Thursday, April 27, 2017

Golden Lil' Cassini -- Now Beaming Silvery Torrents Of Data Back To JPL and NASA, From First Ring Plunge


Images very shortly -- and maybe a poem or two. [Gold loops at right represent current orbital series.]

But more immediately, here's the very good NASA news:

. . . .As it dove through the gap, Cassini came within about 1,900 miles (3,000 kilometers) of Saturn's cloud tops (where the air pressure is 1 bar -- comparable to the atmospheric pressure of Earth at sea level) and within about 200 miles (300 kilometers) of the innermost visible edge of the rings. . . .

"No spacecraft has ever been this close to Saturn before. We could only rely on predictions, based on our experience with Saturn's other rings, of what we thought this gap between the rings and Saturn would be like," said Cassini Project Manager Earl Maize of NASA's Jet Propulsion Laboratory in Pasadena, California. "I am delighted to report that Cassini shot through the gap just as we planned and has come out the other side in excellent shape."

The gap between the rings and the top of Saturn's atmosphere is about 1,500 miles (2,000 kilometers) wide. The best models for the region suggested that if there were ring particles in the area where Cassini crossed the ring plane, they would be tiny, on the scale of smoke particles. The spacecraft zipped through this region at speeds of about 77,000 mph (124,000 kph) relative to the planet, so small particles hitting a sensitive area could potentially have disabled the spacecraft. . . .


Grinning ear to ear -- at a [redacted] sac plat -- clearly elegant (but of course!). Lovely. . . Hah! [Forecasting Dept.: a likely blog outage, starting Friday early morning, through Monday late night -- off grid.] Keep it spinning in good karma, whilst I'm away, one and all. . . .



नमस्ते

As Legacy Schering-Plough's Vytorin® Goes Generic... We Will Re-Run The ENHANCE Study Delay Settlement


[Dateline: October 2014] The sad thing is that a competent Chairman and CEO -- any competent one -- would have saved this $688 million, and might have avoided having to merge into Merck (under significant duress), altogether. [And, over $116 million in plaintiffs' attorneys' fees as well. Perhaps double that, in defense fees. Ugh.]

So in a very real sense, this $688 million is being taken from the Merck shareholders' pockets (and their insurers), due to the acts and omissions of the ex-Schering-Plough top six executives (Hassan, Cox, Sabatino and Saunders, et al.), and board of directors -- relative to the delays in releasing the (Vytorin®) ENHANCE study results.

Here's a bit of the latest motion for a dispositive order, from Friday:

. . . .PLEASE TAKE NOTICE that on October 20, 2014, at 10:00 a.m. or as soon thereafter as counsel may be heard, the undersigned counsel for Lead Plaintiffs shall move before the Hon. Esther Salas, U.S.D.J. at the Martin Luther King Building & U.S. Courthouse, 50 Walnut Street, Newark, New Jersey 07101 for entry of the accompanying Order Approving Distribution Plan, which will, inter alia:

. . .direct the distribution of the Net Settlement Fund to Claimants whose Claims have been accepted as valid and approved by the Court, while maintaining a Reserve for any contingencies that may arise; (iii) direct that distribution checks state that the check must be cashed within 90 days after the issue date; (iv) direct that Authorized Claimants will forfeit all recovery from the Settlement if they fail to cash their distribution checks in a timely manner; (v) adopt the recommended plan for any funds remaining following the Initial Distribution; (vi) release claims related to the claims administration process; (vii) approve Epiq’s fees and expenses incurred from October 1, 2013 through May 31, 2014, and to be incurred in connection with the initial distribution of the Net Settlement Fund; (viii) authorize the destruction of Proofs of Claim and supporting documents after the second distribution of the Net Settlement Fund; and (ix) provide that the Court retains jurisdiction to consider any further applications concerning the administration of the Settlement, and such other and further relief as the Court deems appropriate. . . .


And so -- a previously very expensive, only marginally effective cholesterol management medicine falls into the hands of generic makers (Impax and Teva, to start with). To be sure, Kenilworth will be fine, as pembrolizumab will more than fill the hole this generic availability puts in the now-waning cholesterol management franchise. This is the end of the story of Fred Hassan's deceptions -- engineered with his team of sycophant executives (in my opinion). It feels good to be able to finally say "adios" to this narrative. So. . . adios.

In a few moments we will report on the signal acquisition, by NASA -- from Cassini's high gain dish -- a huge passel of millions of miles off, hurling past the ring-plane at about 77,000 miles an hour. . . . she will slip through the ring plane 20 more times, once each week now -- twisting gracefully, all the while. Data (hi-res pictures, and magnetic readings) are now in fact streaming down, like waterfalls, after a brief delay. . . and that is grin-worthy, indeed.

नमस्ते

Wednesday, April 26, 2017

[U -- Poetry] Cassini Has Plunged Through Saturn's Icy Ring Plane -- But Runs Silent, Until Early Tomorrow, Now...


