And Some NASA/JPL Eye Candy — As We Approach Four Days From Annihilation…

September 10, 2017 - Leave a Response

So now we are very near the bittersweet, blazingly fleet-footed end of Cassini:

. . . .The Cassini mission’s epic 13-year exploration of Saturn is coming to a close. On Sept. 15, the spacecraft will make a planned plunge into the atmosphere of Saturn in order to protect pristine icy moons that warrant future exploration. As the mission nears its end, team members reflect on this historic, international collaboration. . . .

Now you know; g’night — onward — to a busy new week ahead!

नमस्ते

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As 23 And Me’s Database Grows… It Turns Out I Am Viking, Too…

September 10, 2017 - Leave a Response

About four years ago, I first mentioned that I had agreed to be sequenced at 23 and Me. Now, three and three quarters years on (post learning my results) — as the genetic database at 23 and Me has grown exponentially, the company is able to provide new ancestry insights to all of us early adopters, based on the increasing depth and breadth of the genome data — now from approaching a million contributors.

As a result, I’ve just recently learned, that at some point, likely in the early 1500s, one of my direct line ancestors was 100 per cent Scandinavian. This is as surprising as any of the things I’ve learned over these years — as my more recent roots are Irish and English and Hungarian/Ashkenazi.

So it was with keen interest, this past week, that I read about one of the most famous Viking warrior burial sites (known and preserved since the 1880s) — and the late breaking DNA analysis of one skull, found there.

It was long suspected, but now it is proved: at least one of the warriors, buried with full honors, was a woman. I’ll leave it to others to guess at how widespread — and high ranking — these women would have been, but it makes no sense at all to assume this was an aberration. Here is the bit:

. . . .New DNA evidence uncovered by researchers at Uppsala University and Stockholm University shows that there were in fact female Viking warriors. The remains of an iconic Swedish Viking Age grave now reveal that war was not an activity exclusive to males — women could be found in the higher ranks at the battlefield. . . .

The study was conducted on one of the most well-known graves from the Viking Age, a mid-10th century grave in Swedish Viking town Birka. The burial was excavated in the 1880s, revealing remains of a warrior surrounded by weapons, including a sword, armour-piercing arrows, and two horses. There was also a full set of gaming pieces and a gaming board. . . .

“The gaming set indicates that she was an officer, someone who worked with tactics and strategy and could lead troops in battle. What we have studied was not a Valkyrie from the sagas but a real life military leader, that happens to have been a woman,” says Charlotte Hedenstierna-Jonson, Stockholm University, who led the study. . . .

Perhaps on a tangent — but it may only be a matter of time before we will be able to extract DNA from the relics of first century apostles, and perhaps the man revered as Christ himself — and in Da Vinci Code fashion, establish that there are now living direct descendants of Jesus Christ.

It remains to be seen however, whether the Vatican would allow a DNA extraction — from any of these reliquaries. But as a recovering Catholic, and more importantly, a man of science — I will hope the church progresses to the point that her Pope, too, would want the answers. . . . here’s to. . . progress! Onward — for a mountain-bike ride, now.

नमस्ते

“Leave It To” One Brenton “Beaver” Saunders… Sheesh.

September 9, 2017 - Leave a Response

At the head, let me say that I favor strong but fair intellectual property protection policies, for science based companies — be they tech- or device- or pharma- or bio-science companies. But after a long patent life, such innovations should go generic. That is only fair. [And poor, non-novel, weak or redundant patents ought to be subject to a robust challenge process — the strong should survive — in the Darwinian sense. Patents are, after all. . . monopolies (antithetical to most other free market rules). But that is all just background, to this latest nonsense. This nonsense will only last one more year — as by then the Supremes will have ruled on this topic. Trust that — this sovereign “game” is short lived.]

While it doesn’t surprise me that Mr. Saunders would use a proud Native American tribe as a “token” — to shore up his patent estate’s immunity from generic challenges, it does disappoint me. This is (of course) the same Brent Saunders who called an anti-inversion tax interpretation by the US Treasury in April 2016un-American.” In his view it was un-American to suggest that his company (with vast US operations and sales revenue) should just pay the same tax rate as all other US operations based companies. Check. Roger that. [A transparently-calculated move of one financial processing center — over to Ireland — ought not be enough to avoid or wildly reduce US taxes on one’s company.]

