Author: condor

Power-Alley: Merck’s Winrevair™ Now Likely Headed To Blockbuster Status — Well-Beyond The Relatively Rare PAH Indication…

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It would seem that Rahway made a very savvy bet, in spending about $11.5 billion to acquire Acceleron in September of 2021.

That company’s lead candidate, sotatercept — originally for PAH, looks now to sail through — with a new series of FDA green lights. [Here’s just one of several, we’ve offered in the past, on the candidate — now approved, as respiratory therapy.]

This is why Merck saw a slight increase in price, on the NYSE today. Here’s some very cogent analysis, from FiercePharma, so I’ll just turn you over — to them:

…Eight months after snaring an inaugural FDA green light, Merck & Co. is bolstering the case for the chief asset in its $11.5 billion Acceleron acquisition.

In the phase 3 ZENITH study, Merck’s activin signaling inhibitor Winrevair, also known as sotatercept, met its primary endpoint of time to first morbidity or mortality event—which included all-cause death, lung transplantation, or hospitalization for at least 24 hours linked to disease worsening—and helped reduce the risk of morbidity or mortality events versus placebo in adults with pulmonary arterial hypertension (PAH) in functional class III or IV.

Patients in the trial’s study drug and control arms both received background PAH therapy, too….

And, we will be closing shop for the week, likely around noon tomorrow — grin. Unless something truly interesting breaks, we may not return here — until next Monday. Be excellent to one another — and be thankful for all that is still wonderful in our world!

We are all so… very fortunate — to be alive at a time when medicine is pushing back the possibility of early-deaths, from avoidable causes.

नमस्ते

Do Make A Habit — Of Reading Empty Wheel, Every Day. This Is The US Resistance 2.0’s Lead “Hot Sheet”!

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She is forever right on time — and on target.

What I am gleaning from her, here day by day, is that “Resistance 2.0” will be a more subtle, and nuanced effort (especially in the period before the next mid-terms, in 2026) than the 2017-2021 version — even though it will also feature lots of federal litigation, outright (especially on border matters).

These Senators will never fear a Tangerine primary threat, again. That matters, quite a bit.

And so, again today she notes the tentative emergence — of spines, among the Art. I Republicans in the Senate. Just 13 people voted, in secret, on the first ballot, for MAGA endorsed Tim Scott, as majority leader. [So, only a quarter of the GOP toed Trump’s line in the sand, on Scott.] Thune was chosen, in secret — on a second vote — plainly against Tangerine’s wishes.

This makes for some very credible / at least possible ally building discussions, among Democrats of good will, who simply do not want to see the Republic slide into an autocracy. The votes are there, with those others inside the regular GOP (who chose to cross Trump) — to rein in many of Tangerine’s hoped-for most lawless maneuvers. Especially in confirmation hearings, for cabinet level positions.

Let’s listen in, to EW’s keen analysis:

…[A]fter [R., Sen., Alaska] Lisa Murkowski said (in a little-noticed Alaska interview) that she won’t vote to confirm any Trump nominee who has not undergone an FBI background check, four more Senators — Susan Collins, Kevin Cramer, Rounds, as well as Joni Ernst — joined Murkowski in expressing support for background checks (though without making them a litmus test), with Bill Hagerty scoffing at the entire idea that they’re necessary.

There are far too many Democrats dismissing the possibility that there can be meaningful opposition to Trump from Congress. The Senate, especially, held up some of Trump’s plans the first go-around, even before he sicced an armed mob on them. And if nothing else, these people love their own prerogatives, and so will — at least selectively — defend those (as the bid to insist on FBI background checks would be a means to do)….

To be clear, I might mildly disagree with her assessment that there may be no opportunity to hold any elections, in the 2026 mid-terms. That, these Art. I GOP-ers will NEVER G’ on down for any such… outcome.

Bank on that.

So — (with truly minor dissents) we march, onward. Do read her, daily. She’s that good!

नमस्ते

Very Good Thanksgiving Week News: US CDC Lifts Travel Advisory — On Rwanda — Marburg Outbreak ’24 Ending…

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Great coordinating work and cooperative effort, between Rwandan teams on the ground, and the WHO and its EU, US, Japanese and UK partners — is to be credited for this outcome.

The latest Marburg outbreak is now effectively at an end. US CDC has lifted its former travel restrictions, as of mid-last week. Here’s the latest (in Rwanda) reporting:

…The United States has lifted its Level 3 Travel Health Notice for Rwanda after the successful containment of the Marburg virus outbreak, a move welcomed by the Africa Centres for Disease Control and Prevention (Africa CDC).

The advisory, issued on 7 October 2024, had effectively restricted American travel to Rwanda, impacting the country’s economy during its response to the outbreak….

Rwandan Health Minister Dr Sabin Nsanzimana credited Africa CDC’s support in containing the outbreak within Rwanda’s borders. The organisation continues to advocate against travel bans as primary responses to health crises, emphasising the importance of global cooperation in managing outbreaks….

It has now been over 21 days since the last patient was discharged; there have been no new cases, in 42 days (a double incubation period) — so, this outbreak is at an end, effectively speaking. Onward — with my youngest man in by tomorrow afternoon, by jet from the Pacific Northwest. Grin!

