Friday, October 20, 2017

More Sales Force Cuts At Merck -- 1,800 Positions "Ghosted" By January 2, 2018...


This follows on the heels of similar moves at Lilly (3,500 positions), just a month ago. And two months ago, generics maker Teva announced 7,000 would be let go.

So it cannot be entirely unexpected (at least on Wall and Broad) -- and even though the affected folks may "self-nom" for newly created roles (960 of them, in chronic care alone). . . and they have until New Years to find different roles inside the company -- this is never easy.

FiercePharma first had the story -- do go read it all. But this is about real people, losing their jobs -- their careers. Whole families being dislocated, almost as effectively as Harvey or Irma both recently did. Know that our thoughts and meditations are with each of you. [Been there; done that; got that tee shirt.]

Onward. And know that soon enough, the sun will also rise, for each of you.

नमस्ते

Even If It Is $275 Million... It Is Immaterial. Yawn.


There were some fairly breathless reports overnight -- mostly third party guesses, actually -- as to the potential size and scope of the mid 2017 cyber attack that struck Merck, among other multinationals. At the size reported, it would be. . . simply immaterial to Merck -- and Merck need not comment at all on the matter.

It should be noted that Kenilworth has definitively said that it is still unable to estimate a range of exposure for the attack, all in. Under applicable SEC rules, the company need only provide such a guestimate if it is (i) reasonably likely to be material (i.e., more than five percent of annual revenues -- or more than about $2.4 billion), and then (ii) reasonably capable of any confident estimation.

So -- for my part, while I expect that the vaccine interruption may ultimately total a little more than these breathless guesses, the range would have to grow about ten-times larger, to be "material" under current SEC guidance.

And I think that possibility is vanishingly remote. Which is likely why the company's stock rose on the NYSE yesterday, and will likely trade about even with the overall large cap pharma market today. Earlier this week, J&J reported a solid quarter (Q2 2017); I expect Merck to do much the same, in fairly short order. Its earnings call is one week away.

Now you know -- as we offer a "this day in history" moment on the masthead -- just. . . for fun. Perhaps of more current relevance (but since I didn't want to take the darker historical moment, and fashion any visual allegories), it was exactly 70 years ago this morning (October 20, 1947) that the US House Un-American Activities Committee began issuing subpoenas to people in Hollywood, essentially accusing them of communism -- as a way to enforce conformity.

As I say, I didn't want to wallow in negative karma, but the current occupant of 1600 Pennsylvania seems to now daily tweet decidedly pungent bits -- aimed both at the NFL owners, and players -- trying to enforce his own brand of conformity, upon NFL players -- union members, all. As I've written before, not only is that antithetical to a free and just labor market -- and our society of ordered liberty, it is an arguable violation of federal law. So -- instead -- as dawn arrives here, luminous and clear -- let us contemplate the Louisiana Purchase! Smile. . . . onward, as I say. [I think Trump is simply trying to use his seat to get even with (settle scores) related to the three decades ago failure of his USFL NJ Generals. . . he has always blamed the NFL for that.]



नमस्ते

Wednesday, October 18, 2017

Now, With Another Victory For Pluralism And Economic Freedom -- In Maryland, Overnight -- Trump Is 0-For-15!


A 91 page opinion has issued against Trump, in the federal district courts of Maryland, overnight. It comes on the heels of Hawaii's ruling, yesterday -- and this makes him 0-for-15, on the merits. His Ban 3.0 was slated to take effect today. No more.

Two items of note, here. First, the opinion carefully addresses the US Supreme Court's removal of the "2.0" dispute from its own docket -- explaining that while the earlier Fourth Circuit opinions are no longer technically precedential, the reasoning found there remains sound, and so the trial court quotes it where appropriate, but enters its own conclusions of law, independently. It also relies on the Ninth Circuit's holdings, since the Supremes haven't technically vacated those yet, either.

Second, this is a preliminary injunction, nation wide -- while in contrast, the Hawaii opinion is a TRO (i.e., generally of shorter duration). This, then is the next step toward a permanent shut-down of Trump's Muslim banning schemes. Of course, 45 will appeal, but here is a bit:

. . . .At issue is whether this latest travel ban should be enjoined by this Court because it is the latest incarnation of the “Muslim ban” originally promised by President Trump as a candidate for the presidency, and thus violates the Establishment Clause of the First Amendment to the United States Constitution, or because the issuance of the travel ban exceeds the President’s delegated authority under the Immigration and Nationality Act to suspend the entry into the United States of classes of immigrants and nonimmigrants. For the reasons set forth below, the Court concludes that a preliminary injunction is warranted. . . .

In response to the injunctions against EO-1, President Trump maintained at a February 16, 2017 news conference that EO-1 was lawful but that a new Order would be issued. J.R. 91. Stephen Miller, Senior Policy Advisor to the President, described the changes being made to the Order as “mostly minor technical differences,” emphasizing that the “basic policies are still going to be in effect.” J.R. 319. White House Press Secretary Sean Spicer stated that “[t]he principles of the [second] executive order remain the same”. . . .

In [its later] ruling, the Fourth Circuit described EO-2 as one that “drips with religious intolerance, animus, and discrimination.” Id. at 572. After finding that an individual plaintiff had standing to challenge the ban and concluding that upon a showing of bad faith it could “look behind” a proffered “facially legitimate” reason for the action, the court applied standard Establishment Clause analysis to conclude that because EO-2 “cannot be divorced from the cohesive narrative linking it to the animus that inspired it . . . the reasonable observer would likely conclude that [EO-2’s] primary purpose is to exclude persons from the United States on the basis of their religious beliefs.” IRAP, 857 F.3d at 586, 590-92, 601. . . .

