May 1 UPDATE: Amazon / NLRB Wrangling Update, Related To AMZN / JFK-8 Lawless Union Busting Tactics…

Here is our monthly check in, to highlight the NLRB staff counsel’s very cogent brief in defending a post decision ruling, out of Phoenix, against Bezos’ serial labor relations violator, called Amazon.

Here, the staff counsel argues that seizing union literature, and destroying it cannot be re-cast as permissible “tidying up” of the lunchrooms, because the VIDEOTAPE shows security guards stealing only the union pamphlets and posters, and leaving garbage on the tables. . . untouched. Charming, thus:

. . .Spence then returned to the breakroom and saw [Security Guard] Hill holding copies of the Notice that Spence had distributed. See Tr. 543:7-12. Spence approached Hill and asked Hill why he removed the papers from the tables. See Tr. 1064:12. Spence told Hill that the papers concerned a union. See Tr. 1064:12-14. Spence further said that Hill didn’t “work for Amazon,” and that it’s not Hill’s “job to break the law.” Tr. 543:13-17. Approximately 20 Amazon associates were present in the breakroom at the time. . . .

[Security Guard] Koplevich took photo- graphs of ALU activity taking place at a public bus stop adjacent to JFK8. See Tr. 1067:10-18, 1081:19-21. Troy immediately asked Bertone to have Metro One remove Koplevich from JFK8 because she was acting outside of her authority, as Metro One guards are only allowed to take photographs or make videos during an active investigation. . . .

There is much more at this link. But truly, the union will keep its win — on that you may rely. Onward.

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Of “Vampire Facials”… That End Up Being… Debilitating, Life Long Medical Problems.

It has been a minute since I put up an “unlicensed, unapproved” medicines post.

But this one. . . is so egregious, it rivals Jim Bakker’s colloidial-silver solution being sold on cable-TV as “a cure” — for COVID-19 — back in 2020. Despicable.

In this current case, at least three women have tested positive for HIV, the virus that causes AIDS, apparently after being micro-needled, in a “vampire facial” from an unlicensed supposed med-spa, in New Mexico. Understandably, the owner is facing jail time. Here’s a bit, from NPR:

. . .Many popular cosmetic treatments are delivered with needles, such as Botox to iron out wrinkles and fillers to plump lips. A “vampire facial,” or platelet-rich plasma microneedling procedure, involves drawing a client’s own blood, separating its components, then using tiny needles to inject plasma into the face to rejuvenate the skin. . . .

The New Mexico Department of Health began investigating the spa in the summer of 2018 after it was notified that a woman in her 40s had tested positive for HIV even though she had no known risk factors. The woman reported exposure to needles through the procedure at the clinic that spring.

The spa closed in fall 2018 after the investigation was launched, and its owner was prosecuted for practicing medicine without a license. . . .

The idea that a “lip plumper” (or similar) treatment could / would lead to AIDS. . .? Damn. Just. . . Damn. Be careful out there. Always — always, demand to see every license, on paper before sitting down. Out.

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Anon. Points Us To The Layoff News At BMS — As Its Keytruda® (Pembrolizumab) Competitor, Called Opdivo®, Saw Declining Sales Last Year, And In Q1 2024…

From about mid-2014 to late-2017, the immuno oncology “horse race” was on, between Merck’s bio-engineered PD-1 inhibitor (branded as Keytruda) and BMS’s. . . theirs being called Opdivo. We covered it with at least 100 posts in that time frame. [Search the upper left dialog box if you’d like some background, from our perspective — here. And, Merck has hit the $22 billion a year mark a year ahead of Wall Street’s estimates — here in 2024, not 2025.]

But as the markets matured in immuno-oncology, in the main, Rahway’s has shown stronger statistically better (longer term) survival data than BMS’s agent has. [In the US, it is difficult to get full reimbursement for a “second best” agent, with a winner already available, in many solid organ tumors.] And so — as of last Thursday, Bristol Myers Squibb began retrenching, thus:

. . .Bristol Myers Squibb on Thursday said that around 2200 staff will be impacted by cost-cutting measures designed to save about $1.5 billion by the end of 2025, with two-thirds of the savings coming from R&D. The initiative will reduce management layers in an effort to speed decision making, along with pipeline rationalisation and site consolidation. . . .

However, revenue from Opdivo fell 6% to $2.1 billion.

Chief commercialisation officer Adam Lenkowsky explained that the PD-1 inhibitor was hit by changes in buying patterns in the US, but the company is “confident we will see accelerating growth this year. . . .”