नमस्ते

“Sounds a little like a swamp to me.” — It’s Actually Much Worse Than That, Paul. And You Know It.

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Let’s at least give Mr. Mirengoff credit for telling the truth — even if his telling of it… is woefully incomplete.

He says this morning, correctly, that Tangerine’s utter lack of competence and discipline… leads to his sitting atop a Beltway style “swamp” inside Mar-A-Lago, like a fat bullfrog. Burping into the humid, hot nights — but not doing much of anything else.

True.

But that’s not the half of it. As we saw in Trump 1.0, he actively fosters dysfunctional cut-throat infighting, among his various teams. He likely favors pretty blondes, and men who beat their wives — or cheat on them.

We saw it in Corey Lewandowski, his own son, Don Jr., and in Stephen Miller — among dozens of others.

Consider — in the “pretty blonde” category — that one Jenna Ellis has been suspended from the practice of law (she’s the woman standing right behind Rudy Giuliani, in the iconic photos of the brown goo leaking from Rudy’s head, at the “stop the steal” dis-information / lies / press conferences, of early 2021) — and she is now rabidly anti-Trump.

So Paul, yes Tangerine runs a much worse swap than any he complains about in DC.

And the fact that “no drama” Obama was just that — and Mr. Biden’s team kept a tight ship… is, in no manner any indication of a DC “swamp”.

At bottom, Paul just doesn’t want to admit that even he… hates Trump’s chaos machine.

Buckle up for four years of what you wished for, Paul (and John and Scott) — AGAIN.

Out.

The DOGE “Tooth Fairy” Bites Hinderaker, Tonight…

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So… John tonight breathlessly tells us that his think tank’s polling arm in Minnesota has found that 96% of registered voters there like the (non-existent) Dept. Of Govt. Efficiency “concept of a plan”.

Y A W N.

And they would like… tooth fairy visits, too.

We had earlier mentioned here, that in order for Mr. Musk to run this so-called department, since he refuses to be any part or employee of the federal government, under Trump… he would be required to register and make massive disclosures — as a lobbyist (on all his conflicting interests), in order to create the mythical “department”.

That he will never do, even if he truly believes in the idea. He would be required to explain his financial interests in Tesla and SpaceX, and the full value of their contracts with the federal government. As well as detail all the tax subsidies that Tesla currently enjoys. Under the “no revolving door” rules, he might even be required to divest most of his holdings of Tesla, and SpaceX.

No way meet… no how.

But even more than that, we have Tangerine’s history as our guide. When he was president, he widely promised that he would completely overhaul prescription drug pricing in America, lowering it for ordinary consumers.

Not only did he not do that, he did not even try. He ran on a mantra of repealing Obamacare, and though his party was able to muster 60 separate votes in Congress, never once were they able to modify Obamacare — let alone repeal it.

[If anything, he’s become more scatter-brained and delusional… in his ranting MAGA policy sound-bites.]

And so, in sum, there is zero chance that any responsible federal judge, when asked to review whether Mr. Musk may lawfully run a department of “government” — wholly outside of the government, subject to no oversight… that a near instant nationwide injunction will NOT be entered.

See… the Constitution expressly prohibits additional branches of government — by preznit / fiat actions… even if Mr. Musk makes all these disclosures, and then divests his conflicting interests.

So it is immensely precious that Hinderaker thinks that polling in Minnesota, about rainbow hued unicorns, all served with… strawberry sherbet… and cotton candy… means anything.

It does not.

Onward.

EmptyWheel Offers A Great Line Of Questioning — For The Senate Pam Bondi Confirm. Hearings To Come…

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EmptyWheel, as ever — is well-ahead of the MAGA forces… on how to make the worst nominees show their true colors, when/if they reach any Senate confirmation hearing (around mid-2025).

As to purported US AG, Pam Bondi — I love all of this:

…“Because Trump didn’t properly vet his pardons the first time around, at least seven of them quickly returned to crime, with many of them beating their spouses. How will you ensure that Trump’s bypassing of normal pardon protocol don’t put violent men back on the streets?” You can pick some of the January 6ers — like hardened criminal Shane Jenkins, who almost had a fundraiser at Bedminster, or NeoNazi Timothy Hale-Cusanelli, who did — to ask Bondi how coddling such criminals is consistent with the law-and-order promises she makes….

I realize that about two-thirds of the MAGA legislators won’t even understand her question (the words are too big — and too many, in a row!) — but the answers (dissembling, actually) will be … enlightening. For we do stipulate that Bondi (unlike many others) is very competent — and intelligent.

This one line of questioning will pin her, forever.

Excellent — onward.

Hinderaker’s Malignant — And Advancing — Senility: On Full Display Tonight (Re Hegseth).

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In Hinderaker’s enfeebled, bitter mind, now — since Tangerine has nominated a long string of clowns, to various cabinet positions… the best he can do, is decry the outgoing Democratic Administration’s nominees… because (wait for it!) no Democratic Senator voted against any of their nominations.

