranian officials in response to assassination plots

 The United States has implemented sanctions against several individuals who are members of or associated with the Iranian military who have been involved in “a series of terrorist plots.” 

The Treasury Department said in a release on Thursday that it is targeting three individuals and a company affiliated with the Iranian Islamic Revolutionary Guard Corps (IRGC) Qods Force and two senior officials for the IRGC’s Intelligence Organization.

The release states that the individuals have been involved in assassination plots against former U.S. government officials, dual U.S. and Iranian nationals and Iranian dissidents. 

“The United States remains focused on disrupting plots by the IRGC and its Qods Force, both of which have engaged in numerous assassination attempts and other acts of violence and intimidation against those they deem enemies of the Iranian regime,” Under Secretary of the Treasury for Terrorism and Financial Intelligence Brian Nelson said in the release. 

The release notes that the Treasury Department has previously addressed terrorist plots from the IRGC’s Qods Force and Intelligence Organization, including an October 2011 designation of top officials involved in planning to assassinate the Saudi Arabian ambassador to the U.S. and the December 2020 designation of an individual involved in plans to carry out operations in the Middle East and United States. 

The department also sanctioned Iranian intelligence agents in September 2021 who targeted a U.S. citizen and Iranian dissidents in other countries. 

The release states Mohammad Reza Ansari, one sanctioned official who is a long-term member of the Qods Force, is also a member of a unit that undertakes operations against Iranian dissidents and non-Iranian nationals in other countries. Ansari and Iranian national Shahram Poursafi planned and tried to assassinate two former U.S. officials. 

Hossein Hafez Amini, a dual Iranian-Turkish national, has used his Turkey-based airline to help the Qods Force’s operations, including kidnapping and assassination schemes, according to the release. 

Former IRGC Intelligence Organization counterespionage official Rouhallah Bazghandi has been involved in overseeing plans to assassinate journalists and Israeli nationals in Istanbul, while Foreign Intelligence Chief Reza Seraj has been involved in failed operations in Asia and operations targeting U.S. citizens.

https://thehill.com/policy/international/4030196-us-issues-sanctions-against-iranian-officials-in-response-to-assassination-plots/

US tries to force company to issue recall of air bag inflators

 The U.S. government is stepping up its quest to force ARC Automotive to recall 67 million potentially dangerous air bag inflators by ordering the company to answer questions under oath and threatening fines if it doesn’t respond.

NHTSA argues that the recall is justified because two people have been killed in the United States and Canada and at least seven others have been injured by ARC’s inflators. The explosions, which first occurred in 2009, have continued as recently as this year.

The special order from the National Highway Traffic Safety Administration asks multiple questions about whether ARC expects any of its inflators to blow apart in the future, and whether it has notified customers about the risk.

The agency wants ARC Automotive Inc., based in Knoxville, Tennessee, to recall the inflators, which could explode with such force as to blow apart a metal canister and expel shrapnel. But ARC is refusing, setting up a possible court fight.

ARC maintains that no safety defect exists, that NHTSA’s demand is based on a hypothesis rather than technical conclusions and that the agency has no authority to order a parts manufacturer to carry out recalls.

NHTSA has tentatively concluded that the inflators are defective. The next steps are a final conclusion, public hearing and potential lawsuit asking a judge to order a recall.

Since ARC inflators can be in both driver and passenger front air bags, people who travel in at least 33 million U.S. vehicles could be at risk.

https://thehill.com/homenews/4029826-us-tries-to-force-company-to-issue-recall-of-air-bag-inflators-after-deaths-injuries/

ATF: Marijuana users in Minnesota can’t own firearms despite new law

 Just one day after Minnesota legalized the recreational use of marijuana, an agency that regulates the use of firearms warned that any current user of marijuana is prohibited from possessing firearms or ammunition.  

The Bureau of Alcohol, Tobacco, Firearms and Explosives (AFT) field office in St. Paul, Minn., issued the clarification Tuesday shortly after Gov. Tim Walz (D) signed a bill legalizing recreational marijuana. The clarification states that under federal law, current users of marijuana are prohibited from possessing, receiving, transporting or shipping firearms or ammunition.  

“Until marijuana is legalized federally, firearms owners and possessors should be mindful that it remains federally illegal to mix marijuana with firearms and ammunition,” Jeff Reed, ATF’s acting special agent in charge of the St. Paul Field Division, said in a statement.

