Friday, May 18, 2018

[U] We Await Word, Now -- On Whether WHO Has Declared 2018 DRC Ebola Outbreak "Of International Concern"...


The WHO body responsible for making the determination -- as to whether the outbreak should be upgraded from a "regional" concern, to an international one -- based on the two cases inside the riverport city of Mbandaka. . . is meeting as I type this.

We should know in a few hours. An upgrade would release additional NGO and EU funding -- but the US is largely on the sidelines on this one (either way), due to Mr. Trump's early 2018 cuts at CDC (for international pandemic responses) and last week's singularly ill-timed cuts to Ebola aid, generally (eliminated $250 million).

Even so -- we will remain hopeful -- that the vaccine is now quickly, and widely, deployed -- in the riverport city of over a million souls. Onward, on a clear cool Friday. . . let's be better to one another. . . than our president is. Much better.

UPDATED: at days end, the WHO officials have decided (for now) they will not escalate the 2018 Congo outbreak's designation, as it hasn't crossed a geopolitical border as yet.

नमस्ते

Thursday, May 17, 2018

Nuvaring® MDL Close-Out Mechanics -- Status Call In Federal Court In Missouri Underway Now....


Slowly. . . but surely, this $100 million settlement is winding its way down.

Here is the complete agenda as a three page PDF, and a bit:

. . . .1. Next group of cases for remand.

2. Anticipated motions to dismiss by Defendants for certain pending cases in which Plaintiffs have not provided discovery.

3. Plaintiffs’ request for updated Periodic Adverse Drug Experience Reports submitted to the FDA. . . .


Of these, Item 3 is potentially the most interesting, depending on what might be disclosed, in those subsequent adverse event reports, to date in 2018. Now you know.

Off to the food trucks -- under sunny skies: lobster rolls and tomato bisque with cilantro for lunch now! [All with beautiful, twisting copper-torso visions -- of exactly four years ago, this week. . . and a "Divergent" Wednesday matinee -- complete with changing room antics -- pulsing through my mind, and soul. . . smile.]

नमस्ते

[U] Significantly Disconcerting Ebola News, Out Of Mbandaka, DRC: One New Viral Case, Inside A City Of 1.2 Million People


UPDATED @ 2 PM EDT -- in one rather hopeful sign here over lunch, the NYT is reporting this afternoon that the two cases inside the city are a pair of brothers who earlier attened a funeral in Bikoro -- thus making it likely that this is all one transmission chain, out of Bikoro, and not a separate (previously undetected line) originating inside the city of 1.2 million -- a city that is a river-port and transportation hub. That is good news. Still, this all could rapidly become an international pandemic, if every contact of every contact is not ring-vaccinated essentially immediately. [End, updated portion.]

This is not intended to unduly alarm people, but thus far -- in the main -- ebola outbreaks have been confined to remote rural areas, and small villages.

This May 2018 DRC outbreak may be regarded, as we look back some years from now, as a "game changer" -- in the words of Dr. Peter Salama, a WHO official presently leading the emergency response efforts.

You see, there is now a confirmed case of Ebola -- the highly contagious, ruthlessly lethal virus (more than half of those who contract it will die of it) -- inside a Congolese riverport city of over 1.2 million people. From the WHO update, of earlier this morning, local time:

. . . .One new case of Ebola virus disease (EVD) has been confirmed in Wangata, one of the three health zones of Mbandaka, a city of nearly 1.2 million people in Equateur Province in northwestern Democratic Republic of the Congo. . . .

"This is a concerning development, but we now have better tools than ever before to combat Ebola," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “WHO and our partners are taking decisive action to stop further spread of the virus. . . ."


It is true that WHO (thanks in no small part to the efforts of Merck, NewLink and the Public Health Agency of Canada governmental research labs) is in a much better state of preparedness.

Specifically, we do have Merck's rVSVΔG-ZEBOV-GP vaccine stock available, at the ready for overnight flight shipping -- but this could get seriously out of hand -- and quite rapidly so. Keep a good thought -- that Trump's karmic deficits don't cause significant loss of life, and any more suffering inside Mbandaka, Wangata, DRC. Onward, now. . . on, to the morning trains.

नमस्ते

Wednesday, May 16, 2018

Status Update, On Propecia®/Proscar® Settlement Next Week; Final Dismissal Lists By August 15, 2018


Our latest copper colored, fleet-of-foot visitor has twisted by -- orbit bent, only slightly -- and completely harmlessly so, overnight. So. . . it is back to regular fare, here.

