Category: Uncategorized

Power Alley: Merck Makes A Very Smart Flu Therapy Candidate Acquisition: Price? $9.2 Billion US.

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Rahway can certainly afford the smallish risk that these emerging flu therapies… crater. And it is hedging against the (largely non-scientific view, at the moment) that vaccines against influenza are somehow inherently suspect (thanks a ton, RFK, Jr.).

CD388 is looking effective against all strains of influenza. . . and can be sold year in and year out, to all who catch a more than moderate flu bug. So this is a smart use of about $10 billion (after rationalizing the production facilities, at scale). [The commentary in some quarters that Merck needs it — due to a patent cliff for pembrolizumab… is ill-informed. Merck will use the injectible version as a hop — and will see exclusivity into the mid-2030s. Mark my words.]

In any event, here’s the story, from CNBC, this am:

…Cidara’s experimental long-acting antiviral drug CD388 is not a vaccine and is expected to be efficacious in individuals regardless of immune status. It has the potential to be a single-dose, universal prevention against all flu strains….

It aims to protect those at higher risk of flu, with the potential to provide season-long protection.

“While this deal is somewhat complementary, it is not perfectly ‘plug and play’ with the rest of the Merck portfolio,” said Bernstein analyst Courtney Breen, calling Cidara “essentially a single asset story….”

Errata: it seems I was going too fast this morning, in search of a laugh. The comet that broke apart is technically NOT the one Avi Loeb claims is “intelligently designed“. But my point — and joke — both remain unsullied: that is a dirty snow ball, not a faster than light transport. So… it traveled for perhaps billions of years… and did… nothing? Seems less than likely. Onward, just the same.

नमस्ते

Friday Funnies: Hmm. Would Any Alien “Intelligence” Fly — For Millions Of Years, To Dip Close To Our Sun — And Only Then [Incompetently] Break Their Ship, Into Pieces?!

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Admittedly, this is making fun of Prof. Loeb, at his considerable expense. But overnight we learned that 3I/ATLAS (as comets very often do!) has broken up, into three irregularly shaped shards, due to both the heating of approaching the Sun, and the gravity slingshot it endured, as it accelerated past Sol.

Those three chunks of dirty snow are now speeding past Earth’s orbit, in the next few days, at a very safe distance. This is, in sum, a very old… but entirely non-intelligent… comet. Here’s the Space.com story:

…Astronomers have captured striking footage of the solar system comet C/2025 K1 (ATLAS) breaking apart on the nights following Nov. 11 after it was destabilized by a close brush with the sun in early October.

Comet C/2025 K1 (ATLAS) brightened significantly in the months following its May 2025 discovery. As it got closer to the sun and heated up, the frozen [simple chemical elements] in its core turned into gas and formed a reflective cloud around it known as a coma. Solar wind caused this gas to blow out behind it, forming the characteristic tail seen on most visible comets.

Sadly, C/2025 K1 (ATLAS) didn’t brighten enough to become a naked eye comet. However, its close approach to the sun on Oct. 8 does appear to have wreaked havoc with the comet’s structural integrity, setting the stage for the dramatic fragmentation of its ancient nucleus.

Luckily for us, the fragmentation was captured on Nov. 11-12 by astronomers using the 1.82 m Copernicus telescope at the Asiago Observatory in Italy….

Smiling — on a sunny, warming Friday — and separately, we learned that NASA’s Goldstone deep space radio dish was damaged, likely by operator error, some time in the last few months, but since the shutdown, no one has officially come forward to explain why we are relying on Italy and Australia to phone “Vger” (Voyager) One and Two, from time to time — and not… our own Goldstone dish — in California. Yikes.

नमस्ते

A Critical New Chicago Fed. Court Order, And Two New Filings, In The Various Cases Against Noem / Bovino, Et Al….

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The firehose of violations continues — so too then, do the federal appeals filings and trial court filings.

In arguably the most sweeping one, USDC Judge Cummings today ruled that up to 630 detainees must be essentially immediately released, and each need only temporarily submit a $1,500 bond (with that bond to be returned as soon as it is established that they were picked up without a warrant — in violation of the 2018 consent decree — all of which looks to be the case for about 95% of the detainee-records reviewed, so far).

The second one lays out in the Seventh Circuit both why Bovino lost at the trial level, and why the Seventh should bounce his specious appeal.

