Nothing more needed. Res Ispa…
Month: April 2023
German Merck’s DAX Shares Tumble — As Phase III MS Study (On BTK Inhibitor Evobrutinib) Is Halted For New Enrollees; Adverse Events.
As ever, I post this here mostly to make clear that this is not the US company. The two are not related, and are in fact engaged in a decades long series of lawsuits about the name “Merck”. This is the German KGaA.
In any event, it had an MS candidate in Phase II/III clinical trials, called evobrutinib — and just saw a safety signal in a few patients. The liver problems seemed to resolve once the medication was discontinued. So — more study and analysis, to be certain — before it might ever resume. Here’s Reuters, on the topic — this morning:
. . .Merck shares were 6.3% lower… and slid to the bottom of Germany’s blue-chip DAX index on news of the setback.
The FDA’s decision, Merck said, was in response to laboratory results which suggested drug-induced liver injury during phase III studies. The two cases identified had been asymptomatic and the patients’ liver enzymes had fully normalized after discontinuation of the study medication.
“Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib,” it said in a statement….
A trial testing Sanofi’s rival candidate tolebrutinib – from the $3.7 billion takeover of Principia Biopharma in 2020 – was put on partial hold by the FDA in June 2022 on concerns over harmful effects on the liver. That meant recruitment of new participants was stopped….
Now you know — with it almost 80 and sunny — unseasonably wonderful for mid-April… a mountain bike is next on the agenda! Grin….
नमस्ते
Fascinating: Betsy Stauffer Chooses This SINGLE Mental Health Impairment Episode At A Target Store… So, We Offer The More Common Versions — By TikTok Feed.
To be discouragingly honest — these sorts of confrontations happen all over the nation, inside Targets and other big box retail outlets. Every damn day.
They are an ugly fact of life.
But it is plain that Bitsy wants only to highlight the racial component — wherever she can tease it out.
This is a pattern at Powerline, as a few months ago, Hinderaker went way out of his way to falsely label the people he imagined were conducting large scale, organized smash & grabs at Targets… as Black (and Brown). There was no such data. Target said it was not factual.
John simply made it up.
Just as Bitsy chooses not to mention this woman’s mental issues — only her skin color.
So — let me offer you… all these mostly whyte Karens — going off in Target retail outlets — right here.
The numbers are stark — about 10 to one, because most people of color know they go to jail if they don’t quickly pipe down. [Or… get knocked the f- out.] Whyte Karens almost never do, no matter how awfully they behave — and they almost NEVER get punched out by store management.
Smoke that, Bitsy. And shut your pie hole.
@weseeyoukaren #Karen proves that apparently the meaner and more racist you are the more help you receive at some #Target locations 🤦🏼♀️ #karen #karensgoingwild #karensoftiktok #karensgonewild #karenalert #fyp #viral #foryoupage #karenvskaren #weseeyoukaren ♬ original sound – Super Karen
Mr. Jones Is Already Back In His Seat, Today — In Tennessee, Mr. Pearson Will Be Voted Back In… Tomorrow.
And so… despite all the GOP’s Klux-Klanning, down there in Nashville — the whole thing is… all but over (except for the shouting).
It was however a very clear demonstration of “what Hinderaker’s GOP has become” (or perhaps reverted back into), though.
I know John is embarrassed by it — and his party’s devolvement… into pre-Reconstruction era politicking.
But he cannot say so, for being labeled disloyal to the Klanners in the party.
D a m n.
Good luck ever winning another national election, son.
The “Good Guys'” Amici Briefs Are Already On The Docket, In The 5th Cir.: Opposing Any Implementation of Kacsmaryk’s Loony Texas Order… Is Docketed.
As Hinderaker whines impotently about taxes on his own personal wealth (so big of him!)… we are pleased to offer some sanity — against Matthew Kacsmaryk’s lunacy down in Texas of last Friday night.
Do go read the brief. All of it.
After Dobbs, the Supremes made plain that it is to be a state by state decision, within the first two trimesters, as to whether a given state chooses to continue to allow abortion, and on what parameters. Of course, Matthew Kacsmaryk’s unhinged order of last Friday purports to take that right away from all states, nation wide — for at least half of all such procedures, since about 52% overall are now by pill, not invasive scrape. [And that pill is by far the safer way to go, not incidentally. A safer side effect profile, overall, than over-the-counter Tylenol.]
So the states have today filed in the Fifth Circuit, to join HHS, and explain that Kacsmaryk’s ruling ignores the plain commands of Dobbs, from the Supremes, last term.
You may read it all, here — but there is essentially zero chance, once the dust settles, that this nutty opinion will stand. I wanted to get out some solid legal arguments, as to why that is so — so that you all may repeat them to your friends who might claim the “right to life” is all that young Matthew Kacsmaryk sought to protect in Texas. That is simply… a lie. Here’s a bit:
…Although the Supreme Court, reversing longstanding precedent, concluded that the U.S. Constitution does not protect the right to obtain an abortion [in Dobbs], the Court endorsed the States’ authority to safeguard access to abortion for their residents, explaining that it was “return[ing] the issue of abortion to the people’s elected representatives.” Id. at 2243. The district court’s order could eviscerate the sovereign decisions of many amici States by disrupting access to mifepristone across the country, including in States where abortion is lawful….
Medication abortion promotes access to early abortion, when it is safest and least expensive, thereby reducing complication rates, decreasing costs, and easing burdens on the health care system overall. Medication abortion can also safely be provided in a variety of contexts and practice areas — for example, in a private physician’s office, an ob-gyn or family practice setting, or even at home with appropriate medical supervision. The availability of medication abortion within mainstream medical settings not only lifts constraints on access but also offers added privacy and security for both patients and providers — benefits that are particularly critical given persistent and escalating violence at abortion clinics….
