Archive for the ‘Uncategorized’ Category

O/T: Just A Few Random Throw-Aways… Saturday .45 Special Edition
July 22, 2017

Ahem. We now have a sitting US President who cannot discern (and doesn’t care to learn) the difference between the word “counsel” — and the word “council”. This is not the first time he has used the wrong version of that word in his tweets, but I note it today, since it points to a lack of focus — a lack of rigor — a stunning lack of. . . work ethic — the work, of applying the gift (i.e., an education) he was given — but plainly never. . . actually earned.

It may seem trivial or venial, even — for my critique to start there. But truly it all goes decidedly downhill, from here. His tweet-storm this morning is a cornucopia of. . . nonsense.

He asks why Mr. Mueller is not investigating HRC for various things. Um. . . because the special COUNSEL (note spelling, Mr. Trump) has a limited charter. And it doesn’t include looking at anything that is not related to complicity with Russian efforts to undermine our election — but tellingly, it DOES INCLUDE looking at anyone’s efforts to obstruct that investigation.

It is only focused on you, Mr. President, and your people — precisely because it is not a fishing expedition. It is a focused look, at your ties to the Russian oligarchy. And yes, it plainly now includes looking into the financial incentives you (and your family empire) might have – to be complicit with that oligarchy’s requests — the American people, national security (and worldwide security). . . be damned.

Yes, Mr. President — I am hinting at. . . treason. But I will let Mr. Mueller do his job. [And we all now know this is why we couldn’t see your (and your family empire’s) tax returns. But Mr. Mueller has, already — I’ll guarantee that much.] Your tweet about “no crime” perhaps unintentionally tellingly — and thus ironically — modified the phrase “no crime” with a “so far“.

It may take Mr. Mueller six or seven more months, but I think you are right — in that at least your “so far/yet” is clearly a wise turn of phrase.

There is so much more packed in to these completely deranged views, at right — but I will close with just this: it is your duty, Mr. President to uphold the law. To explain to “so many people” that Mrs. Clinton holds no office; is not the focus of any bipartisan Congressional committee — let alone a Special COUNSEL (that darn word again!) — all because you FIRED the regular one. Finally, as if it even needed saying(!), no one else has threatened Mr. Mueller, by telling The New York Times that Trump family finances are a “red line” — one the duly appointed Special Counsel Mueller ought not cross (despite the charter clearly authorizing EXACTLY that very inquiry). You are cooked, Mr. Trump. You just can’t admit it “so far. . .” or. . . “YET“. Or should I say. . . “nyet“?

Please do the nation a favor, and. . . step down, willingly. Nixon did (on far less egregious matters — a bungled burglary of a DC hotel, to get Democratic secrets — and the smoking gun was 18 minutes of missing audiotape). Not collusion with Russian oligarchs, to throw our election [where entire federal tax returns (thousands of pages — which even Nixon made public) are “missing” — from public view]. Step down, Mr. President.

नमस्ते

CDC: Merck’s Adult Hep B Vaccine Is Stocked Out, Through The End Of 2018
July 21, 2017

Almost seven years ago this month, we faced this sort of a situation with Merck’s adult Hep B vaccine, leading some (myself included) to wonder whether Merck was simply withdrawing from the market, albeit in a soft-spoken way. That turned out not to be the case.

Tonight, we’ve learned — from the CDC’s updated availability charts, that Kenilworth’s sourced Hep B vaccine is stocked out. Glaxo however will be able to cover the shortage in the near term (just as it did in the summer of 2010). Pediatric Hep B vaccines will be unavailable from Merck now, before mid-January 2018. The adult version faces even longer stock-out projections: it will be unavailable for all of 2018, and perhaps a little beyond. Per the CDC’s web resource, just updated, then:

. . . .Merck is not currently distributing its adult Hepatitis B vaccine and does not expect to be distributing adult Hepatitis B vaccine between now and the end of 2018. Additionally, Merck anticipates that its pediatric Hepatitis B vaccine will be unavailable between early August 2017 and mid-January 2018.

