Friday, July 21, 2017

In A Reversal Of Long Term Prior Trend Lines... Pfizer And Merck Spent About Equally, In Q2 2017, On Lobbying

The magnitude in this reversal in trend-lines is amplified -- when one considers that Pfizer is about a third larger than Merck -- by annual revenue.

Yet here we are -- instead of Pfizer essentially doubling Merck's spend per quarter (as was often the prior case) -- the two are roughly even -- at a little over $2 million during Q2 2017. [Not quite all the reports are in to the Senate's disclosure office yet, but the reversal seems plain. I'll update this, if something wildly off-kilter emerges over the weekend.] Much of that effect seems to be driven by an increase in Merck spending, though a little of it is a decrease in Pfizer spending, as well.

We will wait to see how the full year turns out, now. But this is interesting -- especially the bolded bits, below. Here is most of what Kenilworth was lobbying Congress for, during Q2:
. . . .340B (no specific bill), Hepatitis C (general education; no specific bill), Human papilloma virus and vaccine policies (general education; first dollar coverage; preventative services), shingles vaccine policies (general education), antimicrobial resistance (general education), biosimilars (no specific bill), cost and value of medicines (no specific bill), women's health (general education), Prescription Drug User Fee Act (PDUFA; general education), Affordable Care Act, general pharmaceutical issues (transparency, formulary design, prescription drug coverage), H.R. 1628 - American Health Care Act of 2017, Implementation of P.L.114-255 - 21st Century Cures Act, S.204/H.R.878 - Trickett Wendler Right to Try Act of 2017, S. 469 - Affordable and Safe Prescription Drug Importation Act, S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017. . . .

Comprehensive tax reform (no specific bill), House Republican tax blueprint, international tax proposals (no specific bill). . . .

Medicare Part D (general education, no specific bill), Independent Payment Advisory Board (general education, no specific bill), Medicare Part B (general education); Medicaid (no specific bill); Antibiotics/stewardship; Vaccines for Children Fund; Hospital Outpatient Prospective Payment proposed rule (CMS). . . .

Better Care Reconciliation Act (BCRA); FY2017/FY2018, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations; FY2017/FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; FY2017/FY2018, Department of Defense Appropriations; TRICARE formulary and reimbursement issues. . . .

Diabetes Prevention & Treatment, including related provisions of HR 309, The National Clinical Care Commission Act. . . .

Legislative issues related to Pharmaceutical patent issues; Legislative issues related to the FDA Regulation of Biosimilars. . . .

Now you know. . . with some deliciousness (as imaged) at the ready on this moistly sweltering Friday -- by the open air concert venue, at lunch. . . . smile. Onward.


Thursday, July 20, 2017

Merck Gets FDA Nod For Sanofi Biosim Insulin Glargine Injection -- But Must Now Litigate The Patent, Under Hatch-Waxman

Merck has (as of January 2017) already been given an EU clearance on this insulin bio-sim, and if I recall correctly, it is on sale throughout the EU. This is part of Merck's co-venture with Samsung Bioepis, as we've long reported.

The news this morning is that Kenilworth cleared FDA (older February 2014 background on it, here; February 2013 backgrounder here), but now must litigate with Sanofi, under the relevant Hatch-Waxman (up to 30 month) stay period. Of course, Merck could win out -- in the federal patent case, and launch sooner -- we shall see. From the NASDAQ-filed press release then -- a bit:

. . . .The U.S. Food and Drug Administration has granted [Merck/Samsung Bioepis] tentative approval for LUSDUNA Nexvue or insulin glargine injection 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis.

With the tentative approval, LUSDUNA Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement. . . .

To this moment, we haven't reported on that piece of patent litigation very closely (as it was immaterial to Merck, until it secured FDA approval) -- but now we obviously will cover it -- and do so, closely. I'll get up to speed, on it -- with the baby on my lap, in the Loop -- tonight. Smile.

To be clear, at least two other life science major players have one bio-sim in the cue -- so the field could get crowded (background on Dr. Gottlieb's new initiative at FDA, here), and prices could drop -- pretty quickly.

In fairness to the historical record, Dr. Gottlieb is mostly putting forward a slightly-tweaked version of an early ObamaCare era proposal -- one that sort of fell by the wayside, in 2014. The idea is sound, and would benefit US consumers immensely, so I don't care if a Trump appointee says it is "new" (when it is in truth a revision of a 2012-13 proposed FDA policy) -- it remains a good idea, even if I know it was originally conceptualized under Mr. Obama. Now you know. Onward, into the rain -- but smiling, just the same. . . . whoosh!


Wednesday, July 19, 2017

[U] Many Former US Intelligence Officials Weigh In, On 45's Generally Goofy Supremes Gambit...

UPDATED @ 3 PM EDT: Well, the Supremes have issued their short order -- 6-3 that (as existing immigration/refugee law has provided for 50 plus years) grandparents are bona fide family. That split is probably how the entire case will play out in the fall. The matter about "bona fide relationships" has now been returned (remanded, technically speaking) to the Ninth Circuit -- where it belongs (under any normal reading of federal appellate practice rules). Onward. [Yawn -- just as I had predicted this early morning -- though FoxNews is saying some entirely. . . silly things about it all. No surprise there.] Here it is -- in full: The Government’s motion seeking clarification of our order of June 26, 2017, is denied. The District Court order modifying the preliminary injunction with respect to refugees covered by a formal assurance is stayed pending resolution of the Government’s appeal to the Court of Appeals for the Ninth Circuit. Justice Thomas, Justice Alito, and Justice Gorsuch would have stayed the District Court order in its entirety. [End, update.]

