The Plan — For My Lil’ Mining Buddy — On Mars, Going Forward…

March 21, 2019 - Leave a Response

We are still at least a week or so away from knowing that the hammer has been freed up — and is making progress toward its five meters deep target drill depth.

But this is the latest, from NASA, JPL and DLR — the fine German hammer’s engineering team:

. . .Later this month, the team plans to conduct a 10-to-15-minute hammering test. That will allow InSight’s seismometer to “listen” to the mole striking whatever obstacle it has hit, offering possible clues as to what may be blocking it. Meanwhile, the camera on InSight’s robotic arm will photograph the mole’s support structure in the hopes of catching any possible motion induced by the mole during hammering. . . .

Now you know. Keeping my fingers. . . crossed, on this one.

नमस्ते

This May Be One Of The Very Few (Only?) Times I’ll Quote Kavanaugh With Approval…

March 19, 2019 - Leave a Response

Ahem — the (dated) graphic at right is NOT what this case was about.

Do I wish the decision came out the other way? Yes. But I do firmly believe. . . an extremely strict statute, signed by then-President Clinton — also means what it says, in common-sense English. [That is, it is now up to the Congress to change it — should it see fit to do so.]

So. . . as to this morning’s Nielsen v. Preap splintered timber of opinions (but reaching 5-4, for a modified version of. . . the government’s view) — I’ll say that it is quite important to understand what the case is NOT about — and here, I’ll candidly admit, Kavanaugh is right. So, let’s let him. . . go get a beer, now (imagine Matt Damon, on SNL, here!):

. . . .I write separately to emphasize the narrowness of the issue before us and, in particular, to emphasize what this case is not about.

This case is not about whether a noncitizen may be removed from the United States on the basis of criminal offenses. Under longstanding federal statutes, the Executive Branch may remove noncitizens from the United States when the noncitizens have been convicted of certain crimes, even when the crimes were committed many years ago.

This case is also not about whether a noncitizen may be detained during removal proceedings or before removal. Congress has expressly authorized the Executive Branch to detain noncitizens during their removal proceedings and before removal. 8 U. S. C. §§ 1226(a), (c), and 1231(a). This case is also not about how long a noncitizen may be detained during removal proceedings or before removal. We have addressed that question in cases such as Zadvydas v. Davis, 533 U. S. 678 (2001), Clark v. Martinez, 543 U. S. 371 (2005), and Jennings v. Rodriguez, 583 U. S. ___ (2018).

This case is also not about whether Congress may mandate that the Executive Branch detain non-citizens during removal proceedings or before removal, as opposed to merely giving the Executive Branch discretion to detain. It is undisputed that Congress may mandate that the Executive Branch detain certain noncitizens during removal proceedings or before removal. Congress has in fact mandated detention of certain noncitizens who have been in criminal custody and who, upon their release, would pose a danger to the community or risk of flight. As relevant here, Congress has mandated detention “when” such noncitizens are “released” from criminal custody. 8 U. S. C. § 1226(c)(1).

The sole question before us is narrow: whether, under §1226, the Executive Branch’s mandatory duty to detain a particular noncitizen when the noncitizen is released from criminal custody remains mandatory if the Executive Branch fails to immediately detain the noncitizen when the noncitizen is released from criminal custody. . . . [Today we hold it remains mandatory under that statute.]

In sum, all the Supremes said today is that a “truly bad” convicted (“dangerous”) criminal, may one day be before the court, re-arrested, and subject to deportation (after such process as is “due” him or her). Again, it is up to the Congress to change that, if it feels there should be an outer limit, on how long the Executive may “lie, in wait” — to re-arrest the non-citizen. [Even so, Kavanaugh’s listing above implies that there may be a case, where it would in fact violate the Constitution (the Fourteenth Amendment and/or the Fourth or Fifth or Sixth) — to re-arrest, many decades later, when the non-citizen was in his 80s, for example, and had lived here peaceably, after serving his original time, ever since. In sum, the Clinton-era statute might be unconstitutional, as applied, in that setting, under Zadvydas v. Davis, 533 U.S. 678 (2001). But that was NOT today’s case.]

That (at least to me) is. . . rather unsurprising. So the Fox News folk who couch this as some big win for Team Trump. . . are just looking for anything — anything, at all — to suggest even one little bit of Team Trump ideas. . . . have currency. The problem is. . . this idea had currency, ever since Bill Clinton was in office. I don’t think Fox wants to say Trump is so grateful to Bill Clinton’s prior leadership, on this score.

Now I’ll. . . hush.

नमस्ते

Merck Has Agreed To Pay Gilead AT LEAST $15 Million In Legal Fees, In California Patent Case…

March 18, 2019 - Leave a Response

Regular readers will recall (as we return to our “power alley” narrative line, here) that a former Merck patent attorney engaged in dirty tricks, back before Gilead acquired Pharmasset — when Merck itself was looking at Pharmasset, under an obligation of confidentiality.