A couple of hours ago (local time), after twisting with unwasted grace -- to face its large dish into the path of potential damage, much like a shield -- Cassini likely whizzed through a gap in the Saturnian rings, completely unscathed.

But because she is running silent, we won't know whether she hit a stray block of ice or rock (perhaps even just the size of an SUV), and was damaged or obliterated, until very late tonight. So we wait -- and hold our breath:

. . . .If all goes as planned:

-- 5 p.m. PDT (8 p.m. EDT) on April 25: Cassini is approaching Saturn over the planet’s northern hemisphere in advance of its first of 22 planned dives through the gap between the planet and its rings.

-- 1:34 a.m. PDT (4:34 a.m. EDT) on April 26: As it passes from north to south over Saturn, Cassini begins a 14-minute turn to point its high-gain antenna into the direction of oncoming ring particles. In this orientation, the antenna acts as a protective shield for Cassini’s instruments and engineering systems.

-- 2 a.m. PDT (5 a.m. EDT) on April 26: Cassini crosses the ring plane during its dive between the rings and Saturn. The spacecraft’s science instruments are collecting data, but Cassini is not in contact with Earth at this time.

-- No earlier than around midnight PDT on April 26 (3 a.m. EDT on April 27): Earth has its first opportunity to regain contact with Cassini as the giant, 230-foot (70-meter) Deep Space Network antenna at Goldstone, California, listens for the spacecraft’s radio signal.

-- Likely no earlier than 12:30 a.m. PDT (3:30 a.m. EDT) on April 27: Images are scheduled to become available from the spacecraft. . . .


While we wait -- we will gaze skyward, facing generally south; smile expectantly, and read appropriately relatable poetry -- sharing bits of that here -- with an edited image -- late in the day. Onward -- and, in honor of this shepherded moon-lette -- do today "dare mighty things", just as the Cassini team has, for over 13 years now.

नमस्ते

Tuesday, April 25, 2017

[U] And Now, 45's Unconstitutional Threat To Cut Off Funding To Sanctuary Cities... Is Toast -- Enjoined.


UPDATED -- 04.26.17 @ 9 AM EDT: Mr. Trump has tweeted (silly boy!) that the below-opinion (and the Ban 2.0 rulings) are "ridiculous" -- and smack of "judge shopping. . . ."

You read it here first: Mr. Trump will lose -- on his sanctuary city threats executive order, 9-0, in the United States Supreme Court. Not a single USSCT Justice will agree that he possesses the power to violate the Tenth Amendment -- which is exactly what he vainly tried to do, here. Condor doesn't just predict -- on this -- no, Condor flat out guarantees. . . 45 loses (again). [End, updated portion.]

I've not mentioned this piece of federal litigation here before, as it all seemed painfully obvious on its face -- but 45 was just officially handed another courtroom loss -- in his apparently unending quest, to be the least Constitutionally literate President. . . in our 240-plus years of history.

A nationwide preliminary injunction order, in the federal courthouse in San Francisco was just issued -- leaving 45 rather completely hamstrung, in trying to end funding to Chicago, New York, San Francisco, Denver, Seattle, Milwaukee and various other cities around the nation. See The New York Times -- here:

. . . .Judge William H. Orrick of United States District Court for the Northern District of California, issued a nationwide preliminary injunction against the administration, directing it to stop trying to cut off aid to sanctuary jurisdictions. But the order does not prevent the federal government from moving forward on designating certain places as “sanctuaries,” nor does it keep the administration from enforcing conditions for doling out federal money if they already exist, as the Justice Department has already begun to do with some law enforcement grants.

San Francisco and Santa Clara County, which had asked the judge for an injunction, “have a strong interest in avoiding unconstitutional federal enforcement and the significant budget uncertainty that has resulted from the Order’s broad and threatening language,” the judge wrote, referring to Mr. Trump’s January executive order on immigration. . . .


And, from the able Judge Orrick's opinion, then:

. . . .Although the Government’s new interpretation of the Order is not legally plausible, in effect it appears to put the parties in general agreement regarding the Order’s constitutional limitations. The Constitution vests the spending powers in Congress, not the President, so the Order cannot constitutionally place new conditions on federal funds. Further, the Tenth Amendment requires that conditions on federal funds be unambiguous and timely made; that they bear some relation to the funds at issue; and that the total financial incentive not be coercive. Federal funding that bears no meaningful relationship to immigration enforcement cannot be threatened merely because a jurisdiction chooses an immigration enforcement strategy of which the President disapproves. . . .

The Supreme Court has acknowledged that applying a narrow construction to an unconstitutionally overbroad statute does not address the confusion and potential deterrent effect caused by the language of the law itself. See, Erznoznik v. City of Jacksonville, 422 U.S. 205, 216 (1975) (concluding, in a First Amendment case, that a narrow construction of an overbroad statute was likely inappropriate because the “deterrent effect on legitimate expression is both real and substantial.”). As discussed below, the coercive effects of the Order’s broad language counsel against adopting a narrow construction that deprives it of any legal meaning. The Government’s construction is not reasonable. It requires a complete rewriting of the Order’s language and does not “save” any part of Section 9(a)’s legal effect. There is no doubt that Section 9(a), as written, changes the law. . . . [and thus fails]. . . .