Yet more news, out of the United States Supreme Court, on the ill-starred, and wrong-headed Muslim Ban 2.0, overnight:

The Supremes could -- and likely will, very shortly -- rule Mr. Trump's latest goofy USSCt moving papers out of bounds, without any opinion. Just an order. One line -- or three.

Or so "I, Condor. . ." predict (heh). The denial and remand order (to the Ninth Circuit) could come at any time today or tomorrow -- depending on how well (and where) Justice Kennedy is, in the process of caring for his injured wife, in Saltzburg, Austria. [It is already getting to be later afternoon, there, now.] And while we wait for that expected order -- here is what the able former US intel folks are on record about -- in this case, in a 23 page PDF friend of the court brief (courtesy the highly-esteemed, filed overnight with the Supremes:

. . . .[The Trump Administration's] narrow interpretation of [the Supremes' cert. order] in fact would do harm to the security and foreign policy interests of the United States. As amici have explained elsewhere, the Government’s reliance on generalized bans on travelers and refugees without an individualized assessment of security threat is counterproductive from a security perspective. This generalized approach is likely to: endanger U.S. troops in the field, by barring many foreigners who have assisted our troops at great risk to their own lives; disrupt essential counterterrorism, intelligence, and other security partnerships with countries that are critical to our country’s efforts to address the threat posed by terrorist groups such as IS; feed IS’s propaganda narrative, while hindering law enforcement efforts to fight homegrown terrorism by alienating Muslim- American communities; cause serious humanitarian harm; and result in economic damage to the United States, economic sectors such as defense, technology and medicine. . . .

The Government’s narrow interpretation of this Court’s Order suffers from these same flaws. The Government would exclude from the United States any number of individuals with bona fide relationships with this country who create no security risk and would benefit the nation, simply because they are uncles rather than brothers, or have formed a relationship with one entity in the United States rather than another. This approach is at odds with the nation’s contextualized and individualized approach to screening travel to the United States. It also imposes an arbitrary travel ban upon countless individuals in ways that could do real harm to the United States’ national security or foreign policy interests.

[The individuals signing this brief] include a number of officials who have held for extended periods of time the most senior responsibility within the U.S. Government for overseeing the refugee resettlement process. . . .

I expect the Ninth Circuit will also rule against 45 pretty shortly after the regular briefing schedule, in September. Then the Supremes will see briefs, and on and on. . . Now you know -- with nothing but truly independent and free. . . happiness in store today, in sunny Chicago.


Tuesday, July 18, 2017

[U] Hawaii (Unsurprisingly) Tells The Supremes That Grandparents Are "Close Family"... [Trump Is No Gen. MacArthur Edition]

Here is in a few moments, we will have the latest US Supreme Court filing (a 38 page PDF file, from the "Aloha State" of Hawaii) on Muslim Ban 2.0. More soon. I will note that the able lawyers for the Aloha State have called Mr. Trump's latest arguments. . . "nonsense". And I quite heartily agree -- see below (and do note -- the last bit is 45's tweet on the OrangeCare implosion).

It is hard to imagine how embarrassing it must be to have a primitive in chief as one's client:

. . . .The Government asks this Court for emergency relief that is procedurally improper and substantively unnecessary. It seeks to leapfrog its own pending motion and appeal in the Ninth Circuit and obtain an expansion of the stay this Court issued just three weeks ago. And it contends this extraordinary relief is appropriate because the District Court’s recent modification order has “eviscerated” this Court’s stay.

That is nonsense. The District Court faithfully applied this Court’s opinion, holding that “close relatives” like grandparents and nieces are permitted to enter, and recognizing that the charities, non-profits, and churches that have made a formal, contractual commitment to shelter and clothe refugees would suffer “concrete hardship” if those refugees are excluded. . . .

The Government’s complaint boils down to the belief that any interpretation that meaningfully diminishes the practical consequence of its bans must be wrong. But the lower courts and this Court explicitly sought to minimize these practical consequences to the extent they inflict concrete harms on American individuals and entities. . . .

There is no reason for this Court to take the extraordinary step of granting a stay, certiorari before judgment, or mandamus relief. The District Court’s opinion is correct. And, in any event, the Ninth Circuit — where the Government has filed an almost identical set of requests — is fully capable of fulfilling its normal role as the first line of appellate review. The Government’s motion should be denied. . . .

In a remarkable bit of doublespeak, the Government suggests. . . [a section of the INA] supports its distinction between “close” and “extended” family. But the provision explicitly refers to siblings-in-law, grandparents, and grandchildren as “close family”; there is no ambiguity about it.

Other provisions of the INA likewise permit persons in the United States to sponsor their “grandchildren,” “grandparents,” “nieces,” and “nephews” for immigration or naturalization — in each instance indicating that Congress believed such persons have a concrete and cognizable stake in their relatives’ entry. . . .

[SEGUE -- Mr. Trump tweets, on stunning health care defeat, 07.17.2017:] . . .We will return. . . .

While we wait for the people's brief in the US Supreme Court, I must cry out, loud and long -- at 45's overnight tweet on his utter collapse, regarding any health care measure.

He presumably was aware (when he tweeted) that Gen. Douglas MacArthur said "I shall return" -- when he escaped the Philippines (as the islands fell tragically into the hands of the enemy), in one of the darker moments of WW II, in the Pacific theater.

How dare he equate his own tiny-handed hubris, and vain political ineptitude -- to the deep purple valor, of men who bled and died there, and on Corregidor, to protect Gen. MacArthur's retreat? [The Allies did eventually retake the islands -- but 45 is a. . . pig -- for trying to draw any parallel.]