By next Tuesday, we should know how much progress has been made on the finasteride MDL/MCL settlement mechanics, by way of a jointly-filed letter update, from the two sides' legal teams. [My recent backgrounder on the settlement may be found, here.]

The below is the full text of the able judge's overnight order:

. . . .The parties are to provide a joint update by 5/22/2018 describing the progress of the Settlement Program and confirming that they will advise the Court by 8/15/2018 which claims can be dismissed.

Ordered by Judge Brian M. Cogan on 5/15/2018. . . .


Now you know. And. . . onward, on an otherwise fine morning -- but one that sees Trump for the unsophisticated, primitively-naive rube (ignorant of history) he is -- now being easily manipulated for the world to watch, by a North Korean crackpot dictator (and to a lesser extent, by his son-in-law, in carving up the Kushner family spoils, from the move to Jerusalem). Once again, like the ZTE-China-Indonesia Trump Resort deal -- clearly, corrupt emoluments are. . . in process. Sad!

More hopefully, though -- I might add that after listening to the full audio feed of the Ninth Circuit's DACA II oral arguments late last night, I am increasingly comfortable that 45's attempt to pull the rug out from under young people who relied to their detriment on it. . . will fail. Onward, then -- as a new day opens, before us -- full of possibilities.

नमस्ते

Tuesday, May 15, 2018

[U] Some Lighter Fare: Interstellar Space Science -- And... Another "Sorta' Close Shave", This Evening?


At around 6 PM EDT this evening, a football field sized rock will whiz by, at 28,000 miles an hour -- passing fairly close, inside the orbital distance between the Earth and her moon. [There is just too much hatred -- in the hard news stories, of this day. . . . so we will shift to celestial poetry, and ancient mountain canyons echoing the same, in their running waters.]

It is absolutely no existential threat, and may truthfully only be seen with a mid-range (or better) telescope, and then, only if the skies are clear tonight -- and one knows exactly where in the sky to. . . look. Even so, I am already hearing the echoes of silvery words, writ in water. . . . of shepherded moons:

. . . .Like many. . . in [the high Rockies,] where the summer days are almost Arctic in length, I often do not start [river rafting] until the cool of the evening.

Then in the Arctic half-light of the canyon, all existence fades to a being with my soul and memories and the sounds of the [headwaters of the Arkansas] River and a four-count [oarsmen's] rhythm and the hope that a trout will rise [not too far ahead of the bow, shimmering in the rose light].

Eventually, all things merge into one, and a river runs through it. The river was cut by the world’s great flood and runs over rocks from the basement of time. On some of those rocks are timeless raindrops. Under the rocks are the words, and some of the words are [mine, to you]. . . .

—Norman Maclean, A River Runs Through It (1976)


This rock, called Asteroid 2010 WC9 -- like me -- poses no even remotely plausible existential threat to anyone's family, or life, on Earth. Now you know. And, some of those words are mine, to you. . . . working from home this fine Tuesday. Smile -- baby duty early, today. [To burn at a distance, or to freeze. . . nearby?]

नमस्ते

Monday, May 14, 2018

[U X2] Congo 2018 Ebola Outbreak: Bikoro Update -- 22 Probable And Confirmed Cases -- May 14, 2018


UPDATED @ 1:00 PM EDT -- There are suddenly 19 dead, and two of them are health care workers (greatly increasing the odds that the virus has now been transmitted regionally). This is how explosively dangerous the virus in the wild can be. On the plus side, here at lunch however, WHO has obtained clearance to vaccinate, from local health authorities. And starting now the initial up to 4,000 doses are being administered, in Bikoro region.

Even so, the WHO team is tracking at least 400 contacts of contacts. We should expect that as many as a third of those may become sero-positive, without a vaccine. This all via a Wa Po update. Sure is a good thing that just last week, 45 cut the remaining $250 million of US funding for Ebola fighting efforts in Africa, calling a working (life-saving!) vaccine candidate. . . "wasteful." I am beyond disgusted by him (this is more of his "shithole-self", emerging). [End, updated portion.]

As I had intoned earlier, the news will be worse for a while, before it starts to get better.

