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A First Ever Clinical Trial — For A Therapeutic, For Marburg’s — In Rwanda, Using Gilead’s Remdesivir (The Covid Therapeutic)… Now Underway.

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As with Mpox, it is increasingly looking like the rate of new cases is… trending in the right direction — toward zero.

As ever though, with no approved anti-virals for the specific Marburg outbreak, we have lots of work to do, yet. To that end, Gilead is testing its highly effective COVID treatment (not a vaccine) called Remdesivir, in Rwanda now. There is significant reason to think that it will work — using much the same mechanisms of action — as the ones that largely successfully bested viral loads, in COVID-19. Here’s that latest news:

…Rwanda has begun the world’s first clinical trial for a treatment of the Ebola-like Marburg virus, which has killed more than a dozen people in the country, the World Health Organization said Tuesday….

“Encouraging news from Rwanda,” WHO chief Tedros Adhanom Ghebreyesus said on X.

He hailed that the country had launched the “world’s first clinical trial for Marburg virus disease”, in collaboration with his agency, involving the use of a drug used to treat COVID-19.

The Marburg outbreak was first announced in Rwanda in late September and a vaccination program using a trial vaccine was launched earlier this month….

Marburg is transmitted to humans from fruit bats, and is part of the so-called filovirus family that includes Ebola. With a fatality rate of up to 88 percent, Marburg’s highly infectious hemorrhagic fever is often accompanied by bleeding and organ failure.

There are currently no officially approved vaccines nor approved antiviral treatments, but potential treatments, including blood products, immune and drug therapies are being evaluated….

Now you know — and do let football gods find the Buffs be ready, when tested in Arizona — at 3 pm local, this Saturday. Smile….

नमस्ते

Good News! An Added €20 Million — For Mpox Relief, In Africa — From The European Commission For International Partnerships…

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The situation in the seven or so nations inside Africa affected by this 2024 Mpox outbreak is improving — now that vaccines are being administered in ring fashion, to be sure. And this outbreak is not nearly as lethal as the current Marburg’s virus outbreak is, nor as any ebola flare up. But still, it afflicts primarily the very young, and runs at an about 10% mortality rate, now. So it is an urgent concern.

The prevailing thought among health care practitioners is that older people (age 30 and above, in Africa) likely acquired some mpox immunity, by virtue of being vaccinated against small pox, decades ago. The youngest (under age 10) in Africa remain largely unvaccinated, and are thus more susceptible to Mpox. Or so the common wisdom holds. In any event, here’s the latest good news, from the EU Commissioner for International Partnerships:

. . .Jutta Urpilainen, European Commissioner for International Partnerships, has announced an additional €20 million funding towards the fight against Mpox outbreak in the Democratic Republic of the Congo (DRC). This additional funding contributes to the DRC’s Mpox response and supports preparedness against epidemics as part of the EU’s objective to support the strengthening of health systems in Africa. Commissioner Urpilainen discussed the new announcement and coordination needed to tackle Mpox outbreaks with Director-General of the Africa Centres for Disease Control and Prevention (Africa CDC), H.E. Dr. Jean Kaseya….

The additional funding for the DRC complements the 215,000 doses of mpox vaccines donated by HERA to the Africa Centres for Disease Control and Prevention (Africa CDC) to address the current crisis across the African continent as well as the 365,000 doses of mpox vaccine donated by Team Europe.

“We are committed to tackle health crises and increase resilience together with the African partners. This is a joint mission to improve global health security. The additional funding of €20 million comes on to previous support and vaccine donations by the EU and its Member States.” — Jutta Urpilainen, EU Commissioner for International Partnerships

The funding announced today is part of a coordinated response by the EU towards strengthening the preparedness and response capacities for both current and future health emergencies in affected countries. Team Europe is a lead investor in global health initiatives such as the Pandemic Fund which is fast-tracking funds for enhanced laboratory capacity, surveillance and detection of the virus, and the training of emergency workforce for vaccinations.