What a complete coward Mr. Trump must be -- if he feels the need to equate his own obvious idiocy and endless prevarications, on ObamaCare -- to the courageous General's words, in a real, live battle, with real honorable enlisted men literally dying around him, to help him escape safely, to. . . "fight another day".

What a. . . small, impotent man-child, indeed. . . . I am well-beyond being disgusted.


[U] Merck Ordered To Pay $12.6 Million Of Gilead's Legal Fees, For Former Merck Patent Counsel's "Egregious Misconduct"

I have been in the wild northern wood -- where not even cell-phone coverage exists (as a general rule). [But this is a follow up, from a year past.]

Regretably, and consequently -- I missed mentioning on Friday past, that the ever able Judge MayBeth Labson Freeman, in the US District Court in San Jose, California has now finally entered her opinion (as a 17 page PDF file), as to the specific amount of attorneys' fees to be awarded -- and ruled that Merck must pay $12.59 million worth of its opponent's legal expenses, in the Sovaldi® patent litigation, from last summer.

. . . .Specifically, the numerous unconscionable acts included lying to Pharmasset, misusing Pharmasset’s confidential information, breaching confidentiality and firewall agreements, and lying under oath at deposition and trial. The Court found that any one of these acts — lying, unethical business conduct, or litigation misconduct — would be sufficient to invoke the doctrine of unclean hands; but together, these acts unmistakably constitute egregious misconduct that equals or exceeds the misconduct previously found by other courts to constitute unclean hands. . . .

Gilead is entitled to $12,591,636.53 for the work done by Fish through June 30, 2016.

Since the total amount of reductions is about 9.35% based on Fish’s fees through June 30,2016, the additional fees incurred after June 30, 2016, are subject to the same proportional reduction based on the parties’ agreement. . . .

Gilead is also entitled to fees of $1,365,470 for Deloitte’s work. . . .

The case (overall) is still pending on appeal, in the Ninth Circuit. But the notion that Merck would have to pay for Gilead's fees was well known -- the exact amount of those fees awarded wasn't known before Friday.

And NOW, you know. Onward -- to a gloriously busy week. . . with Saturn D Ring Plunge Number 13 now underway as I post this, twisting as it streaks past, in a near blur -- into the dawn "out there. . ." smile. . . .

UPDATED -- mid morning: We wish Justice Kennedy's wife a speedy and full recovery, from her hip fracture. She apparently took a fall, while traveling with the Justice, in Saltzburg, Austria -- and (since he is assigned to handle West Coast petitions, during summer recess) that may delay action on the pending clarification request, on Ban 2.0, in the Supremes. Even so, we expect the People of Hawaii will have a brief on file at the nation's highest court in about two hours, now. We will provide it in a new post, then -- at noon Central, today.


Consider the Irony, Here: Merck Taps Texas State Funds For $6 Million...

In a few moments, I will have a new post up. That post will be a counterpoint to this happy news, from MSD and the Governor of Texas, overnight.

We are updating our April 2017 post -- to indicate that Merck has now secured the commitments for the $6.8 million in taxpayer funds it earlier sought.

[Snark] If I were a cynic, I would guess that this announcement was timed to blunt/blot out any coverage (even here, on this meager estate) of the far less favorable Kenilworth news out of San Jose, California. But I am earnestly trying to be. . . less cynical. Truly, I am [/snark]. Per the Austin Statesman, then:

. . . .Gov. Greg Abbott on Monday announced that Merck Sharp & Dohme Corp. will move forward with plans to develop a major technology innovation center in Austin, becoming the key anchor for an innovation district developing around the Dell Medical School.

The global pharmaceutical titan made the announcement after the governor’s office announced it would provide the company a $6 million grant from the Texas Enterprise Fund. That grant comes on top of a 10-year, $856,000 city tax incentives package approved by the Austin City Council in April.

In return, Merck said it will create at least 600 jobs, paying an average annual salary of $84,586, and it would invest almost $29 million to build and equip the new innovation center. . . .

Do see my next post -- as we ponder how it is that massive (and wealthy) US companies regularly access the public fisc, even after clear findings of egregious misconduct, and abuse of the legal process.

Ponder that, indeed. I have much to say on it -- but will lay rest to the grace in my tongue, this luminous but clear dawn. . . I have much better things to spend my energy on -- and others will make this argument more eloquently than I might. Onward.


Friday, July 14, 2017

[U] Grandparents ARE Family -- Over Coffee On The Shore

That. . . was essentially immediate. Updated: 07.17.17 -- The Trump Administration has filed a notice of appeal, in the Ninth Circuit, as well as asked the Supremes to review and clarify. They will not prevail. End, update.

Trump Ban 2.0 thwarted -- Again! The law is clear, here:

. . . .Upon careful consideration of the parties’ expedited submissions, the Court concludes that on the record before it, Plaintiffs have met their burden of establishing that the requested injunctive relief is necessary to preserve the status quo pending appeal regarding the definition of “close familial relationship” employed by the Government with respect to Sections 2(c), 6(a) and 6(b) of EO-2.

Plaintiffs have similarly met their burden with respect to refugees with a formal assurance, as it relates to the Government’s implementation of Sections 6(a) and 6(b) of EO-2, and participants in the Lautenberg Program. Plaintiffs’ Motion is accordingly GRANTED in these respects. . . .

Lovely -- and just. Sipping hot coffee, at the beach -- where I found some cell service. All this -- by iPhone (Huzzah!). More later.


Thursday, July 13, 2017

Shorter State Of Hawaii Reply -- Grandparents Have A "Bona Fide Relationship" -- To Their Grandchildren

Mr. Trump's policies are "as wrong as they are cruel. . . ." Well put, Hawaii. Well-put.