Quite so. And so -- on some sunny Spring afternoons, it seems the entire Universe vibrates perfectly as one, in sublime synchronicity. This moment is one of those. Smile. . . . you know who you are. . . .

नमस्ते

In The "It Is Much Easier To LIE (On The Campaign Trail) -- Than To Lead (In The White House)" Department...


It scarcely bears mentioning that 45's latest bluster on doing something -- anything -- about health care delivery is. . . D.O.A.

The Washington Post gets it quite right here, this morning -- so just go read it:

. . . .[O]ne of the proposals that’s moved to the center of the conservative focus on reforming Obamacare — removing the mandate that preexisting conditions be covered — is opposed by majorities across the political spectrum. Even a majority of Trump voters think that there should be a national standard to protect preexisting conditions. . . .


Unlike all those I care about, this whole ball of wax is decidedly. . . DOA. Onward on a perfect sunny Tuesday, with not a worry, or care -- on this green Earth. Or at least that's how the whole rest of the Earth will see. . . me -- because I get to decide that. . . for me. . . .

नमस्ते

Monday, April 24, 2017

In What Is Likely A First, CSPAN-TV Will Broadcast Ninth Circuit Hearing On "Ban 2.0" LIVE, On May 15, 2017


UPDATED -- 04.27.2017 @ 7 PM EDT: The Fourth Circuit has entered an order allowing an audio only feed, allotted to CSPAN, in real time -- on May 8, for that oral argument -- and the court will post an audio archive on its website, late that day. That's good news, for transparency -- but it still puts the Ninth Circuit in the position, one week later, of having the only video-broadcast of the Muslim Ban 2.0 arguments, I think. Fascinating. It seems CSPAN only applied for an audio feed, in the Fourth Circuit -- but I do not see a local rule prohibiting video, in the Fourth. Onward to that day, then. End, updated portion.

It is (I think) wise to allow the people of this great nation to see how their system of checks and balances functions, in their name.

But it is a rare thing, indeed, to see the inside of a federal appellate courtroom, LIVE, in real time, in session -- on television. However, that is just exactly what's on tap for May 15, in the Ninth Circuit, in Seattle. Excellent -- per the court's order, tonight:

. . . .C-Span applied to broadcast live, the case captioned above, scheduled to be heard at The William K. Nakamura Courthouse in Seattle, WA on Monday, May 15, 2017. C-Span’s request to broadcast live is GRANTED.

C-Span will serve as the pool-feed for all media organizations that submit an application. . . .


That is wonderful, truly -- I am smiling ear to ear, here. But, in darker doings, do see the masthead -- I couldn't make this sort of Don-foolery up -- if I tried. As of 10 PM EDT, the Trump Administration had removed the ad for his golf club from the Department of State website. Like many a person completely unaware of how others see them, I guess. . . but very nauseating -- just the same. . . . G'night.

नमस्ते

In What Might Be Thought Of As A "Nuisance Value" Patent Payment...


. . .over the weekend, Kenilworth apparently agreed to pay a waifish one time amount to a patent estate managing bio-science company with its HQ in Incline Village, Nevada. [That tells you something. Grin.]

The fact that it is less than $20 million, paid once only, and grants Merck perpetual freedom from nonsense value suits filed against pembrolizumab patents, tells us much about the context, here. Merck would spend that much, in all likelihood, should a trial and appeal occur -- so all Merck has done here is avoid paying more legal fees, by simply and cheaply buying peace with the so-called Queen patent-holder (which PDL apparently itself acquired from a third party). From Yahoo! News:

. . . .Under the terms of the agreement, Merck will pay the Company a one time, lump-sum payment of $19.5 million, and the Company will grant Merck a fully paid-up, royalty free, non-exclusive license to certain of the Company's Queen et al. patent rights for use in connection with Keytruda as well as a covenant not to sue Merck for any royalties regarding Keytruda. In addition, the parties agreed to dismiss all claims in the relevant legal proceedings. . . .


So Kenilworth made one payment of something well-shy of one half of one per cent of its likely 2017 sales of this product -- to close PDL out. And with that, we are back at full-speed! Baby-Face grinning, on a sunny Monday. . . . Onward!

UPDATED: Signal acquired. Smile. Now you know -- sunny and crisp here -- still awaiting signal acquisition from Cassini, after her bend around Titan for the final time -- yes, that lil' "shepherd moon-lette" I've grown so fond of. Smile.


नमस्ते

Sunday, April 23, 2017

Update: The Ninth Circuit Is Once Again Back To A Three Judge Panel, On 45's Muslim Ban 2.0


This order was entered while I was in the air on Friday.