The new funds will contribute to tackling both the current and future health emergencies in a coordinated intervention with partners such as the WHO and affected countries….

This is clearly a welcome step — but in Africa, both on Marburg and Mpox — and public health generally but (with prophylactic vaccine programs running decades behind)… much more work is needed. And much more funding, obviously.

[And equally obviously, the Powerline boys have nothing useful, or even interesting to say any longer… with Tangerine spending about 40 minutes… staring vacantly into space at his “town hall”, and bobbing his head — while classical arias blare at high-volume. The ancient reprobate coot has… completely lost it.]

As has Elon Musk — despite his chopsticks success over the weekend past. Onward.

नमस्ते

Onward, To… Europa — And A 2030 Series Of Sails, Around Lord Jupiter.

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At right is the “writ in water” multi-languages sound of the word for water tile, affixed to the body of the Clipper. Smile.

What a long, and commanded journey this will be: out to Mars, for a slingshot gravity assist, then back in a very close pass — to whip around Earth — for another gravity assist… then on to Europa, circa 2030. Here’s the NASA update, on it all:

…The largest spacecraft NASA ever built for a mission headed to another planet, Europa Clipper also is the first NASA mission dedicated to studying an ocean world beyond Earth. The spacecraft will travel 1.8 billion miles (2.9 billion kilometers) on a trajectory that will leverage the power of gravity assists, first to Mars in four months and then back to Earth for another gravity assist flyby in 2026. After it begins orbiting Jupiter in April 2030, the spacecraft will fly past Europa 49 times.

“Congratulations to our Europa Clipper team for beginning the first journey to an ocean world beyond Earth,” said NASA Administrator Bill Nelson. “NASA leads the world in exploration and discovery, and the Europa Clipper mission is no different. By exploring the unknown, Europa Clipper will help us better understand whether there is the potential for life not just within our solar system, but among the billions of moons and planets beyond our Sun.”

Approximately five minutes after liftoff, the rocket’s second stage fired up and the payload fairing, or the rocket’s nose cone, opened to reveal Europa Clipper. About an hour after launch, the spacecraft separated from the rocket. Ground controllers received a signal soon after, and two-way communication was established at 1:13 p.m. with NASA’s Deep Space Network facility in Canberra, Australia. Mission teams celebrated as initial telemetry reports showed Europa Clipper is in good health and operating as expected….

Now you know — and onward, as we have dusty snowflakes here, and some small hailstones (wind-chills of 35 degrees, already!) as I head over to get some taco-truck deliciousness. Heh. Nuthin’ gets in the way of that gravity-assisted… slingshot!

नमस्ते

[U] Take A Look — After [More Than] Ten Years… Still A Train-Wreck; All The Same Tired Old Schemes.

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We will be are now back, to explain, but see this 2013 backgrounder.

We were put in mind of this, because a long time reader was checking up on our older (2012-2014) predictions, as to specific stock bets, long and short, in the life sciences vertical.

This one in particular was pretty obvious to anyone who is versed in… the math of finance. Add to it, that the successive crews of management, and board seats… were mostly known for over-levering assets, in order to pay out what amounted to wasting dividends to private equity investors, and then often filing a chapter if all the rosy predictions didn’t turn out as planned. [And that is almost exactly what happened to Valeant — as it became Bausch Health.]

Here in 2024, nearly a full decade later, a renewed team is going to split the biz into a revamped B+L brand, and leave the lower margin businesses (in a remain-co, called “Health”)… to likely whither and die. You could look at the symbol “BHC” and read all the 2024 coverage on it. Or… you could just re-read anything I ever wrote here, about Brent Saunders and / or Fast Fred Hassan.

Same old; same old. Here’s the chart, for the record — now, more than a decade’s worth of “paths, diverging in the wood“:

…[T]he [Bausch Health company has endured a] shocking decline over three years. Indeed, the share price is down a whopping 72% in the last three years. So we’re relieved for long term holders to see a bit of uplift. The thing to think about is whether the business has really turned around.

Since Bausch Health Companies has shed US $136 million from its value in the past 7 days, let’s see if the longer term decline has been driven by the business’ economics….