Do go read it all -- whilst I'm outside of cell coverage. Here is the opening bit (of 22 pages filed overnight):

. . . .The Government has spent two weeks carrying out its unconstitutional order against the vulnerable and the weak. It justifies its conduct on national security grounds, excluding people such as a Ukrainian granddaughter trying to reunite with her 93 year-old grandmother, Ex. G at 1 (Decl. of Erol Kekic); a refugee stranded in Malawi while his uncle waits for him here, Ex. H ¶¶ 10-11 (Decl. of John Feruzi); and countless individuals who have been promised housing and resettlement in this country by a dedicated refugee organization. . . .

The Government claims these individuals have no ties to the United States and their exclusion burdens no one. That position is as wrong as it is cruel, and it makes a mockery of the Supreme Court’s directive that any alien with a “bona fide relationship” to this country cannot be denied entry. . . .

Note that the Ukraine is not even one of the six countries putatively the subject of Ban 2.0 -- yet the jackboots storm on. . . Now you know -- soaring. . . . gliding really, over an improbably hot zone -- inexplicable by classical physical laws. It must be the proximity to that long lost copper goddess -- it must be. Smile. Be excellent to one another -- I'm the ghost with the most, now. . . .


Wednesday, July 12, 2017

Of Martin Shkreli -- A Felony Trial Update: "No Remorse" Edition...

Subtitled as "How 'Insulting, Contemptuous' Behavior Differs From 'Remorse'."

Overnight, after a very bad day for the defense, in Brooklyn's federal courthouse, Mr. Shkreli went out to drink expensive champagne at a Milo Y. debauched soirée. Perhaps it was the champagne talking, but he returned to his Murray Hill digs, to say on a YouTube live stream that -- if convicted -- he will get only three years -- citing CFTC v. Park.

This is the take-down of that notion -- from our other property, this morning.

The good soul FTD stayed up late (my condolences!) to hear Mr. Shkreli claim in a YouTube live feed that he will (if convicted) only do three years or less. [I would encourage the able AUSAs to pin this to their cork boards, for a possible September sentencing date -- this is. . . motivation. And my graphic is sincerely intended to suggest that she is. . . a "saint", by comparison -- to Mr. Shkreli, at least.]

Mr. Shkreli based that on CFTC v. Park -- a recent CFTC regulatory case (i.e., not a DoJ/US Attorneys SEC one), stemming from "commodity pool operator" charges -- not wire fraud, and "parking" charges, related to public company securities.

Ms. Park never “parked” public company securities — his on the other hand, is an eight count indictment (hers was only seven; some of which were not even felonies — all of Mr. Shkreli’s are), and she agreed to a guilty plea. She wept openly at sentencing, taking full responsibility for her crimes, and expressing genuine remorse -- to her victims (mostly friends and family).

Importantly, she is not the subject of a raft of securities class actions, spanning at least two public companies, as a control person -- leaving one very ugly public company bankruptcy, in her wake. Oh -- and she didn't menace and threaten the wife and children of one of her employees -- with whom she had sought to fraudulently "park" those same securities (essentially hiding her level of control of the involved public company -- with the goal of manipulating the entire market for that public company's shares). That's all. . . Mr. Shkreli.

And she wasn’t charged with wire fraud — she didn’t act as the kingpin, in a series of schemes in which she allegedly co-opted a lawyer, for cover (my “allegedly” is out of respect for Mr. Greebel's presumption of innocence).

Most importantly, hers is a CFTC case — not a case involving the market manipulation of an SEC-registered public company. That is, she never controlled a public company, and then defrauded the public shareholders of that ’34 Act company (twice! At KaloBios too). That all matters quite a bit. Hers was in no respect an open market fraud on our system of capital raising -- and secondary market trading. She was trading commodities which are by definition not. . . securities.

She didn’t force the government to spend enormous resources on a trial; she wasn’t contemptuous of the Judge — didn’t call the AUSAs the “junior varsity”. . . there is much more, but it all gets rather. . . redundant after a bit, no? So I'll stop with factual analysis, here.

In sum, even if Mr. Shkreli were to plead guilty right now, he’d get a minimum of ten years. He may only do five, with day for day credit, but he’ll get ten.

That’s my guess. But we shall see. . . .

Now you know, on a gray Wednesday morning here. Even so, we still eagerly await image acquisition, of the hot spot, by hovering our "science experment" fingertips over the copper swirls of. . . Jupiter. Smile.


An Iceberg The Size Of... Delaware. In Antarctica...

Well -- we have been talking about this for two years. Most recently, last week.

The largest iceberg in recorded human history just calved from the Antarctic ice shelf. Here it is -- just now, from the Beeb:

. . . .An infrared sensor on the American space agency's Aqua satellite spied clear water in the rift between the shelf and the berg on Wednesday. The water is warmer relative to the surrounding ice and air - both of which are sub-zero.

"The rift was barely visible in these data in recent weeks, but the signature is so clear now that it must have opened considerably along its whole length," explained Prof Adrian Luckman, whose Project Midas at Swansea University has followed the berg's evolution most closely.

The event was confirmed by other spacecraft such as Europe's Sentinel-1 satellite-radar system.. . .

Now you know. But climate change is akin to flat Earth theory, according to Mr. Trump's EPA leaders [/snark]. Onward.