[Today's injunction] is limited to barring enforcement of Section 2 against those individuals “who have a credible claim of a bona fide relationship with a person or entity in the United States.” Trump, 137 S. Ct. at 2088. For individuals, the injunction covers visa applications by individuals with immediate family members, such as parents, children, or siblings, as well as “grandparents, grandchildren, brothers-in-law, sisters-in-law, aunts, uncles, nieces, nephews, and cousins of persons in the United States. . . .”


Onward -- still with glimmers of hope, for my Cubbies -- and that -- at 0-3 is decidedly more hope than for any chance Mr. Trump will ever do anything sensible, or lawful.

His widely corroborated remarks to Mrs. Myeshia Johnson, the young widow of Sgt. La David T. Johnson, our brave serviceman killed in the line of duty in Niger (12 days ago -- i.e., a long silence from 45) are. . . simply deplorable.

Even so, we will look forward to Bobby Three Stick's conclusions -- near Christmas 2017.



[Masthead updated, in the sincerely-held hope that people representing Katherine Johnson will soon consent to her inclusion -- in the "NASA STEM on Fleek" a/k/a "NASA Cool Women Lego" set. . . . smile.]

नमस्ते

Tuesday, October 17, 2017

Well... Some Things Never Change -- And Some Things... Do.


At least last year, the Cubbies were world champs for the first time in over 100 years. At the moment they are down 0-2 to those transplanted Brooklyn Dodgers -- but coming home, to the friendly confines, tonight. So, among us faithful. . . there is hope.

Okay. Roger that. Now. . . the last time Mr. Trump won any final, on the merits decision on his Muslim Bans 1.0, 2.0 and 3.0 was. . . Oops! Never. He's zero for something like 14 now.

On to the Ninth Circuit (on Judge Watson's fine decision, here -- even though it is only a TRO -- that's been the Administration's prior approach: take immediate appeals, rather than await a final injunction order, as 45 well knows it is coming). And all of this, while we await a trial court level TRO ruling in Maryland -- with likely the same outcome as below. [Busy deal day -- so I am late with this. My apologies.]

Here's the full 40 page PDF of the opinion, from the correct and courageous USDC Judge Derrick Watson, just now -- and a bit:
. . . .On June 12, 2017, the Ninth Circuit affirmed this Court’s injunction of Sections 2 and 6 of Executive Order No. 13,780, 82 Fed. Reg. 13209 (Mar. 6, 2017), entitled “Protecting the Nation from Foreign Terrorist Entry into the United States” (“EO-2”). Hawaii v. Trump, 859 F.3d 741 (9th Cir. 2017). The Ninth Circuit did so because “the President, in issuing the Executive Order, exceeded the scope of the authority delegated to him by Congress” in 8 U.S.C. § 1182(f). Hawaii, 859 F.3d at 755. It further did so because EO-2 “runs afoul of other provisions of the [Immigration and Nationality Act (‘INA’), specifically 8 U.S.C. § 1152,] that prohibit nationality-based discrimination.” Hawaii, 859 F.3d at 756.

Enter EO-3. Ignoring the guidance afforded by the Ninth Circuit that at least this Court is obligated to follow, EO-3 suffers from precisely the same maladies as its predecessor: it lacks sufficient findings that the entry of more than 150 million nationals from six specified countries would be “detrimental to the interests of the United States,” a precondition that the Ninth Circuit determined must be satisfied before the Executive may properly invoke Section 1182(f). Hawaii, 859 F.3d at 774. And EO-3 plainly discriminates based on nationality in the manner that the Ninth Circuit has found antithetical to both Section 1152(a) and the founding principles of this Nation. Hawaii, 859 F.3d at 776–79. . . .

Accordingly, based on the record before it, the Court concludes that Plaintiffs have met their burden of establishing a strong likelihood of success on the merits of their statutory claims, that irreparable injury is likely if the requested relief is not issued, and that the balance of the equities and public interest counsel in favor of granting the requested relief. Plaintiffs’ Motion for a Temporary Restraining Order (ECF No. 368) is GRANTED. . . .


Me? I am grinning ear to ear. As is Professor Albert Einstein -- likely beyond the event horizon, on the other side of the known Universe.

नमस्ते

And Let's Discuss The "Secret" Trump Muslim Ban 3.0 Report, Too...


Here is the latest, on that score, as well. And a bit of the filing:

. . .A basic premise of our adversarial system is that each party is permitted to view and consider documents material to the resolution of its case. Only the most extraordinary circumstances justify a departure from that practice. This case does not present such a circumstance. . . .


More, on the morrow. . . .

नमस्ते

Monday, October 16, 2017

Let's Discuss This Tomorrow, Shall We? Worlds Of Gold And Platinum...


The new masthead overnight is particularly fortuitous confluence of events. . . for it is Einstein's general relativity that is more solidly proven, as a fact, by the below light bursts, and billions of tons of gold and platinum formation, from the collision of two neutron stars -- to say nothing of the gravity wave observed.

