The EU Has Approved Merck’s Welireg® — “Green-Lit” Last Year By US FDA… Immaterial, But Good Friday News.

This is nice Friday news, but many, many kidney cancer patients in the EU were already on the agent, in various clinical trials. And US patients have been receiving it since 2023, under a prior FDA clearance (see legacy graphic at right).

Fierce has the flurry of activity from across the pond, here — and a bit:

…In a flurry of decisions Friday, the European Medicines Agency’s human products committee recommended 17 new drugs for approval while letting Takeda withdraw from market an inflammatory bowel disease complication medication.

Merck’s kidney cancer drug Welireg, Bayer and BridgeBio’s transthyretin amyloid cardiomyopathy (ATTR-CM) therapy acoramidis, and Gilead’s primary biliary cholangitis (PBC) treatment seladelpar were among the 17 for which the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions.

For Welireg in third-line clear cell renal cell carcinoma and in tumors associated with von Hippel-Lindau disease, the CHMP is recommending a conditional marketing authorization. Both indications have counterpart approvals from the U.S. FDA….

Now you know — dinner out, in the chills, and then gallery viewing — on Michigan Ave. with old buddies… smile.

नमस्ते

Hinderaker Claims MN Holds An $800 Billion “Reserve” Of Copper And Other Ores… WHOPPER/Wishful Thinking.

We will use our generic “wishful, magical thinking” graphic again tonight, as Hinderaker makes the facially preposterous claim that the minerals under Minnesotans’ soil are “worth” ~$850 billion.

Having worked (loading dynamite, and running a jack-leg!) in hard rock mines more than a mile underground… I well know that copper / zinc / iron / platinum and gold ores… are only “worth” what your net profit will be, after all the extraction costs.

The ores in the upper Midwest are extremely low grade — which means open pit mining, and vast grinding / slurry and floatation pond operations (and then electrolysis operations — using thousands of megawatts of electrical energy per month!) remains the only way to extract the metals. That (for copper) would amount to perhaps 1,000 pounds of malleable metal, for every 200 tons of rock moved. That would require copper to trade at thousands of dollars a pound (close to gold pricing!) just to break-even. Damn.

There is simply no way on Earth to make that a profitable operation, even if there were ZERO environmental regulations to meet. Hinderaker knows it — but it is going to let him offer more boot licking, for Musk/Tangerine talking points about exempting billionaires from our EPA and NLRB and yes FDIC laws.

None of it makes a bit of logical sense — and all of it requires significant new legislation to pass both Houses of Congress. Read: it will never happen before 2026, and if any of it advances very far toward law, we may confidently predict that Democrats will regain control of either or both chambers by 2026 mid-terms.

So sure, Johnnie, spin your tales — just as Trump today mused that he might abolish the FDIC.

H I L A R I O U S.

The Wall St. bros listening aren’t even smart enough to realize he speaks all day, every day… about “doing things” he’s expressly forbidden by Congress… from doing.

And today he’s admitting that lowering the price of groceries — something he promised as “first week in office” on the campaign trail, over and over… is going to be “very hard”.

In sum, he didn’t even remotely understand the problems — and has zero solutions.

Just like John’s “metals reserves” in Minnesota — you cannot get there, from here, idiot.

Out.

Amazon Labor Strife Update: Over 1,000 California Amazon Workers Join Teamsters; Demand Immediate Bargaining With Management. Wow!

This is our monthly item, on the mess that Mr. Bezos has made of his labor relations, over two decades, by thinking of himself as some 19th Century railroad-, or mining- robber-baron. He has so badly overplayed his hand, as to now face perhaps decades of wickedly expensive labor strife — on nearly 1.5 million workers he employs, directly or indirectly. Yikes.

The latest? The Teamsters today announced that over 1,000 Amazon team members have joined the union in San Bernadino, California.

…Over 1,000 Amazon workers at the company’s KSBD air hub in Southern California have formed a union with the Teamsters and demanded union recognition with a “March on the Boss” held this morning. The KSBD warehouse in San Bernardino is a crucial hub in Amazon’s logistics network and the largest air facility on the West Coast.

Today’s announcement comes on the heels of the Teamsters notifying Amazon of a December 15 deadline to follow the law and agree to bargaining dates for a union contract, on behalf of thousands of Amazon delivery drivers and warehouse workers who have organized with the Teamsters nationwide.

The San Bernardino workers launched their union drive to organize with the 1.3 million-member Teamsters in November. Now, they join thousands of Amazon workers across California, Illinois, Georgia, and New York in unionizing with the Teamsters to take on the e-commerce giant in an unprecedented, coast-to-coast organizing wave.

“As Amazon prepares to rake in record profits this holiday season, it’s time Amazon workers get our fair share, and that’s exactly why we’re joining the Teamsters,” said Maggie Perez, an air hub worker at KSBD. “Every day we’re on the job, we’re breaking our bodies to get packages out on time and to keep Amazon customers happy. In return, all we’re asking for is livable wages, fair treatment, and respect. For a company worth trillions of dollars, that should be the bare minimum….”