I would not bet on many more high growth quarters for BMS’s Opdivo — Keytruda has become the gold standard choice here (especially inside the US). So we extend our best meditations, to the families of the 2,200 BMS people being let go. Onward — now you know.

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It Seems Dark Energy — Universe-Wide — Is… “Thawing?” That Is, It Seems To Be… Waning.

As ever, first — the caveats: the data is strong, but the universe is very vary large. Very large. So over billions of light years, small differences in measured assumptions. . . can become magnified. That is, it could be a measurement error. [But two independent sources are now converging on this, as being real, and not an artifact.]

Moreover, this is approaching five sigma, nearly a gold standard for significance. More to come, of course — but the notion is that maybe the universe is a closed system — an endless series of big bangs and big collapses. [In a poetic/metaphorical sense, confirming endless “reincarnations” of all that we will ever see.] That we are not flying apart, never to fall back in, to a center.

Here’s the latest, via Wired.com:

. . .If dark energy is weakening, it can’t be a cosmological constant. Instead, it may be the same sort of field that many cosmologists think sparked a moment of exponential expansion during the universe’s birth. This kind of “scalar field” could fill space with an amount of energy that looks constant at first—like the cosmological constant—but eventually starts to slip over time.

“The idea that dark energy is varying is very natural,” said Paul Steinhardt, a cosmologist at Princeton University. Otherwise, he continued, “it would be the only form of energy we know which is absolutely constant in space and time.”

But that variability would bring about a profound paradigm shift: We would not be living in a vacuum, which is defined as the lowest-energy state of the universe. Instead, we would inhabit an energized state that’s slowly sliding toward a true vacuum. “We’re used to thinking that we’re living in the vacuum,” Steinhardt said, “but no one promised you that.”

Joshua Frieman, a cosmologist at the University of Chicago and a member of the DESI collaboration who didn’t work on the data analysis, said he would be glad to see Lambda CDM fall. As a theorist, he proposed theories of thawing dark energy in the 1990s, and he more recently co-founded the Dark Energy Survey — a project that searched for deviations from the standard model from 2013 to 2019 and created one of the three supernova catalogs DESI used. But he also remembers being burnt by disappearing cosmological anomalies in the past. “My reaction to this is to be intrigued,” but “until the errors get smaller, I’m not going to write my [Nobel] acceptance speech,” Frieman joked. . . .

The beauty of all this is that Einstein (were he alive) would celebrate wildly, if the next-gen data refutes his “constant” definitively. He always said that we learn the most when our best presumptions turn out to be. . . in error. Onward, grinning into a busy week ahead.

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As In June of 2021, Hubble’s Third Gyroscope Is Rendering Inconsistent Readings — Hubble May Go To A One Gyro- Slew Configuration…

This ‘scope has been in service since 1990 — and last had six gyros installed in 2009, by the then space shuttle “capture” missions. So it has had a wonderful ride. . . but is, indeed a very old spacecraft.

With the next-gen space scope (JWST) operating flawlessly, and providing far sharper imagery. . . it may be, that in due course, this one is allowed to safely deorbit. But for now, science will continue (once the fix is applied, ground-side) — even if need be, on one gyroscope. Here’s the latest:

. . .The telescope automatically entered safe mode when one of its three gyroscopes gave faulty readings. The gyros measure the telescope’s turn rates and are part of the system that determines which direction the telescope is pointed. While in safe mode, science operations are suspended, and the telescope waits for new directions from the ground.

This particular gyro caused Hubble to enter safe mode in November after returning similar faulty readings. The team is currently working to identify potential solutions. If necessary, the spacecraft can be re-configured to operate with only one gyro, with the other remaining gyro placed in reserve . The spacecraft had six new gyros installed during the fifth and final space shuttle servicing mission in 2009. To date, three of those gyros remain operational, including the gyro currently experiencing fluctuations. Hubble uses three gyros to maximize efficiency, but could continue to make science observations with only one gyro if required. . . .

Now you know. . . onward, grinning, with a legacy graphic — and baby girls due here this evening.

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Just A Little More Color, On One Franchise That Will Begin “The Backfilling” — In The 2030s, As Pembrolizumab Begins To Lose Exclusivity, Then: Winrevair®

To be clear, Keytruda^® will roll on, with global revenues increasing about 20% per year. . . into the early 2030s. That’s a huge competitive advantage — lapping the field, year after year. But should unforeseen patent trouble arise (in the form of a Congressional move, to more forcefully limit patent evergreening) — it will be products like winreviar, that keep Merck chugging along like the cash flow juggernaut it is.