So yes — I should not be surprised that he would opportunistically exploit the sovereign immunity accorded to native peoples, in order to gain advantage over the USPTO. Here’s the bit — from the New York Times, overnight:

. . . .“Indian tribes have sovereignty that is stronger than states,” Mr. White said, pointing to recent Supreme Court cases that have ruled in favor of tribes. “We feel that we have an extremely strong case.”

Michael Carrier, a professor at Rutgers Law School who studies patent law, called the announcement Friday a “concerning” development, in part because the Mohawk tribe played no role in developing the drug. And he said the administrative-review panel served a worthy purpose. “Challenges at the patent office play a crucial role in overturning invalid patents, and that role could be undermined by agreements like this,” Mr. Carrier said. . . .

It does gall me that (as he learned from Fred Hassan — and as Martin Shkreli learned from Fred Hassan) there is no goal other than minimizing tax, in the US — and maximizing revenues retained — with no acknowledgement that the US provides the best, deepest and richest capital market on the planet for fostering the innovations of his kind of science companies. The hypocrisy is stunning.

And yes, Anon. (you know who you are!), your earlier mention of “he, of the high forehead” is why I wrote this on a fine, cool but sunny Saturday morning, over a hot coffee, OJ, banana and a bowl of the last of this Summer’s dark and sweetly-ripe cherries. . . smile. Onward. . . time to work out; then a hot stone massage, this afternoon. . . .

नमस्ते

[U] BREAKING: The Felon Martin Shkreli Has Failed To Meet His Bail Conditions — “Off To Jail, NOW!” Sez US Attorney…

September 7, 2017 - Leave a Response

UPDATED: 09.08.2017 @ 2 PM EDT — The able judge has bumped up the date for the hearing, and the correlative dates for submission of briefs. We are now five days away from Marty’s likely incarceration. I’ve updated the order copy, below. I would say this is a strong indicator that the able judge is putting Martin behind bars.
This morning, Mr. Shkreli wrote — on his Facebook page “. . .Fuck the government. I will never kiss their ring or snitch,” he wrote. “Come at me with you [sic] hardest because I haven’t seen anything impressive yet. . . .” I would expect that there is precious little his defense team can now say to prevent his incarceration.

End update.

We will save celestial wonders for tomorrow — as breaking news out of Brooklyn may well mean that Martin Shkreli is in jail by a week from tonight. DO read on. . . .

Hat tip to FTD — for this priceless find!

CNBC has it as well. But here is the motion to immediately revoke his freedom, pending sentencing on his three felony convictions.

Lovely.

Simply lovely — read it all. It seems the Secret Service has had to increase protection around HRC — due almost exclusively to his lunacy.

And — now even his Lauren Duca threats are being cited by the AUSAs:

. . . .Near the end of his trial and since his conviction on August 4, 2017, Shkreli has made at least two public statements harassing specific women. As has been widely reported, Shkreli was banned from Twitter in January 2017 after harassing journalist Lauren Duca.

In early January 2017, Shkreli had sent Duca a message via Twitter asking her to be his “+1” or companion to the inauguration of President Donald Trump. (See Exs. A & B.) Duca publicly rejected the request. In response, Shkreli called Duca a “cold you know what” on Twitter and famously changed his Twitter profile picture to a doctored image appearing to show Duca on his lap on a couch.(Id.). This conduct earned Shkreli a ban from Twitter. On July 27, 2017 — on the eve of the final trial summations — Shkreli made the following statements on Facebook: “Trial’s over tomorrow, bitches. Then if I’m acquitted, I get to fuck Lauren Duca[.]” He added, “And Anna Kasperian, she’s pretty hot,” referring to a political pundit.

Thus, just as the case was to be submitted to the jury, Shkreli made a public threat against two women whom he dislikes and with whom he has feuded in the past. . . .