First, though, on the more hopeful side: Merck's "cold chain" delivery logistics seem to have worked: large numbers of Ebola vaccine vials, still at sub-zero (and thus likely plenty-potent), are on the ground now in and around Bikoro. Next, WHO health workers, well-trained, and battle-tested, from last time around (in Guinea and the Congo), are on-site, and collecting contacts-of-contacts data (for vaccination deliveries). Finally (on the plus side of the ledger), a smallish airstrip is being cut out of the verdant but mountainous, and twistedly tangled forest -- around Bikoro -- to speed future aid and medical personnel arrivals.

And now, the as-expected bad news: case counts are increasing (from 11 as of Friday, last), thus (per WHO-tweets):

. . . .Latest case count:

2 confirmed cases

20 probable

17 suspected. . . .


That's likely 39, from what was 11 only four days ago. Time to start vaccinating all contacts of contacts, in and around Bikoro. To the trains -- in a cool, foggy rain, then. . . . be of good cheer, just the same.

नमस्ते

[U] After Trump Demanded A US Bailout -- For ZTE -- A "MASSIVE" China-Based Phone Maker, I Immediately Flashed On This...


. . .of course, it's lame, as acting performances (and free-style rap performances) go, but there is much truth. . . in these words -- even 20 years later.

And it is true of BOTH Democrats and Republicans -- the same ills that beset us in the latter days of the Reagan-Bush 41 era have returned -- in a more virulent, more cynical form, under Donald Trump.

UPDATED: A mere 72 hours later, we know what Trump Inc. got, in return for the above ZTE announcement: $500 million from China, for a Trump resort in Indonesia. Deplorable.

The saddest part of all of this is that the Trump apologists in DC, and in red states, are going to make up excuses -- rather than ask directly: "Who paid him what sort of a corrupt emolument, for his sudden preference for a Chinese billionaires' company (one under US trade sanctions) -- over US workers who've lost their jobs (at least under his professed view, as a result of unfair competition from these same Chinese manufacturers). . . .?"

To be clear, I do not ascribe to that bogus theory of voo-doo economics. But if 45 is going to say it is true, and claim he wants to put "America First" (again), he ought to explain how a Commerce Department bailout of ZTE is consistent with any of. . . his previous lies.



Yes -- the video is low quality screen cap, and yes, Warren Beaty was mis-cast. But he is channeling Don Cheadle's earlier monologue in most of his rap.

The words of "America First" were always lies -- glaringly obvious ones, in fact -- but still I bet the GOP will cover for Trump here, on Monday morning.

Obscenity?! Ob-scen-i-ty?! Obscenity!

नमस्ते

Sunday, May 13, 2018

The Hep C "Unclean Hands" Patent Fees Determination May Come From The Federal Circuit (Appellate) Court, Not The Trial Court...


The ever-capable Judge Labson-Freeman has (as of Friday night) granted the extension of the deadline on any additional fee petitions (presumably while Merck decides whether it will just pay up, without any more fighting). I think it ought to -- as there is little left to be gained here -- and any additional proceedings will. . . simply enrich the lawyers. [As if that were a bad. . . thing(?). Heh.]

I write a new post this cool, clear Sunday morning though -- to note Judge Labson-Freeman has suggested that if it is going to be contested, Gilead might consider bringing it before the Federal Circuit, under Rule 47.7:

. . . .The Court GRANTS the parties’ stipulation. The Court, however, notes that Federal Circuit Rule 47.7 sets forth how a party may request “attorney fees and expenses incurred” before the Federal Circuit.

At this time, the Court is uncertain whether determination of fees on appeal will be remanded to this Court or determined by the Federal Circuit.

PURSUANT TO STIPULATION, IT IS SO ORDERED.

May 11, 2018. . .


Now you know -- and a most joyous Mothers Day -- to all the biological, and step-, and by-proxy- moms on the planet. To all women, in fact, who have served as a role model -- or mentor -- to. . . anyone, ever. . . we honor you as well today. Be of good cheer. . . smile.

नमस्ते

Friday, May 11, 2018

A Slight Delay -- In Additional Fees Motions: Friday Hep C Case Trivia, Post Gilead's Win, On Appeal


Gilead is entitled to -- and will almost certainly be awarded -- all the fees it spent in defending Merck's appeal out of USDC Judge Labson Freeman's wise federal trial level orders, in San Jose, California last year. The question from an overnight filing, is when all that will get underway.

Here it is.

. . . .The parties agree that it is mutually desirable for the parties and the Court to allow Merck sufficient time to consider Gilead’s request for a supplemental award of attorneys’ fees, and to meaningfully meet and confer with Gilead, before Gilead files any motion for an award of supplemental attorneys’ fees.