The final one (for tonight!) lists all new violations in Little Village, and Cicero and on Western Avenue — including firing pepper balls into a car peacefully driving AWAY from the ICE agents, striking a one year old baby in the car with the pepper.

[Gawd-dammit! He needs to be in jail, like… tomorrow.]

नमस्ते

To Keep The Record Rolling: We Will Also Offer Details Of Amazon’s Mega Spend — Through Three-Quarters Of 2025…

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I had forgotten that we usually also detail the categories of spend from Mr. Bezos’s companies. We do so, because his delivery businesses now increasingly provide (at a price) “docs in a box” (at least to his workers), and delivers prescription meds in some jurisdictions (where he’s helped change laws to allow that). . . and he/they/it now owns a few health-care bizznesses, outright.

And so, his “side hustles” dwarf, in spending — even the behemoth in pharma called… Pfizer. [Yep, Amazon is an 800 lbs. silver-back in these spaces.]

Here’s just a partial selection — of his latest jawboning efforts — largely focusing on the worker / insurance matters and health-tech and tele-health related stuff, as well as some protection of rights on IP, and med-delivery / drug compounding:

…Issues related to broadband access and affordability, satellite communications, space safety, device accessibility, Section 230 reform, content moderation, online video, and the Universal Service Fund (USF), including implementation of the Infrastructure Investment and Jobs Act (P.L. 117-58)….

Issues related to intellectual property, including the NO FAKES Act (S. 1367), counterfeits, music licensing, and issues related to patent reform, International Trade Commission Section patent investigations, intermediary liability, and patent reform, including the RESTORE Patents Act (H.R. 1574 / S. 708), the Patent Eligibility Restoration (PERA) Act (H.R. 3152 / S. 1546), and the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (H.R. 3160 / S. 1553)….

Issues related to taxes, digital goods and services, renewable energy tax credits, and international and corporate taxation, including the American Innovation and Jobs Act (S. 1639), H.R. 1 – To provide for reconciliation pursuant to title II of H. Con. Res. 14. (P.L. 119-21), the American Innovation and R&D Competitiveness Act (H.R. 1990), the Growing and Preserving Innovation in America Act of 2025 (H.R. 1062), the United States-Taiwan Expedited Double Tax Relief Act (H.R. 33 / S. 199), and implementation of the Tax Cut and Jobs Act (P.L. 115-97)….

Issues related to postal rates, service performance, and the transportation of hazardous materials….

Issues related to immigration, high-skilled immigration, and non-immigrant visas, including issues related to employment-based visas, green card backlog, and the STEM visa exemption provision….

Issues related to US trade policy, including USMCA, the World Trade Organization, the World Customs Organization, China, country of origin labeling, US customs policy and procedures, US tariffs, foreign direct investment….

Issues related to technology, procurement, and space policy, including the Fostering Reform and Government Efficiency in Defense Act (draft bill – no numbers)….

Issues related to drones and air cargo, including implementation of the Federal Aviation Administration Reauthorization Act of 2024 (P.L. 118-63)….

Issues related to USDA SNAP online purchasing, including reauthorization of the Agricultural Improvement Act of 2018 (P.L. 115-334), the Farm, Food, and National Security Act of 2024 (H.R. 8467), Electronic Benefit Transfer, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and food safety….

Issues related to veterans hiring and training, employee compensation and benefits, workplace safety, competition, and contracting. and minimum wage, including the Warehouse Worker Protection Act (S. 2613)….

Issues related to IT modernization, cybersecurity, FedRAMP, open data, and government procurement, including implementation of the Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 (P.L. 118-159), implementation of Federal Acquisition Reform; implementation of the Foundations for Evidence-Based Policymaking Act of 2018 (P.L. 115-435)….

Issues related to health information technology, Medicare, healthcare and telehealth, including the Telehealth Expansion Act (H.R. 1650 / S. 763), the CONNECT for Health Act (S. 1261), the Telehealth Modernization Act (H.R. 5081 / S. 2709), and the Primary Care Enhancement Act (H.R. 1026)….

Now you know. Onward, grinning — ever grinning.

नमस्ते

Rural, Remote DRC Lacks Solid Deep Cold Storage Facilities: Means Significant Spoilage of Precious Mpox Vaccine Stocks…

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The Japanese company KM Biologics had, earlier this year, donated three million doses of its lyophilized Mpox vaccine LC16 to public health authorities in DRC. It had to be trucked for many days over tough jeep trail “roads” — into the remote regions where the Clade 1b virus is flaring. But that is the beauty of vials of powdered vaccines — they stay stable, even in 90 degree weather with 90 plus per cent humidity.