And exactly 84 years ago, the man himself was among the "huddled masses, yearning to breathe free". . . this, while Trump reviews, endorses and signs secret reports -- the object of which is the banning of disfavored nationalities. . . where have we seen that behaviour, before? Hmmmm. . . . I'll let you decide, gentle readers.

In any event, from NASA, we offer this, as we wander off to sleep:



". . . .For the first time, NASA scientists have detected light tied to a gravitational-wave event, thanks to two merging neutron stars in the galaxy NGC 4993, located about 130 million light-years from Earth in the constellation Hydra.

Shortly after 8:41 a.m. EDT on Aug. 17, NASA's Fermi Gamma-ray Space Telescope picked up a pulse of high-energy light from a powerful explosion, which was immediately reported to astronomers around the globe as a short gamma-ray burst. The scientists at the National Science Foundation’s Laser Interferometer Gravitational-wave Observatory (LIGO) detected gravitational waves dubbed GW170817 from a pair of smashing stars tied to the gamma-ray burst, encouraging astronomers to look for the aftermath of the explosion. Shortly thereafter, the burst was detected as part of a follow-up analysis by ESA’s (European Space Agency’s) INTEGRAL satellite. . . .
"

I am simply agog, with the white-hot light, and gravitational waves, of colliding neutron stars. . . . see ya' mañana. . . .

नमस्ते

The Able Judge Bryson (In Texas) Ultimately Reserves On The Issue Of Legitimacy... But Expresses "Serious Reservations" About It, While Leaving The Question -- For IPR Proceedings


We will have to wait for the IPR proceedings to answer the question, definitively -- but it sure seems that the able Judge Bryson feels Brent Saunders' gambit, "to rent" sovereign immunity from a tribe of indigenous people. . . should be struck, as a sham transaction.

Ever employing the rule of parsimony, he did not rule exactly that, this morning -- to be clear. He ruled only that many of the patents are invalid -- but reserved for the IPR proceeding, the precise question of whether Mr. Saunders' artifice of "rented immunity" will be enforceable in the federal courts. Here's the judge's memorandum and opinion -- and a bit:

. . . .The Court has reviewed the information and briefs filed in response to the Court’s order. From that information, it is clear that Allergan’s motivation for the assignment was to attempt to avoid the IPR proceedings that are currently pending in the PTO by invoking the Tribe’s sovereign immunity as a bar to those proceedings. . . .

The Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed. The essence of the matter is this: Allergan purports to have sold the patents to the Tribe, but in reality it has paid the Tribe to allow Allergan to purchase -- or perhaps more precisely, to rent -- the Tribe’s sovereign immunity in order to defeat the pending IPR proceedings in the PTO. This is not a situation in which the patentee was entitled to sovereign immunity in the first instance. Rather, Allergan, which does not enjoy sovereign immunity, has invoked the benefits of the patent system and has obtained valuable patent protection for its product, Restasis. But when faced with the possibility that the PTO would determine that those patents should not have been issued, Allergan has sought to prevent the PTO from reconsidering its original issuance decision. What Allergan seeks is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits through the administrative mechanism for canceling invalid patents. . . .

But sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities. It is not an inexhaustible asset that can be sold to any party that might find it convenient to purchase immunity from suit. Because that is in essence is what the agreement between Allergan and the Tribe does, the Court has serious reservations about whether the contract between Allergan and the Tribe should be recognized as valid, rather than being held void as being contrary to public policy. . . .

While it is important to ensure that any judgment in this case will not be subject to challenge based on the omission of a necessary party, the Court is not required to decide whether the assignment of the patent rights from Allergan to the Tribe was valid in order to resolve the question whether to add the Tribe as a co-plaintiff. Instead, the Court will adopt the safer course of joining the Tribe as a co-plaintiff, while leaving the question of the validity of the assignment to be decided in the IPR proceedings, where it is directly presented. . . .


Now you know. Onward, on a lovely fall afternoon here.

नमस्ते

Saturday, October 14, 2017

As Promised: The Dueling Restasis® Memos (Public Versions) On Joinder Of The St. Regis Mohawk Tribe...


The redacted versions have been uploaded to PACER in Marshall, Texas overnight.

I will quote from the defendants' memo opposing the addition of the Tribe to the suit, on the central grounds that the entire license transaction was a sham, to subvert the existing US patent law review process. But I will also link to Allergan's memo setting forth its argument -- as to why joinder might be proper here -- to be fair.

Since Allergan has argued in favor (related to its Botox® line of products) of exactly what is now arguing against, just one year later (on its Restasis® lines) -- I'd say the defendants have the better of the argument:

. . . .This transaction was not a genuine purchase of intellectual property by the Tribe. Rather, Allergan paid for the use of the Tribe’s sovereign immunity to thwart the parallel inter partes reviews (“IPRs”) before the Patent Trial and Appeal Board (“PTAB”). Allergan admitted as much in its October 10 filing with the Court conceding that the alleged “consideration” provided by the Tribe was nothing more than the Tribe’s promise not to waive its sovereign immunity in the IPR proceedings. Thus, there has been no real change in ownership — just a maneuver to derail the PTAB’s ongoing review of Allergan’s patents. . . .

The sham nature of the transaction with the Tribe is further underscored by the fact that the Tribe did not pay Allergan a cent for the patents claiming Restasis, which generated $1.4 billion in 2016 sales, or $4 million dollars a day. Instead, it was Allergan who paid the Tribe $13.75 million up-front to take faux title to the Restasis patents. . . .