Accordingly, the parties stipulate and agree that Gilead shall have up to and including May 23, 2018 to file a motion for a supplemental award of attorneys’ fees. . . .


Be excellent to one another.

नमस्ते

[U] These Various Narrative Lines -- Vines, Actually -- Are Growing... TANGLED: Trump, On [PhRMA-Infused] US Drug Pricing.


UPDATED: My buddie, Ed Silverman, at STATNews gets the credit for obtaining this quote from a Novartis insider: “With a new administration coming in, basically, all the traditional contacts disappeared and they were all new players. We were trying to find an inroad into the administration. Cohen promised access to not just Trump, but also the circle around him. It was almost as if we were hiring him as a lobbyist. . . .” [End, updated portion.]

Apparently Mr. Cohen is a better "fixer" than Mr. Stiller's otherwise spot-on caricature portrayed, in last Saturday's SNL cold open. [It hasn't been since the earliest Chevy Chase days (only shortly-post Nixon), that these SNL skits regularly looked tame, by comparison to the ensuing week's ACTUAL unfolding hard news events.]

The White House has officially said, as of last night -- that in today's "US drug prices day" announcements, the primitive-in-chief will not, despite "promises" to the contrary (Q.: what might that word even mean -- to a guy like him?), allow direct negotiations on drug prices -- by Medicare and the VA Health system.

So, it seems that the $1.2 million was well-spent, by Mr. Jimenez (also, PhRMA's contribution to the 2017 inaugural now looks a savvy play). [I do think it an arguable five year stint felony, though, that both Messrs. Jimenez (now no longer with Novartis) and Cohen (now the target of multiple felony grand jury proceedings) didn't file LDA disclosure forms about this "like a lobbying" arrangement. There is also the argument that Mr. Cohen should have filed as a foreign agent lobbyist, under US law, since Novartis is a non-US HQ-ed company.]

In any event -- the main story here is Trump going all squishy (just as Mr. Cohen was offering to broker/fix, apparently):

. . . .US Rep. Elijah Cummings,D-Md., and Rep. Peter Welch, D-Vt., met with Trump in March 2017 to give him a copy of their proposal, which would allow the U.S. to negotiate lower prices for prescription drugs under Medicare, the biggest purchaser of prescription drugs.

"You know what we got in return? Radio silence. Nothing," Cummings said, adding Trump never responded to three additional letters over the past year. "He ignored us. And since then, our bill has been collecting dust."

Democrats were initially optimistic about working with Trump on the issue. He has decried the influence of pharmaceutical industry lobbying in Congress, warning last year that the drug industry is “getting away with murder. . . .”


Message today, from the sitting Administration? "Murder away!" [No surprise there, given this.]

And so, I'll resolve. . . to enjoy more Spring sunshine today, once dawn arrives. Smile.





नमस्ते

Thursday, May 10, 2018

[U] ELEVEN New Cases -- And One Death, Thus Far -- In 2018 Congo Ebola Outbreak


Unfortunately, the news out of WHO regarding the May 2018 DRC Ebola outbreak is likely to get worse now, before it gets. . . better. [UPDATED: Earlier story here; August 2016 backgrounder, on the longer longitudinal scars of these outbreaks, here.]

As if ripped from the script-pages of Scandal, House of Cards (or maybe even Game of Thrones), Mr. Trump on Tuesday cut over $250 million, in foreign aid earmarked for Ebola, calling it wasteful. [It was left-over funding -- from the 2016 outbreak, in which the vaccine worked quite well to quickly arrest the spread. So. . . Doctors Without Borders, WHO -- and the impoverished people in the northwest Congolese mountainous forests -- are being penalized. . . for progress in fighting Ebola, by 45. Yep. Sounds about right -- for him.]

We are on the bleeding, leading edge, of the viral knife's deadly arc, across the muscular chest of Africa, now -- and the sooner local ring vaccinations can begin, the sooner we will see the trailing edge -- of that knife (and begin to stitch it over, so a scar will form, as it heals). But right now, blood is all we see. From the CNN story then, just now:

. . . .One death of Ebola hemorrhagic fever and 11 new cases have been confirmed in the outbreak in the Democratic Republic of Congo, Minister of Health Dr. Oly Ilunga said Thursday in Kinshasa. . . .


And so. . . I am soundly discouraged, this evening -- we seem to have the life-science all figured out, to fight this scourge.