It restores the Ninth Circuit's clear timing advantage, in getting an opinion out first. And I for one believe the Ninth will preserve the nationwide injunction against the Ban 2.0. The order, then:

. . . .The full court was advised of the petition for initial hearing en banc. A judge requested a vote on whether to hear the matter en banc before the limited en banc court. Another judge requested a vote on whether to hear the matter en banc before the full court. The matter failed to receive a majority of the votes of the nonrecused active judges in favor of initial en banc consideration. Fed. R. App. P. 35. Therefore, initial en banc proceedings are concluded, and all remaining issues will be decided by the three-judge panel. . . .


Now you know. G'night to all of good will.

नमस्ते

While I Was Away... News On Samsung/Merck; And J&J Remicade® Connections...


We have been following this specific arc of narrative for just over four years now (and the more general S-P Remicade® choke, for going on eight). Whilst we were off grid, our buddy John Carroll very-ably picked up the slack. Do go read all of his, from Friday, past. It is spot-on.

Even so, there is more history to be re-told here. As they say, one's history is defined by the narrator, after the fact. [We hinted at some of this when we discussed J&J results, last week.]

In this case, the story (in our opinion) starts with less than careful lawyering by the then-GC at legacy Schering-Plough. And it devolves into a multi-billion dollar arbitration with J&J -- in the settlement of which, Merck is required to surrender the US rights to Remicade®, to its opponent -- J&J. So, when John closes below by saying that Merck will compete in the US against the branded version, while selling its new biosimilar with collaborator Samsung Bioepis -- that leaves unsaid WHY that odd state of affairs now exists (with Merck still selling the branded version in Europe). It exists, in my opinion, due to a far too cute attempt to skirt a plainly enforceable contractual provision (which favored J&J/Centocor) -- by the lawyers who (last-minute) tried to engineer a more-favorable sale -- of legacy Schering Plough -- to Merck, in late 2009/early 2010.

. . . .The FDA has approved a new knockoff of J&J’s top earning drug Remicade, which may finally start to shift the market dynamics toward greater competition with lower prices.

This new one is dubbed Renflexis and comes from Samsung Bioepis, one of the big players in the biosimilars field. And it arrives in the US market close to a year after the EMA approved it for Europe.

J&J’s Remicade earned close to $7 billion last year, making this by far its biggest drug in the portfolio. And as J&J noted a few days ago during its Q1 call with analysts, the pharma giant has yet to feel much of an impact from the first Remicade biosimilar from Pfizer, Inflectra (infliximab-dyyb), which was developed by Celltrion and then bagged by the pharma giant in its acquisition of Hospira. That was approved last fall.

Now Merck will pick up the commercialization work of this second knockoff as J&J enters a new stage in defending the huge franchise. Ironically, Merck will now market Remicade in Europe, while competing with it in the US. . . .


But if you're a regular reader, here -- you already well-knew that the irony mentioned above was born in the feverish opium den of drug and biologic non-discovery that was Fred Hassan's version of Schering-Plough. . . smile.

And so, as we slip into the easy chair in our city-flat, on another languid, clear Sunday night -- we will observe that this all unfolded, just as we had predicted -- in 2010, 2013, 2014 and 2015. Grin-worthy. Onward. . . as we "wait for sleep to find us" -- but tonight, we'll not need to wait very long, at all [as sometimes it feels like we "write like we are running out of time," indeed].

नमस्ते

Thursday, April 20, 2017

As I Head Off-Grid -- For A Long Weekend, Of "Unwasted Grace"...


This evening, I will note the sublime synchronicity here -- gossamer-like, and gracefully twisting, the dark-amber, almost cinnamon hued Cassini (at least as seen by these eyes, in the perpetual half-light that is Saturn, and her moons). . . will this weekend make her final close fly-by of the haze-shrouded big moon Titan.

[It seems I too will make a derivative-equations-laced version, of such a final fly-by, within hours of that time -- but in our own southern states.] This has put me in mind of ways to best handle things that come naturally, but sweetly. . . to their ends. As all good things. . . do.

So as we often are wont, on such occasions, we will offer some poetry, welded to an image of that moment [click it to enlarge] -- and a solid space science video, after the NASA pull-quote. Do enjoy, the wonder here offered:

. . . .NASA's Cassini spacecraft will make its final close flyby of Saturn's haze-enshrouded moon Titan this weekend. The flyby marks the mission's final opportunity for up-close observations of the lakes and seas of liquid hydrocarbons that spread across the moon's northern polar region, and the last chance to use its powerful radar to pierce the haze and make detailed images of the surface.

Closest approach to Titan is planned for 11:08 p.m. PDT on April 21 (2:08 a.m. EDT April 22). During the encounter, Cassini will pass as close as 608 miles (979 kilometers) above Titan's surface at a speed of about 13,000 mph (21,000 kph).

The flyby is also the gateway to Cassini's Grand Finale -- a final set of 22 orbits that pass between the planet and its rings, ending with a plunge into Saturn on Sept. 15 that will end the mission. During the close pass on April 21, Titan's gravity will bend Cassini's orbit around Saturn, shrinking it slightly, so that instead of passing just outside the rings, the spacecraft will begin its finale dives which pass just inside the rings. . . .