Tuesday, July 11, 2017

Some Sixteen States Weigh In, Preemptively -- To Help Hawaii -- In "Re-Establishing" That Grandparents Are... Close Family

The able USDC Judge Watson will receive the first of 45's lawyers' briefs later today, purportedly explaining why -- despite a US Supreme Court order plainly preserving existing law, the Administration chose to rewrite the well-settled definition of what constitutes "close family" -- in most immigration law settings.

Smartly, almost all the states that have long opposed Muslim Ban 2.0 (or "3.0", if you prefer -- but we will keep the issued retail version, as 2.0 here -- since the Supremes haven't really allowed anything new, beyond existing prior law, to this point), have taken a pre-emptive bite at the apple, by filing as amici as of last night. It is a well-taken bite, too.

Here is a bit, from the 18 pages (PDF) of those sixteen states' amici brief:

. . . .The States of New York, California, Connecticut, Delaware, Illinois, Iowa, Maine, Maryland, Massachusetts, New Mexico, Oregon, Rhode Island, Vermont, Virginia, and Washington, and the District of Columbia submit this brief as amici curiae to urge this Court to grant the motion of plaintiffs the State of Hawaii and Ismail Elshikh to enforce, or alternatively, to modify this Court’s preliminary injunction (as amended on June 19, 2017, ECF No. 291), in order to ensure that the injunction is implemented in a manner consistent with its purpose and the Supreme Court’s modification as to its scope. . . .

First, the federal government’s interpretation is not supported by the language used by the Supreme Court in leaving part of the injunction in place. The Supreme Court, while staying the underlying injunction in part, broadly held that sections 2(c), 6(a), and 6(b) of EO-2 “may not be enforced against foreign nationals who have a credible claim of a bona fide relationship with a person or entity in the United States.” Trump v. IRAP, 2017 WL 2722580, at *6. The Court made clear that the exclusionary provisions of these sections can be enforced only against those “who have no connection” or “no tie” to the United States. . . .

The [US Supreme] Court’s recognition that a person’s relationship to his or her mother-in-law “clearly” presents a close enough relationship to qualify for protection, id., necessarily implies that the Court viewed the injunction as encompassing a broad category of relationships beyond those found within a traditional nuclear family. . . .

The federal government’s cramped view of what counts as a “close familial relationship” is contradicted both by social science research and by common experience. In particular, the relationship between grandparents and grandchildren is widely recognized as close to — and sometimes a substitute for — the relationship between parents and children. . . .
Indeed. Now you know -- and what sweet and sublime honey dripping thermodynamic wonders will we learn, on Thursday night -- from the JunoCam? Will we finally have an answer (proof, really) as to why it is that some fingers, floating directly above her copper-occluded storms -- radiate, with over three hundred degrees of "extra" heat -- far more than we would expect, from the normal (mortal) physical models, alone? I. For. One. Think. We. Will. Smiling now, wryly. . . .


[U] New Practice And Procedure Order Coming, In Merck's Federal Propecia®/Proscar® MDL in Brooklyn USDC

UPDATED @ Noon EDT: Looks like settlement talks are back on, here. . . .

I see some increased probability that the parties have active settlement discussions (and likely, on a global -- state and federal -- basis) underway, now. This is new -- and is simply my conjecture, based on the fact that all discovery is stayed, until September 20, 2017. [End, update.]

The schedule of events -- and timing for motions, may be changing -- based on a telephonic conference hearing, yesterday. We will let you know, right here, with an update when now taht the amended scheduling order has been filed, through PACER. Here's a bit -- from the order entered this morning:

. . . .Discovery in this matter is stayed until September 20, 2017. Accordingly, the deadlines governing the remainder of discovery are hereby revised as follows.

1. Expert Depositions. All expert depositions must be completed by November 6, 2017.

2. Motions. All motions to exclude or limit expert testimony pursuant to Federal Rule of Evidence 702 and all dispositive motions shall be filed as follows:

a. Opening Briefs: November 27, 2017;

b. Opposition Briefs: December 27, 2017; and

c. Reply Briefs: January 10, 2018. . . .

The Court [still] anticipates that the First Bellwether Tranche shall be trial ready by March 2018. Following the entry of all orders disposing of all Daubert motions and dispositive motions, the Court will issue a scheduling order governing all trial related obligations, including the specific date for commencement of trial. . . .

Onward. There is no guarantee that there will be a global settlement -- or any settlement, at all. But I think it more likely now, than it has been in at least the past three years.


Monday, July 10, 2017

51 Years Ago, This Very Afternoon -- Chicago Freedom Movement And MLK, Jr. -- At Soldier Field...

It is with some truly-profound pride, and yet, all due humility, that each year I mark July 10.

This year, it happens that events above Jupiter dominate my morning's thoughts, but by afternoon and evening -- I will be pondering this. From WikiPedia, with my now departed father in law, in the upper far left, as he was hosting Dr. King that day (as President -- of the local NAACP). . . smile.

. . . .About 35,000 persons jammed Chicago's Soldier Field for Dr. King's first giant 'freedom rally' since bringing his civil rights organizing tactics to the city. . . ." Other guests included Mahalia Jackson, Stevie Wonder, and Peter, Paul and Mary. By late July the Chicago Freedom Movement was staging regular rallies outside of Real Estate offices and marches into all-white neighborhoods on the city's southwest and northwest sides.

The hostile and sometimes violent response of local whites, and the determination of civil rights activists to continue to crusade for an open housing law, alarmed City Hall and attracted the attention of the national press. During one demonstration King said that even in Alabama and Mississippi he had not encountered mobs as hostile to Blacks' civil rights as those in Chicago. . . .

Now you know. Beaming with pride, and. . . later tonight -- well done, Doc. . . . Well-done.