But it seems our White House lacks. . . the will-power, to do so. $250 million is a pittance, compared even to his "military parade" spending -- and (in contrast to that awful parade idea), this continued Ebola eradication funding will literally save lives.

I get it, 45 -- they are black lives -- from what you derisively called "shithole countries". But even you must have. . . a small shred of soul, left. Even. . . you.

नमस्ते

I Am 24 Hours Late To This -- But It Needs To Be Mentioned... Sheer US Pharma Audacity & Stupidity Dept.


I was off grid in court all day yesterday -- and a major story broke, one that crosses deeply into two of the core narratives of this blog. [I need not link it -- as every major outlet has mentioned it. These are matters of substantial public concern. I will link this silly overnight side car -- from McDermott Will -- as it does indeed deserve more critical mention, and wider circulation. But it doesn't change the thrust of the narrative -- one iota. Note that none of that undercuts the Novartis (and AT&T) "no consult" consulting "work" payments theme. Those two public multi-billion dollar companies have made public statements largely admitting to the below.]

Okay. Normally I won't call out an individual pharma company by name, any longer -- unless it is related to the legacy companies that generated this blog. Today, I make an exception -- and make that company the masthead feature.

You see, at the same time this company was signing a $1.2 million "consulting" agreement (with a guy who looks like he'd mostly be capable of. . . stealing the mints, from front desk, at the local doctors' offices, as opposed to having dink competent, to say -- about US health care delivery policy) -- its then-Chairman was being elected to lead PhRMA.

He is no longer leading Novartis, but Novartis never listed this as a lobbying relationship -- under existing LDA disclosure provisions, nor complied with the rules mandating a public transparency form in the office of the US Senate. Relatedly, Mr. Cohen never disclosed he was lobbying Mr. Trump -- never registered as a lobbyist, again violating federal criminal law (a five year stint -- Mr. Cohen cannot, as a licensed lawyer, claim ignorance of the LDA's provisions).

Normally at this point in the story, I would make some (hopefully humorous) snark-laden remark -- to drive home a subtle point -- but these (now established) facts are so starkly unlawful, I will just leave this all hanging, in the air. . . right here.

[Almost trivially, at this point -- this narrative intersects with the Mueller Russia investigation. And the portrait now emerging, based on public admissions from the likes of AT&T and Novartis. . . is that Messrs. Cohen and Trump were secretly putting our nation's governance up for auction -- to the highest bidder -- IN ADDITION to selling votes on international policy to the mobbed-up Russians connected to. . . ole' Vlad.]

And, tragi-comically, I am now old enough to remember when real Republicans would have been furious about such. . . brazen graft. These small r republicans taunt Mr. McCain -- long one of their own, as he fades into his illness and eventual death, for now finally telling the truth.

Stay away from Mr. McCain's eventual memorial Mr. Trump. You are no Republican -- nor are any of your defenders, at this point. You are all just. . . thieves. [Note that I did not -- in relation to Russia -- and need not. . . call it treason -- as being bribe-able used to be. . . disqualifying.]

Onward. This is the end-game, now.

नमस्ते

Tuesday, May 8, 2018

[U] With Another Small Flare Up Of Ebola In Africa, Merck's Zaire Strain Vaccine Likely To See Renewed Use In The Congo


UPDATED: 05.11.18 @ 4 AM EDT -- Sadly there are now 11 confirmed cases, and the first fatality -- from this new flare-up. And Mr. Trump has cut $250 million of funding for Ebola relief this week, calling it. . . wasteful. I've made that angle an entirely new post, above. What sort of a soul-less "primitive in chief" does such things? [End, updated portion.]

This is hard news to read -- and report. But tonight, another outbreak of the deadly Ebola virus has been confirmed in the northwest corner of what used to be called simply the Congo (now known more formally as the Democratic Republic of the Congo). There had been no reports of the virus in nearly a year, in all of Africa -- so these two confirmations are. . . disheartening. [Even so, philosophically speaking, we know that viral life, like all life, finds a way. . . and it has, again.]

As difficult as this news is -- of two new cases -- there is reason to be hopeful. This time around (like last time in 2016-17), and unlike 2014. . . we have a ring vaccination strategy in place at WHO, with the still largely pro bono efforts (no FDA approval means no revenue, either) of the vaccine professionals at Merck -- as a joint effort of Westpoint, and in the Research Triangle (IIRC). Here is a bit, from CBS this evening (the WHO is not yet formally reporting it -- on its website):

. . . .Congo's government on Tuesday declared a new outbreak of Ebola in the country's rural northwest, after two cases of the deadly virus were confirmed in Bikoro. Congo's Health Ministry said that of the five samples sent to the National Institute of Biological Research in Kinshasa, two came back positive for the Zaire strain of Ebola in the country's Equateur Province.