Further, the illicit purpose of the transaction — to subvert the PTAB’s lawful review and not to facilitate this litigation — provides ample reason to deny joinder. It bears noting in this context that Allergan used the IPR process against a third party’s patent that was inconvenient for Allergan’s best-selling Botox franchise only one year ago. Allergan even sought a stay of parallel district court proceedings on the ground that the IPR “would save both judicial and party resources, consistent with Congress’ intent in passing the America Invents Act.” Allergan Memorandum in Support of Motion Stay, No. 1:15-cv-03372, Dkt. No. 40 at 1-2 (N.D. Ill.). It is remarkable that Allergan considered the IPR process a valid, equitable proceeding for challenging patent validity when it filed its own IPR petition just last year — yet, now that the same tribunal is scrutinizing Allergan patents, Allergan and the Tribe consider IPRs “double jeopardy” administered by a “kangaroo court.” See Ex. 4 at 3. Given its own recent, successful reliance on IPRs, Allergan’s attempt to justify its sham assignment by labeling the IPR process inequitable, harmful “double jeopardy” is pure hypocrisy. . . .


Now you know -- a rainy but happy weekend here -- BladeRunner 2049 is a fine piece of art, and an entertaining diversion. Do re-screen the original, before going to the theater though -- the back story is critical, here. . . "sometimes to show true love, one must disappear -- become a stranger, entirely -- to best protect the immortal beloved. . ." Truer words were never spoken. Out.

नमस्ते

Friday, October 13, 2017

[U X 2] A New Patent Spat To Follow, Here: Allergan's IP Moves On Restasis® -- Mohawk Tribe Gambit


UPDATED: @ 3:15 PM EDT -- Well. . . all the operative motions due today have been. . . sealed. [Paging the New York Times and CNBC -- time to file a formal request, down in Texas. . . these are all of our courts. The case is pending in the Eastern District of Texas -- 2:15-cv-01455-WCB; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al.; William C. Bryson, presiding.] I gather that the defendants oppose the joinder of the Tribe -- and that Allergan believes joining the Tribe will not waive the Tribe's sovereign immunity. Beyond that, we will have to wait for the able Judge Bryson's order -- in East Texas, to learn more. [Second Update -- at day's end, Friday -- by tomorrow, I will have a new post, on the defendants' opposition (public version), to joinder of the Mohawk tribe (claiming the whole Saunders-led transaction is a sham, to thwart the US patent system). Until then. . . Blade Runner tonight -- and. . . End, updated portion; off to hit the food trucks for some red velvet cake, with cream-cheese icing!]

As several of my regular commenters have noted here, and at our other properties -- this odd-ball dispute does in fact relate to the original animating narrative surrounding this site, insofar as it is all being guided by Brent Saunders -- long a "Fast Fred" Hassan protégé, and confidant. It involves Allergan's Restasis®.

So we will track it -- starting today. Later today, we expect that the lawyers for Mr. Saunder's Allergan, at Fish, Richardson will explain for the able judge why, exactly, it is that the tribe has not yet joined the suit as a party.

That explanation is due by close of business today, Friday, but is not yet on file -- in the mean time, here is a six-page PDF of a background Allergan response to an order, from last week -- to get you up to speed if you haven't been following it in the newspapers (along with a pull-quote):

. . . .The Court’s October 6, 2017 Order (Dkt. 503) directed Allergan to provide the Court with “copies of those documents pertinent to the terms of the assignment of the patents-in-suit to the Tribe, including any information as to payments made or to be made either by the Tribe or by Allergan in connection with the transaction. . . .”

In its October 10 Order, the Court also directed Allergan to identify what the “good and valuable consideration” referred to in the assignment of the patents-in-suit to the Tribe “consisted of, and to provide any documentary evidence confirming the payment by the Tribe of any such consideration for the assignment of the patents.” (Dkt. 509 at 2-3.) The promises and commitments made by the Tribe in the simultaneously-executed assignment and license agreements, and the subsequent performance of those promises, provides such consideration. . . .


Now you know -- this one promises to be a barn burner -- with Judge Bryson highly skeptical of Mr. Saunders' attempt to game the existing US patent law dispute-, review-, expiration- and interference- systems. Stay tuned, and have a sparkling weekend, one and all -- I know I will, with a very dear adult niece in town late tonight, for a short visit -- before heading out to points west, by rail. . . . Good fun!

नमस्ते

Thursday, October 12, 2017

[U] Another “Nothing Burger”: Trump's Dubious (MEWA?) Exec. Order -- On Obamacare...


We now know he's signed it -- but until we can actually read a copy of it, in full, we cannot say for certain that it violates existing federal law.

However, I strongly suspect it does, based on what he "says" it does. 45 has lied anew. It does almost nothing he claims it does.

UPDATED @ 3:30 PM EDT — I’ve now read it. It’s aspirational only. A nothing burger — to wit:

“...Sec. 2. Expanded Access to Association Health Plans. Within 60 days of the date of this order, the Secretary of Labor shall consider proposing regulations or revising guidance, consistent with law, to expand access to health coverage by allowing more employers to form AHPs. To the extent permitted by law and supported by sound policy, the Secretary should consider expanding the conditions that satisfy the commonality‑of-interest requirements under current Department of Labor advisory opinions interpreting the definition of an "employer" under section 3(5) of the Employee Retirement Income Security Act of 1974. The Secretary of Labor should also consider ways to promote AHP formation. . . .