[Confidential Hint Dept.: it hasn’t (as to the first) and it has been, as to the second. Cheers!] Onward.

नमस्ते

It Remains Immaterial To Rahway, But A Nice Validation For Exelixis’s Zanzalintinib Candidate — In Head and Neck, and Renal Cell Carcinomas…

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We had previously-mentioned Merck’s December 2023 FDA approval for Welireg®, in renal cell carcinoma patients.

Now, Welireg will be tried in combination with Exelixis’s Zanzalintinib candidate (in what amounts to a “supply agreement on steroids“, for Merck). The same sort of enhanced supply arrangement will obtain with Merck’s Keytruda® — which will be studied by Exelixis, in head and neck cancers with Zanzalintinib — for added progression free survival / efficacy. Here’s all of that good news, this afternoon:

…Exelixis and Merck announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor, or TKI, zanzalintinib with Merck’s anti-PD-1 therapy Keytruda in a phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma, or HNSCC, and zanzalintinib with Welireg, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor, in a phase 1/2 trial and two phase 3 pivotal trials for the treatment of patients with renal cell carcinoma, or RCC.

Under the terms of the collaboration, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase 3 STELLAR-305 pivotal trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC. In addition, Merck will sponsor a phase 1/2 trial and two phase 3 pivotal trials in RCC.

Merck will fund one of these phase 3 studies, and Exelixis will co-fund the phase 1/2 trial and the other phase 3 study, as well as supply zanzalintinib and cabozantinib. Exelixis maintains all global commercial and marketing rights to zanzalintinib….

Now you know — be excellent to one another. Onward. Ever, onward… toward Europa by the decade’s end. Smile.

नमस्ते

Tangerine-Fed Insanity: Over The Weekend, FEMA Workers In Rural North Carolina Received Threats From Armed “Militiamen”. Damn.

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There can be no doubt: this chaos is by design — it is exactly what Tangerine intends, by making completely false threats against hard working federal employees. He (insanely) believes that the more (he pretends) that the world is burning… the greater the chance he can slip in, as a purported. . . strong man.

This is… simply disgusting. We must vote him down, in a landslide — in a little over three weeks now.

Here’s the latest:

…On Saturday, FEMA workers had to halt their work in Rutherford County due to reports National Guard troops saw “armed militia” threatening the workers, CNN affiliate WBTV confirmed after reviewing messages sent to employees of a FEMA contractor. The threats were first reported by the Washington Post….

Some FEMA operations were also paused Sunday in Ashe County, near the borders of Tennessee and Virginia, out of an abundance of caution, Sheriff B. Phil Howell said on Facebook. This included in-person applications for aid in at least two locations “due to threats occurring in some counties,” according to the county’s emergency management office. Those locations reopened Monday, the sheriff and emergency management office announced.

Howell urged residents to “stay calm and steady during our recovery, help folks and please don’t stir the pot….”

Good advice, indeed — will the Tangerine dotard heed it? Don’t hold your breath. [And of course, the Powerline boys will never Rebuke him, for endangering his fellow Americans. Sheesh.]

Out.

नमस्ते

[U] “The IV Supplier To The World” Expects To Fully Recover From Helene By Year End 2024…

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And in the mean time, competitor B.Braun (in central Florida) has reported that Hurricane Milton didn’t do as serious damage as was feared, so it reopened IV manufacturing as of this past Friday.

Even so, it will be months yet that US clinics and hospitals are on “supply / order limits” — to stave off stock-outs. And source plants in the EU, Canada and even China will fly in pallets of bags to shortage-hit areas, under emergency FDA authorizations. Here’s that story from last week, mostly — at NPR:

…Flooding from Hurricane Helene in late September shut down the largest suppliers of IV fluids in the U.S, a factory in Marion, N.C., about 35 miles outside of Asheville. Owned by Baxter International, the plant made products like saline, sterile water for injection and other fluids that are crucial to the health care system.