The samples were gathered after the Equateur Province Health Ministry notified Kinshasa on May 3 of some 21 cases of a hemorrhagic fever in the Ikoko Impenge area, including 17 deaths, according to the World Health Organization (WHO) and Congo's government. There are various hemorrhagic fevers.

A team was sent by the WHO and Doctors Without Borders over the weekend to investigate and strengthen coordination. The five new cases were then identified and sent to the laboratory, Congo's government said.. . .


Let us hope that this time around, the vaccine may be quickly deployed to the affected villages -- though as we have long explained, this terrain is well-nigh unpassable -- even by Jeep. Only motorbikes are really useful in these mountainous wooded regions. And the vaccine must be kept very cold, for the entire journey, under a blazing African sun.

So do keep a good thought, tonight -- I'm off to bed, now. Up early for federal court appearances (pro bono sanctuary city cases) in the morning. Sleep tight -- under the brightening lord Jupiter's copper hued glow, tonight. Smile. नमस्ते

Lighter (Lunchtime) Fare: With "Breakthrough Listen" Now Using Australian 'Scope/Dish Time -- I'll Re-Run This Hopeful One.


SETI's "Breakthrough Listen" project is partnering with the Australian folks who run and operate the CSIRO Parkes 'scope, in New South Wales. This is a vast leap forward, in the search for a radio signal that might be evidence of another life-form's communications. So we are grinning widely, and reflecting on Oumaumau, from early November 2017, today. . . see below:

UPDATED -- Dawn in Italy, on Tuesday 11.21.2017: I bumped this back up to the top. We could all use some happier-science infused ju ju, here. [End, updated portion.]

Let's just have the sublime ESO video do the 'splainin', shall we? [She's been named "Oumuamua", by her discoverers -- which translates from the native Hawaiian as "first arriving messenger, from afar".] Yes. . . let's. See below.

It is highly unlikely that this object will ever see her arc bend backward, and twist, toward our sun again -- she is passing through our lives but once. Like so many odd, yet preciously graceful, things. . . indeed.

. . . .Astronomers have recently studied an asteroid that has entered the Solar System from interstellar space. Observations from ESO’s Very Large Telescope in Chile (and other observatories around the world) prove that this unique object was travelling through interstellar space for millions of years before its chance encounter with our star system. It appears to be a darkly reddish (red-bone!), highly-elongated, high-metal-content object. . . .




As ever -- the idea of a dusky metallic visitor -- from near the "time, before time". . . at least relative to our own local group. . . fires my imagination. No doubt (being a man of science, after all!), under this graceful, roughly Mount Blanc pen-shaped metal, are the vestiges of one or more timeless raindrops -- and under those raindrops, are the words -- and some of those words, are mine to you. Travel well -- and do travel light.

नमस्ते

The Excedrin Killer, 30 Years On: Her Federal Release Date Doesn't Arrive Until 2040... She Is 74 Today.


In truth, find myself in a strange mood this morning -- as the matter at the bottom of this post has suddenly (much as my cream swirled in the piping hot coffee, just now) been blended into. . . the former.

So I will re-edit an old graphic, and drop in a link -- even though I had considered making an entirely new one solely on the Excedrin murderer. And so, I guess I am asking you to just bear with me, dear readers -- as we first visit the (likely non-availing) parole possibility for. . . one Stella Nickell. Her crimes were largely responsible for a completely new set of packaging precautions related to over the counter (but still FDA-regulated) drugs.

Do read all of it, in Canada's Globe and Mail, this morning -- with a bit, here:

. . . .May 8, 1988: Bruce Nickell was initially thought to have died of natural causes. But when a woman named Susan Snow, who also lived in Seattle, died the same month from taking Excedrin capsules laced with cyanide, investigators grew suspicious. Nickell had also taken the headache-pain reliever before being rushed to hospital, where he was pronounced dead.

The sensational case caused several drug companies to offer a $300,000 reward to find whoever had poisoned the pills. Stella Nickell, Bruce’s wife, swore she was innocent, but the FBI discovered she had recently taken out two insurance policies on his life, including one that would pay out $100,000 if he died accidentally.