So do treat each other well, whilst I'm twisting around Alabama -- for if you do not, I will know of it, via astro-dynamics -- and come visit, as a shipwreck -- amongst those shepherded orbital ellipses -- smile. . . . [Oh. And, my -- did those 'Hawks looked awful, tonight. Congrats to Nashville. Next year. Next year. . . .]

नमस्ते

Another Excellent Brief -- By Amici -- In The Ninth Circuit, Tonight...


This time, the amicus brief is authored by a coalition of the most esteemed Constitutional law professors our nation has to offer. So, I'd trust their views.

And this time, a great bit of scholarly attention is paid (in a 43 page PDF) to the Free Exercise and Establishment Clauses of the First Amendment -- and long standing precedents there under. As you might imagine, Mr. Trump's twin (but serial) Muslim banning orders flunk every imaginable test -- and so, the Framers' whose views are recounted here, and the language the amici use to convey the same is. . . towering, in its command of our system of ordered liberties (as this case is almost -- but only almost -- without precedent):

. . . .The bill against which James Madison famously remonstrated has been consigned to the dustbin of history. But the underlying evils against which Madison warned are still with us. This case does not present them in disguise. No, “this wolf comes. . . as a wolf.” Morrison v. Olson, 487 U.S. 654, 699 (1988) (Scalia, J., dissenting). President Trump repeatedly and ostentatiously expressed the animus that brought it forth in his calls, and subsequent acts, to ban persons of a single faith from entering the United States. For liberty to endure, the Order must be rejected. . . .

The Framers thus understood that their task was to design a “government for a pluralistic nation — a country in which people of different faiths had to live together.” Jon Meacham, American Gospel: God, the Founding Fathers, and the Making of a Nation 101 (2006). As George Washington wrote, “the government of the United States. . . gives to [religious] bigotry no sanction, to persecution no assistance.” Letter from George Washington to the Jews (Aug. 18, 1790). . . .

Thomas Jefferson, in turn, saw the Establishment Clause as “proof that [the people] meant to comprehend, within the mantle of [the law’s] protection, the Jew and the Gentile, the Christian and Mahometan, the Hindoo. . . [and] every denomination.” Thomas Jefferson, Writings 40 (Merrill D. Peterson ed., Library of Am. 1984). . . .

Even acknowledging the deference due to the President in matters of immigration and national security, it is hard to imagine a clearer case of governmental action motivated by animus toward a single religion. . . .

[A]s a matter of law, the Supreme Court has never suggested that statements in some fora — such as campaigns — are uniquely irrelevant to motive analysis. To the contrary, courts must consider “the historical background of the decision under challenge, the specific series of events leading to the enactment or official policy in question, and the legislative or administrative history, including contemporaneous statements made by members of the decisionmaking body.” Lukumi, 508 U.S. at 540 (opinion of Kennedy, J.) (citing Arlington Heights, 429 U.S. at 266). That reflects simple common sense: “[T]he world is not made brand new every morning.” McCreary, 545 U.S. at 866. . . .


[Now, as to that last bolded bit -- in other contexts, I do so wish. . . that it were.] But so it goes -- we try anew, tomorrow. And. . . a reckoning soon arrives -- on swift and dark wings, indeed. That much is now a certainty -- so I will smile -- and smile widely, tonight. . . . Word.

नमस्ते

Merck Adds Another $300,000 In Cash -- To Neglected Disease Eradication -- In Africa...


The total will rise to $600,000, as it is a matching grant -- for anyone else who decides to chip in [that's a hint, Mr. Reed. . . grin]. And the World Health Organization has set an aspirational goal of eradicating this scourge, and many others, throughout Africa -- by 2020. This latest cash commitment is in addition to some 2.5 billion doses of free medicines.

This underscores our post of Monday -- and reminds the world of Kenilworth's almost solitary original role (since the late 1980s -- later picked up by GSK and others) in ending river blindness, in Africa. This is the highest and most noble calling -- of stewardship, at a life science company blessed with the resources Merck enjoys. [In fact, in October of 2015, a former Merck scientist did win a Nobel for this work.] Kudos, Mr. Frazier -- and a bit:

. . . .Merck announced today a $300,000 cash donation to support non-governmental organization (NGO) partners working to eliminate river blindness (onchocerciasis) and lymphatic filariasis (LF) in Africa. The donation will be offered to 10 NGOs beginning this year, and will be administered through the MECTIZAN® Donation Program (MDP), a public/private partnership established in 1987 following the announcement by Merck to donate MECTIZAN® to control and eliminate river blindness.

River blindness and LF are targeted for elimination in the World Health Organization’s (WHO) Roadmap on Neglected Tropical Diseases (NTDs), and NGOs have long played a critical role in the broad partnership focused on achieving those targets. Grants will be given to support activities focused on the elimination of river blindness or LF, and will be offered to our partner NGOs who are directly involved in the distribution of MECTIZAN®. Eligible NGOs will be able to request funds through an application process in which they will be required to secure a 50-50 matching grant, effectively doubling the resources to $600,000. . . .