Merck’s supply of the dialysis formulation of Hepatitis B vaccine, however, is not affected and is expected to remain available. GSK has sufficient supplies of adult and pediatric Hepatitis B vaccines to address these anticipated gap in Merck’s supply of adult and pediatric Hepatitis B vaccines during these time periods; however, preferences for a specific presentation (i.e., vial versus syringe) may not be met consistently during this time. Updated Jul 2017. . . .

So it goes. Off to sleep now. . . smiling just the same — as the night sky is powdered with stars, from here. . . .

नमस्ते

Both The Aloha State, And 45 Seek To Avoid Delays — And Oral Arguments — In Ninth Circuit
July 21, 2017

Given that the Supremes have sent Mr. Trump’s appeal back to the Ninth Circuit, insofar as it concerns interpretations of the Supremes’ cert. grant — and given that the parties will now be arguing first thing in the morning, before the Supremes, on October 10, 2017 — both sides are trying to accelerate things through the Ninth Circuit.

Thus, this evening, they have filed this joint motion to expedite (the first brief had previously not been set to be filed until August 11, 2017 — now it will be mid next week):

. . . .On July 14, 2017, this Court docketed this appeal and issued a briefing schedule, by which the opening brief and excerpts of record are currently due August 11, 2007; the answering brief September 8, 2017, or 28 days after service of the opening brief, whichever is earlier; and the optional reply brief within 21 days after service of the answering brief.

The parties have conferred and jointly move for the following expedited briefing schedule:

July 27, 2017 – opening brief and excerpts of record

August 3, 2017 – answering brief and supplemental excerpts of record (if any)

August 9, 2017 – reply brief

The parties believe expedition of the briefing schedule is appropriate given the urgency of the issues involved in this preliminary injunction appeal.

Given the need for expedition, and the nature of the underlying issues presented on appeal, the parties believe that the appeal can be resolved without oral argument. Should the Court believe that argument would be useful, however, the parties respectfully request that argument be scheduled as soon as practicable following the conclusion of briefing. . . .

Now you know — and. . . now I am really crashing!

नमस्ते

Minor Federal Propecia®/Proscar® MDL (Procedural) Spat: Counsel Should Train — And Occasionally Check-In On — Their Paraprofessionals
July 21, 2017

I will post a Friday trivia item here — and redact the involved counsel’s name. It won’t in any manner affect the outcome in any finasteride suit (and to be clear it involves a plaintiffs’ side lawyer’s office) — but it is a good warning: do read the order entered just yesterday, in Brooklyn’s federal District Court, below. . . all I can think of to say is. . .

Oops!

. . . .ORDER. The Court has received two telephone calls from a paralegal in Mr. [Redacted’s] office in which she demanded identification of Court staff, which was refused pursuant to Chambers policy, and then asked to speak to the Judge.

This paralegal used a rude tone.

Mr. [Redacted] is advised that this person is not to call Chambers again and any further attempt to engage in an ex parte communication with the Court will result in a sanction against Mr. [Redacted].

Ordered by Judge Brian M. Cogan on 7/20/2017. . . .

Now you know — do always be courteous on the phone, and in person, with any court clerk’s offices. . . and do have a wonderful, joy-filled weekend, one and all — I know I will. . . .

नमस्ते

In A Reversal Of Long Term Prior Trend Lines… Pfizer And Merck Spent About Equally, In Q2 2017, On Lobbying
July 21, 2017

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 here, 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.

नमस्ते

Merck Gets FDA Nod For Sanofi Biosim Insulin Glargine Injection — But Must Now Litigate The Patent, Under Hatch-Waxman
July 20, 2017

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!

नमस्ते

[U] Many Former US Intelligence Officials Weigh In, On 45’s Generally Goofy Supremes Gambit…
July 19, 2017

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 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 SCOTUSBlog.com), 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.

नमस्ते

[U] Hawaii (Unsurprisingly) Tells The Supremes That Grandparents Are “Close Family”… [Trump Is No Gen. MacArthur Edition]
July 18, 2017

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.

नमस्ते

[U] Merck Ordered To Pay $12.6 Million Of Gilead’s Legal Fees, For Former Merck Patent Counsel’s “Egregious Misconduct”
July 18, 2017

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.

नमस्ते

Consider the Irony, Here: Merck Taps Texas State Funds For $6 Million…
July 18, 2017

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.

नमस्ते