Messrs. Musk, and Tangerine… too, should take note: “We, the people” — the real Americans — will never let you solicit bribes, in the form of “make a $1 billion investment — in US business” that would purport to let foreign (even “fren-emy”?) actors / oligarchs skirt all the EPA, SEC and federal labor laws. Never — even if, by some miracle, the US Chamber of Commerce didn’t sue — saying that all the fine upstanding US businesses that have ALWAYS complied with all laws are being put out of business by this move. Damn. Bezos and Musk — what a pair of… putzes. Onward.

नमस्ते

It Has Been A Few Years Since We’ve Detailed Merck’s Vast Array Of Large Cap Institutional Stockholders…

I think the last time we detailed a quarterly rundown of changes in holdings by 5% or more holders of Merck was before the pandemic in 2019 or so. So it has been… a minute — and it is time to catch up, again. So, here we go.

Below is the money shot of an automated / likely AI generated item, from an NYC-based rag:

…State Street Corp lifted its holdings in Merck by 1.3% during the third quarter. State Street Corp now owns 119,026,412 shares of the company’s stock valued at $13,606,360,000 after purchasing an additional 1,536,474 shares in the last quarter.

Wellington Management Group LLP lifted its stake in Merck by 4.6% in the 3rd quarter. Wellington Management Group LLP now owns 75,809,383 shares of the company’s stock valued at $8,608,914,000 after buying an additional 3,327,404 shares in the last quarter.

Geode Capital Management LLC raised its holdings in shares of Merck by 3.7% during the third quarter. Geode Capital Management LLC now owns 59,155,004 shares of the company’s stock valued at $6,696,060,000 after acquiring an additional 2,134,296 shares during the last quarter.

Charles Schwab Investment Management Inc. raised its position in shares of Merck by 2.8% in the third quarter. Charles Schwab Investment Management Inc. now owns 18,807,293 shares of the company’s stock valued at $2,135,785,000 after buying an additional 514,060 shares during the last quarter.

Finally, UBS AM, a distinct business unit of UBS Asset Management Americas LLC lifted its stake in shares of Merck by 1.8% in the third quarter. UBS entities now own 17,756,021 shares of the company’s stock worth $2,016,374,000 after buying an additional 309,656 shares in the last quarter.

Hedge funds and other institutional investors own 76.07% of the company’s stock….

All of that means, in general, this stock is highly unlikely to see irrational panic selling… ever — and it sports a gaudy 3.5% annual dividend at present. Now you know.

नमस्ते

Tangerine 2.0: “Bribes ‘ᴙ‘ Us!”

So Hinderaker thinks the nonsense at right is… conservatism?!

[This “idea” merits… only a few lines, to dismiss — out of hand. It is governing by bribe paying: what about all existing US businesses that made the investments to comply with our laws, John and Tangerine?!]

I guess to him, that word means… bribe-ready!

First — it will never happen.

See, the Tooth Fairy we mentioned, previously.

But if he does go this route, what stops Russian or Chinese state affiliates from driving legitimate, law abiding US companies off the map?

Nothing… obviously, you moron, Hinderaker.

Sure, John — that’s great for… Americans who’ve followed the rules.

Yeh. He’s not a serious preznit.

Sheesh.

Hinderaker & Mirengoff: Fabulists; And Xenophobic, Too. YAWN.

Hinderaker thinks this was a bad thing. Updated: both of these clowns think they’ve uncovered diamonds, in this afternoon’s NYT reporting. Paul Mirengoff’s is here — and John’s, here.

Both try to make hay out of the fact that there have been lots of people who’ve immigrated to the USA in the last ten years. Silly. That’s a good thing, despite their fallacy of composition / anecdotes about a random criminal or two. [By far, more whyte, born in America, or very-long term US citizens commit horrible crimes, than all immigrants put together — since 1960 or earlier. Geez.]

I wonder who waits their country club tables… who mows their lawns… and I wonder if either is aware that mRNA vaccines (that have saved about 10 million lives so far) wouldn’t exist (or be available) in the USA, if there hadn’t been fairly forgiving immigration standards, over the last forty or so years.

Take a look at the science… immigrants offer us:

D A M N.

Out.

Tell Us, Steve: What Would Healthcare Cost Trends Look Like WITHOUT The ACA of 2010?!

Steve isn’t even a particularly… useful idiot. In the main, he can’t read his own charts. Not with an eye to critical thinking at least.

The knucklehead declares Obamacare a failure, based on a chart that shows healthcare costs are rising in the United States. [All reasonable estimates from just before the ACA of 2010, projected that health care costs would become about 24% of the US GDP by 2022, if we didn’t act. Today, in 2024, 14 years on… health care amounts to about 19% of GDP. Still very high, but a full five points, or 25% lower than those costs would have been, without Obamacare. ]

He neglected to compare that data he cites, with the periods prior.