Sunday, July 9, 2017

In Hawaii -- Re-Establishing That Grandparents are "Close Relatives" [Insanity Alert].

I've hinted at it before -- but now I am convinced of it. Mr. Trump has apparently instructed his underlings to violate the letter of the U.S. Supreme Court's order, of last month.

That was an order granting a hearing in October -- not resetting his authority in any form of broad terms. US immigration law has long held that grandparents are close relatives for the purpose of seeking asylum. Yet 45 now moves to exclude them -- from the six countries. The Supreme's cert. grant order was limited to preserving existing law -- not creating new law.

I will stop there for now -- but there is much more. The latest, from the very able US DC Judge Derrick K. Watson in Honolulu: "The Court is in receipt of Plaintiffs' Motion to Enforce or, In the Alternative, to Modify Preliminary Injunction. Dkt. No. 328. Defendants shall file their opposition by Tuesday, July 11, 2017. Plaintiffs shall file any reply by Wednesday, July 12, 2017. The parties' opposition and reply briefs are limited to no more than 15 pages each." And a bit from the motion, filed on Saturday (yesterday), out of the State of Hawaii:

. . . .One thing is clear: This Court should not permit the Government to flout its directives at the expense of countless Americans and their loved ones, and it possesses the authority to prevent the Government from so doing. . . .

As “partially limit[ed]” by “the Supreme Court’s order,” this Court’s injunction prohibits the Government from excluding aliens who have “a bona fide relationship with an individual or entity in the United States.” Slip Op. at 12. The Government cannot categorically exclude grandparents, nieces, or refugees with extensive ties to this country; and its ongoing efforts to do so should be enjoined. . . .

I predict he able Judge Watson will rule that Mr. Trump cannot treat grandparents any differently than "close family" -- they are close family. Now you know. Onward, on a glorious Wisconsin triathlete's top five finish Sunday morning! Smile. . .


Sunday Political Stuff; Forgive Us -- Weekly Roundup

Out west, in the Ninth Circuit (and in the District Court of Hawaii), lawyers for the State of Hawaii are bouncing back and forth between courthouses in seeking an order that Mr. Trump cannot (consistent with the Supremes' grant of cert.) exclude grandparents of people from the six countries who have bona fide ties to our nation (i.e., their grandchildren) -- all of which simply preserves pre-existing law.

And now, in response to anonymous commentary during the week -- we address the case for obstruction against 45; preceded by Turner v. US, decided two weeks ago by the Supremes. While the exculpatory evidence withheld may not have been outcome determinative, that ought not be the test -- in my view. When a prosecutor acts intentionally (as here) to withhold exculpatory so-called Brady evidence, there must be a consequence to the prosecutor for that breach of constitutional duties. Even if actual innocence may not be proved thereby. I think Justice Kagan's dissent is well-framed.

We the citizens need to know that our law enforcement arms "obey the law," themselves. This is a sad case -- and hopefully will be limited to its very narrow and unique fact pattern. I short, it ought to become a largely dead letter -- outside this specific fact pattern. [Much of the conviction rested on the notion that the convicted acted as part of a mob of others -- and there were in fact multiple witnesses who said so.]

And, turning now to the case for obstruction against 45, I agree with the commentator's implied view that Slate's take on it all is cogent -- and the case is quite strong (as Slate makes plain), in my view. Here's a bit:

. . . .Clearing the room before he allegedly raised the Flynn matter with Comey is strong evidence the president knew what he was doing was “improper.” It is also impossible to see how Trump’s purpose here can be deemed “proper” without placing the president above the law. Even the president’s keenest defenders must concede that attempting to stop the Flynn matter by offering a bribe to Comey or threatening his family, physically or economically, would have been improper.

Trump’s alleged actions were somewhat less flagrant here. But courts have ruled, for example, that an attorney can be charged with obstruction when engaging in conduct that would otherwise be ordinary and allowable for a lawyer—like filing lawsuits or giving advice to witnesses—if the lawyer does so for the purpose of protecting himself or his associates from prosecution. Similarly, if a president wields his normally legal executive power for the purpose of halting the investigation of himself or his associates, he acts with an “improper purpose” to obstruct justice. . . .

I do think Mr. Mueller will ultimately say that a charge of felony obstruction will lie -- against 45. And he will refer it to Congress for articles of impeachment. And I do believe there will be principled Republicans who will vote those Articles -- all within a year. There you have it. Onward -- to a new week!


Saturday, July 8, 2017

[U] Space Science Saturday: I've Been Waiting A Year For This...

[Bumped, to top -- for Monday morning. . . . And yes this means we will ignore 45's disturbingly-unhinged tweets of this early morning -- at least until tomorrow.]

Not long after twisty long legged Juno safely used a gravity-assist/breaking maneuver -- to enter a stable orbit around mighty Jupiter (and another perfectly tiny copper-colored girl was born), I ran across this -- and knew the day would come, when we would get direct observational proof. [And we'd have a "she's one!" birthday party, to boot!]

Here almost exactly one year later, we are going to get that direct observational proof. At about 10 pm Eastern time, on Monday night, July 10, 2017, Juno will whiz over (at the lowest altitude, and closest approach ever attempted) the largest storm on Jupiter -- a yawning maw, some three times the size of the whole Earth. And it will almost certainly record temperatures that are hundreds of degrees hotter than the available, but faint sunlight would be capable of generating on its own.

Here is the NASA/JPL bit from last July:
. . . .NASA-funded research suggests that Jupiter’s Great Red Spot may be the mysterious heat source behind Jupiter’s surprisingly high upper atmospheric temperatures. . . .

