Push The Boeing Crewed Launch Back Another Week: May 17, 2024 — Earliest. “Space Is… Hard”

This is wise — and there is literally no reason to. . . rush it. As we’ve long said, it is no longer clear that humans on Mars yields any significant science dividend, compared to robotic missions — especially in view of not having solved for the radiation problems such a long voyage entails, to human health.

Obviously, the stepping stones are crewed missions in this capsule, then crewed missions to the Moon in it. That, at some point in the mid-2030s or beyond might lead to a crewed mission to Mars — but only after better shielding for radiation is worked out. So — here’s the latest, on it all. As ever, safety is (and should be) the prime objective:

. . .NASA’s Boeing Crew Flight Test now is targeted to launch no earlier than 6:16 p.m. EDT Friday, May 17, to the International Space Station. Following a thorough data review completed on Tuesday, ULA (United Launch Alliance) decided to replace a pressure regulation valve on the liquid oxygen tank on the Atlas V rocket’s Centaur upper stage.

ULA plans to roll the rocket, with Boeing’s Starliner spacecraft, back to its Vertical Integration Facility at Cape Canaveral. . . to begin the replacement. The ULA team will perform leak checks and functional checkouts in support of the next launch attempt.

The oscillating behavior of the valve during prelaunch operations, ultimately resulted in mission teams calling a launch scrub on May 6. . . .

Now you know. Onward, smiling — sun peeking through here, now.

नमस्ते

A Slight (Immaterial) Setback In Post-Surgical Endometrial Tumors, With Chemo And Pembrolizumab…

This morning, Merck released top line results for a trial designed to show enhanced survival from Keytruda in post surgical settings, for certain endometrial cancers in women. It is immaterial, because Rahway already possesses two approvals for pembrolizumab in such cancers. [Our prior mention, here — as background.]

The stock is rising slightly on the news, as proof of immateriality. So, onward, the juggernaut rumbles — (perhaps to confirm) this cogent analysis, from Fierce:

. . .While Merck & Co.’s Keytruda already boasts a pair of approvals to treat certain forms of endometrial cancer, a recent effort to prove the PD-1 inhibitor’s worth as a post-surgery add-on therapy in newly diagnosed patients has fallen short.

Adjuvant treatment with Keytruda and chemotherapy — with or without radiotherapy — failed to hit the mark for disease-free survival (DFS) in newly diagnosed, high-risk endometrial cancer patients who received surgery with curative intent, according to an interim analysis of Merck’s late-stage KEYNOTE-B21 study. DFS refers to the length of time after a primary treatment ends that a patient survives without any signs or symptoms of their cancer. . . .

Now you know — smiling and trusting all is well, in the soaked South, after a hectic weather night. . . onward.

नमस्ते

With Scant “On Topic” News — One More Tangent: The Father Of Modern Chemistry, Beheaded This Day — In Paris, May 8, 1794.

Let us stipulate at the top: Antoine Lavoisier was born into money. He was a French aristocrat, from the go. And in the end, that is probably why he was executed at age 50. But his immense advancements in the sciences, chemistry in particular, are why I write to commemorate him, today. [I don’t think we’ve covered him before here.]

It is not too much of an exaggeration to say that much of what pharmaceutical sciences have achieved in the ensuing three plus centuries. . . stems directly from his pioneering work. Rather than focusing on his untimely demise, in a time of mob-rule, let us remember his achievements (via easy Wikipedia!):

. . .It is generally accepted that Lavoisier’s great accomplishments in chemistry stem largely from his changing the science from a qualitative to a quantitative one. Lavoisier is most noted for his discovery of the role oxygen plays in combustion. He named oxygen (1778), recognizing it as an element, and also recognized hydrogen as an element (1783), opposing the phlogiston theory.

Lavoisier helped construct the metric system, wrote the first extensive list of elements, and helped to reform chemical nomenclature. He predicted the existence of silicon (1787) and discovered that, although matter may change its form or shape, its mass always remains the same. His wife and laboratory assistant, Marie-Anne Paulze Lavoisier, became a renowned chemist in her own right. . . .

[Just for the record, the ultimate charge by the revolutionaries — accusing him of tax fraud, by selling “adulterated” tobacco, was completely trumped up — and for that, he was put to death.]

Onward, smiling a slightly sad, soaked sort of smile. . . do be excellent to one another. Now you know.

नमस्ते

Long Thought Lost To The Deep Silty Riverbed, A Storied Arts & Crafts Typeface… Rises — And Echoes The Words, In A River Cut By Ancient Floods… [Yes, A Tangent]

I was put in mind of this story, which I saw only last week — by what will likely be the overnight flooding of a certain river, near Nashville, Tennessee — and how the rivers run through. . . all of us, truly.