It was indeed an excellent Q1 2024, and the NYSE-traded stock should reach into the $140-something range — perhaps even before year end 2024 — as the amped up guidance offered by Mr. Davis yesterday appears in the as actually-reported results next quarter and beyond. Here’s that story, from FiercePharma, as part of its review of Rawway’s first quarter 2024 “upside surprise” results:

. . .Four months into Davis’ tenure as CEO in 2021, the company acquired sotatercept in an $11.5 billion buyout of Acceleron. Data analytics group FactSet has projected sales of Winrevair to reach $3.9 billion by 2029.

“Strategic business development focused on the best external science remains an important priority,” the CEO said. . . .

When asked to estimate Winrevair’s sales this year, Davis reiterated that the company does not provide guidance for its individual products. He did declare that the launch is off to a strong start, with prescriptions increasing along with repeat prescriptions. Shipments to patients’ homes is underway. And the company is seeing excellent access with “no real limits,” Davis said, which is a good sign considering the drug was approved less than a month ago, he added.

R&D chief Dean Li, M.D., Ph.D., said that there will be continued “data flows that will continue to inform and strengthen,” Winrevair’s profile. The company also is working on an auto-injector that should improve uptake for the drug, which is currently provided in a vial.

“We believe that the vast majority with time will use it as self-administration,” Li said. “This is a patient population that’s quite used to doing injections. . . .”

I continue to believe that $250,000 a year — even though it is a life saver. . . is overpriced, for most US retail patients — as that means Merck makes back all $11 billion it paid for the whole company, in about five years.

The drug will remain on patent for over 20 years. The Condor’s view is that moves like that, indeed, are likely going to lead to more Congressional action to restrict US-drug pricing — or incentivize the company to more sharply increase EU and/or Canadian and Japanese prices — to allow the US prices to come down. . . between now and 2028, on all life-saving pharmaceuticals, generally.

[We’ve already seen one version of this (as we mentioned last week), with Merck allocating more supply of Gardasil to EU and Japan and UK — while shorting its contractual commits — to WHO/GAVI/UNICEF — for very low priced African deliveries, in this supply constrained year.]

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Merck Posts Very Strong Q1 2024 Results — And Expects Even Better — In The Back Half Of 2024…

The pembrolizumab franchise is clocking ever-increasing sales. . . and is as we’ve said, now the world’s highest selling single therapeutic agent. That will continue past 2030 — as I’ve long explained, despite less rosy guesses from Wall Street, about earlier patent expiries. It is always possible that a better agent for oncology comes along. . . but other than that (which no one might foresee at this point), the runway is clear.

So Merck is back over $130 a share — and probably is looking at a 12 month fair value closer to $140, once Winrevair sales really start accelerating. Here’s the Reuters analysis:

. . .[T]he company is making good progress on improving access to Winrevair, with several insurers and other payers already establishing coverage for it.

“Overall, we see today’s results as consistent with the recent solid trends seen from Merck’s business,” J.P.Morgan analyst Chris Schott said.

The primary focus for Merck is Winrevair, Schott said, adding that he expects rapid uptake of the novel PAH drug, from the second half of the year. . . .

New Jersey-based Merck said it expected annual earnings between $8.53 and $8.65 per share, up from its previous forecast of $8.44 to $8.59. Analysts had expected earnings of $8.56 per share. The company’s new forecast includes a $0.26 per share charge for its $680-million acquisition of cancer drug developer Harpoon Therapeutics, which closed in the first quarter of 2024, Merck said. The drugmaker forecast 2024 sales between $63.1 billion and $64.3 billion, up from its previous forecast of $62.7 billion to $64.2 billion. Analysts had expected sales of $63.83 billion. . . .

Now you know — onward, grinning into the sunshine, here.

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[Plus Video!] Courtesy Our Commenter, A Look At A Miles-Wide Obsidian / Gem-Like “Volcanic Lake” On Tempestuous Moon Io, Around Jupiter.

It would be quite a sight to see — a nearly mirror-like obsidian / “volcanic glass” surface, about 127 miles long, with a great white peak in the center. . . reflecting the vast face of Lord Jupiter, from time to time — highlighted, in the dim sunlight on that violent world.

