FDA can't solve drug shortages on its own, agency's oncology chief says

 As oncologists ration critical platinum-based cancer drugs in the U.S., government officials are busy seeking to alleviate the problem. But the government can't do it alone, one leader said.

The FDA has a hand in mitigating cancer drug shortages, but its abilities are limited, the director of the FDA's Oncology Center of Excellence, Richard Pazdur, M.D., told The Cancer Letter.

The root cause of shortages of chemo drugs such as cisplatin and carboplatin is ultimately a failure by the industry to invest in building capacity, Pazdur told the publication. 

With cisplatin specifically, the shortage started at one manufacturing facility after the FDA identified quality issues after an inspection. The plant then had to shut the production line, which triggered a “ripple effect" in the supply chain, according to Pazdur.

The FDA has offered assistance to the five manufacturers that produce the drug and is “exploring temporary importation," but the agency can’t do much to fully alleviate the shortage, Pazdur told The Cancer Letter.

As it stands, the FDA can’t require a company to manufacture a drug, nor can it make a manufacturer report increases in demand that could lead to a shortage, Pazdur explained. It also can’t require that essential drugs, including chemo, have diversified supply chains.

Even for drugs with more than one manufacturer, most facilities are operating near capacity. This means they aren't able to provide extra supplies if another plant stops production, Pazdur said.

Meanwhile, some companies have been reporting to the FDA that manufacturing costs have exceeded sales prices, forcing them out of certain markets, according to the oncology chief.

One potential solution would be a government contract with manufacturers to produce a “buffer stockpile” of essential oncology drugs, Pazdur said.

There are currently shortages of 17 cancer drugs, and the FDA is working with industry players to address them. For example, one of the three approved manufacturers of fludarabine injection was granted “regulatory discretion” to use unapproved, but FDA-evaluated, raw materials.

Ultimately, the FDA can’t solve this problem on its own, Pazdur told The Cancer Letter. A shortage is “the end result of a failure in the market,” Pazdur emphasized.

It’s an issue that the agency has been pressed on before. In March, the FDA’s actions in preventing and responding to the shortages were probed in Congress as the House Committee on Energy and Commerce launched an investigation to uncover if the agency is “effectively using its existing authorities.”

https://www.fiercepharma.com/manufacturing/failure-market-results-persisting-shortages-fda-oncology-director-says-report

FDA warns on compounded versions of Novo Nordisk's Ozempic, Wegovy

 In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday.

Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs.

Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out.

The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective.

The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with the FDA.

The agency also suggests users of online pharmacies screen them through its BeSafeRx campaign.

Over the last several weeks, authorities in states such as Louisiana, Mississippi, North Carolina and West Virginia have threatened to take legal action against compounding pharmacies making unauthorized versions of Ozempic and Wegovy.

Five weeks ago, Novo Nordisk promised a supply boost of Wegovy after lining up a second contract manufacturer. But, during the company’s first-quarter earnings report, it said that it would “temporarily” reduce U.S. supply of lower dosage strengths of the treatment.

https://www.fiercepharma.com/pharma/fda-warns-compounded-versions-novo-nordisks-ozempic-and-wegovy

J&J faces new trial over talc cancer claims, amid settlement push

 

Johnson & Johnson on Wednesday faced the first trial in almost two years over claims that asbestos in its baby powder and other talc products cause cancer, as it seeks to settle thousands of similar cases in bankruptcy court.

Emory Hernandez, 24, says he developed mesothelioma, a deadly cancer, in the tissue around his heart as a result of exposure to J&J's talc products beginning when he was a baby. The company has denied that its talc contains asbestos, which is linked to mesothelioma, or causes cancer.

Joseph Satterley, a lawyer for Hernandez, urged jurors in Alameda County, California court to reject the company's defenses and hold it responsible for his client's illness.

"I can assure you the evidence will be very strong," Satterley said. "Mesothelioma is a signature disease of asbestos."