Here is the order, for the hearing come one week from today, at 4 PM EDT — in Brooklyn:

. . . .The court will hold a hearing on the government’s motion to revoke bail on September 1314, 2017 at 2:00 p.m. at 225 Cadman Plaza East, Brooklyn, N.Y., 11201, Courtroom 6C South, before Judge Kiyo A. Matsumoto. Defendant shall file a response to the government’s [362] motion by September 12, 2017 at 5:00 p.m., and the government shall reply by September 1213, 2017 at 5:00 p.m. In its reply, the government shall indicate if it intends to call witnesses, and shall advise the court of the anticipated length of the hearing. Ordered by Judge Kiyo A. Matsumoto on 9/87/2017. . . .

Say bub-bye, Marty. You have likely lost your pre-sentencing temporary freedom — entirely due to your own idiocy. What a. . . tool.

The AUSAs definitely have a motivational bulletin board somewhere — with Marty’s endlessly threatening Facebook (and now ebay) posts tacked up. Hilarious.

Yep that’s your karma calling Marty. Buckle up.

USDC Judge Derrick Watson (HI) Affirmed: Trump Loses, Again — 0-12 Now…

September 7, 2017 - Leave a Response

As the Martin Shkreli news was breaking, the three member panel of the Ninth Circuit issued its opinion affirming the courageous US District Court Judge Watson.

In sum, Trump’s lawyers were told there is no rational basis for excluding grandparents — and that (as we advised, in June) a letter from any recognized aid organization would be a sufficient reason (in the view of the SCOTUS) to admit a refugee, into the US. Here is just a bit — but do go read all 36 pages:

. . . .For the reasons that follow, we conclude that in modifying the preliminary injunction to preserve the status quo, the district court carefully and correctly balanced the hardships and the equitable considerations as directed by the Supreme Court in Trump v. International Refugee Assistance Project, 137 S. Ct. 2080, 2088 (2017), and did not abuse its discretion. We affirm. . . .

As the district court correctly identified, a refugee is covered by the preliminary injunction, as modified by the Supreme Court’s stay order, if the refugee has a bona fide relationship with an entity in the United States, meaning a relationship that is formal, documented, and formed in the ordinary course rather than to evade the Executive Order. See Trump, 137 S. Ct. at 2088–89. Applying this standard, the district court held that formally assured refugees have bona fide relationships with resettlement agencies and are covered by the injunction because the assurance is formal, documented, and formed in the ordinary course rather than to evade the Executive Order. Mindful of the narrow standard that governs our review, we affirm, considering the individualized screening process necessary to obtain a formal assurance and the concrete harms faced by a resettlement agency because of that refugee’s exclusion. . . .

Zero for 12, Mr. Trump. Expect much the same — if you actually do try to do anything (other than impotent, and now waffling bluster) related to the dreamers’ status as Americans. Onward on a wonderful if gray Friday — things are finally looking up. . . even as regions as far inland as middle Tennessee brace for the Irma onslaught next week. Be safe. [I’ll tuck this one under the Shkreli news, even though it was written at 8 am Friday. Peace.]

नमस्ते

Merck’s Federal Court Name Spat/Lanham Act Proceeding: Proposed Scheduling Order Entered…

September 7, 2017 - Leave a Response

This was jointly filed last night, prior to the next status hearing on September 12, 2017 in Newark, New Jersey.

Not much else to say. . . in truth here, I find myself a little bored by it all — but this is the very slow road toward a comprehensive global settlement — that remains my opinion. Full scheduling letter (a three page PDF file), plus a bit:

. . . .1. The parties’ production of documents shall be completed by October 31, 2017.

2. The parties need not produce unresponsive family members in the production, but must produce such family members of specifically identified documents by the opposing party upon request in a reasonable time period.

3. All other fact discovery, including depositions of fact witnesses, shall be completed by April 1, 2018.

4. All fact discovery disputes (other than those arising during depositions) shall be filed with the Court in a joint letter pursuant to the Court’s November 7, 2016 Pretrial Scheduling Order no later than December 15, 2017.

5. Plaintiffs’ affirmative expert reports shall be delivered by May 1, 2018.

6. Defendant’s affirmative and rebuttal expert reports shall be delivered by June26, 2018.

7. Plaintiffs’ rebuttal and reply expert reports shall be delivered by July 16, 2018.

8. All expert depositions, including the completion of expert depositions, shall be completed by August 23, 2018. . . .

Now you know. Onward — with sweet space science to come. . . late this evening!