Now, the company and government officials are trying to make sure existing shortages aren’t worsened by the natural disasters….

[T]he Food and Drug Administration announced it has authorized 19 IV products for temporary importation from Canada, China, Ireland and the U.K.

Baxter is limiting how much of its IV fluids customers like hospitals can buy to prevent hoarding and to try to ensure equitable access to the supply that is available. It’s also trying to increase manufacturing at its other facilities to bridge the gap….

Now you know — and last week, some elective surgeries were being postponed in Dallas for-profit hospitals, due to short supply — of IV sets. And… the Europa Clipper mission has reached a stable orbit.

More prosaically, the Buffs travel to face a tough Arizona team this weekend… onward!

नमस्ते

Update: Mpox Cases Have Now Appeared In Zimbabwe, As Well…

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Add another local African nation to the list of Mpox outbreak geographies here in Fall 2024. Zimbabwe now joins Zambia, DRC, Ghana, Central African Republic, and Nigeria — as nations inside Africa with more than one case.

And so, Zimbabwe faces a public health calamity — with one case in Harare, the capital — and one in the southern corner of the country, in Mberengwa. Here’s that news, via Reuters:

…Zimbabwe has confirmed its first two cases of mpox, the health ministry said on Sunday, without specifying which variant had been recorded.

The first case was detected in an 11-year-old boy who developed symptoms last month after travelling to South Africa, the statement said. The second case was in a 24-year-old man who fell ill after travelling to Tanzania, it said.

Both patients are recovering and contact tracing is underway, the statement said. The cases were in capital Harare and the southern town of Mberengwa….

Now you know… and it seems that a man with several fake passports and a few weapons was picked up this afternoon near a Tangerine rally (he’s a registered Republican and a podcaster about corruption — and his vehicle sports a homemade sovereign citizens movement-type plate). Whatever he was doing there… this is not the answer, folks. Out.

नमस्ते

Tangerine’s 2020 Campaign Settlement Counsel Will have To Appear — On November 20 — To Discuss Damages To Be Paid To Eddy Grant In Manhattan.

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Since summary judgment has already been granted — to the owners of the rights to “Electric Avenue” (which Tangerine stole in his 2020 campaign ads), the discussion will center on how much he must pay for that theft of intellectual property.

Flawless — and a high ranking officer from the 2020 Campaign (or if dissolved, as he has claimed — his current one)… must attend. Here is a bit from the three page order entered at the end of last week:

…No later than five (5) business days before the conference, counsel for each party must send the party’s Ex Parte Settlement Letter, marked “Confidential Material for Use Only at Settlement Conference” to [redacted] @nysd.uscourts.gov. This letter should not be sent to the other parties.

The letter should include, at a minimum, the information described in paragraph 3 of the Procedures. The parties should exchange their initial settlement demands and responses in advance of their Ex Parte Settlement Letter submissions.

The parties — not just the attorneys — must attend the settlement conference. Corporate parties, labor unions, and insurance companies (or any other party that is not a natural person) must send to the conference the person ultimately responsible for giving settlement authority. The parties have represented that party representatives with full settlement authority to participate….

Now you know — and Eddy certainly deserves this payday. He absolutely earned it. Onward.

नमस्ते

In Which Hinderaker… Insults NASA’s Science Teams. Sheesh.

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Hinderaker simps for Musk.

Y A W N.

In the process, he badly mis-states the last 20 years of NASA’s amazing missions. [Spoiler alert: and no surprise — Elon Musk supports Tangerine.]

He makes the preposterous claim that Musk is the only thing “going right” in the US space program.

It goes without saying that John’s opinion is woefully misinformed, and probably even malignantly so.

[Musk has had some success — but his Mars transport rocket is almost just a pipe dream — and a decade late.]

I guess John missed the helicopter missions on Mars, which had exactly zero to do with Elon.

He also forgets the JWST — discovering exoplanets, by the tens of thousands.

In sum, Hinderaker’s NASA knowledge seems to have ended — at about 1998.

What an outdated, irrelevant codger he’s become.

Out.