J&J in a statement on Wednesday said it "deeply sympathizes with anyone suffering from cancer and understands they are looking for answers. However, the science doesn't support that the exceedingly rare form of mesothelioma at issue in this case is connected to talc exposure."

A lawyer for J&J was expected to deliver an opening statement later on Wednesday.

J&J subsidiary LTL Management in April filed for bankruptcy in Trenton, New Jersey proposing to pay $8.9 billion to settle more than 38,000 lawsuits, and prevent new cases from coming forward in the future. It is the company's second attempt to resolve talc claims in bankruptcy, after a federal appeals court rejected an earlier bid.

Litigation has largely been halted during bankruptcy proceedings, but U.S. Chief Bankruptcy Judge Michael Kaplan, who is overseeing LTL's Chapter 11, allowed Hernandez's trial to go ahead because he is only expected to live a short time.

Even if Hernandez wins, he will not be able to collect on the judgment while the bankruptcy is ongoing.

Still, the outcome of the trial could influence whether other plaintiffs decide to join in the proposed settlement.

Asbestos plaintiffs are seeking to have the latest bankruptcy filing dismissed, and have argued it was brought in bad faith to insulate the company from litigation.

J&J and LTL have argued bankruptcy delivers settlement payouts more fairly, efficiently and equitably than a "lottery" offered by trial courts, where some litigants get large awards and others nothing.

https://www.marketscreener.com/quote/stock/THE-LOTTERY-CORPORATION-L-137106461/news/J-J-faces-new-trial-over-talc-cancer-claims-amid-settlement-push-44005679/

Jamie Dimon Hints At Run For Public Office; Bill Ackman Endorses Him For President

 PMorgan's CEO may be getting swept up in the Jeffrey Epstein scandal, but for a billionaire like Jamie Dimon, whose catch phrase is "that's why I'm richer than you" and may as well be "that's why I will always be freer than you", all that will be needed to avoid long-term "legal complications" will be a check with several zeroes on it... or maybe some political immunity. Which may be why the head of the largest US bank is already hinting that after he is done gobbling up all the small and regional banks and gets tired of running JPM, he is considering running for public office.

“I love my country, and maybe one day I’ll serve my country in one capacity or another,” he said in a Bloomberg Television interview, when asked if he’s ever considered a public office position. His comments, made at the bank’s annual Global China Summit in Shanghai on Wednesday, come as the US gears up for its 2024 presidential race.

For now, he’s focused on his job running the largest US bank, a role he’s “quite happy” in. “I love what I do,” he said. JPMorgan does “a great job for helping Americans, for helping countries around the world.”

Dimon also reiterated his view that “business can be a force for good,” and said he’s an American patriot who would follow the US government: “Everyone knows I am a patriot,” he said. “I am a red-blooded, full-throated, free enterprise capitalist.”

As BBG notes, the billionaire Wall Street banker is among a group of long-tenured Wall Street chiefs that also includes Brian Moynihan, 63, who’s led Bank of America Corp. since 2010, and Morgan Stanley’s James Gorman, 64, who became CEO at the start of 2010 and is stepping down within 12 months. Dimon, 67, who has been head of JPMorgan since 2005, has repeatedly said that he plans to remain atop the biggest US bank for five more years.

And while in the past, Dimon has been quick to publicly shut down speculation that he planned a presidential run, shortly after the story about Dimon's "public run" broke, none other than weepy Bill Ackman, who one year ago sold his NFLX impulse buy locking in losses of $400 million when he would have broken even had he sold it yesterday, endorsed Dimon for president in one of his lengthy, trademark Twitter posts.

You will never believe just how long the post is...

Jamie Dimon is one of the world's most respected business leaders. Politically he is a centrist. He is pro-business and pro-free enterprise, but also supportive of well-designed social programs and rational tax policies that can help the less fortunate. He is extremely smart, thoughtful, and pragmatic, and he knows how to bring opposing parties together. He is highly respected by the Right, the Left, and the Center.

