Rahway To Run A Phase 2b/3 Clinical Trial, On MK-8748 / Tiespectus — For Wet Macular Degeneration…

This continues to mark progress, on one of the more important of Merck’s other recent candidate acquisitions, toward ultimate FDA approval.

We will watch the outcomes closely, as diabetic / wet macular degeneration is a very high-burden condition in the US and Europe.

Here’s the latest, out of Rahway:

…Merck today announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus), a novel investigational bispecific antibody that directly activates Tie2 signaling and inhibits vascular endothelial growth factor (VEGF), for the treatment of neovascular (wet) age-related macular degeneration (NVAMD).

The study, known as MALBEC, is the first trial of a broader late-phase development program for MK-8748, with a second study in NVAMD scheduled to begin this year (NCT07496567). The decision to advance into pivotal studies is based on results from the Phase 1/2a RIOJA trial (NCT06664502), a two-part study evaluating MK-8748 in patients with either NVAMD, macular edema secondary to branch retinal vein occlusion (BRVO) or diabetic macular edema (DME)….

Now you know — onward, on a rather chilly gray day, here.

[And that seems apropos, as I lost my fifth-youngest brother on this day, exactly six years ago, to COVID-19 — right at the start of that awful US epidemic.]

नमस्ते

All “-Pox” Blood Testing At Federal Level Is Being Returned To The Individual State Health Authorities — Due To DOGE/Tangerine 2.0 Cuts… Ugh.

As we are all certainly well-aware, the goal of having one central federal agency conduct public health outbreak screening tests. . . is to ensure that we are uniformly applying rigorous science — in a timely manner, to mistake proof the effort, across the vast 50 separate States.

A missed (or delayed) assay in Alabama (for example) could plausibly result in an epidemic, throughout the Southeast, and beyond. But due to Trump cuts, the CDC must now return responsibility to each state — for testing for suspected cases of rabies, chicken-pox, measles, small-pox, mpox and mumps and rubella, among others. Damn.

Here is the NYT on it all, overnight:

…The diseases were removed from a list of tests the agency conducts for state and local health departments. Experts worry that with drastic staff reductions, the testing may not resume….

The Centers for Disease Control and Prevention has temporarily paused testing for rabies and pox viruses, the family of viruses that includes smallpox and mpox, according to an update to the agency’s website on Monday.

The C.D.C. offers testing for dozens of pathogens to assist state and local public health laboratories that are not equipped to conduct them. The organization began evaluating its tests in late 2024 as part of an agency-wide review.

But widespread layoffs, hiring freezes and resignations have shrunk the number of qualified scientists who can assist state labs. The C.D.C.’s rabies and pox virus teams have lost many of their members. By July, the rabies team will be down to just one person with the clinical expertise to advise state and local officials, and the pox virus team will have none….

What a dark and senselessly self-destructive time we find ourselves in, indeed — due to an exceedingly poor choice in leadership. Damn.

नमस्ते

Doctors Without Borders Presses Gilead — To Provide Much More Of The (Discounted Price) Wonder HIV Drug Lenacapavir, For The Emerging Markets…

This seems like one “access” argument Gilead could afford to bend a lil’ on.

The twice a year drug will make tens of billions in each year, in the post industrial world, for several years, now.

And in any event, with generic versions coming into at least some markets in about a year, Gilead could let Africa and South America receive near generic pricing.. today. The doctors’ charitable group is right: these vast advances in standard of HIV care should be made as widely available as possible. [Much like the river blindness drug Ivermectin, which Merck has made available for free in Africa for decades now.]

My buddy, Ed Silverman is excellent on this timely topic (but just FYI, that is a paid subscription link — for Stat subscribers, only). And so, here is the original MSF letter, to Gilead’s CEO, Daniel O’Day:

…Both the pace of the current lenacapavir rollout and the scope of ambition for future scale-up fall far short of what the moment demands and the needs of the world’s most marginalized communities. The plan to reach 2 million people over three years is a fraction of the estimated need. When requests for purchase are refused, access is restricted, and prices remain secret, it is hard to believe Gilead is committed to equitable access rather than maintaining control over the product for maximum profit….

MSF currently accesses a limited number of lenacapavir doses through the Global Fund, which Gilead has supplied with enough lenacapavir for 2 million people over three years. This is currently the only avenue available to us. Gilead has indicated that this is all the supply available for low- and middle-income countries (LMIC) until generic versions come online in 2027….

We call on Gilead to respond by April 13, 2026 clarifying:

Whether you will sell lenacapavir directly to MSF?

If not, why, given your stated production capacity?