“As regulators of the firearms industry and enforcers of firearms laws, we felt it was important to remind Minnesotans of this distinction as the marijuana laws adjust here in the State of Minnesota.” 

According to an analysis by the RAND Corporation, nearly 40 percent of residents in Minnesota reported owning a gun between 2007 and 2016. According to the Centers for Disease Control and Prevention, about 18 percent of Americans reported using marijuana in 2019.  

The agency said that those looking to purchase firearms must attest whether they are a user of marijuana on their applications. The agency also noted that there is no exception for those who marijuana for medical purposes.  

On Tuesday, Minnesota became the 23rd state in the nation to fully legalize marijuana, allowing those 21 and older to carry up to 2 ounces of marijuana and possess 2 pounds of the substance at home beginning Aug. 1.  

“We’ve known for too long that prohibiting the use of cannabis hasn’t worked,” Walz said in a statement. “By legalizing adult-use cannabis, we’re expanding our economy, creating jobs, and regulating the industry to keep Minnesotans safe.” 

https://thehill.com/homenews/state-watch/4028705-atf-marijuana-users-in-minnesota-cant-own-firearms-despite-new-law/

Leaked documents show Iran planning new phase of attacks against US troops in Syria: WaPo

 Newly revealed leaked documents reveal Iran could be readying for new attacks against U.S. troops in Syria, according to a new Washington Post report.

The Post reports Iran is arming militants in Syria and building and training forces to use bombs specifically intended to target U.S. military vehicles — and to kill U.S. personnel. 

The escalatory move could risk U.S. lives in the region and prompt a more direct military confrontation with Tehran, according to the report. 

Another leaked document reportedly shows Russia, Syria and Iran are working on a broader effort to push the U.S. out of Syria. The U.S. has maintained a military presence in the country to guard against a resurgence of Islamic State militants.

he Post reports the documents show Russian, Iranian and Syrian officials met last year to agree on a “coordination center” — though the Post notes the documents don’t indicate Russia is directly involved in planning the purported bombing campaign.

A Department of Defense contractor was killed and five U.S. service members were wounded in northeast Syria in March when a suspected Iranian-origin drone struck a facility on a Coalition base near Hasakah. 

The U.S. in turn ordered strikes on facilities used by groups affiliated with Iran’s Revolutionary Guard. President Biden said the U.S. would respond “forcefully” to protect its personnel in the region, though he stressed the U.S. “does not seek conflict with Iran.”

https://thehill.com/policy/international/4029985-leaked-documents-show-iran-planning-new-phase-of-attacks-against-us-troops-in-syria-report/

Greene says McCarthy will release Jan. 6 tapes to three more outlets

 Rep. Marjorie Taylor Greene (R-Ga.) announced Wednesday that three additional media outlets will receive access to footage from the Jan. 6 attacks on the Capitol.  

“Huge news: As I promised the J6 tapes will be released,” Greene tweeted.

Greene said in her post that three outlets will receive “unfettered access to the J6 tapes,” noting that reporting on it will start Thursday. House Speaker Kevin McCarthy (R-Calif.), according to Greene, will give the tapes to Just the News founder John Solomon and Julie Kelly, a senior writer at American Greatness — but she did not mention what the third outlet would be.

Discussions over whether the Jan. 6 tapes should be released to media outlets ramped up earlier this year after McCarthy granted former Fox News host Tucker Carlson access to more than 44,000 hours of footage from the attacks on the Capitol. The move prompted criticism from Democrats and media pundits who warned that the footage could threaten security procedures at the Capitol.  

When airing the footage on his program, Carlson described the attacks as “mostly peaceful chaos.”  

That prompted Greene to reiterate her calls to publicly release all the Jan. 6 footage, saying earlier this month that she was “wondering” when the tapes would be released.

“We need to release the J6 tapes to a public on line source so that everyone knows what did and didn’t happen, we need to restore fair justice, and America can move on,” she tweeted at the time. 

News organizations filed a lawsuit last month to gain access to the tapes, alleging that federal agencies have not given them the requested footage. The news organizations also wrote that they had asked McCarthy to grant them access to the footage.

“Plaintiffs have continued to press the Speaker’s Office for access to the videos as quickly as possible and on equal terms with other media requestors, only to be told that the Speaker’s Office will not even provide a timeline for when such access might begin,” the complaint states. 