[B]ecause carrying a pregnancy to term is 14 times more risky than early abortion [See National Acads. of Scis., Eng’g & Med., The Safety and Quality of Abortion Care in the United States 10, 55 (2018)], curtailing access to medication abortion would likely lead to a steep rise in birth-related mortality rates, worsening a crisis already disproportionately faced by Black women….
Let ALL our voices be clear as a ringing bell — in this night of one-eyed ignorance, and myopia: this is an e pluribus unum nation (many voices, one FDA).
We are not a nation ruled by a single, backward state (Texas and one judge’s supposed Roman Catholic religion… entering his chambers — and appearing in his judicial opinions) to effectively rule us all (just as young USDC Judge Bruce Drew Tipton had to learn two years ago, out of Texas, on dead hand provisions, on immigration). Each of the states have an equal, independent right to decide; and the FDA has nation-wide authority to allow doctors in every state to have access to abortion medications. Out.
नमस्ते
With A Likely Multi-Billion Dollar Zetia® Antitrust Trial Looming, Glenmark Said To Consider (Again) Selling Its API Businesses…
We are now less than two weeks away (with likely a week’s time, in court after official opening day — to get all the way to the opening of the first bits of actual evidence — and beyond just preliminaries and opening arguments) from what will almost certainly be a multi-billion dollar civil antitrust class action trial against Glenmark, and Merck — in what is alleged as a “pay to delay” scheme.
In this decade long action, Glenmark was an API supplier, and a potential generic market entrant, that agreed to delay its US entry with a ezetimibe agent — in return for hundreds of millions, from Merck (and earlier, legacy Schering-Plough).
This morning we read that Glenmark may exit its API business in total, to pay down debt coming due, in India. Here is Fierce Pharma’s latest — ever on the case — on it all:
…Facing a debt problem in 2019, Glenmark considered selling off its active pharmaceutical ingredient (API) business before opting instead for a spinoff.
Four years later, with the same debt issues, Glenmark is taking another look at selling its stake in the API business, called Glenmark Life Sciences. The Indian pharma company has contacted potential buyers and has hired Kotak Mahindra Capital to oversee the potential sale, sources told news outlet Mint.
Glenmark is looking to sell off a majority stake in the API subsidiary. The company owns 82% of the business. The company was already required to sell a part of Glenmark Life Sciences by August of 2024, according to Mint, to reach a 75% ownership threshold required by Indian regulators….
Now you know… time for another warm sunny bike ride, by the clear lake waters… smile.
नमस्ते
Hinderaker Again, Knifing Tangerine, Tonight. Delicious.
I will just drop a link to this one, and… laugh. No sane human thought it would end any other way.
Which is why Hinderaker thought he was… a serious preznit.
Few others ever did (privately).
That is now plain.
But they ALL rode him — to their deplorable ends. Especially the Powerline boys.
Now Trump is solely burnt flesh — by his own career of endless… criminality.
So to quickly pivot away from his own awful judgment, Hinderaker goes on to complain about… the Fed.
What a feckless… tool. Damn.
Hilarious.
Both Of These Guys… Will Be… ’24 LOSERS. Bank On It.
I just find it precious… that Tangerine thinks he holds some moral high ground — as some form of dark lord of the MAGA movement.
He’s just the worst of them.
And unafraid to say so.
But his criminal indictments (multiple) are soon to sideline him.
And DeSantis’ book banning will end his 2024 chances.
Hilarious.
If The Settlement Discussions Aren’t Finalized By Then, A “FINAL” Pretrial Conference Will Be Held Before The Judge On July 6, 2023 In Lanham Act: Merck v. Merck.
The parties here have been discussing settlement on and off, for over two years now.
But no signed agreements have resulted — despite numerous conferences, in person — with the able Magistrate in NJDC. So, to move them along, the court has set a July 6, 2023 pretrial date. That would be the moment when each side must answer “ready for trial” — or explain why, after nearly a decade in motion practice… one or the other is NOT ready.
Indeed, this is mostly just to impress on both sides… that a trial will occur this summer if they don’t come to terms, and soon. So this was entered this afternoon, on the federal docket, in Newark:
…TEXT ORDER:
Final Pretrial Conference set for 7/6/2023 at 11:00 a.m. in Newark – Courtroom 2C. Trial counsel must be present at the conference. The parties shall jointly file a proposed final pretrial order by 6/22/2023. The parties shall mail a tabbed courtesy copy to Chambers by 6/22/2023. Please mark your calendar accordingly.
So Ordered by Magistrate Judge Michael A. Hammer on 4/10/2023….
Onward, grinning on a lovely Spring afternoon — to now ride a mountain bike, by the crystal clear lake waters. First of the season!
नमस्ते
Hinderaker: That “Structural Advantage”? It Is… Saner, More Humane… Policies. Period.
This afternoon, Hinderaker whines that the Democratic Party in the US has an unfair “structural” advantage. He means that there are more people — especially young people — registering as new Democrats, than GOP members. In fact, many GOP party members are… dying off.
But again — senile, bitter old John lacks reasoning capacity: the “root cause” of that state of affairs… is the GOP’s five decades now of intentional cruelty.
Cruelty, and failed fiscal management.
A lethal combination.
So… get used to… losing, Hinderaker. And losing… a lot, more. [I’ve graciously ignored all the typos in his quoted source — his own 501(c)(3) / hard right think tank. Here’s a hint — “don’t use possessive when you mean the plural case. It is difficult to take such ignorance seriously, on any point of policy, then.” Cheers.]
Out.