That led to an order (since affirmed on appeal) that Merck must pay for Gilead’s legal fees — in defending in California — against Merck’s (thus largely specious) patent infringement claims — due to the Merck (former) patent counsel’s “unclean hands“. Most recently, we estimated that amount as around $15 million — it is likely higher now, with interest tacked on, and subsequent negotiations about. . . who owes what, given the long appeals process.

So, my guess is the total is closer to $19 million, than $15 million — but there is zero chance that Gilead will settle for anything below the full $15 million (thus our “at least” headline). Here is the status briefing, from last week:

. . . .The parties have reached an agreement in principal concerning the total amount that Merck will reimburse Gilead for the Court’s award of attorneys’ fees (ECF No. 489), Gilead’s appellate attorneys’ fees, and pre- and post-judgment interest, and are diligently working to obtain the necessary signatures to execute that agreement. Gilead has signed the agreement and Merck is in the process of obtaining the authorized signatures needed for execution. The parties expect that the agreement will be executed in the near term, and payment remitted to Gilead within 10 calendar days of the last Merck signature needed for execution. The parties will further update the Court on this matter by April 1, 2019, or by another date requested by the Court. . . .

Of course, the amount is financially immaterial to both parties, so we may never see the actual figure, in any SEC report (and I am virtually certain the amount will not be required to be disclosed by the able judge) — but it should serve as a nearly $19 million warning — against being cavalier with confidentiality agreement obligations, in M&A due diligence — especially concerning patents, on promising life science candidates.

Onward.

नमस्ते

Merck’s $300 Million Acquisition Of Immune Design Has Cleared The Hart-Scott Antitrust Waiting Period — Early.

March 18, 2019 - Leave a Response

Not remotely surprising, here (given the lack of real competitive overlap of any size — my February 2019 backgrounder, here), but the parties had jointly asked for — and have now been granted — early relief on the normal Hart Scott anti-trust pre-merger notification (the so-called “second request” rules), and waiting period rules. In sum, as soon as a bit of likely ill-founded litigation (alleging that target Immune Design failed its SEC disclosure obligations, in the past) is cleared up, this deal will close.

Here is the relevant SEC filing — and a bit:

. . . .Section 16 of the Offer to Purchase is hereby amended and restated by deleting the second paragraph of the subsection titled “Antitrust Compliance” and replacing it with the following:

On March 5, 2019, each of Parent and IMDZ filed its respective Premerger Notification and Report Form with the FTC and the Antitrust Division in connection with the Offer. Parent also made a request pursuant to the HSR Act for early termination of the waiting period applicable to the Offer. On March 15, 2019, the FTC granted early termination of the waiting period applicable to the Offer. Accordingly, the HSR Condition has been satisfied. . . .

Now you know — onward, on a fine, fine morning, here. . . smiling. Picking my brackets, awaiting the public release of BHO 44’s 2019 March Madness picks — to set up a comparison / competition here, as ever, since 2009.

नमस्ते

[U] DRC Update: Second Worst Ebola Outbreak In World History — And It May Last A Year, Yet…

March 16, 2019 - One Response

As I’ve repeatedly said, I’m afraid the news will get worse before it gets better. This may last a full year, from now. But the good news (so far) is that the vaccine is 100 per cent effective, very well-tolerated, and still shows (overall) pretty positive acceptance attitudes, as a social science matter, in the DRC.

The University of Minnesota CIDRAP site‘s excellent overnight update is here — and I’ll quote a bit:

. . . .The four new cases are in Mandima, Katwa, Butembo, and Kayina. Also, 240 suspected illnesses are under investigation. The new cases push the outbreak total to 936 cases, which includes 871 confirmed and 65 probable infections.

Four more people died from their infections, including two in community settings in Mandima and Butembo, an occurrence known to raise the transmission risk. Two of the deaths occurred in Ebola treatment centers, one in Mabalako and one in Beni.

Since the outbreak began, 591 people have died from Ebola. . . .

It is a little surprising that this — second only to the 2013-14 outbreak in which more than 11,000 died — is essentially completely “off the radar“, in most US major city newspapers. UPDATED — Saturday afternoon: Latest weekly chart, from WHO.int:

Onward to a sunny bike ride, along the lake. . . spring comes on faltering little legs, much like a lamb. . . . smile.

नमस्ते

Update: Merck’s Bladder Cancer Med TICE BCG Will Be In Short Supply Into 2020, As Well…

March 15, 2019 - Leave a Response

As we reported in early February of this year, back then, the bad news was that TICE BCG (Live) would be “on allocation” — for all of 2019. That’s now been revised and down-dated — to cover all of 2020. So the shortage will stretch at least two years. [Query whether Sanofi could be persuaded to start production again, between now and then?]