In court, Stella Nickell’s 28-year-old daughter testified that her mother had discussed killing Bruce Nickell. A jury was convinced she had tampered with pills and put them back on store shelves, killing her husband and Snow. In May, 1988, Nickell became the first person to be convicted of causing death by drug tampering in the United States. She was sentenced to 90 years in prison under a federal law that was created after seven people died in 1982 in the Chicago area from taking Tylenol laced with cyanide, a crime that remains unsolved. She is eligible for parole this year. . . .


I don't think she will ever be paroled. I expect that she will die in prison, sometime before she turns 96 -- and the arrival of her mandatory release date (should she survive the abominable health care afforded at, and generally austere conditions in FCI Dublin -- in rural Alameda County, California).

Onward -- as apparently, I just had a taste for the. . . macabre, this morning -- with George Zimmerman being re-arrested. Of course, he shot and killed young Trayvon Martin, in a case we followed closely -- just five years ago, here.

नमस्ते

Monday, May 7, 2018

As Many May Have Noticed -- Merck Has Been/Remains Very "Steady State" -- For The Last Two Years...


But the idea here -- as broadcast (well, narorow-cast, actually), and written, from Wall and Broad, at least -- among sell side analysts, seems to be. . . to try just a little too hard to "manufacture" a story. [For our part, we prefer to just. . . fall silent -- as one may readily observe.]

As FiercePharma correctly notes this morning, at least two analysts -- one of whom has covered Merck since the time well before Merck and Schering-Plough became one company -- made largely "noise" stories, out of something that wasn't a "signal" at all.

This seems to be because Kenilworth, under Mr. Frazier's wise leadership -- no longer puts out much in the way of. . . puffery. And we all know even good analysts abhor a vacuum, even if the steady state information is. . . just. . . steady state.

Do read all of the Carly Helfand piece -- but here's a bit:

. . . .It all started last on Merck’s first-quarter conference call, when the company confirmed that data from the Keynote-407 trial—which is examining Keytruda alongside two different chemo regimens as a treatment for first-line, metastatic squamous non-small cell lung cancer—would be released at June’s American Society of Clinical Oncology (ASCO) annual meeting.

The thing was, Merck hadn’t yet released any top-line data from that trial, a factor that “led to fears that perhaps Merck was sitting on bad data,” Bernstein analyst Tim Anderson wrote in a note to clients. . . .


Of course, those "fears" were. . . just faux night fevers -- from the sheer terror of having. . . nothing. . . to say.

Now you know -- and onward, as a cool clear spring afternoon calls to me, anew. Be good to one another. Or, even better than good -- awesome!

नमस्ते

Friday, May 4, 2018

[U X4] Perfect Launch And On Course For Mars, Now -- From California -- For The NASA Insight Mining/Drilling Mission...


Flawlessly nominal early this morning, five by five, in all respects -- so, now on to. . . Barsoom:



It is (for me) eternally humbling -- to ponder the precision of the physics calculations (and all the flawless engineering -- of a gossamer winged spacecraft -- married to a hulking rocket). . . all of which allows a select few of our species (solely on scientific merit) to toss a pebble some 300 million miles into the inky blackness, and land it softly, effectively on a pre-selected dime, in the middle of thousands of square miles of a cinnamon-powdered but long-frozen desert plain. . . essentially all by blind calculating, and dead reckoning.

I am agog -- each time we make it out of Earth's pull, and whisk off to a neighbor in the distant Southern Summer night skies. Here's what you need to know, from NASA:

. . . .The early-morning liftoff on Saturday of the Mars InSight lander will mark the first time in history an interplanetary launch will originate from the West Coast. InSight will launch from the U.S. Air Force Vandenberg Air Force Base Space Launch Complex 3E. The two-hour launch window will open on May 5 at 4:05 a.m. PDT (7:05 a.m. EDT).

InSight, for Interior Exploration using Seismic Investigations, Geodesy and Heat Transport, will launch aboard a United Launch Alliance (ULA) Atlas V rocket. InSight will study the deep interior of Mars to learn how all rocky planets formed, including Earth and its Moon. The lander's instruments include a seismometer to detect marsquakes, and a probe that will monitor the flow of heat from the planet's interior.

The ULA rocket will carry the spacecraft over the Channel Islands just off the California Coast and continue climbing out over the Pacific, shadowing the coastline south beyond Baja California. InSight’s Atlas will reach orbit about 13 minutes after launch, when the rocket is about 1,200 miles (1,900 kilometers) northwest of Isabella Island, Ecuador. . . .