If yes, at what price and how soon can delivery begin?

The health of many people depends on your answers to these questions….

Indeed — and, onward, grinning — with our crew headed out, toward the Moon, with a “Wiley E. Coyote” move (and one to get back home!). Smile….

नमस्ते

[U, X2: Success — In High Orbit!] We Are (Again) Less Than Two Hours — From Launch Time… Will The Artemis II Crew Get Their Rocket — To Circle The Moon? We Shall See…

UPDATE: At the 1:54 mark, the team has identified an issue with the emergency Flight Termination System software. They are seeing unexpected readings, and so the solution is to go pull a piece of hardware that was last used “live” during the Space Shuttle era, and see if it confirms that these readings are nominal — or okay to go, for flight. Wow. I suspect the window is going to slip a bit. Do stay tuned, to the YouTube Live, below. End updated portion.

The best news so far is that there have been no “call outs” — or unscheduled holds, either — relating to tanking / hydrogen leak issues.

And the launch “window” is ample… at least two hours — about two hours, from now (1 hour and 58 minutes, actually) — or around 6: 20 pm Eastern.

We wish the crew — and the brilliant working scientists and engineers at NASA… all the best.

I will be off grid when the launch window actually opens, but will report, later tonight — either way. Onward.


नमस्ते

Berlin, Germany Now Seeing ‘Locally Spreading’ Mpox Clade 1b Outbreak: 35 Men Are Ill…

Well, we all knew this might come — viral vectors bear Darwinian imperatives, too. The communities at risk need to be more vigilant, as well. Still — we hold out hope — that wider vaccination protocols… will arrest this outbreak.

Here is the disappointing news, out of Berlin — from CIDRAP:

…A rapidly expanding cluster of mpox caused by clade 1b virus has been identified among men who have sex with men (MSM) in Berlin, Germany, according to a rapid communication published last week in Eurosurveillance. Of the 35 identified cases from December 2025 to last month, 34 were most likely acquired locally.

The sharp increase in locally acquired infections marks a shift from historic patterns in which most mpox cases in Europe were largely travel-related. Clade 1b of the mpox virus (MPXV) was newly identified in the Democratic Republic of the Congo and several other countries in East and Central Africa in 2023….

Tough news, indeed. But onward, now — to see whether Artemis II has solved the tanking / liquid hydrogen leaks problem, around this noon-time, Eastern.

नमस्ते

And, Good News For PBS And NPR — From The Able USDC Judge Randy Moss, In DC…

I won’t belabor it — but Tangerine 2.0’s lame-a$$ effort to punish journalists he disfavors… was dealt another [likely lethal] blow, today.

He will doubtless appeal. But that too will fail. Here’s a bit, but do go read all of the 60-plus pages:

…These consolidated cases raise the question whether the First Amendment permits the executive branch to put an end to all federal funding across agencies and programs for two private entities — here, National Public Radio (“NPR”) and the Public Broadcasting Service (“PBS”) — merely because, in the President’s view, “neither entity presents a fair, accurate, or unbiased portrayal of current events.” Ending Taxpayer Subsidization of Biased Media, Exec. Order No. 14290 § 1, 90 Fed. Reg. 19415 (May 1, 2025) (“Exec. Order”)….

The President may, of course, engage in his own expressive conduct, including criticizing the views, reporting, or programming of NPR, PBS, or any other news outlet with whom he disagrees. The government may also fund its own speech and may fund government programs that promote specific perspectives on issues of public importance, and it may decide which views or perspectives to convey — and which not to convey — in any such government speech or program. And it may impose limits on federal grants to ensure that they are deployed to further the legitimate purposes of the program and may pick and choose among applicants based on legitimate criteria. But the First Amendment draws a line, which the government may not cross, at efforts to use government power — including the power of the purse — “to punish or suppress disfavored expression” by others. Nat’l Rifle Ass’n of Am. v. Vullo, 602 U.S. 175, 188 (2024).

As the Supreme Court and D.C. Circuit have observed on more than a dozen occasions, the government “may not deny a benefit to a person on a basis that infringes his constitutionally protected… freedom of speech even if he has no entitlement to that benefit.” E.g., Agency for Int’l Dev. v. All. for Open Soc’y Int’l, Inc., 570 U.S. 205, 214 (2013).

Executive Order 14290 crosses that line. It does not define or regulate the content of government speech or ensure compliance with a federal program. Nor does it set neutral and germane criteria that apply to all applicants for a federal grant program. Instead, it singles out two speakers and, on the basis of their speech, bars them from all federally funded programs….