So here it is — not life science, per se — but more the history of art. . . recovered. [Which is, after all — some measure of the life of all of us, recorded for eternity.]

Well over a century ago, now. . . two partners had a falling out over whether one was being “swindled” by the other, over some small rights-payments, for an enigmatic-but-beautiful leaden typeface the two had designed several decades earlier — in London.

And so, one of them tossed every single tangible, leaded bit of the proprietary face. . . into the muddy Thames River, near Fleet Street, off the Hammersmith Bridge one night.

While many printed paper books (and even bibles, from the 1910s and 1920s) still preserve what the font looked like when struck, no versions of the molded lead dies remained. It was indeed — thought lost, to the raindrops, under the rocks, from the basement of time — in that ancient riverbed.

Then in 2014 — a century on, an enterprising art historian got to work, sifting the Thames. . . in just the right spots (do go read it all!):

. . .With its extra-wide capital letters, diamond shaped punctuation and unique off-kilter dots on the letter “i,” Doves Type became the press’s hallmark, surpassing fussier typographic attempts by their friend and sometime collaborator, William Morris.

The letterforms only existed as a unique 16 pt edition, meaning that when Cobden-Sanderson decided to “bequeath” every single piece of molded lead to the Thames, he effectively destroyed any prospect of the typeface ever being printed again. That might well have been the case, were it not for several individuals and a particularly tenacious graphic designer.

Robert Green first became fascinated with Doves Type in the mid-2000s, scouring printed editions and online facsimiles, to try and faithfully redraw and digitize every line. In 2013, he released the first downloadable version on typespec, but remained dissatisfied. In October 2014, he decided to take to the river to see if he could find any of the original pieces. . . .

And so. . . as other rivers likely leapt their banks this evening, what treasures lost to pre-civil war Tennessee. . . might be washed onto the otherwise dry flats? We shall soon possibly. . . see. Onward, grinning. . . .

नमस्ते

Part Five, Of Five: Amgen’s $3.3 Million Q1 2024 Lobby Spend — By Detailed Buckets…

[The second graphic below is a legacy one, from prior Amgen lobby efforts.]

Here’s what $3.3 million bought — in terms of pro-, and con- ear bending:

. . .[US House] Issues related to drug pricing reform: Changes to Public law 117-1769 Inflation Reduction Act; Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act. . . .

S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Manager Transparency Act; HR 830/ S 1375 HELP Copays Act; HR 485 Protecting Health Care for All Patients Act; HR 5378 Lower Costs, More Transparency Act; R 2534 PROTECT 340B Act of 2023; HR 3561 the PATIENT Act; S. 1542 DRUG Act; S. 1967 PBM Act; HR 3503 The NIH Clinical Trials Diversity Act. . . .

Issues related to cardiovascular disease awareness and treatment; Issues related to Federal Trade Commission; FDA issues; Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters; Biosimilars reimbursement issues, no specific bill; Supply Chain Issues, no specific bill; Issues related to 340B. . . .

Issues related to pharmacy benefit managers: Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid; Drug Rebate Program; HR 4818/ S. 2407 Treat and Reduce Obesity Act; S. 2305 Biosimilar Red Tape Elimination Act; S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act. . . .

Issues related to PAHPA reauthorization: Modernizing and Ensuring PBM Accountability Act (Finance Committee); S. 652 SAFE Step Act; S 2474/ HR 5376 Share the Savings with Seniors Act; S 2456 Protecting Seniors from High Drug Costs Act; HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; HR 3281 Protecting Patients Against PBM Abuses Act; HR 4822 Health Care Price Transparency Act of 2023; S 1339 Pharmacy Benefit Manager Reform Act; HR 2679 Pharmacy Benefits Manager Accountability Act; HR 4507 Transparency in Coverage Act of 2023; HR 1352 Increasing Access to Biosimilars Act of 2023; HR 2880 Protecting Patients Against PBM Abuses Act. . . .

Issues pertaining to the implementation of PL 97-414 “Orphan Drug Act,” all provisions; HR 5539 Orphan Cures Act; HR 5547 Maintaining Investments in New Innovation Act; S 3558 BIOSECURE Act; HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act); S Res 566 Cholesterol Education Month 2024; HR 7635 340B PATIENTS Act of 2024; H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act. . . .