InSight's landing on Mars is planned for Nov. 26, 2018, around noon PST (3 p.m. EST). . . .

JPL manages InSight for NASA's Science Mission Directorate. InSight is part of NASA's Discovery Program, managed by the agency's Marshall Space Flight Center in Huntsville, Alabama. The InSight spacecraft, including cruise stage and lander, was built and tested by Lockheed Martin Space in Denver. NASA's Launch Services Program at the agency's Kennedy Space Center in Florida provides launch management. United Launch Alliance of Centennial, Colorado, is NASA's launch service provider of the Atlas 5 rocket. A number of European partners, including France's Centre National d'Études Spatiales (CNES) and the German Aerospace Center (DLR), are supporting the InSight mission. In particular, CNES provided the Seismic Experiment for Interior Structure (SEIS) instrument, with significant contributions from the Max Planck Institute for Solar Systems Research (MPS). DLR provided the Heat Flow and Physical Properties Package (HP3) instrument. . . .


I'll likely rise early -- to catch it all live, on NASA TV. Now you know -- g'night, all. . . .



UPDATED 05.05.18 @ 6 AM EDT -- Added a kid friendly explainer of the mission:



Original video:



Oh. And back here on Jasoom, your Kentucky Derby winner is... Justify. Smile. . . . "'cause we're justified and we're ancient. . . and we like to roam the land. . . ."

नमस्ते

Kenilworth Once Again Boosts Its Net Investment, In Unicorn Moderna -- Looking At A Cancer "Vaccine" R&D Program


Over the last three and a half years, we have kept tabs on the Moderna-Merck escalating series of investments -- from $100 million to $300 million, in 2016 -- and a late 2017 update, here.

Over the last 24 hours, Merck has bumped its investment by over 25 per cent -- or $125 million -- to $425 million in total. Still immaterial for the mothership, but the idea of personalized cancer vaccines seems less and less sci fi -- and more. . . life science, here nearing mid 2018.

So it is appropriate that we write about it on Yoda's day. Here's a link to the overnight article, from CNBC's Meg Terrill, and a bit:

. . . .Moderna Therapeutics is banking an additional $125 million in an expanded partnership with Merck around a personalized cancer vaccine.

The product, called mRNA-5671, targets mutations in a gene called KRAS that Moderna says occur in about 90 percent of pancreatic cancers and 30 percent of non-small-cell lung cancers. It's the fourth program on which the two companies are collaborating.

The $125 million from Merck comes in the form of series H preferred equity; Moderna completed a series G fundraising round earlier this year. It's now raised more than $1.6 billion in equity and $1 billion through partnership payments, CEO Stephane Bancel said in a telephone interview Thursday. . . .


Yep -- with a valuation north of $7 billion -- that sound you hear is. . . a formerly strictly sci-fi unicorn, now becoming a privately-held life science R&D juggernaut. "Away put your weapons, as absolute power I have. . . ."

Grinning ear to ear, here in dawn's luminous and rose-colored half light. . . . have a great day -- but beware that Sunday. . . cometh; and with it -- the revenge.





Yes, now you know -- I try to play it off. . . .

नमस्ते

Thursday, May 3, 2018

A New Civil Lawsuit (Against Martin Shkreli) Offers An Odious "Peek Under The Hood" -- At Turing (Now Vyera) Pharma....


[Cross posted from another of our properties.] I think this simply confirms much of what we largely long-suspected about the private company now called Vyera.

Rather than walk you through all the salacious details -- and there are LOTS of them -- I'll just link the 29 page PDF file, and quote the most innocuous bit (do go read it for yourself):

. . . .On June 22, 2017, the very next day after Defendant Shkreli’s Facebook post to “Drain the [Turing executives] Swamp,” Ms. Costopoulos was stripped of all duties and authority in her capacity as Senior Vice President, Chief Compliance Officer and General Counsel of Turing. Mr. Mulleady, acting on behalf of the Company, at the direction of Defendant Shkreli and his personal attorney, Mr. Scott Vernick of Fox Rothschild (“Mr. Vernick”), advised Plaintiff that she was being placed on administrative leave pending an investigation into unspecified misconduct. A company-wide memorandum was circulated announcing the same. . . .


Well. That was a stupid thing to do. But, that's Marty for ya'.

Do enjoy -- and a sincere hat tip -- to an anonymous friend of the blog, for this! Off now, to bake Yoda, C3PO and R2D2 cookies, etc. . . . smile.

नमस्ते