I doubt it — Sanofi has very-likely reconfigured its own relevant manufacturing facility significantly (and likely irretrievably), to make an entirely unrelated bio-drug — so no easy fix, to the dire short supply situation will appear in my estimation.

In any event, the most relevant bit of the update, then from the excellent people at FiercePharma, this morning:

. . .Merck says it’s been the sole supplier of TICE BCG, an important bladder cancer med, since 2012 after Sanofi and another drugmaker ran into manufacturing problems. Sanofi never reintroduced its drug, Merck says. In 2016, Sanofi confirmed it was exiting the market.

As the lone supplier, Merck says it has expanded production by more than 100% and cut 40% off its manufacturing time. It’s now at full capacity, producing 600,000 to 870,000 vials annually.

Still, Merck can’t quite keep up. Demand is growing around the world, and Merck still sometimes suffers from issues in a “lengthy and complex” manufacturing process. In January, the company started “proportionally allocating the medicine across countries where the company is the sole or primary supplier, including the United States” based on historical averages. . . .

As we explained before, this is something like baking a huge soufflé, for 100,000 people, all at once. It is a very complicated bio-process — if one batch fails, a reset is required — and Merck cannot now increase its capacity any more, without essentially building entirely new facilities, from the ground up. So people saying “just make more”. . . fundamentally under-appreciate the complexity of the bio-chemistry, involved. Now you know. Onward, to a warm St. Patrick’s weekend here. Smile. . . .

नमस्ते

Merck Wins First Line EU Wide Lung Cancer Approval For Keytruda® (Pembrolizumab)… Good News.

March 14, 2019 - Leave a Response

It has been a minute, since I mentioned all the good results Merck’s immuno-oncology juggernaut is posting. [In fact, my sales chart is over a year old, at right. But you get the drift of it.]

This morning, the EU regulators cleared pembro-, as a first line lung cancer treatment — and the sales in Europe are going to accelerate appreciably. True, the price point is lower, on a per patient treated basis, than the comparable US regimen’s prevailing reimbursed rate, but lung cancer is the highest burden cancer in all of the EU. So this is quite good news.

Increasing channel volume uptake highly likely, now — from the presser of this morning:

. . . .Merck today announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC). This approval is based on data from the Phase 3 KEYNOTE-407 trial, which demonstrated that KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumor expression status, reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008).

“In KEYNOTE-407, first-line treatment with KEYTRUDA in combination with chemotherapy resulted in significant improvements in overall survival for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain. “Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer.”. . .

Now you know — sourced my pie — it’s in office fridge, ready for 1:59, on the dot. Smile. . . .

नमस्ते

Propecia®/Proscar® MDL “Opt Out” Cases Will Remain In Federal Court, In Brooklyn…

March 13, 2019 - Leave a Response

Over the weekend, the able Judge Cogan decided to keep the remaining opt-out Propecia plaintiffs’ individual cases in Brooklyn — and appoint a magistrate to handle all pre-trial matters. These are the people who decided not to take the settlement offered by Merck — over a year ago, now.

The names of the remaining plaintiffs are listed in this PDF version. Here is the order, in plain text:

. . . .The above-captioned cases relate to the multi-district litigation captioned In re: Propecia (Finasteride) Products Liability Litigation, No. 12-md-2331.

The Court previously ordered the parties to show cause why these cases should not be transferred out of the Eastern District of New York in light of the Court’s orders approving the settlement of the multi-district litigation and distribution of settlement funds. Defendants filed a response in each of the above-captioned cases that opposed transferring these cases out of the Eastern District of New York. The Court has also received responses to defendants’ submissions in some but not all of the above captioned cases.

Upon consideration of the responses to the Court’s order to show cause, the cases will remain in the Eastern District of New York.

As explained in the transfer order that originated this multi-district litigation and in Practice and Procedure Order No. 3, the civil actions in this multi-district litigation were consolidated for pretrial purposes to eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary. Because not all pretrial proceedings in the above-captioned cases have been completed, the Court finds that it would advance the purposes of the multi-district litigation to maintain the above-captioned proceedings in the Eastern District of New York.

Court refers the above-captioned proceedings to Magistrate Judge Kuo for completion of all non- dispositive pretrial proceedings. . . .

Now you know. . . in truth, I’m still pretty rattled by yesterday’s “buy your seat at Stanford” story. That sort of fraud and graft, for the one percenters — truly is corrosive to any kid’s future belief in the American Dream (just work harder than. . . everyone, and you will rise to the top) — as so many of us have lived it, these last decades. What will our children’s children. . . think?

नमस्ते

Once Again — Celebrating Pi Day, Tomorrow…

March 13, 2019 - Leave a Response

For a second decade. . . now. Will eat cherry pie — with real unsweetened whipped cream. Smile. . . .

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