Here on Earth, sunlight heats the atmosphere at altitudes well above the surface—for example, at 250 miles above our planet where the International Space Station orbits. Scientists have been stumped as to why temperatures in Jupiter’s upper atmosphere are comparable to those found at Earth, yet Jupiter is more than five times the distance from the sun. They wanted to know: if the sun isn’t the heat source, then what is?. . . .

“The extremely high temperatures observed above the storm appear to be the ‘smoking gun’ of this energy transfer,” said O’Donoghue. “This tells us that planet-wide heating is a plausible explanation for the ‘energy crisis,’ a problem in which upper-atmospheric temperatures are measured hundreds of degrees hotter than can be explained by sunlight alone. . . .”

NASA's Juno spacecraft, which recently arrived at Jupiter, will have several opportunities during its 20-month mission to observe the Great Red Spot and the turbulent region surrounding it. Juno will peer hundreds of miles downward into the atmosphere with its microwave radiometer, which passively senses heat coming from within the planet. This capability will enable Juno to reveal the deep structure of the Great Red Spot, along with other prominent Jovian features, such as the colorful cloud bands. . . . [posted July 29, 2016]

Do go read the link, to understand how the massive storm's gravity waves, and acoustic compression waves, crashing into one another, are thought to generate the excess heat. Indeed -- onward, and fittingly so -- to a perfect copper colored one year old baby girl's. . . birthday party, in a few hours. Grinning ear to ear, now -- on a sunny, hot and humid morning here. . . . We hope you enjoy yours, as well. . . . of course, it will take a few weeks to download the data, from Juno's solid state memory arrays. So we will be -- as ever -- patiently waiting.


Friday, July 7, 2017

Ancillary Merck Biz Dev Updates Dept.: Kenilworth's Stake In BeiGene Became 38% More Valuable -- In One Day...

We last looked in on Merck's very fortuitous investment in, and relationship with BeiGene in March of 2017. [More background here -- on what was originally a $10 million investment by Kenilworth -- now worth high hundreds of millions, including money already taken off the table.]

On Wednesday (while I was busily writing on the Martin Shkreli felonies prosecution in Brooklyn), Celgene did a multi-part, multi-asset deal with BeiGene, related to BeiGene's PD-1 candidate (and related Asian hard assets). Do go read the link below for all the details, but BeiGene stock popped about 38 per cent on the news, over the last two sessions -- nicely increasing the value of Merck's nearly seven per cent stake in the Chinese newly public company.

The price Celgene actually paid for the stock is hard to determine, since part of that price was the transfer of Celgene's China facilities and business operations. So we cannot compare Merck's stake directly to the cash recited in exchange for Celgene's six per cent of BeiGene. But I guarantee that Mr. Frazier is smiling about his investment, now.

The bite, from Xconomy New York, then:

. . . .The deal announced late Wednesday calls for Celgene to pay $263 million up front in licensing fees for global rights to BeiGene’s lead cancer drug in solid tumors. BeiGene keeps the right to develop and commercialize the drug in Asia, except for Japan, whose rights go to Celgene. If Celgene succeeds in developing the drug and commercializing it, the company could owe BeiGene as much as $980 million in milestone payments.

The transaction also includes equity. While Celgene has agreed to pay $150 million for a 5.9 percent ownership stake in its partner, BeiGene will take over Celgene’s China operations. The deal also grants BeiGene rights to manage the sales and marketing of three Celgene cancer drugs that are already approved in China.

The centerpiece of the deal is BeiGene’s lead compound, BGB-A317. The antibody drug is in a class of cancer treatments called checkpoint inhibitors. These drugs block the PD-1 protein, which some cancers can use to avoid detection by the body’s immune system. BeiGene developed its drug for targeting solid tumors as well as blood-borne cancers. . . .

Have an excellent weekend, one and all -- do go enjoy your celebrations -- as my biggest boy (and lil'est baby-girl) are having a special weekend, too. . . . smile.


Thursday, July 6, 2017

[U] Cassini Saturnian Ring Plunge No. 12 Completed -- Signal Acquired! Underway Right Now

We are now more than halfway -- to the dramatic death-burn, and vanishing, in silence -- of September 15, 2017.

This is the midpoint of orbit 12 -- of 22, in this ever tightening orbit series -- each a foreshadowing of the final noose, of sorts. On that September morning, local time -- at the end point of orbit 22, twisty copper colored Cassini will be vaporized as she skims and glides, out of fuel -- deeper and deeper -- into Saturn's atmosphere. . . a somewhat melancholy notion, indeed. . . .

But on this glorious summer's morning, she is still performing revolutionary (pun intended!) gas giant planetary science. Here is the overview, from NASA's mission logs:

. . . .During this orbit, Cassini’s Ultraviolet Imaging Spectrograph (UVIS) stares at the star Kappa Canis Majoris, as parts of the C ring and A ring pass between the spacecraft and the star. The spacecraft’s Composite Infrared Spectrometer (CIRS) observes the occultation as well.

Cassini’s imaging cameras, the Imaging Science Subsystem (ISS), observes some of Saturn’s known ring propeller features, then targets the border region of the F ring and A ring to study ring dynamics there.

Cassini’s UVIS instrument also studies small-scale structures in the rings.

During this orbit’s ring-plane crossing, the spacecraft is oriented such that its high-gain antenna (the big dish) faces forward (called “HGA to RAM”) to help shield the spacecraft from ring particles.

Also during ring-plane crossing, in the brief period in which impacts are most likely, the Radio and Plasma Wave Science (RPWS) instrument "listens" for the impacts of ring particles, which produce detectable plasma clouds when they strike the spacecraft. The antenna protrudes several meters beyond the protection of the high-gain antenna and so still detects impacts. . . .