नमस्ते

$2.54 Billion Post Trial Patent Case Motions Hearing In Delaware Tomorrow At 11 AM EDT

September 6, 2017 - Leave a Response

The able federal District Court Judge Leonard Stark, sitting in Wilmington, Delaware, just adjusted the time for tomorrow’s oral argument on the Hep C patent verdict in favor of Merck, in the amount of $2.54 billion — and entered against Gilead.

We will let you know what comes of tomorrow’s arguments — but here is the “as adjusted” schedule:

. . . .ORAL ORDER:

IT IS HEREBY ORDERED that:

(1) tomorrow’s motions hearing will begin at 11:00 a.m., instead of 10:00 a.m., and at approximately 1:00 p.m. the Court will take a recess of approximately one hour; and

(2) the Court wishes to hear argument on all issues that are ripe for decision, including those presented in Idenix’s motion. ORDERED by Judge Leonard P. Stark on 9/6/17. . . .

Do tune in tomorrow — for the outcome, at end of day — and also because as we will likely have some sublimely celestial space science news in tow, as well. Smile.

नमस्ते

The Estimable John Carroll, On Today’s Smallish EU Immuno-Oncology Acquisition…

September 6, 2017 - Leave a Response

True enough, this pathway is still pre-clinical, and yet — in much the same way as Kenilworth did with Scotland’s IO Met in January of 2016 — by buying in now, Merck gets the tech on the cheap — in relative terms, at least.

Of course at Phase I the risk is correlatively higher, but the $600 million is immaterial to a company this size —
even if it all vanishes. But I don’t imagine that will happen. Here’s a bit — do go read it all:

. . . .Munich-based Rigontec is delivering a solid return for its venture backers. Merck $MRK has struck a rare deal to buy the biotech for $150 million in cash and another $453 million in milestones, snapping up a 3-year-old fledgling that raised just €30 million to get to this point.

For Merck it’s another example of how Roger Perlmutter likes to augment the work being done around its PD-1 superstar Keytruda with the occasional add-on. It’s a small deal for the pharma giant, and he’s clearly impressed with the potential the Bonn University spinout has in activating RIG-I as a key pathway in the innate immune system.

The technology is designed to activate an immune response, just as PD-1 can eliminate a defensive network protecting cancer cells. . . .

Now you know. Onward, on a glorious 70 degree morning here, and I am once again put in mind of new life, and all it holds (from January of 2016). . . smile.

नमस्ते

On DACA: This Is What REAL Leadership Looks Like… Thank You, Mr. President!

September 5, 2017 - Leave a Response

As he promised he would if 45 made a move to end DACA, our 44th President now breaks his self-imposed silence — and weighs in, via Facebook.

I will say almost nothing more — other than to say he is unquestionably in the right. And Mr. Trump is both unquestionably wrong here, from a moral perspective — and engaging in a cowardly act of political Kabuki theater. But I’ve said that before, just yesterday. Here is what a real leader sounds like:

. . . .Immigration can be a controversial topic. We all want safe, secure borders and a dynamic economy, and people of goodwill can have legitimate disagreements about how to fix our immigration system so that everybody plays by the rules.

But that’s not what the action that the White House took today is about. This is about young people who grew up in America – kids who study in our schools, young adults who are starting careers, patriots who pledge allegiance to our flag. These Dreamers are Americans in their hearts, in their minds, in every single way but one: on paper. They were brought to this country by their parents, sometimes even as infants. They may not know a country besides ours. They may not even know a language besides English. They often have no idea they’re undocumented until they apply for a job, or college, or a driver’s license.

Over the years, politicians of both parties have worked together to write legislation that would have told these young people – our young people – that if your parents brought you here as a child, if you’ve been here a certain number of years, and if you’re willing to go to college or serve in our military, then you’ll get a chance to stay and earn your citizenship. And for years while I was President, I asked Congress to send me such a bill.