Because the First Amendment does not tolerate viewpoint discrimination and retaliation of this type, the Court will issue judgment against the federal agency defendants declaring Section 3(a) of the Executive Order is unconstitutional and will issue an injunction barring those defendants from implementing it….

Excellent!

नमस्ते

“Missing”, At Mars: Maven Mission Update. [Not Good News.]

We have reported on this before — it is almost certainly… end of mission.

And, I am rather skeptical that we will ever learn the root cause of the loss of signal in early December 2025.

And so, consequently, I am pretty sure we won’t ever “get eyes on” the Maven craft, again. She flew, and flew well — long beyond her expected life. And that may be all we will ever know. Here’s the latest, from NASA, on the Barsoomian happenings:

NASA Anomaly Review Board Investigates MAVEN Loss of Signal

A NASA anomaly review board, convened in mid-February, is evaluating the recovery efforts undertaken for the agency’s MAVEN (Mars Atmosphere and Volatile EvolutioN) spacecraft orbiting Mars. The spacecraft was last heard from on Dec. 6. The board also will assess the probable current state of the spacecraft and the likelihood of its recovery….

So it goes. Keep a good thought — for Artemis — mañana… smile.

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Trivia: I Don’t Care How Kristi Noem’s Husband Presents, Or Otherwise Decides To Dress — Among Fellow Adults… But I REFUSE To Believe She Had “No Idea” — And Was “Blindsided”.

This is truly… trivial — except for the STAGGERING hypocrisy, of it all.

How he dresses on Tinder and/or wherever it was, or elsewhere… is his business, alone. And even though it may not be exciting to me, personally… he should plainly keep the right to present as he pleases. But c’mon, man — the vetting by NSA would have found this very public profile, well before when she was appointed. [Or even before — during her stint as Gov. in the Dakota territory. To a certainty, everyone at the top of Trump World would have been briefed. Period.]

So… where I come up short is… how often these supposedly-Bible believing MAGA nuts… lose their lil’ minds, about someone cross-dressing — refusing an adult’s right to be themselves. And… then, for Kristi to ask for “prayers” because her family has been “devastated” by this… is just utterly… non-plausible.

She knew. She didn’t care — until it became a liability to her credibility inside the top of MAGA World. What a pile of deplorables these people all are. Man, oh man. Or… woo-man. I. Don’t. Care. Out.

नमस्ते

Power Alley: Merck To Spend Up To $838 Million, With Infinimmune, To Get “First Refual” Rights — On Human Memory B Cell Antibodies…

The Rahway company continues to invest in its 2030s future, here getting a first look at Infinimmune’s high value antibody targets for various diseases (both viral and cancerous) — to become candidates for therapies or vaccines.

Here’s the latest, from Fierce Biotech:

…Merck & Co. is rounding out its March deal flurry with an antibody discovery pact that could be worth as much as $838 million.

The New Jersey pharma is tapping Infinimmune to hunt for antibodies for as-of-yet undisclosed targets. The $838 million total comes from an undisclosed upfront payment and future potential milestone payouts, according to a March 31 release. Once Infinimmune identifies a potential antibody under the deal, Merck will have the exclusive right to take over development and commercialization.

Infinimmune’s platform uses a large dataset sourced from human memory B cells, which the company believes makes its antibody candidates already primed to become new drugs….

Onward, grinning….

नमस्ते

The Nancy Grace Roman Space ‘Scope: Fully Assembled!

This wide field, deep space mapping telescope will be ready for lunch as early as September 2026 — but will launch no later than Spring of 2027. It truly is a marvel of fine engineering.

And, in yet another echo of “Hidden Figures“, this will be the first space telescope ever named for a woman. We have mentioned it on and off over the last decade, as our regular readers will know. Here’s the latest, from NASA:

…The Roman observatory is slated to launch no later than May 2027, with the team aiming for as early as fall 2026. The mission will revolutionize our understanding of the universe with its deep, crisp, sweeping views of space.

More than a thousand technicians and engineers assembled Roman from millions of individual components. Many parts were built and tested simultaneously to save time. Now that the observatory is assembled, it will undergo a spate of testing prior to shipping to NASA’s Kennedy Space Center in Florida in summer 2026….

Onward, smiling — into a beautiful new Spring morning. Even in these times of darkness, there are many reasons to smile and greet the day. Our advancing knowledge of interstellar space, chief among them:

[To be clear, I wish the Artemis crew all the best — but I just see scant valid scientific reasons, to risk these crewed Moon missions — other than 1600 Penn’s insatiable hubris, for a 250 video show. Out.]

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