[End, update.]

More very soon whenever 45 decides to stop being so opaque. [Under Mr. Obama, executive orders were posted to the web as he signed them.] Not so, with the adult day care center, at 1600 Pennsylvania.

And so, until then -- a graphic. If All it is is an aspirational MEWA authorization, it is meaningless -- like almost everything else he has written on health care. And it will not affect November 2017 enrollment periods, in any event. But now we wait for the adult day care center to declare a recess, and let us inspect and analyze. . . his scribbles. Out, for now.

नमस्ते

Surprising No One Dept.: Ebola Vaccine Shined; CETP Inhibitor Anacetrapib Discontinued...


As expected, the placebo controlled results are in on Merck's Ebola vaccine (by way of NewLink) -- and on GSK's two dose version: each works -- and works very well. Not likely to be a huge money maker, but clearly the right thing to do -- in the saving of perhaps hundreds of thousands of at-risk fellow human beings department.

Also as expected, and thus not likely to much move Merck's NYSE price -- Kenilworth will not seek FDA approval for cholesterol management candidate Anacetrapib. The data is just not compelling. And this sort of discipline is to be admired, at Merck. It is a welcome shift from the "Fast Freddie" days at legacy Schering-Plough.

Here's a bit on CETP, from the esteemed John Carroll -- do go read it all:

. . . .The pharma giant looked over a set of positive but troublesome Phase III data for its drug anacetrapib and concluded today that they will relegate it to the same graveyard that has greeted every over CETP heart drug so far. . . .

The decision underscores a tidal shift in drug developer’s standards for launching a big new drug into a major market, where the data has to point to a compelling market opportunity. Failing that, marginal drugs don’t stand a chance, even if they might pass muster at the FDA. . . .


Now you know. And the lovely, copper colored, long legged Jupiter-kissing Juno will make another close plunge over the Jovian poles soon -- more on that later -- as she too floats, with unwasted grace. . . smile.

नमस्ते

Tuesday, October 10, 2017

[U X2] Hawaii Has Buried 45: A Rock-Solid 44 Page THIRD Amended Complaint -- On Muslim Ban No. 3!


UPDATED: 10.11.17 @ 10 AM EDT -- Overnight the able Judge Watson has ordered 45's lawyers to produce, by October 14, the document (apparently not yet made public, in violation of the applicable federal rules) upon which the Trump Administration relies as the would be empirical support for Ban No. 3, thus:

"The Government is ordered to provide, with its response to Plaintiffs' filings, a copy of the September 15, 2017 Report submitted by the Secretary of Homeland Security, which is referenced in Section 1(h) of Proclamation No. 9645 entitled "Enhancing Vetting Capabilities and Processes for Detecting Attempted Entry Into the United States by Terrorists or Other Public-Safety Threats." The September 15, 2017 Report is due no later than 6:00 AM H.S.T. on October 14, 2017. . . .

IT IS SO ORDERED. (JUDGE DERRICK K. WATSON). . .
"


This is significant -- I was not aware that 45 was withholding rules-required documents from the public view, on this latest ban attempt. If we are a nation of laws, Mr. Trump will no longer be able to avoid explaining his rationale for Muslim Ban No. 3 now -- and so, it will fail. [End, updated portion.]

Do read it all -- including exhibits, it weighs in at nearly one hundred pages.

I've attached only the 44 page amended complaint, proper. 45 will lose in Hawaii, and he will lose in Maryland. Here's a bit:

. . . .On September 15, 2017, the President issued a tweet stating: “The travel ban into the United States should be far larger, tougher and more specific but stupidly, that would not be politically correct!”

The White House Press Secretary has confirmed that President Trump’s tweets represent “official statements”. . . . The President has never renounced or repudiated his calls for a ban on Muslim immigration. . . .

Six of the seven countries whose nationals are subject to entry restrictions under EO-3 — Chad, Iran, Libya, Syria, Somalia, and Yemen — have majority-Muslim populations. Approximately 55.3% of Chad’s population is Muslim. Among the other five countries, the percentage of the population that is Muslim ranges from 92.8% to 99.8%. . . .


Between issuing patently unconstitutional proclamations (and helping his current -- and former -- wives argue about who is the "real" First Lady -- yeesh!), and engaging in sophomoric tweet battles with both his Secretary of State (over IQs!), and now, demeaning the height of the Republican Senator from Tennessee -- I often wonder: what exactly is this guy doing, to earn a tax-payer funded paycheck?

FINAL UPDATE: 10.12.17 @ 4:00 PM EDT -- In the Maryland case, Trump's lawyers (just now filed, as a new motion) make the preposterous claim (at pages 28 to 32) that once Congress delegates some immigration power to the President, it may never amend those delegtions, nor take any of them back. They rely on a 1918 version of the statute -- to say his powers are unreviewable ever since 1918. Thus, they argue that the 1966 amendments to the INA cannot be a basis for stopping 45's "nationality-based pogroms". That is absurd. But they have to argue that, because his are plain violations of the 1966 amendments. [End updated portion.]

He clearly golfs too much, wastes weeks doing nothing (telling private employers what they must tell their unionized workers to do or not do -- most recently, threatening NFL tax status — all in arguable violation of 18 U.S. Code § 227), and then talks way too much nonsense trash -- to be anyone's effective leader. He should return all of his federal paychecks. Right now. Out.

नमस्ते

Merck Could Pay KalVista Up To $715 Million For Phase II Diabetes-Related Eye Treatments...