The rub though is that unlike here — where deeply refrigerated cold boxes, inside clinics — would be the norm… none of that infrastructure exists in rural villages in the hilly forests of remote DRC. So, a standard powder vial containing 250 doses will mostly go to waste, if you only have 50 to 100 people to vaccinate, since once the sterile water is added, the shelf life in 80 plus degree weather is under a day — maybe even only a few hours, if it is midday.

Here is that story from Reuters. My guess is it is likely not feasile, from a mass production / economic standpoint, to make five- or ten-dose “mini” vials — and then give them away, for free. The materials costs then (for very small vials — in the millions, per run) become very significant:

…Around a third of mpox vaccines donated by Japan to Democratic Republic of Congo are being wasted because they cannot be stored once prepared for use, the head of Congo’s mpox response told Reuters.

Japan has donated three million doses of its LC16 vaccine to Congo to help fight a new form of mpox known as clade Ib, which spread internationally and sparked a global health emergency last year. The second tranche of 1.5 million doses arrived in Congo in September, around two years after the outbreak began….

LC16, made by KM Biologics, is the only vaccine approved for children and is being given to children aged one and above as well as adults, but it is technically complex, requiring a specific needle and technique.

There are also challenges delivering the vaccine in some of the worst-affected provinces, which are remote or politically unstable, Kacita said. But the vaccine has still helped tackle mpox, particularly in Kinshasa [the densely populated capital city], he said….

Now you know. And, separately, as early as this afternoon perhaps up to six hundred wrongfully arrested people in and around Chicago (for lack of papers, alone) may begin to be released to their families on minimal bond — by USDC Judge Cummings. Sweet. All of Bovino’s lawlessness… is being undone. Onward!

नमस्ते

In An Older Federal Class Action Case — From Trump 1.0, Brought In Chicago — USDC Judge Cummings Is Likely To Release A Substantial Portion Of Humans Picked Up, Without Any Prior Warrant…

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The terms of this 2018 settlement consent and decree required that ICE/DHS/BP obtain prior warrants (from a REAL court, not an immigration agency employee), before seeking to arrest a person without papers who was not already wanted on any separate federal criminal warrant.

Here below is a refresher on that case’s status; and now many many humans may see the Fourteeth Amendment means what it says — from several of the earlier filings, strung together — thanks to the able USDC Judge Cummings, here:

…In 2018, five individual plaintiffs (Margarito Castañon Nava, John Doe, Miguel Cortes Torres, Guillermo Hernandez Hernandez, and Erick Rivera Sales) and two organizational plaintiffs (the Illinois Coalition for Immigrant and Refugee Rights and Organized Communities Against Deportations) filed this class action lawsuit against defendants including the Department of Homeland Security (DHS) and the U.S. Immigration and Customs Enforcement (ICE) to ensure that ICE complies with its statutory obligations under 8 U.S.C. §1357(a)(2) when conducting warrantless arrests of persons who have not obtained lawful immigration or citizenship status in the United States….

After the Court (then Chief Judge Pallmeyer) denied ICE’s motion to dismiss, the parties agreed to settle this case…. The Agreement imposed several obligations on ICE related to arrests of persons without a warrant for a civil violation of U.S. immigration laws within ICE’s Chicago Area of Responsibility (namely, the states of Illinois, Indiana, Wisconsin, Missouri, Kentucky, and Kansas). The Agreement had a three-year term that was set to expire on May 12, 2025, unless enforcement provisions within the Agreement triggered its extension.

The parties agree that they were able to resolve any disputes concerning ICE’s compliance with the Agreement during the first two-and-one-half years of its term. However, shortly after the second Trump Administration began in late January 2025, plaintiffs’ counsel received multiple reports from class members alleging that ICE agents had arrested them without warrants in violation of the Agreement and the governing law (8 U.S.C. §1357(a)(2)). After trying, without success, to resolve their disputes with ICE, plaintiffs filed their motion to enforce the Court’s order regarding the parties’ Agreement….

ICE has engaged in repeated, material violations of the Agreement and it seeks relief on behalf of twenty-six class members who plaintiffs claim were subjected to unlawful warrantless arrests. To be clear, plaintiffs do not challenge … the authority of ICE and other law enforcement authorities to arrest foreign nationals with judicial arrest warrants issued in connection with alleged violations of federal and state criminal laws….