Moreover, he forgets that in Texas almost no one could afford any kind of healthcare insurance prior to 2010. Same in Florida, Louisiana, Mississippi, and Tennessee.

What do each of these states have in common?

That’s right, they were, and are ruby red states… run by hard right governors and legislators… That coincidentally also happened to have very robust very profitable private for profit hospitals and doctors’ groups.

So it was that Obamacare ended at least some of that excess. It does still exist though to be sure.

In a semi-related tangent, these Powerline boys (Hinderaker and Johnson mostly) are trying to make the assassin named Luigi Mangione a “lefty…“ are hilarious. His family has donated millions to GOP and hard right causes, including PACs pushing Trump’s 2016 and 2020 election efforts.

He has expressed admiration for Elon Musk and Peter Thiel. At bottom — I suspect he’s just a spoiled brat who was angry that he didn’t get his back care covered. And it is clear he is mentally ill.

In any event, I would have expected that the Powerline boys would have preached mantra of family responsibility – that is, they would lay blame for his views at his parents’ feet. What did those parents do? Or not do?

So yeah, guys — give it a rest. Your con won’t work on us.

Out.

No, Paul — We Are Smarter Than That. We See That Tangerine IS NOT CAPABLE Of Not… Imploding This Time.

Silly Paul. This morning, he would have us believe that “The Left” is lying in wait for Tangerine 2.0.

Not so.

We are going — in the main — to let the regular GOP do our work for us. And, we will count, once again, on Trump’s staggering, towering… incompetence to be.. plain to all.

Heck — even you (and most of the Powerline boys) now openly admit that you see it:

…This time, Trump has picked any number of Cabinet nominees who would never have been picked for the positions they hope to hold by a normal Republican president.

Their merits aside, I’ll cite Pete Hegseth, Tulsi Gabbard, Robert Kennedy Jr., and Matt Gaetz (before he stepped aside) as examples. At the sub-cabinet level and ambassador level, I’ll add Kash Patel, Metmet Oz, and convicted felon Charles Kushner. [McMahon, too.]

In addition, the Trump transition team reportedly is asking applicants for high-level positions in the Defense Department and intelligence agencies whether they believe the 2020 election was stolen from Trump and what they think about the January 6, 2021 riot. The “wrong” answers, reportedly, are that the election wasn’t stolen and that the rioters shouldn’t have tried to overturn the result.

If this, in fact, is how applicants are being screened, it doesn’t strike me as normal….

So yes, Paul — we are locked and loaded — but we likely won’t need much fire, this time. Flawless.

Yep — you people will do it, for us. There still are some in the GOP who see that Tangerine 2.0 is already lame ducking himself. [That includes you, John Hinderaker, and Scott Johnson. OTOH, Lloyd Billingsley and Steve Hayward both remain true to the loyalty / fealty oath Tangerine requires. Candidly, I’m not certain about your boy Bill Otis though.]

Out.

Malaria — And Malnutrition Are The Culprits — In At Least 143 “Mystery” Deaths In Kwango Province, DRC…

At a charity dinner tonight, but I saw that the likely causa bella is… malaria.

The ever-excellent CIDRAP website has the breaking story — more in a minute (or after midnight, actually):

…Abdi Mahamud, MD, interim director of alert and response coordination for the WHO, said malaria is endemic in the area and the rainy season has come with an increase in respiratory diseases within expected levels. For example, he said Kinshasa is seeing a rise in flu and COVID activity.

He said the epidemiologic data don’t show an explosive increase in cases or deaths. He added, however, that the high infant mortality shows that the issue needs to be addressed in Panzi and other vulnerable regions.

Mike Ryan, MD, who leads the WHO’s health emergencies program, praised DRC health officials for their work on the outbreak. Officials recognized that the cluster was unusual enough to report to the WHO, he said. “This is a sign of a system working, even in an extreme environment….”

He also said officials are working with the US government to set up an airlift into an airport that is 150 km (93 miles) from Panzi….

That is a relief, actually, as it is not an utterly unknown foe. We do have a vaccine for malaria. The trick will be getting it to the quite remote reaches of Panzi district, and quickly. That, and getting adequate food sources to these children, via airlifts. Onward.

नमस्ते

Dhillon?! Ineffectual, She’ll Be , John. Zero “Mass Resignations”.

John is again deep in his demented/deluded mode… thinking that one appointment to the DOJ Civil Rights Division… is going to cause dozens of career ASA’s to depart. Her arrival… won’t.

But again he needs to be seen licking the right boots — so he yammers on for several paragraphs. Unlike others though, she’s likely to clear the Senate.

That’s about all I can say.

None of Tangerine‘s picks the first time around were able to really “change the course” — on civil rights enforcement law; it will be much the same this time — in Trump 2.0.

BTW, I see he has tasked an “on camera” (but unindicted) January 6 riot mob participant with (once joining his mal-administration), onboarding / vetting national security hires.

Nope. There’s nothing crazy… about that.

“Just move along now, people… nothing to see here.”

Cheers, Johnnie boy!

Out.