That bill never came. And because it made no sense to expel talented, driven, patriotic young people from the only country they know solely because of the actions of their parents, my administration acted to lift the shadow of deportation from these young people, so that they could continue to contribute to our communities and our country. We did so based on the well-established legal principle of prosecutorial discretion, deployed by Democratic and Republican presidents alike, because our immigration enforcement agencies have limited resources, and it makes sense to focus those resources on those who come illegally to this country to do us harm. Deportations of criminals went up. Some 800,000 young people stepped forward, met rigorous requirements, and went through background checks. And America grew stronger as a result.

But today, that shadow has been cast over some of our best and brightest young people once again. To target these young people is wrong – because they have done nothing wrong. It is self-defeating – because they want to start new businesses, staff our labs, serve in our military, and otherwise contribute to the country we love. And it is cruel. What if our kid’s science teacher, or our friendly neighbor turns out to be a Dreamer? Where are we supposed to send her? To a country she doesn’t know or remember, with a language she may not even speak?

Let’s be clear: the action taken today isn’t required legally. It’s a political decision, and a moral question. Whatever concerns or complaints Americans may have about immigration in general, we shouldn’t threaten the future of this group of young people who are here through no fault of their own, who pose no threat, who are not taking away anything from the rest of us. They are that pitcher on our kid’s softball team, that first responder who helps out his community after a disaster, that cadet in ROTC who wants nothing more than to wear the uniform of the country that gave him a chance. Kicking them out won’t lower the unemployment rate, or lighten anyone’s taxes, or raise anybody’s wages.

It is precisely because this action is contrary to our spirit, and to common sense, that business leaders, faith leaders, economists, and Americans of all political stripes called on the administration not to do what it did today. And now that the White House has shifted its responsibility for these young people to Congress, it’s up to Members of Congress to protect these young people and our future. I’m heartened by those who’ve suggested that they should. And I join my voice with the majority of Americans who hope they step up and do it with a sense of moral urgency that matches the urgency these young people feel.

Ultimately, this is about basic decency. This is about whether we are a people who kick hopeful young strivers out of America, or whether we treat them the way we’d want our own kids to be treated. It’s about who we are as a people – and who we want to be.

What makes us American is not a question of what we look like, or where our names come from, or the way we pray. What makes us American is our fidelity to a set of ideals – that all of us are created equal; that all of us deserve the chance to make of our lives what we will; that all of us share an obligation to stand up, speak out, and secure our most cherished values for the next generation. That’s how America has traveled this far. That’s how, if we keep at it, we will ultimately reach that more perfect union. . . .

And, once again — we (the collective ACLU “we“) will see Mr. Trump’s lawyers in court, and answer them there — on all these topics. And just like Ban 2.0, they will. . . lose. Onward — and Forward — as one.

नमस्ते

Merck Scores New EU Approval For Keytruda® — In Certain Bladder Cancers

September 5, 2017 - Leave a Response

I’ll use a throwback graphic, from a time when the candidate was known by its chemical name — and not yet branded. To be certain, this is decidedly good news.

While both Kenilworth and BMS expect important new US FDA indication approvals in the last few days of September of this year (for Opdivo® and Keytruda®), the entrance of additional immuno-oncology agents (from two other competitors) has dampened the significance of any one approval out of FDA. Each of BMS and Merck will make perhaps $5.8 billion in revenue next year on their immuno offerings alone. Here’s a bit of the latest EU nod — for Merck:

. . . .[T]he European Commission has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Specifically, KEYTRUDA is approved for use as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy.

The approval in patients previously treated with platinum-containing chemotherapy was based on superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), as demonstrated in the randomized, phase 3 KEYNOTE-045 trial.

The approval in patients ineligible for cisplatin-containing chemotherapy was based on phase 2 data from the KEYNOTE-052 trial, which demonstrated an overall response rate (ORR) of 29 percent (95% CI, 25-34).

The approval allows for the marketing of KEYTRUDA in these two new indications in all 28 EU member states plus Iceland, Lichtenstein and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity. . . .

Now you know — as a shortened office week begins. Onward, after a wondrously languid and long holiday weekend. . . . now a quite busy day ahead, as it is high time to get after Trump (on his unlawful DACA detainers), over at the federal courthouse on Dearborn.

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