[Senate] Issues related to drug pricing reform; Changes to Public law 117-1769 Inflation Reduction Act; Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Manager Transparency Act; HR 485 Protecting Health Care for All Patients Act; HR 5378 Lower Costs, More Transparency Act; HR 2534 PROTECT 340B act of 2023; HR 3561 the PATIENT act; Issues related to cardiovascular disease awareness and treatment; Issues related to ESRD; Issues related to asthma and self-administered drug list; Issues related to reimbursement for biologics/biosimilars; Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program; HR 4818/ S2407 Treat and Reduce Obesity Act; S2129 Ensuring Access to Lower-Cost Medicines for Seniors Act; Issues related to PAHPA reauthorization; Modernizing and Ensuring PBM Accountability Act (Finance Committee); S. 1542 DRUG Act; S652 SAFE Step Act; HR 3281 Protecting Patients Against PBM Abuses Act; HR 4822 Health Care Price Transparency Act of 2023; S 1339 Pharmacy Benefit Manager Reform Act; HR 2679 Pharmacy Benefits Manager Accountability Act; HR 4507 Transparency in Coverage Act of 2023; S 2474/HR 5376 Share the Savings with Seniors Act; S 2456 Protecting Seniors from High Drug Costs Act; HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; HR 1352; Increasing Access to Biosimilars Act of 2023; HR 2880 Protecting Patients Against PBM Abuses Act; HR 5547 Maintaining Investments in New Innovation Act; HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act); HR 7635 340B PATIENTS Act of 2024; H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act. . . .

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 3938 Build it in America Act. . . .

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Transparency Act; S. 150 Affordable Prescriptions for Patients Act of 2023; S. 148 Stop STALLING Act; S. 142 Preserve Access to Affordable Generics and Biosimilars; 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 False Claims Act; Issues related to FDA/PTO coordination; Issues related to patent thickets/product hopping; Issues related to obviousness/ double patenting; S.2140 Patent Eligibility Restoration Act of 2023; S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act; S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents; H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress; H.R. 3535 Advancing Americas Interests Act; H.R. 5475 Prohibiting Adversarial Patents Act of 2023. . . .

And that does it for the Q1 series — see you in later July, for Q2 2024 rundowns!

नमस्ते

Boeing’s Starliner Must Reschedule Crewed Mission To ISS. Now No Earlier Than Friday, May 10…

Tonight’s launch — scrubbed.

Faulty second stage oxygen relief valve, apparently.

Live press conference was here, but now is over, so drag the lower video bar to 2:32 in the feed, to see the astronauts leaving the capsule, after launch was scrubbed:

नमस्ते

Heady Times: First Patient Receives Vertex’s ~$3 Million Sickle-Cell “Cure” — Six Months After FDA Approval.

No doubt this is a piece of very good bio-science news: the cure for sickle-cell anemia — a painful and often debilitating disease is now being administered to select patients, in the US. That’s a huge win. [Here is one of several backgrounders we posted, over the years — on it.]

But the patients are “select” precisely because the therapy is priced somewhere between $1.8 million and $3.1 million for a full course of treatment, depending on whom one believes. Do read all the excellent NYT piece has to offer on the topic, this morning:

. . .For the estimated 20,000 people with sickle cell in the United States who qualify for the treatment, the start of Kendric’s monthslong medical journey may offer hope. But it also signals the difficulties patients face as they seek a pair of new sickle cell treatments.

For a lucky few, like Kendric, the treatment could make possible lives they have longed for. A solemn and shy adolescent, he had learned that ordinary activities — riding a bike, going outside on a cold day, playing soccer — could bring on episodes of searing pain.

“Sickle cell always steals my dreams and interrupts all the things I want to do,” he said. Now he feels as if he has a chance for a normal life. . . .

As I say, do go read it all. It is especially gratifying to finally see life-science efforts aimed (at a very robust scientific level) at a disease that disproportionately afflicts a population other than whyte european descended humans.

That said, I am unconvinced that the treatment should be priced by reference to what a patient without it will incur / cost, over a life-time, in hospital stays and other out of pockets. Perhaps a better metric for the already wildly profitable Vertex (one of the makers of the cure) would be. . . what it would cost to recover the R&D burden Vertex shouldered over say a 15 year life span for the remaining patents — if X number of patients were granted access to the drug, per year. [If even only about half of the 20,000 potential patients receive it, at $3 million per course of treatment, the companies will have generated added revenue of. . . $30 BILLION! There is a nearly-zero chance that the R&D cost more than $2 billion. So a 15X return on investment seems. . . a little too high.] Just a thought. Onward.

नमस्ते

NASA Highlights A Paper On “Synthetic Life” — That Might Be Engineered In Zero Gravity…

There are profound ethical questions here. Ones that reasonable people will no doubt disagree about.

And to their credit, NASA scientists are not shying away from grappling with them. Because some of this will ultimately occur in zero gravity, the connection is. . . obvious — and the paper below has a lead author who works at NASA.

“. . .Cells are the fundamental units of life, forming the variety of all living things on Earth as individual cells and multi-cellular organisms. To better understand how cells perform the essential functions of life, scientists have begun developing synthetic cells – non-living bits of cellular biochemistry wrapped in a membrane that mimic specific biological processes.