[O]n September 26, 2025, plaintiffs filed a “notice of additional violations of consent decree and request for status conference” in which plaintiffs allege that ICE has engaged in over twenty-five additional violations of the Agreement in connection with “Operation Midway Blitz,” a major on-going immigration enforcement campaign targeting the Chicagoland area. (Dckt. #199 at 2). Plaintiffs further noted that they have received over seventy additional referrals of potential violations of the Agreement. (Id. at 2–3). On September 30, 2025, plaintiffs filed a “supplemental notice of consent decree violations” in which they allege that ICE has “dramatically escalated” its enforcement in Chicago in violation of the Agreement….

[T]he Court finds that plaintiffs have shown by a preponderance of the evidence that ICE arrested twenty-two out of the twenty-six claimant class members without a warrant in violation of the Agreement and the requirements of 8 U.S.C. §1357(a)(2). The Court orders ICE to provide relief to those individuals under the terms of the Agreement and to pay the attorney’s fees that plaintiffs incurred in bringing their motion to enforce. Second, the Court, in its discretion, finds that plaintiffs have met their burden under Rule 60(b)(5) of showing that a modification of the Agreement is warranted because ICE has failed to substantially comply with its terms….

[From this later order, in the case — signed by Judge Cummings:]

In their 10/31/25 submission, plaintiffs assert that “Defendants have only produced arrest records for 21 individuals of 67 they reviewed.” [238 at 6]. To the extent that they have not done so already, defendants shall produce to plaintiffs’ counsel the arrest records of the remaining forty-six individuals referenced above by 9:00 a.m. on 11/5/25 and they shall thereafter promptly meet and confer regarding whether these individuals were arrested in violation of the terms of the Settlement Agreement.

If the parties agree that one or more of these individuals were arrested in violation of the terms of the Settlement Agreement, they shall promptly be released from custody without conditions….

Excellent. Sanity is in fact making a comeback. Onward, to more free-wheeling time-lapse GoPro drone footage, of the aurorae, in the high Rockies, tonight… grin.

नमस्ते

The Last — Of This Series: Lilly’s Lobby-Spend, Through Three Quarters Of 2025… [And Comparative Trends]

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To close out the quarter, here are Lilly’s details.

While it spent less last year, it is still a significant force, in shaping US health care and pharmaceutical and biotech legislation and regulations, thus:

…Patient protection; Pharma- ceutical supply chain issues and shortages; Drug pricing, coverage, value, access and quality; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Policy matters related to Artificial Intelligence in health care; One Big Beautiful Bill Act (HR.1)….

Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil; US Tariffs. . . .

Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement pricing, coverage, value and access; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; One Big Beautiful Bill Act (HR.1)….

Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value, access and quality….

Pharmaceutical intellectual property issues; Implementation and extension of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax; Pension and retirement benefit issues; round-tripping; One Big Beautiful Bill Act (HR.1)….

Hospital discounts; 340B program; Prescription drug value, access, quality and compliance with Drug Quality and Safety Act….

Now you know. Onward — as the malign cretin Greg Bovino tucks tail, and runs (like a coward) out of the City of Big Shoulders. Good Riddance, you lawless tear gasser — of children!, and now… perjurer.

नमस्ते

So Another Launch Delay, For Blue Origin “To Barsoom” — Twin ESCAPADEs…

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Probably wise — not to take a fried electronics risk — since this mission will orbit Earth for almost a year, before lighting the fuse, to head out to Mars.

So we will wait probably a week or more, now — for a new launch schedule (it was to be this evening — after a ground-based weather / Florida rainout — over the past weekend):

…11.12.25 | UPDATE | NG-2 / New Glenn is ready to launch.

However, due to highly elevated solar activity and its potential effects on the ESCAPADE spacecraft, NASA is postponing launch until space weather conditions improve.

We are currently assessing opportunities to establish our next launch window based on forecasted space weather and range availability….

So it goes — with some of the best high Rockies shots, in the margins… forwarded by family — overnight. Woot.

नमस्ते

Amgen: Also Being Outspent In 2025 (Through Three Quarters) — But Was The Leader Among The Three, In Election Year 2024…

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More power alley disclosures, now — as to by whom, and why-for — our Congress-critters are being wined and dined, in 2025.