The upfronts here -- payable by Kenilworth -- are fairly modest, with a less than $10 million investment in KalVista's equity, for an about 10 per cent stake in of KalVista, plus nonrefundable R&D cash allotment draw of about $37 million.

Diabetics face daunting vision loss, in many, many advanced cases -- and these proprietary KalVista investigational small molecule protease inhibitors, ultimately in an oral form, may provide a meaningful advance in treatment options.

The big money (potentially up to three quarters of a billion dollars) is contingent on research-, development-, study- and regulatory-filing-milestones being met. Here's a bit -- but do go read it all:

. . . .“We are pleased to collaborate with Merck for the continuing development of KVD001 and future oral programs for patients with DME,” said Andrew Crockett, Chief Executive Officer of KalVista. “Plasma kallikrein inhibition is a novel approach to the treatment of DME that we believe may offer benefit to a significant number of patients, and an oral therapy particularly would represent a groundbreaking advance for treatment of this indication.

We have always believed that development and commercialization of our DME therapies would require the resources of a large pharmaceutical company, and we believe Merck has the wherewithal and resources to help us advance development of our DME drug candidates. Importantly for KalVista, this collaboration also meets our strategic objectives of maintaining control of our oral HAE portfolio that we plan to develop independently. We look forward to providing more details about the Phase 2 trial for KVD001 in DME patients as the trial commences.”. . .


Now you know -- and onward, with a grin -- one full year later. . . and more.

नमस्ते

Monday, October 9, 2017

In Two Federal District Courthouses -- In Maryland And Hawaii -- Trump Is This Week Poised To Be Soundly Beaten, Again.


As I said I would on Friday, the below very aggressive timeline is why the tiny handed tyrant's lawyers will have their hands full this week.

In Maryland, the main motions hearing will be a week from tomorrow, October 17, 2017, at 9:30 AM EDT. Much of 45's hardline framework, released just yesterday, will befall the same fate as his now three banning attempts. On that you may reliably bank -- and for all the reasons we've articulated, since at least January of 2017. About 45 posts' worth.

His insistence on a "white supremacy" enabled immigration policy has thus far been his undoing -- and the Sunday framework is very much more of the same. Sen. Corker is right: someone missed their adult day care shift, at 1600 Penn yesterday. Who, indeed, was supposed to minding the miscreant in chief, yesterday? Jared? Ivanka? General Kelly? No matter -- Bobby Three Sticks will likely see him impeached by Christmas. Here's the latest, from Honolulu:

. . . .Upon consideration of Plaintiffs' Motion to Lift the Stay, and to Increase the Word Limit and Set a Schedule for Briefing on Plaintiffs' Forthcoming Motion for a Temporary Restraining Order ("Motion") (Dkt. No. 363), and good cause appearing therefor, the Court's April 3, 2017 stay of the proceedings in this case is hereby lifted (Dkt. No. 279).

Plaintiffs shall file their Motion for Leave to File a Third Amended Complaint and Motion for a Temporary Restraining Order by 6:00 AM Hawaii Standard Time ("H.S.T.") on October 10, 2017. The Government shall file its response to both Plaintiffs' Motion for Leave to File a Third Amended Complaint and Plaintiffs' Motion for a Temporary Restraining Order by 6:00 AM H.S.T. on October 14, 2017. Plaintiffs shall file their reply briefs by 12:00 Noon H.S.T. on October 15, 2017. The Court intends to rule on Plaintiffs' Motions without a hearing. The request to increase the word limit associated with the Motion for a Temporary Restraining Order is denied.

IT IS SO ORDERED. . . .


Now you know. Get ready to suffer more losses, 45. You've earned them. And Senator Corker (R, TN) is right -- about you being a WW III threat.

Even so, I am smiling -- the latest from Dan Brown is a fun light-hearted page turner, called Origin -- and now. . . soon I am off, with my passport readily at hand -- and pleasurable travel ahead.

नमस्ते

Sunday, October 8, 2017

[U X2:] What The Grown-Ups In The Room Are Offering -- As Improvements To ObamaCare...


I will henceforth generally ignore 45's tweets on or about health care delivery in the United States.

They are (like he is, generally). . . impotent. Increasingly isolated, and acting alone, he will be able to do next to nothing. But I did want to mention that if he thinks expanding the ways in which employers may deny women family planning coverage is going to help him win any broader changes in the ACA of 2010 -- he is mistaken. See below, from the venerable Gray Lady, overnight:

. . . .In a statement on Saturday, Mr. Schumer said: “The president wanted to make another run at repeal and replace, and I told the president that’s off the table. If he wants to work together to improve the existing health care system, we Democrats are open to his suggestions. A good place to start might be the Alexander-Murray negotiations that would stabilize the system and lower costs.”

Senators Lamar Alexander, Republican of Tennessee, and Patty Murray, Democrat of Washington, have held on-again, off-again talks about a bipartisan plan to stabilize the insurance markets under the Affordable Care Act, which have been roiled, in part, by the persistent uncertainty over the fate of the law. . . .

An aide to Mr. Schumer said the timing of Mr. Trump’s call was particularly awkward, given that the administration had just announced rules to expand the right of employers to deny women coverage for contraception on religious grounds — a move widely condemned by Democrats.

The Trump administration, the aide said, needed to stop sabotaging the law before bipartisan negotiations could begin. . . .