Now you know. And now with feelings of a sweet reckoning abounding -- and copper colored satellites once again twisting gracefully overhead -- I cannot stop smiling. Word. . . .

नमस्ते

Wednesday, April 19, 2017

Q1 2017 Forecasting: Will Merck's Sales Lines Look Light, Again -- As J&J's Just Did?


As is often the case, we take a moderate amount of "Kentucky windage" -- on Kenilworth's prospects -- by looking at other similar large cap mulinational life science companies. One of those would be J&J. And J&J this past quarter saw the first truly pronounced full-quarter's effect -- of biosimilars to, and Pfizer's branded alternative for, infliximab on market, post-launch. But sales were soft in several of its traditional pharma strongholds -- including the diabetes space. And that might be worrisome for Merck.

[J&J is also in devices, while Merck is not -- but that isn't comforting for followers of Merck, since J&J's growth in devices was reasonably robust -- and Merck doesn't offer any entrant, in any device segment.]

While we ought not get ahead of ourselves, I would expect only modest constant currency growth in most of Merck's franchises -- with Keytruda® as the stand out growth franchise -- on both volume and price. J&J has no such flagship oncology product, so overall we remain sanguine for an in-line quarter at Merck. The company reports nearer month's end.

It is also true that both J&J and Merck have now seen a full quarter's effect of more aggressive price negotiating at US formularies by insurers (and similar toughness -- by government payers in the UK and EU). In any event, here is Morningstar's take on J&J latest results:

. . . .J&J reported first-quarter results largely in line with our expectations, and we don’t expect any major changes to our $108 fair value estimate. We continue to view the stock as slightly overvalued as the growth prospects for the company’s divisions don’t appear strong enough to support the current market price. . . .


Backgronders here, on infliximab going bio-similar (from October 2015), and the overall arbitration fight, from 2010 -- triggered by poor deal lawyering, at legacy Schering-Plough. Now you know. Onward -- toward the University of Alabama campus.

नमस्ते

Tuesday, April 18, 2017

Meanwhile -- Out West, In The Ninth Circuit -- Another Muscular Amicus Brief Was Filed, This Afternoon...


This amicus brief was filed just today, by the MacArthur Justice Foundation. It -- as much as any of the others -- has buried 45's chances, on appeal, in my estimation.

In my view, an unflinchingly accurate and impolite recitation of the facts -- in this case, will all but compel the result (a complete loss for 45's Ban 2.0), sua sponte. . . even at the Supremes.

Here is just a bit -- but do go read all 33 pages:

. . . .This President of the United States, Donald Trump, selected an unpopular minority faith that makes up 1% of the nation’s population, ran a campaign that vilified and spread propaganda about that minority faith, and built an administration that has repeatedly equated the members of that faith with terrorists. He now expects the Court to turn a blind eye to that record of animus and, instead, accept the Government’s pretextual assertion of national security. . . .

That would be a serious abdication of the Court’s critical role in safeguarding discrete and insular minorities, and in preventing the use of Executive power to attack unpopular groups — the sort of abdication that has, in the past, left a permanent stain on American history [Ed. Note: the reference to Korematsu here is crystal clear -- a U.S.S.Ct. case that belatedly stands for exactly the opposite of its original holding -- against just these sorts of general and bigoted actions]. . . .

As early as April 11, 2011, Mr. Trump began advocating that a “Muslim problem” exists in the U.S., and suggesting that Islam teaches a “very negative vibe” and “tremendous hatred.” He recounted: "Bill O’Reilly asked me is there a Muslim problem? And I said absolutely, yes. In fact I went a step further. I said I didn’t see Swedish people knocking down the World Trade Center. . . . I mean I could have said, ‘Oh absolutely not Bill, there’s no Muslim problem, everything is wonderful, just forget about the World Trade Center.’ But you have to speak the truth. . . . The Koran is very interesting. . . . I’m certainly not an expert, to put it mildly. But there’s something there that teaches some very negative vibe. . . . there’s tremendous hatred out there that I’ve never seen anything like it. . . ." [Ed. Note: Except of course whenever 45 himself. . . speaks, on the topic.]

[And again -- Mr. Trump, speaking in December 2015 about then-President Barack Obama, with a questioner]. . . .

"Questioner: “We have a problem in this country. It’s called Muslims.”

Mr. Trump: “Right.”

Questioner: “You know our current president [Mr. Obama] is one. You know he’s not even an American.”

Mr. Trump: “We need this question.”

The President has adhered to his view that people of the Muslim faith are a “problem” and vilified them on numerous other occasions. . . .

On November 22, 2015 [Mr. Trump] stated: “There were people that were cheering on the other side of New Jersey, where you have large Arab populations. They were cheering as the World Trade Center came down. . . there were people cheering as that building came down—as those buildings came down. And that tells you something . . . . There were people over in New Jersey that were watching it, a heavy Arab population, that were cheering as the buildings came down. Not good. . . . [Ed. Note: this Trump assertion is universally known to be a complete lie.]