The development of synthetic cells could one day hold the answers to developing new ways to fight disease, supporting long-duration human spaceflight, and better understanding the origins of life on Earth.

In a paper published recently in ACS Synthetic Biology, researchers outline the potential opportunities that synthetic cell development could unlock and what challenges lie ahead in this groundbreaking research. They also present a roadmap to inspire and guide innovation in this intriguing field. . . .”

Here is what the original paper’s authors say, in their abstract:

. . .The de novo construction of a living organism is a compelling vision. Despite the astonishing technologies developed to modify living cells, building a functioning cell “from scratch” has yet to be accomplished.

The pursuit of this goal alone has — and will — yield scientific insights affecting fields as diverse as cell biology, biotechnology, medicine, and astrobiology. Multiple approaches have aimed to create biochemical systems manifesting common characteristics of life, such as compartmentalization, metabolism, and replication and the derived features, evolution, responsiveness to stimuli, and directed movement. Significant achievements in synthesizing each of these criteria have been made, individually and in limited combinations.

Here, we review these efforts, distinguish different approaches, and highlight bottlenecks in the current research. We look ahead at what work remains to be accomplished and propose a “roadmap” with key milestones to achieve the vision of building cells from molecular parts. . . .

What a time to be. . . alive. Smile. . . Forever Young came up just short.

नमस्ते

Now, Abbott Labs, A Second Tier Pharma… Has Spent About What Lilly Did, In Q1 2024, On Lobbyists.

In other years, I had compared Abbott to Baxter, but as Baxter retools and likely spins off or sells the Kidney Care business, it has dropped lobby spend to only about $320,000 in Q1 2024. So Lilly becomes a natural comparator to Abbott — since Abbott spent a little more, and Lilly. . . a lot less, in Q1.

See at right, but here is what Abbott Labs lobbied about:

. . .S. 2477/H.R. 1770 Equitable Community Access to Pharmacist Services Act; S. 2922 Advancing Research for Chronic Pain Act of 2023; H.R. 2369 Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023; Proposals related to sterilization of medical devices; Proposals related to the President’s Emergency Plan for AIDS Relief (PEPFAR); Proposals related to Department of Defense coverage of continuous glucose monitors; Proposals to advance policies related to effective pain management; Proposals related to future pandemic preparedness; Proposals related to the advancement, testing, and detection of Traumatic Brain Injury; Proposals related to the safe manufacturing of medical devices; Proposals related to the use of diagnostic tests in CLIA-waived settings. . . .

S. 1000/H.R. 1835 Saving Access to Laboratory Services Act; H.R.3674 Providing Relief and Stability for Medicare Patients Act of 2023; Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule; Proposals related to Medicare coverage of continuous glucose monitors; Proposals related to outpatient coverage of cardiovascular medical devices. . . .

Proposals related to U.S. global health programs and pandemic preparedness; Proposals to advance global virus surveillance; Proposals related to preserving critical medical supply chains; Proposals regarding infant and child nutrition marketing. . . .

Proposals related to access to infant formula. . . . [This is spending related to a very old (since 1950s) legacy Abbott brand (Ross Labs). . . .]

Now you know — And. . . . my exacta box bet is now down, at Churchill Downs — let’s see how they all break!

नमस्ते

Actually, This Past Quarter, Lilly Spent Even Less Than Merck — Lobbying (Despite The Insulin Pricing Battle In Congress)…

Part Two, of the likely five part series on Q1 2024 Lobby-Spend trends, now appears for “Fourth Be With You” day. . . .

Lilly has worked diligently since about mid-2021, to lobby Congress to preserve its right to price the later-gen insulin products (and very aggressively — on the weight loss ones). . . in any manner it likes, in the US. Some of that has succeeded — some hasn’t. And true enough, all the majors spend less during a presidential election year, as Congress is not likely to move major new initiatives, on either side of the coin during 2024.

Even so, Lilly (and to a lesser degree, Merck) are spending far less than would have been expected, here in Q1 2024. [We gave you some granularity on Rahway on Wednesday, here.] This is what Lilly was working to bend Congressional ears on:

. . .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. . . .

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care. . . .

Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement, coverage and value; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; The INSULIN Act. . . .

Multilateral threats to IP and the biopharma- ceutical industry; Drug importation; Prescription drug value and access. . . .

Pharmaceutical intellectual property issues. . . .

Implementation 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. . . .

Hospital discounts; 340B program. . . .

Now you know — but clearly patent evergreening is top of mind, for insulin products at Lilly, in Carmel, Indiana. Smile — now let’s see that Japanese champ come in No. One, or No. Two — as an exacta box, with Fierceness? Forever Young!

नमस्ते