Jamie is beloved by his 240,000+ employees, highly respected by our military as well as by the global political and business leaders that matter. He has superbly managed @jpmorgan  through every crisis, and has built the world's best, large, global financial institution working for clients from startups and mom and pops, to global institutions and countries.

Our country is at risk with $32T of debt with no end to massive deficits in sight, heading into a recession at a time of great political uncertainty. We need an exemplary business, financial, and global leader to manage through what is likely to be a critically important decade for our country in determining our destiny.

Jamie Dimon is that leader.

Jamie is of exemplary and unimpeachable character. He is a no bullshit, straight-talking, charismatic leader with an enormous grasp of the world's issues and how to address them. He is a great communicator that makes everyone who hears his words feel respected and inspired. He has enormous energy, vigor, and drive.

He is a wonderful father, friend, husband, and son. In sum, he is the kind of person our country deserves as our next leader. And clearly he is thinking about running:

I can't imagine a better time for him to do so.

@POTUS is extremely weak and in cognitive decline. 70% of Democrats don't want him to run. Biden's weakness sets up a large opening for a qualified outsider to run as a Democrat.

Jamie can beat Biden in the primary and @realDonaldTrump in the general election, but he needs to start now and build name recognition among the broad electorate. He will easily raise billions of dollars from Democrats and Republicans to fund his campaign, and he knows how to build support.

Each year, Jamie gets on a bus and travels around the country meeting with tellers, branch managers, and other employees to spread the culture and inspire the JPM team; great preparation for a presidential run. He will also be incredible on the debate stage.

And there is nothing more for him to achieve at JPM. He has already been crowned the world's best banker. JPM stock will go up even more when he becomes POTUS as he can do more for the bank and our economy as President than he can as Chairman and CEO of JPM.  The bank will be in great shape since he has built a deep succession bench that is more than ready to step up.

There is only one better job for Jamie than CEO of JPM and that's POTUS.

Jamie just needs a push from people he respects and from the broader electorate. If you agree that he should be our next POTUS, give him a call, send him an email or go see him, and like and retweet this tweet.

This will be one of the most important elections in our country's history. Jamie is more likely to run if we build a groundswell of support for him. Let's do our civic duty and make it happen.

Our challenges as a nation are largely due to failures of leadership. America needs and deserves great leadership and we need it now.

Considering several years ago Jamie made headlines with his presidential cufflinks during Congressional testimony (that's when being a recently bailed out Wall Street banker was still frowned upon), it appears that the CEO may just follow Bill's advice.

https://www.zerohedge.com/political/billionaire-jamie-dimon-hints-run-public-office-bill-ackman-endorses-him-president

Thomas H. Lee Partners made $17/share bid for Maravai

 Private equity firm Thomas H. Lee Partners is said to have made a $17 per share all-cash offer for Maravai

https://www.streetinsider.com/Hot+M+and+A/PE+firm+Thomas+H.+Lee+Partners+made+%2417share+bid+for+Maravai+LifeSciences+%28MRVI%29+-+source/21742252.html

Travere: Positive Topline Results in Phase 1/2 Study of Pegtibatinase in Metabolic Disorder

 Data from the four patients treated with the highest dose of pegtibatinase showed a clinically meaningful 67.1% mean relative reduction in total homocysteine from baseline

Pegtibatinase has been generally well-tolerated to date

The Company is engaging with regulators and expects to initiate a pivotal Phase 3 Study by year-end 2023

Company to host conference call and webcast today at 8.30 a.m. ET

Travere Therapeutics will host a conference call and webcast today, Wednesday, May 31, 2023, at 8:30 a.m. ET to discuss the topline results from cohort 6 in the Phase 1/2 COMPOSE Study. To participate in the conference call, dial +1 (888) 394-8218 (U.S.) or +1 (323) 994-2093 (International), confirmation code 7036007. The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

https://finance.yahoo.com/news/travere-therapeutics-announces-positive-topline-110000227.html

Ackman Questions Valuation of Icahn's Firm: Billionaires' Feud

 Bill Ackman and Carl Icahn are back in the limelight. Where have we seen this before? Both legendary investors, Ackman and Icahn duked it out during Ackman's memorable activist short campaign against the dietary supplement and marketing company Herbalife.