The outlets included in the lawsuit are Advance Publications, The Associated Press, CNN, CBS, The E.W. Scripps Company, Gannett, The New York Times, Politico and ProPublica. 

The Hill has reached out to McCarthy’s office for comment.  

https://thehill.com/blogs/blog-briefing-room/4028956-greene-says-mccarthy-will-release-jan-6-tapes-to-three-more-outlets/

'COVID clawback in debt limit deal spurs public health fears'

 Some public health advocacy groups are sounding the alarm over a provision in the debt ceiling deal to claw back about $27 billion in unspent pandemic relief money, arguing it could have consequences for future public health initiatives. 

Unspent COVID-19 dollars have long been a target of Republicans, and taking back some of that money gives Speaker Kevin McCarthy (R-Calif.) a political win.

The federal COVID-19 public health emergency ended earlier this month, and President Biden had indicated he was open to a deal that included coronavirus funding rescissions. That clawback was included in the final measure to raise the debt limit, which cleared the House in a bipartisan 314-117 vote Wednesday and now heads to the Senate, where leaders hope it will pass quickly ahead of a Monday deadline given by the Treasury Department.

According to the White House, some of the unspent money will now be used to help shore up nondefense spending. 

“The appropriators will use some of that money to spread around how they see fit,” said Shalanda Young, director of the White House Office of Management and Budget. “We didn’t get into the individual line items in this bill.”

According to the Congressional Budget Office, a majority of the reductions would come from the Public Health and Social Service Emergency Fund, as well as from certain infrastructure and disaster relief programs.

Over the course of the pandemic, Congress appropriated nearly $5 trillion to various programs and agencies — including the Department of Health and Human Services (HHS), the Small Business Administration, the Department of Veterans Affairs and the Transportation Department.

Across HHS, Congress would take back more than $13 billion from the Centers for Disease Control and Prevention, the Food and Drug Administration and other agencies for programs including vaccine efficacy and supply chain monitoring.

The funds were unspent for a variety of reasons. According to a summary circulated by the White House and obtained by The Hill, some of the programs had concluded, and there was no longer demand for others.  

Still, advocates said they are concerned lawmakers have not learned lessons from the pandemic. 

“I think the issue is that it just speaks to this notion of nothing happened between 2020 and 2023,” said Ellie Dehoney, senior vice president of policy and advocacy at Research!America.

HHS saw a tremendous infusion of cash during the pandemic. According to the Government Accountability Office, six pandemic relief laws appropriated about $349 billion to HHS’s Public Health and Social Services Emergency Fund between March 2020 and March 2021. 

For context, the White House’s 2024 budget request would provide about $278 million for the emergency fund, which would be about $160 million more than what was enacted in the fiscal 2023 spending bill.

The White House summary indicated there was about $20 billion remaining in the fund and said it was able to keep $10 billion to develop the next generation of vaccines, test procurement and research into long COVID.

Georges Benjamin, executive director of the American Public Health Association, said he understands the agreement was probably the best-case scenario with Republicans in control of the House. 

Still, his primary concern was that public health is being sacrificed to make fiscal ends meet.

“They didn’t do this to the military budget. The military didn’t just crash the economy … but an infectious disease did. And we’re still inadequately investing in infectious disease right now,” Benjamin said.

But other experts said the immediate impact will not be significant because the White House was able to protect key investments.

Jen Kates, a senior vice president and global health expert at KFF, said it’s not totally clear what the funds would have been used for. 

As recently as last year, the Biden administration was asking Congress for more money. Republicans rebuffed the requests and insisted the White House hadn’t given an adequate accounting of where the previously appropriated funds had been spent. 

“I think that the federal government has not always shown the details of what [money] is left and why. And I think that doesn’t make your case very well,” Kates said. 

“Congress has basically said COVID is over … they want this money to come back. They have not had any appetite to provide more funding. In their view, COVID is done, and so the fact that this money was sitting there without a clear sense of why did not help [the administration’s] case,” Kates said. 

The larger concern for many is the legislation’s cap on nondefense discretionary spending will be kept roughly flat for 2024 and then given a 1 percent increase in 2025.

The cap could significantly curb spending for health agencies including the Centers for Disease Control and Prevention and the National Institutes of Health, which have been facing GOP attacks. 

https://thehill.com/policy/healthcare/4029227-covid-clawback-in-debt-limit-deal-spurs-public-health-fears/