This man (along with others) must be brought to heel -- like the unruly animal he clearly but vainly tries to be.

I'm taking a bit of time to enjoy a flawless afternoon in the sun, and express gratitude, to our founders for leaving us a very solid means to protect ourselves from animals like him. It is called judicial review -- and I for one like the taste of it. I no longer want to taste lies, spit into my own mouth. Out.

नमस्ते

WHO: With Aid From GSK And Merck, Togo Becomes First Nation In Africa To End Lymphatic Filariasis as a Public Health Problem


After over 10 billion doses of a pair of medicines -- essentially all donated by charitable arms affiliated with the two multinationals, over almost two decades -- Togo has eliminated both elephantiasis and river blindness, as public health concerns, in the country.

The WHO has certified Togo as the first African nation to reach this milestone. Here's a bit -- and to be certain, Kenilworth should rightfully be lauded for this (as should GSK):

. . . ."We celebrate this important achievement with the people of Togo. Lymphatic filariasis is a debilitating, but preventable, disease that not only affects patients and their families but also communities and health care systems,” said Dr. Julie L. Gerberding, Merck’s chief patient officer. “Working with our partners for nearly two decades, we strive to eliminate LF in Africa and Yemen to help improve the lives of tens of millions of people.”

Phil Thomson, president of Global Affairs, GSK said “Achieving elimination of LF is a fantastic achievement for Togo and is testament to the commitment of the Togolese Government and the dedication of the health workers delivering treatments on the front line. We are committed to playing our part with the donation of albendazole for as long as it is needed to replicate this success throughout endemic countries, freeing communities from the burden of LF.”

The MDP’s director, Dr. Yao Sodahlon, is a Togolese national and expert in tropical diseases who worked closely over the years with the ministry of health and other partners to ensure Togo’s success. . . .


This is a story not told often enough, about the morally just contributions of many life sciences companies -- to "the humbled, the lowly -- the least able to pay -- of our brothers and sisters. . ." (to refer to Luke 10:30-37, as Pentecost looms). . . But brothers and sisters. . . all of us, are -- just the same. Now you know. Onward -- with a fiercely independent smile.

नमस्ते

Monday, April 17, 2017

Op Ed: I Don't Think An RA/QA Expert Is A "Must Have" -- At Merck's Board Of Director Level...


I debated with myself, about whether to even mention this, when the proxy filed last week. I chose not to, back then. . . .

But just this morning, the shareholder proponent of a proxy proposal (called Trillium) filed so-called "free writing" solicitation material, ostensibly to answer the company's suggestion that the proponent's proposal isn't worthy of the shareholders' affirmative vote. [NOTE: This post is not intended as proxy soliciting material, of any stripe -- and this blog is affiliated with no one on either side of this debate -- this is merely business journalist commentary and legal analysis, of the issues involved. Merck's position on the matter may be found here (at page 78).]

In essence, the shareholder proponent would like a report, on how best to "strengthen" Merck's QA/RA chops -- at the full board level. From Trillium's SEC filing:
. . . .[Please] issue a report (at reasonable cost, in a reasonable time and excluding confidential information) evaluating the merits and feasibility of Merck (1) strengthening Board expertise in pharmaceutical manufacturing and product quality and safety, (2) adopting an independent board chair leadership structure, and (3) any other related governance improvements the Board wishes to consider. . . .


Aside from the language problems I see with the proposal (that arguably make it inappropriate, under existing SEC rules and releases and no action letters, as a subject for advisory vote by shareholders), I am convinced that the proponent's premise is ill-founded. [And it matters quite a bit that at none of the companies Trillium mentions, is the Chairman and CEO also a lawyer -- Merck's is, and (based on my eight years of close observation) he sets a very appropriate regulatory focus, "at the top."]

That is, I think even though some other multinational public pharmaceutical and life science companies have QA/RA experts at the board level -- it doesn't strike me that such a person is a requirement for effective corporate governance, at Merck -- given its Chairman/CEO's legal background.

True enough, a strong QA/RA function is an absolute requirement for any large pharmaceutical concern, but that is largely an operations and management function (i.e., well below board level). And Merck's is robust, in my independent estimation. Kenilworth may make various mistakes, from time to time. . . but this -- RA/QA -- is one of their long suits, in my view.

If Merck had seven 483s pending right now (it does not), or the FDA shutting down its facilities left and right (nope), then "tone at the top" would be a very important priority -- even reaching into the board room. That may have been the old legacy Schering-Plough problem (i.e., pre-2010) -- but that is clearly not the profile of New Merck.

So. . . were I a shareholder (I am not), I'd vote no on the Trillium proposal.

Now you know. Onward. [I welcome a reply, from Trillium, in comments. I will run it -- as a new post. But note to Trillium: yours will also be "free-writing" material, so do comply with SEC rules. I will run all that you need to do so, should you choose to respond.]

