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.

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.

The Letter, In Full — As Signed By Merck And Pfizer CEOs: In Support Of FDA — Given Kacsmaryk’s Crazy Texas Ruling Friday.

At the moment, around 2:20 pm Eastern on Monday, there are over 500 signatures to the letter, from all corners of the life sciences industry, in the US and globally.

Of course, the CEOs are the headliners, and both Merck and Pfizer have confirmed their CEOs signatures are genuine. Here’s that letter, in full. [Along with many other life science attorneys, I have also added my name.]

…In Support of FDA’s Authority to Regulate Medicines

On Friday, April 7, a federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.

District Judge Matthew Kacsmaryk issued a decision that overturns the FDA’s 23-year old approval of mifepristone, the primary medicine used in abortion and miscarriage care, and which has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin.

The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.

Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone. While the drug development, approval and monitoring process is not perfect, the Agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.

As an industry dedicated to improving human health, and as members of the biopharma industry, we add our signatures to this letter and stand together to unequivocally support the continued authority of the FDA to regulate new medicines.

In the face of laws and rulings that aim to undermine the evidence-based and legislatively sanctioned authority of federally mandated institutions such as FDA to protect public interests, and by putting an entire industry focused on medical innovation at risk, we cannot stay quiet. We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place….

Now you know — J&J and Lilly and Amgen are also confirmed as signers, this afternoon. Onward.

नमस्ते

I Think The Boys Have Now Written… At Least FIVE Pieces, On Which Watered-Down Beer Is… Ideologically Acceptable.

Tell me you have become an irrelevant old whyte men’s embittered media outlet, without telling me you’re now an irrelevant old whyte men’s embittered media outlet department:

The boys have at least five posts up, about the unmitigated horrors of Bud Light… being inclusive.

Okay. You guys are so… um… badass! Or… not.

Steve even went so far as to recommend Coors Light, as a more philosophically-pure version of watered down swill — encouraging a brand switch… somewhere on the site (can’t find it now, nor will I waste another second looking for it).

Which is particularly hilarious — because Coors Light is a very proud sponsor of both the NY version and the Chicago version of Gay Pride each year.

All of which brings me to my only real point here: these embittered old jumokes will soon not have a single national brand of soft drinks, clothing, shoes, hats, cars, toothpastes, beers or wines… or for that matter… toilet paper and bedding… they deem “acceptable“.

What then?

Will the boys and their chuckleheaded followers… knit their own clothes from raw wool from sheep raised exclusively on Posse Committatus land, and beef, fed only non-industrial / Cargill feed, in mountainous Idaho and Washington State? Will only Neo-Nazi goods and services suffice?! Will they distill their own moonshine and brew their own bathtub beers?! Will they only watch Soviet sporting events?!

I know. They won’t. But… they will die off, soon enough. Or be put in nursing homes, by their now middle aged adult offspring — who will have grown utterly exasperated with their lunacy and senility.

And that… will be a form or rough justice, boys.

Out.

“Two-For-One!”: Mirengoff’s Off His Nut Tonight, Too!

This must be the Easter / Passover “reckoning effect” — for both Hinderaker and Mirengoff, just under differing covenants of faith, having heard from their respective preacher / rabbi this weekend — about what they each owe their fellow humans (under each covenant).

Charming; the previous one below was on John — while these two topics are… Paul’s (as at right, and below). Mirengoff leaves his readers with the false impression tonight that the Biden administration is considering ignoring the moronic ruling at right. That is false.

The government has already appealed it; and the USDC Judge stayed his own ruling, in any event — on his own. Moreover, the state of Washington and at least 20 other states will abide by a federal court ruling there affirming that the FDA is indeed empowered to regulate 23 year old on market drugs, not Texas nut jobs in robes — who’ve benefited wildly from forum shopping. So — shut it Paul.

Next he complains that the Vice President is supporting acts that are inconsistent with prosecuting insurrection.

D A M N.

Again, Paul — these were legislators. They were ELECTED by the people of Tennessee. Their job is to protest for more responsible laws, from the GOP super-majority there.

You and Scott and John and Steve would take that right from them, primarily because the gun lobby pays you malignant idiots too much.

I know you know better. You well know that the floors of legislatures are among the purest of free expression zones in the nation. And you know that one cannot “break and enter” there, when it is in session… AND ALL THREE WERE MEMBERS in good stead. This is quite different from a riot where Ashli Babbitt was killed by mob felony murder, while vigilantes stormed our Capitol.

These elected reps will be reseated again, within a few weeks. It is the job the people elected them to do — to oppose super-majority tyranny.

You did see that at least one liberal activist is going to release the details of each GOP members’ mistresses and affair partners… (having received the same in Tennessee) should the GOP try to oppose the two young mens’ re-appointment to their seats… you saw that, right?

To be clear… I don’t approve.

But I understand. When the (national and Tennessee) GOP goes low… like last week… it must notice that not all local Democrats will be as gracious as Michelle Obama, and go high.