Up early (with my youngest, and his significant other, in tow), for the running of the Chicago Marathon in a few. . . and so -- onward, with a grin! That I am able to grin at the buffoon living at 1600 Pennsylvania is a victory in and of itself. There is nothing to take seriously about this man, or his temporary hold on that office.

UPDATED @ Noon CDT: by mid-morning Sunday -- as if to confirm my headline, the REPUBLICAN Senator Bob Corker, from the great (if today soggy) State of Tennessee tweeted -- in direct reply to some nasty lies tweeted by 45 this morning, thus: ". . .It's a shame the White House has become an adult day care center. Someone obviously missed their shift this morning. . . .

12,132 replies 54,162 retweets 133,989 likes
. . . ." That's his own party, speaking to him, gentle readers.

And (truly trivial update number two!) it appears the Veep doesn't understand free expression -- nor 18 U.S. Code § 227: Mike Pence decided to make a big show of walking out of the Niners/Colts game (and then tweeted about it!), because some of the players took a knee -- during the anthem, with their hands over their hearts. Aside from his disingenuous mischaracterization of the reasons for the kneeling (i.e., the "why" they are doing it) -- he shows himself unfit for high office, day by day. Listen to the cast of "Hamilton", sir. Really. Listen.

...... . . .“We, sir — we — are the diverse America who are alarmed and anxious that your new administration will not protect us, our planet, our children, our parents, or defend us and uphold our inalienable rights. . . .

We truly hope that this show has inspired you to uphold our American values and to work on behalf of all of us”. . . .


Out, cold.

नमस्ते

Friday, October 6, 2017

And It Begins -- For A Third Time, Now: No Chance For Trump -- On Muslim Ban No. 3






Once again, the issues are of such great moment -- to firmly re-establishing who we are as a nation (i.e., the polar opposite of 45's myopic and hateful world-views) -- that the language used just to describe them fairly sends chills down my spine.

We are (by 45) being asked to reconsider whether America will remain the land of the truly free -- and a beacon of hope, for the world. There can scarcely be a notion more dramatic than our now 240 plus year promises, to these, the "huddled masses, yearning to breathe free. . . air."

I'll have more on the timelines, next week. Both motions do truthfully tower -- in their command of the historic import of this moment -- but for tonight, I've chosen to quote the Maryland filing, and will also link to the Hawaii one, for good measure:

. . . .For the third time since taking office, President Trump has issued an order banning hundreds of millions of people from entering the United States. Yet again, the overwhelming majority of those who will be blocked from the country are Muslim. The ban, like its predecessors, delivers on the President’s longstanding promise to exclude Muslims from the United States, striking at the very core of our Nation’s founding values of religious freedom and equality. Unlike its predecessors, the new ban is indefinite, and potentially permanent. For those within its immense scope, it replaces Congress’s detailed admissions system with a new one designed by the President. But Congress has not authorized the President to discard and replace its own immigration policy choices, and the Constitution does not allow him to condemn and disfavor a religion. . . .

If the ban goes into effect, the damage will be immediate and widespread. It will separate families, disrupt businesses, imperil courses of study, block needed medical treatment, and prevent academic, artistic, scientific, and cultural exchange. Above all, it will send a message to Muslims everywhere that they are not welcome in this country. This motion therefore seeks a preliminary injunction of the visa and entry restrictions imposed by Proclamation No. 9645 (“EO-3”). . . .


Mr. Trump will lose once again -- at every level -- and in the process, the welcome of our founding fathers, and their rule of law, with respect for ordered liberty. . . will again prevail. [And that is to say nothing of the economic argument that our nation's leadership in the life sciences is predicated on the arrival of the best and brightest, without prejudice as to country of origin.] We are a nation of laws, not kings. Heed the call, 45.

नमस्ते

Thursday, October 5, 2017

Where We Now Stand -- On Muslim Bans 2.0 And 3.0 -- Lyle Denniston Has It All


I won't spend a lot of electrons on this, as within days (perhaps even by tomorrow evening!) I expect the Supremes will dispose of the current challenges, one way or another.

I also expect the lower court losses for Trump will not be wiped off the books, even if the Court holds the dispute now mooted.

If you want a far more complete analysis -- you could scarcely do better than to read the estimable Lyle Denniston, on it -- I'll quote just a bit:
. . . .The opposing sides in the historic controversy over President Trump’s limits on foreign travelers’ entry into the U.S. handed the Supreme Court on Thursday a difficult new question: will the defeats the Administration already suffered in this fight in lower courts remain, or be wiped off the books?

That is a question the Justices probably will take up when they meet in a private conference Friday, to discuss new filings just made in two pending cases, putting the fate of those cases in doubt. . . .

It was the Administration’s own actions that changed the circumstances, and it should not now be allowed to gain what it has been seeking – nullifying the lower court rulings against it – even without a ruling by the Justices on legality, the groups involved in the cases from Hawaii and Maryland contended. . . .

Aside from their dispute over the fate of the lower court rulings issued up to now, the opposing sides in the controversy were sharply at odds over whether the President had made any real change in his approach to foreign travelers between the March 6 version and the new approach announced on September 24. The challengers said the new approach has some or all of the same legal defects as the first. . . .


And here are the various dueling letter briefs -- one from 45's administration, and one from the State of Hawaii. . . and the one from the ACLU.