नमस्ते

An Excellent Fourth Circuit Brief, Filed Over The Long Holiday Weekend...


Do go read it all (a 67 page PDF file) -- but it is no longer even remotely clear to me that the Fourth Circuit will rule in 45's favor.

In fact, it is increasingly likely that the Trump Administration's appeal to the Supremes will come on the heels of both the Fourth (unexpected) -- and Ninth (widely expected) -- Circuits ruling against the Constitutionality his Muslim Ban 2.0.

. . . .The facts of this case are extraordinary. President Trump publicly committed himself to an indefensible goal: banning Muslims from coming to the United States.

The President refused to repudiate that goal on multiple occasions, including after he was elected, and he continues to advertise it to this day on his own website. . . .

The President also explained how he would implement his impermissible goal:

Because people objected when he used “the word Muslim,” he announced, he would instead be “talking territory, not Muslim.”

He followed through on this promise in an Executive Order signed one week after inauguration, and prepared with no input from the relevant federal agencies. . . .

The government has never contested that the extraordinary record in this case, taken in full, establishes that the President adopted the Order with the primary purpose of targeting Muslims. . . . Nor has it ever argued that the government could ban people because of their religion consistent with the commands of the Establishment Clause. . . .


Now you know. Late this week, I'll fly down south, and drive into rural Alabama, for the collegiate Nationals (triathalon); then Mississippi the following weekend. . . smile.

नमस्ते

Large Genome Study: 2014-2016 West African Ebola Epidemic Traveled (Mostly) By "Short Hops"...


From late 2013 to 2016, for the first time in the history of infectious diseases -- and in an Ebola outbreak (actually, in any real viral epidemic of size) -- a vast (near universal) sampling of the blood, and thus the genomes, of infected patients took place. . . .

As the University of Minnesota's CIDRAP reported last week, this in turn led to a treasure trove of data, about how and where, and when the virus was transmitted, and mutated. Do go read it all -- but the learning is that the virus traversed only small geographic distances, in the main. It was spread by very local communities of contact, as a general rule (with urban centers being an exception). Do go read it all, as another study is also detailed there, at CIDRAP:

. . . .The largest genome sample ever analyzed for a human epidemic reveals that the West Africa epidemic unfolded with small, overlapping outbreaks as the virus spread over short distances and that urban settings amplified the spread. . . .

Meanwhile, another study harnessed different advanced scientific tools in the blood of a single sick patient to detail gene-level response during infection. . . .


Now you know -- breakfast at the train station diner, with my graduating senior -- then a walk to the office, on a flawless Easter Monday. Smile. . . be well, one and all. The Universe will sing midnight black rain-songs, tonight, for certain. . . .

नमस्ते

Saturday, April 15, 2017

This Past Week, Several Large Terrestrial Radio Telescopes Cooperated -- To "Image" A Black Hole's Event Horizon...


Using a virtual radio scope, essentially the size of the Earth itself (a half-dozen radio dishes, spanning the globe, were lashed to one another, by software links) -- the idea was to capture a non-visible light "image" of the black hole (and its event horizon) at the center of our own galaxy.

It seems that effort has succeeded. Late in 2017, we will see a representation at least -- of the most lonely of places -- a place from which no light, no heat  -- and no soft, lilting voices ever escape -- an event horizon. Where time itself. . . stops. [It will take weeks to process the data, into an image.]

Until we have that image -- transformed into visible wave-lengths -- for our human eyes to decipher. . . I will leave you with this, at right.

And. . . as I write this down, I know that any amount of  feeling alone is merely a matter of relative degrees -- it dawns on me that we are (as I've modified Taylor) -- simply raindrops on the midnight pavement of stars. . . . among hundreds of billions, in this local cluster alone.


Or as Milton wrote -- we look up, into a Milky Way, "powdered with stars. . . ." powdered with. . . in all likelihood, billions more of. . . us.


Humbling indeed, in her glistening, crinkled space near-eternity. . . [as she increments -- by two. Smile.]

Be well, one and all.



नमस्ते

Friday, April 14, 2017

Without Any Ado, At All -- Or Any Explanation... I Give You... Kim Jon Shkreli!


I genuinely cannot tell if the Facebook user who photo-shopped this (click at right, to enlarge) intended it as deflating satire, or loving homage (as to either character) -- and I don't. . . care. Fair use -- for editorial comment -- is claimed by this site.

My comment is. . . damn.

Just. . . damn.

Enjoy one and all -- that's an (early) Easter goodie!

[Apparently Mr. Shkreli has been trolling undergrad meme boards at the University of Chicago, in Hyde Park -- this week. I am certain he is unaware just how. . . sad that seems to most of the sentient world. Hanging out with undergrads, as he approaches 1-1/2 times their age -- since (obviously) he had no comparable experience, at that point in his life. Speaks to a deep hole, in his soul. . . .]

All grins, here now. . . Nothing to be. . . serious about! नमस्ते