During this orbit, Cassini gets within 2,320 miles (3,730 kilometers) of Saturn’s 1-bar level. Cassini also passes within 2,470 miles (3,980 kilometers) of the inner edge of Saturn’s D ring. . . .

Now you know -- and [UPDATED!] we have seen (thus the new masthead!) should see a signal acquisition ping, from the beautifully twisting lil' shepherded moon-let, as she moves with truly unwasted grace (conserving fuel all the while) -- after midnight local, tonight. . . that will indicate she is safe, sound, hale and whole -- and still sprinting about the planet. . . preparing ultimately for her. . . fiery demise.

Onward, on a gorgeous July morning -- in a ferociously gleaming city
. Smile.


Arriving Late To The FDA's Multiple Myeloma Pembrolizumab Pomalidomide Lenalidomide Halt Decision -- But Merck Likely To Open Off Tomorrow...

We were (quite happily) out, and off grid all night -- with our fun-loving adult kids, and so arrive here after midnight on Tuesday/early Wednesday -- to express our concern. There was a foreshadowing of all this, at mid-June 2017 with the studies' safety monitors imposing a pause, in enrollments. But now FDA has stopped these studies in total. I would expect a one to two per cent additional decline in Merck's NYSE price, beyond the decline in the after-hours session on the NASDAQ, tonight. Sad news, but patients (and patient safety -- i.e., "first, do no harm") must come first.

Much has already been written, in the financial press -- so I'll simply quote the full release here. Some of the most difficult news appears near the end of the presser, with some specificity around non-disease-progression related deaths (even in other cancers):

. . . .The FDA has determined that the data available at the present time indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. All patients enrolled in KEYNOTE-183 and KEYNOTE-185 and those in the KEYTRUDA/lenalidomide/dexamethasone cohort in KEYNOTE-023 will discontinue investigational treatment with KEYTRUDA. This clinical hold does not apply to other studies with KEYTRUDA. . . .

KEYTRUDA (pembrolizumab) was discontinued due to adverse reactions in 5% of 210 patients with cHL, and treatment was interrupted due to adverse reactions in 26% of patients. Fifteen percent (15%) of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 16% of patients. The most frequent serious adverse reactions (≥1%) included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; one from GVHD after subsequent allogeneic HSCT and one from septic shock. The most common adverse reactions (occurring in ≥20% of patients) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%). . . .

KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reactions (in ≥20% of patients) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%). Eighteen patients (5%) died from causes other than disease progression. Five patients (1.4%) who were treated with KEYTRUDA experienced sepsis which led to death, and 3 patients (0.8%) experienced pneumonia which led to death. Adverse reactions leading to interruption of KEYTRUDA occurred in 22% of patients; the most common (≥1%) were liver enzyme increase, diarrhea, urinary tract infection, acute kidney injury, fatigue, joint pain, and pneumonia. Serious adverse reactions occurred in 42% of patients, the most frequent (≥2%) of which were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis.

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Adverse reactions leading to interruption of KEYTRUDA occurred in 20% of patients; the most common (≥1%) were urinary tract infection (1.5%), diarrhea (1.5%), and colitis (1.1%). The most common adverse reactions (≥20%) in patients who received KEYTRUDA vs those who received chemotherapy were fatigue (38% vs 56%), musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%), decreased appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients, the most frequent (≥2%) of which were urinary tract infection, pneumonia, anemia, and pneumonitis. . . .

Now you know. I would expect some share price declines at BMS and at Roche/Genentech as well, in the morning -- as (at least at this early stage) there would be little reason not to think this might be a class wide effect, with the Celgene agent(s). But we shall see. G'night to all of good will -- and in unrelated news, Cassini is completing Ring Plunge 12 as I type this. . . we should see a twisty, copper colored "signal acquired" confirmation -- by tomorrow night. . . .


Wednesday, July 5, 2017

What A Iceberg The Size Of Delaware Might Look Like -- Antarctica’s Larsen C Ice Shelf/Berg

The European Space Agency -- using its CryoSat satellite instrument package, and its Copernicus Sentinel-1 craft -- has today modeled what the most massive ice-berg in history might well look like -- when it calves. See at right. But it will calve, no doubt. It is too massive, and the crack, just too deep -- for any other outcome. Physics tells no jokes.

A solid block of of ice, free floating, roughly the size of Delaware (or Galway, if that's your Irish perspective) -- will be the largest that has ever been witnessed in recorded human history. Thanks, climate change. From, then -- a bit:

. . . .All eyes are on Antarctica’s Larsen C ice shelf as a deep crack continues to cut across the ice, leaving a huge chunk clinging on. When it eventually gives way, one of the largest icebergs on record will be set adrift. . . .

Noel Gourmelen from the University of Edinburgh said, “Using information from CryoSat, we have mapped the elevation of the ice above the ocean and worked out that the eventual iceberg will be about 190 m thick and contain about 1155 cubic kilometres of ice.

“We have also estimated that the depth below sea level could be as much as 210 m. . . .”

Of course, it could break apart nearly immediately, spawning hundreds of smaller bergs, sooner or later, but there will be no way to know. . . until it happens. But it will happen. That is now a mathematical/earth sciences physics certainty. Tonight -- next week, next month -- or in 2018, but likely before 2019.

Now you know. City fun today, in between office work, with my fantastic adult offspring in town, and visiting [doin' all the "Ferris Bueller" stuff -- 1:20 PM Cubs and. . . ("I'm Abe Fromann -- the sausage king of Chicago!. . .")] -- until Sunday night, now! Onward. . . .