Late in the day, lawyers for the State of Hawaii advised the Supremes that they were filing in the trial courts in Hawaii to renew the injunctions, this time against Muslim Ban 3.0. And so it goes. Now you know. G'night.

नमस्ते

As Sputnik Turns 60, And The Cubs Begin Another Stretch Run -- Against DC... Musings, Of Distant (And More Recent) Pasts


At the head, with Friday night's opener looming, I am slightly less sanguine, about my northsiders' chances this year -- to win it all -- but I will keep a good thought just the same.

And fittingly, I ran across a poem that ties the 60th anniversary of the opening of space age, to this nation's oldest pass-time. So I will type no more -- except to say that some times, perhaps when I least expect it -- the Universe moves. . . perfectly -- with unwasted grace, before a hidden alternate mirror of explanation, and self-reflection. . . . This is one of those times:

Sputnik: October 4, 1957

On this day in 1957, Sputnik went up
and my sister Joan and I
and our father went up
to the roof of our apartment house
on Arden Street, and watched the sky.

I don't know what we thought we saw
in the October night amid the lights and white dust
but it wasn't the space race
with our rockets exploding on takeoff
and their monkeys in space capsules orbiting the earth.

Only later did we memorize the names
of the seven clean-cut Project Mercury
astronauts on the cover of Life.
Project Gemini. Rendezvous and dock.
Project Apollo. A soft landing on the moon.

Science in the form of technology was about to deliver a knockout blow
to the antiquated forces of culture,
and in Cambridge, England, they were
preparing to have one hell of a brawl about it,

but we were just glad to be watchers of
the sky from our Manhattan roof top,
and we had our money down on the Yanks
to take game three from the Milwaukee Braves
in the World Series tomorrow night

-- David Lehman


[And the change of masthead art is simply to bring in good karma, anew -- not to say we've forgotten about senible "bump stock" ban legislation, high capacity magazine legislation and AR-15 (and similar) bans.] Now you know. Four years ago -- just this very afternoon -- I was at first puzzled, and then sublimely enlightened -- by close inspection of a mirror of another sort, as I took my return flight, northward. . . Fly onward, one and all -- and do travel light. Smile.

नमस्ते

Wednesday, October 4, 2017

Old Merck Litigation Clean Up: As The ONJ Fosamax® MDL In Manhattan Is Closed...


Here is a small bit of the background, from October 2014 (for the rest, put "ONJ" in the search box) on this long-dormant part of the Fosamax® multi-district litigation -- the part that claimed osteo-necrosis of the jaw bone was a result of prolonged use of the drug, without "drug holidays".

It astonishes me, truthfully, that so much icy-clear river water has run through these mountain canyons, in the half light -- and faded into memory, and being, with my soul -- since I first started tracking these cases, in late-2008. In any event, this was the most recent order:

. . . .JOHN F. KEENAN, United States District Judge:

It is the Court's understanding that all matters in this case have been resolved, the last docket activity having taken place on September 6, 2016. Accordingly, it is hereby:

ORDERED that this action is discontinued without costs to any party. If the parties wish to reopen this matter or extend the time within which they may reopen it, they must make a letter application to this Court within thirty days of this Order.

SO ORDERED.

Dated: New York, New York

September 28, 2017. . . .


It is often "those we know best. . . that elude us most. . ." -- it seems Norman MaClean was right about that too. But in one month, this all. . . will be no more, even if the waters. . . from a time now gone. . . will still haunt the remainder of my days. Yes. . . I am haunted by waters.

नमस्ते

Tuesday, October 3, 2017

Belatedly, On Hep C... But Awake Early... On Merck's Uprifosbuvir Phase II Discontinuation.


Up whilst it is still quite dark -- thinking a bit over coffee and a banana; working on my anti-45 pro bono federal cases, and now blogging a bit, in the old power alley -- largely just to feel. . . normal for a spell.

I'll be only on-grid sporatically, for the rest of this week. And I may be out of the country for the back half of October -- getting to some recently delayed travels. But here is the "Drive's" excellent take, on the weekend news that Kenilworth is effectively conceding this next generation in Hep C -- to Gilead:

. . . .Faced with the success of Gilead's near curative products Harvoni (ledipasvir and sofosbuvir), Sovaldi (sofosbuvir) and Epclusa (sofosbuvir and velpatasvir) — which brought in sales of $2.9 billion in the second quarter of 2017 —and the resulting decline in demand in the market, Merck & Co. has decided to step back from an active R&D role in this disease area. . . .

Once a hot therapeutic area, hepatitis C is no longer considered an urgent unmet medical need. There are still millions who have the chronic disease, but currently available treatments can cure the condition in as little as eight weeks. This ability to effectively cure hepatitis C patients has meant that there are fewer and fewer patients who need treatment, thus shrinking the commercial opportunity. Many of the drugmakers that once worked in this field are now shifting focus to hepatitis B, a similar liver disease still lacking good treatment options.

Last month, Janssen Pharmaceuticals Inc., the drug development arm of Johnson & Johnson, announced that it was terminating the development of JNJ-4178, a regimen that combines three different hepatitis C medications. Janssen is shifting its focus to chronic hepatitis B. . . .


Now you know. Merck will still make lots of money on its current Hep C offerings, but this is a smart move, to take some R&D spend off the table -- where even J&J acknowledges the returns are diminishing. [This is one month's advance notice: the blog may go dormant, as I return to a public company life science role, as early as November 4, 2017 -- to help an old friend.]

नमस्ते