We will likely add Lilly into the mix, by tomorrow night — but see the updated totals at right, and the deets… as to Amgen:

…Issues related to drug pricing; Issues related to cardiovascular disease awareness and treatment; Issues related to FDA; Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters; Issues related to biosimilars reimbursement; Issues related to Supply Chain; Issues related to 340B; Issues related to pharmacy benefit managers; Issues related to biosimilars regulatory standards; Issues related to bone disease awareness and treatment; Issues related to Public law 117-1769 Inflation Reduction Act; Issues pertaining to the implementation of PL 97-414 “Orphan Drug Act,” all provisions; HR 946 Optimizing Research Progress Hope and New Cures Act; HR 1492 Ensuring Pathways to Innovative Cures Act; HR 1672 Maintaining Investments in New Innovation Act; HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14); S 1954 Biosimilar Red Tape Elimination Act; HR 5526 Biosimilar Red Tape Elimination Act; HR 2214 DRUG Act; H.R.1968 – Full-Year Continuing Appropriations and Extensions Act, 2025; HR 5509 Safe Step act; HR 5256 340B Access Act; HR 4581 340B Patients Act; S2296 NDAA FY2026 National Defense Authorization Act, issued related to Biosecure Act….

Issues related to drug pricing; Issues related to Public law 117-1769 Inflation Reduction Act; Issues related to cardiovascular disease awareness and treatment; Issues related to reimbursement for biologics/biosimilars; Issues related to PBM reform; Issues related to bone disease awareness and treatment; HR 946 Optimizing Research Progress Hope and New Cures Act; HR 1492 Ensuring Pathways to Innovative Cures Act; HR 1672 Maintaining Investments in New Innovation Act; HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14); H.R.1968 – Full-Year Continuing Appropriations and Extensions Act, 2025….

Issues related to corporate and international tax, including regarding Public Law 115-97, Tax Cuts and Jobs Act; Issues related to Puerto Rico; Issues related to OECD negotiations on the taxation of global income; HR 1 One Big Beautiful Bill Act (An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14)….

Issues related to tariffs….

Federal Trade Commission related issues, no specific bill; Issues related to the Patent Act, no specific bill; Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill; Issues related to patent thickets/product hopping; Issues related to obviousness / double patenting; Issues related to FDA/PTO coordination; Issues related to skinny labeling; S.1041 A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; S.1040 -A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; S.2296– NDAA (FY 2026 National Defense Authorization Act– BIOSECURE language); S 708/ HR 1574 — Realizing Engineering, Science and Technology Opportunities by Restoring Exclusive Patent Rights Act of 2025 (RESTORE); S.1553/HR3160– Promoting and Respecting Economically Viable American Innovation Act (PREVAIL); S. 1546/ HR 3152 — Patent Eligibility Restoration Act of 2025 (PERA)….

Now you know… “you have to break a few eggs, to make an. . . omelet.” And, separately, all solved on the La Guardia run, and music venue set-up is underway, for later tonight, at the House of Blues. Grin. Onward….

नमस्ते

Headline Club Chicago Will Respond By Thursday Night To The Noemites Motion For A [Purported] Emergency Stay, In The Seventh Circuit… Y A W N.

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So… despite Greg Bovino allowing / causing numerous delays (in part, by not being at all prepared — for his five hours of depos — and not delivering drone video footage he was ordered to deliver, causing it to be spread over several days), and despite (under oath) openly agreeing to several trial court measures, Bovino / Noem now appeals the orders making the TRO essentially permanent and requiring that the field agents wear body cams, and comply with existing federal regulations on use of force.

There is no emergency for Bovino — yesterday he and his goons were snapping selfies in front of Cloud-Gate, in the snow — more commonly called “The Bean” here. His work is neither urgent, nor particularly… lawful. Here’s the latest scheduling order on the appeals:

…ORDER re:

1. Emergency Motion for Stay Pending Appeal and Immediate Administrative Stay.

2. Plaintiffs’ Response to Defendants’ Motion for an Emergency Administrative Stay Pending Resolution of the Motion to Stay.

IT IS ORDERED that [Headline Club Chicago] appellees shall respond to the request for a stay pending appeal by 5:00 p.m. on November 13, 2025.

[Entered: 11/10/2025 07:33 PM]….

Onward, resolutely — this guy ought to be run out of town, on a rail. As he took his selfies, the crowd assembled to peacefully chant “Little Village Monster!” at him. Sweet.

नमस्ते