Io is a very active little moon, regularly squeezed and tugged out of round by Jupiter’s crushing gravitational / tidal forces, and bombarded by Jupiter’s vast magnetic storms / radiation, on the regular. This makes Io. . . an active volcano-rich world — and a nearly-smooth orb, as it is regularly being resurfaced by lava flows that cool, and then reheat — and erupt. What a vision to see — and the graceful Juno craft, via its biggest camera. . . just recently had a front row seat — and saw it all,beaming the raw data back to us here, on our little blue marble.

Here’s the latest, per CNN’s science desk:

. . .Close flybys of Io, one of Jupiter’s moons and the most volcanically active world in our solar system, have revealed a lava lake and a towering feature called “Steeple Mountain” on the moon’s alien surface.

NASA’s Juno spacecraft, which first arrived to study Jupiter and its moons in 2016, flew within roughly 930 miles (1,500 kilometers) of the lava world’s surface in December and February to capture the first detailed images of Io’s northern latitudes.

It has been more than 20 years since a mission flew so closely by Io, and the spacecraft’s camera, called JunoCam, captured high-resolution images that showcased active volcanic plumes, mountain peaks and a glass-smooth lake of cooled lava. . . .

Do click below — for an amazingly artistic interp, of the Juno-Cam data:

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Since Lynparza® Is In The News, Today… We Will Rerun Ours, From 2018, On The Whole Long History Here — Involving Merck/S-P…

FiercePharma has a story on Lynparza out this morning. It is overall immaterial to Merck, as the changing landscape described there. . . doesn’t much move the needle as to Merck everall revenue before 2028 — but it offers a chance to remind, about the longish, and tangled, various corporate histories, here. So. . . see below:

[Original dateline — 12.03.2018:] If you were smart enough to buy in to Tesaro’s Citi Morgan Stanley-managed IPO six years ago — at $13.50/share (or even in the after-market at around $15), and hold — today, you are pretty happy. . . as GSK is buying your holdings for $75/share — all cash. That’s a more than five-fold return, in under six years. Sweet.

Since Tesaro in-licensed several of the legacy Merck (and in the case of rolapitant, at least, legacy Schering-Plough) oncology related cast-offs, after the bust-up of Schering-Plough. . . in truth, we have watched this company’s progress since at least March of 2010, on and off.

[Interestingly, and ironically (since Merck once owned it — via S-P), the rolapitant program came to be a commercial competitor of Merck’s Emend^®, as a nausea treatment in chemo.] In any event, today we learn that, as part of Glaxo’s retooling (shedding consumer health assets; fully redeploying into / entering oncology). . . Tesaro will become. . . GSK. And the nutritional beverages will be off-loaded. Here’s a bit, from one of the many morning stories on it all:

. . . .GlaxoSmithKline is acquiring oncology firm Tesaro in a deal worth $5.1 billion just hours after announcing the sale of its health drinks business in India to Unilever for some $3.7 billion. . . .

“The proposed transaction significantly strengthens GSK’s pharmaceutical business, accelerating the build of GSK’s pipeline and commercial capability in oncology,” GSK said in a statement announcing the Tesaro deal early Monday. . . . It’s all cash with GSK paying $75 a share. . . .

It is said that dull people make their fortunes. . . in real estate (cough — Trump!), while the sharp make theirs in the stock market. . . and the geniuses? Well. They make theirs trading life science companies, in that stock market. Heh. I honestly don’t know anyone who said that, but it sounds good, today. Really stable. . . geniuses — smile.

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Tomorrow, It Will Have Been 54 Loops Around The Sun, Since The Very First “Earth Day”…

So on the eve of it, we will now re-run the one we posted — at a half century on.

. . .It has been [a half century] since that first Earth Day in New York City — and Philly, New Orleans. . . and Boulder. It certainly doesn’t seem a half-century ago — but it now is.

To be sure, the work attached to the movement has never been more vital — more urgent. We all share this fragile orb — and we are all responsible for how we pass it on, to our children, and theirs. So join with the kiddos. . . here:

. . . .Earth Day was a unified response to an environment in crisis — oil spills, smog, rivers so polluted they literally caught fire.

On April 22, 1970, 20 million Americans — 10% of the U.S. population at the time — took to the streets, college campuses and hundreds of cities to protest environmental ignorance and demand a new way forward for our planet.

The first Earth Day is credited with launching the modern environmental movement, and is now recognized as the planet’s largest civic event. . . .

Now you know. Do something, even from home — to move the agenda forward, in your sphere of influence. Please. It will help our fragile, beautiful blue sphere, immeasurably.

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