So — yes, keep up with the false analogies. See where it gets you, oh Tennessee GOP-ers. Besides divorce court, and about ten years of alimony payments.

Hinderaker’s Flat Out Lying — On Florida Public School Library Books… REMOVED.

John well-knows that DeSantis’ chances for national office are growing dimmer, as more of his explicit edicts in Florida receive wider attention. So tonight, Hinderaker tells a series of lies about school library books. [John sees DeSantis as the only viable GOP nominee, having ruled out both Haley and Tangerine.]

While in some more liberal communities — notably near downtown Miami, and inside Celebration, Florida — and parts of Tallahassee… the library books have remained untouched, all year (with the local officials openly saying they will risk having their Florida teaching certifications revoked, as the DeSanits’ laws and local rules now allow)… in many other, more radical right counties’ school districts / areas (i.e., almost essentially all of the panhandle, and most of central landlocked Florida) have ordered the removal or covering of ALL books.

In fact, in one district where over a million titles were available just three years ago, there are only 3,100 approved books left in many schools, in total. This is due to the law requiring all books be removed until each one is deemed “suitable”, by a local parent council. And those councils don’t meet very often, and don’t — frankly — read many books.

As to specifics, teachers in Manatee County and Duval County were told in late 2022 they had to have each book in their classrooms formally reviewed (by what amounts to a local school “censor” board), following the provisions of HB 1467. Until their books are approved by a media specialist and that board, teachers were told to remove or cover ALL their books. Most did, to avoid losing their right to teach, state-wide.

HB 1557, the “Parental Rights in Education Act” (a/k/a “Don’t Say Gay” law) bars classroom instruction on sexual orientation or gender identity in Kindergarten through third grade.

In upper classes, these topics must be delivered in an “age-appropriate” or “developmentally appropriate” way, and only “in accordance with state standards.” Whether the law applies to school libraries or classroom libraries has been a source of confusion; yet teachers found in violation of the law risk losing their professional license.

HB 7, The “Stop W.O.K.E.” Act prohibits teaching someone in a way that they “might” feel guilt or psychological distress on account of their race or sex, similar to educational gag orders with lists of “divisive concepts” passed in numerous states in 2021 and 2022. In deeply red counties, this law has been used to remove any book that even mentions historical facts about slavery, for example.

HB 1467 mandates that schools maintain online databases of every book in their collections “in a searchable format” so that the parent councils can ban books without reading them. The parent councils tend to search for what they regard as offensive words, and then ban the book without even cracking its cover. And yes, that is what is happening in Manatee County [according to public school teachers who are considering an ACLU-led class action lawsuit on behalf of all children in the county].

In sum — Hinderaker (when not delusional) is… a stone cold liar.

And, in order to get back at his own Democratic Governor in Minnesota, John and his allies placed gay porn in the lending library as “a stunt”. Hinderaker thinks this a droll prank — but Florida kids may actually request these books, from Gov. Walz’s lending library — if they know to ask, now that Hinderaker’s pals have trafficked in underage porn.

This is how you know hard right radicals have lost all rational arguments: they resort to potentially harming real children for humorous effect — since no one takes them seriously any longer. This moron ought to be… charged.

Out.

Dr. Daniel Bausch : Aggressive Diagnostics Use Will Be The Key To Managing New Epidemics…

As new viral vectors mutate, emerge and develop, especially in Africa — in transmission from mammalian hosts to human ones, the powerful new diagnostics — if they can be manufactured somewhere in the “middle” expense range… will be absolutely critical. But we need to get them on the ground, there too — close to the spots for the likely next outbreaks, for this all to be transformative.

Here’s NPR, reporting on it all:

. . .For decades, Dr. Daniel Bausch fought the world’s most dangerous emerging tropical viruses directly from the trenches: He has trapped bats in Democratic Republic of Congo in search of the animal reservoir of Marburg virus. He has jumped into outbreaks of diseases such as dengue, yellow fever, Lassa fever and Ebola, spending months at a time treating patients in lower income countries ranging from El Salvador to Guinea….

But now Bausch says of this work, “You realize that’s all on the response side. . . .”

Increasingly, Bausch says, he’s come to appreciate that, “the impact is with trying to change the system….”

“The architecture for outbreak response has changed drastically,” he says. “When we have outbreaks of Ebola in places like the Democratic Republic of the Congo, colleagues at the main research institute there, they’re very experienced now with this.”

“It doesn’t mean that they don’t need – nor receive – any support,” Bausch adds. “But they have gotten this down and figured it out. So things happen much more independently than they did [before].”

“No longer – and this is a good thing — no longer should anybody from the U.S. CDC or the World Health Organization or London or Geneva or anywhere else think, ‘Okay, We’re going to come in and tell people what to do.’ Those of us who are not from that area of the world really need to recognize that we’re there to play an important but a supporting role in the leadership that’s going to come from the African continent….”

Now you know. Off to fly Easter kites with the baby girls, on a perfect Spring Sunday afternoon… grinning — out.

नमस्ते