See, John, that’s because the Biden Administration vetted candidates. Trump simply says “will you lick my boots” when and how I ask?

Then you’re a nominee! That’s… cra cra.

So it is, that tonight, John preposterously offers this — as a “defense” — of Hegseth’s nomination(?!):

…Senate Republicans are not in the mood to give Democrats another scalp. They remember that in 2021, not a single Democrat voted against any of Joe Biden’s cabinet nominees, no matter how radical they may have been. Republicans have had about enough of the double standard….

It seems I’ll need to remind the drooling moron that Hinderaker has become… that not one Biden nominee had a single (even unfounded) allegation of forcible sexual assault attached to their names — not one, ever was tattooed with any avowed whyte supremacy slogan / symbol… not one was a fake news Faux “military analyst”. And on and on… ad infinitum….

So it seems… John is full of sh!t. Again.

Out.

[U] H5N1 (Avian) Virus Was Just Seen In The First US Child, In 2024 — Out In California. Do Be… Vigilant.

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I must say, at the outset that people like Hinderaker should be ashamed of their efforts in “running interference” for manifestly loony potential Tangerine appointees — in US public health roles. Kennedy, if seated — will cause the deaths of perhaps thousands of US children (all of limited means) — kids that need not die, at all. Disgusting — John this is not “shaking things up,” at HHS or CMS — against some mythical “deep state”. This is killing children, and the elderly, as conscious choices… mostly. Own it, you putz!

In any event, the below item, from CIDRAP serves as a reminder that especially in children, we ought to be very vigilant about persistent respiratory symptoms, of any kind.

California regularly tests school kids for illness — which is how this case came to light. This was a child with no farm animal contacts, so the likelihood is that it was a human to human transmission path. Here’s the latest — and do be extra careful, if visiting farm animals (on holiday outings), especially later in this damp Fall weather.

…The US Centers for Disease Control and Prevention (CDC) said today that its tests have confirmed H5N1 avian flu in California’s recent suspected case, involving a child who had no known exposure to infected animals.

Also, California announced another confirmed H5 case in a dairy farm worker. The new developments lift the state’s total to 29 human cases of H5 avian flu and the national total since the first of the year to 55….

The CDC statement noted that the confirmation marks the nation’s first H5 infection in a child, and it reiterated much of what the California Department of Public Health (CDPH) said in its initial announcement of the case on November 19.

The child’s infection was detected through California’s flu surveillance system, and the level of viral material in the specimen was low. Follow-up tests several days later were negative for avian flu but were positive for other common respiratory viruses….

Moreover, somewhat worryingly, it also seems that even seniors are largely foregoing COVID boosters and flu shots this season. We cross our fingers, and hope that this trend doesn’t come back to bite us — nationwide. Onward.

नमस्ते

In Which — After 40 Years, Hinderaker “Figures Out” Who McConnell Is (Was).

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Again, too precious — by half.

It’s what John doesn’t mention… that matters.

This pick of Thune is plainly a rebuke of Trumpism.

That’s all that matters here.

Tangerine’s own guys… are gonna’ knife him (in the front), especially those who held their noses — and his coattails — to get elected again in 2024.

Hilarious!

Hinderaker long knew McConnell was a big spending turtle — but it greased his pet projects… so he pretended he liked it.

As Mirengoff Admits Today, Trump Barely Squeaked By In 2024 — And He Was Deeply Unpopular, Last Time — As A Governing Preznit.

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Sure sure — he will get some of his nominees through the Senate, but there is zero chance now that the Senate will wholesale go on vacation for perhaps six months, so he might make interim appointments, like Matt Gaetz [now ash-canned].

Here’s how Paul puts it:

“…Trump was an unpopular president. Maybe this time will be different. Or maybe he will impose high tariffs that will lead to greater inflation than that which plagued Joe Biden. How popular Trump will be a year from now is anyone’s guess…. Trump [won] the popular vote by only about 1.6 percentage points and his share was a hair less than 50 percent…. Trump’s electoral victory… depended on very narrow margins in the “blue wall” states….”

That’s no mandate — no landslide.

And I’ll predict that Mrs. McMahon… will not be the US Education Sec’y, when the dust settles, after the Senate asks her about the allegations in several lawsuits, that she and hubs sexually assaulted underage girls — who wanted to become professional wrestlers.

I’ll also guess that Dr. Oz, and Mr. Kennedy may not survive a term of more than one year, in the public health roles. The FDA nominee has a better shot, as does the prospective Treasury Sec’y.

But mostly, since Tangerine is almost immediately a lame duck (no honeymoon!), and the nation is divided — and many of the Senators will not face election again, until well after Trump is gone… very little may actually get done on his various “concepts of a plan” for much of anything. [Most of all, I predict there will be no mass deportations — the military will be enjoined immediately, should anyone even wish to do what Tangerine bloviates about.]

But there will be a daily circus — as there was in 2017 to 2021. And he will engage in various forms of personal grifting. Think golf club stays, here — for hundreds — at his own resorts, charging top dollar, for every crappy room. That graft (alone) is likely to eclipse $250 million, by the end of his term.

Count on that.

F U G L Y.

Out.