Icahn took the long side of the bet, and the feud boiled over during an iconic debate on CNBC back in 2013 that saw the two take personal shots at each other.

Now, 10 years later, another battle between the two could be brewing. Icahn's conglomerate, Icahn Enterprises (IEP 0.71%), has come under attack from short sellers this year, and the stock has lost more than 57% of its value. Recently, Ackman made some comments about Icahn Enterprises on Twitter, which seem to be fanning the flames. 

In early May, the investment research firm Hindenburg Research, which focuses on activist short-selling, issued a short report on Icahn Enterprises, a conglomerate that invests in a wide range of sectors, including energy, automotive, food packaging, metals, real estate, and home fashion. Icahn owns 85% of the company.

Hindenburg's short report has three main assertions driving its short thesis against Icahn Enterprises:

• The company previously traded at a 218% premium to its net asset value (NAV), a much higher valuation than any of its peers.
• The company's less liquid and private assets have inflated valuations in the company's financial statements.
• IEP recently incurred more losses due to a big short bet in late 2022 that hasn't worked out. 

Hindenburg also believes IEP's $2 quarterly dividend is unsustainable. This translated to a roughly 16% annual dividend yield before the short report, and now a 36% dividend yield following the huge sell-off. In its report, Hindenburg pointed out that IEP has generated close to -$5 billion of free cash flow since 2014 while paying out $1.5 billion in dividends during this time.

Another big allegation from the Hindenburg report is that Icahn has pledged roughly 60% of his IEP holdings as collateral for personal margin loans, which, if called, could result in a forced asset sale. Icahn has refuted the short report, referring to Hindenburg Research as "blitzkrieg research."

Although there are different ways to look at it, and Herbalife did have to pay $200 million to the Federal Trade Commission for certain violations, from an investment perspective, Icahn is widely considered to be the winner in the Herbalife battle.

Ackman, the founder of Pershing Square Capital Management, had made a $1 billion short bet against Herbalife while also spending significantly to wage a public campaign against the company. Icahn went long on the stock, which ended up much higher toward the end of the battle, although it has struggled a lot more recently.

While Ackman and Icahn have supposedly been on better terms since their public argument on CNBC, that didn't stop Ackman from chiming in on the short thesis against Icahn Enterprises, calling the situation between Hindenburg and Icahn "fascinating."

"The yield is generated by returning capital to outside shareholders, which is in turn funded by the company selling stock to investors," Ackman tweeted, adding that the model depends on "maintenance of the premium and the placidity of Icahn's margin lender(s)."

Ackman, who said he is not short or long the stock, also added that IEP's past performance does not justify the huge premium valuation, but rather one that is discounted to the company's NAV.

It's hard to ever really know what's going on behind the scenes of the heavy hitters, who are likely using tactics to try and move markets in ways that are difficult for most of us to fully comprehend.

While Ackman may not be long or short on IEP, his comments certainly do not seem friendly. At the end of his long tweet about the Hindenburg report and IEP, Ackman said: "Icahn's favorite Wall Street saying: 'If you want a friend, get a dog.' Over his storied career, Icahn has made many enemies. I don't know that he has any real friends. He could use one here."

While they may have patched things up publicly, Ackman and Icahn's feuds date back some 20 years since a bad deal in 2003. Given that Icahn seems poised to fight the shorts, it will be interesting to see how the situation develops and whether Ackman will dip a toe in or seize on an opportunity, with Icahn up against the ropes.

https://www.fool.com/investing/2023/05/31/bill-ackman-questions-the-valuation-of-carl-icahns/