As Widely Expected, Merck Gets Another Keytruda® Nod, From FDA, This Time In Blood Cancer…

March 15, 2017 - Leave a Response

As a counterweight to this rather downbeat story of last night, Kenilworth overnight announced an expected nod for Hodgkin’s lymphoma — handed down by FDA. BMS’s Opdivo® long ago received a similar indication approval, from FDA. [Legacy graphic at right; story here, from as early as December 2014.]

This is very good news, albeit in a not terribly high burden cancer. It is priced in to the NYSE trading, to be sure. Here’s a bit, from PharmaTimes:

. . . .Approval of the anti-PD1 therapy, the first for the drug in a blood cancer, “reinforces the hope that immunotherapy will prove useful in a wide variety of cancers,” noted Dr Roger M. Perlmutter, president of Merck Research Laboratories. . . .

“For the patients with classical Hodgkin lymphoma who are not cured with existing treatments, there are limited options, and treating their disease becomes more challenging,” added Dr Craig Moskowitz, clinical director, division of haematologic oncology, Memorial Sloan Kettering Cancer Center. “This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis, and gives us the opportunity to help patients in their fight against this devastating disease. . . .”

Now you know. Big judicial branch constitutional events due up, later today, out of Hawaii — as it all portends to reinvigorate, and return the nation — to her nearly three centuries’ long steady march, toward true pluralism. This will be the beginning of the end, for Trump’s year of ugliness, on this score. Amendment, First — means just what it says.

नमस्ते

Now Expecting Overflow Crowds — Three Federal Courtrooms Full — Of Galleries… Like 600 People, In Honolulu…

March 14, 2017 - One Response

I imagine that the Hawaii District hasn’t seen as much interest in any trial level proceeding in a generation at least.

We learn overnight, local time, that the able Judge Derrick Watson has authorized remote broadcast of an audio feed, into two adjacent courtrooms. In the federal system, US District courtrooms are vast, and cavernous. I expect each will hold a gallery of around 200 people, tightly packed. [Here is the what the good people of Hawaii have answered the Trump Administration, as the plaintiffs’ latest restatement — in favor of the TRO, as filed tonight. Do read all 34 pages, in prep for the oral arguments. “. . . .The 1965 Immigration Act reflects the determination that such considerations are irrelevant. . . . President Kennedy urged Congress to dismantle the national origins system because “discriminat[ing]” in admission “on the basis of accident of birth” was “without basis in either logic or reason. . . .” Congress concurred. . . .” Br. of NAPABA 13-18 (Dkt. 140-1).“]

So, as many as 600 onlookers will likely see (and at least hear) how our system of ordered liberty — of checks and balances — actually operates. They will see the majesty of the law — that these bedrock ideas, passed to us by the Founders — they rise above mere. . . . men’s artifice — and caprice. Several dozen of them will be media bloggers, with credentials to transcribe in real time. We will update you, from those feeds, tomorrow evening — in near real time:

. . . . Judicial Conference of the United States policy allows a judge to authorize broadcasting of court proceedings to adjacent areas for the purpose of judicial administration. Consistent with that policy, the Court hereby authorizes the audio of the hearing on Plaintiffs’ motion for temporary restraining order, set for March 15, 2017 at 9:30 a.m., to be broadcast in up to two adjacent courtrooms to the extent necessary to accommodate public interest. . . .

Onward. . . . ever, onward. We will henceforth simply “seek to do the right, as we see the right. . . .” [Bonus: who can identify the speaker of that fine bon mot? Hint: he was not an American.]

नमस्ते

Just Announced: New FDA Action Date For Keytruda® sBLA — In MSI-H Cancers — Now June 9, 2017 (Was March 8, 2017)

March 14, 2017 - Leave a Response

Kenilworth just provided some additional local color, on when we might next hear of an FDA action (thumbs up or thumbs down) on pembrolizumab, in these previously treated oncology co-horts.

Here’s a bit of the press release — but all of this news is almost certainly factored-in to Merck’s NYSE trading price, already — in my estimation — just as we discussed it, late last Friday.

. . . .Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. The company recently submitted additional data and analyses to the FDA related to the pending application. The submission of additional data is considered a major amendment to the sBLA under the Prescription Drug User Fee Act (PDUFA), thus extending the target action date by three months. The new FDA target action date is June 9, 2017.


Merck continues to work closely with the FDA to support the review of this sBLA and looks forward to further advancing the science of immuno-oncology in MSI-H cancer. . . .

Now, as to air traffic control, I’m on a short day in the office tomorrow, then on various planes through the weekend. Even so, do get in touch. . . .

नमस्ते

And… In Seattle… More Date Tightening — But Hawaii’s Hearing Will Almost Certainly Happen First.

March 13, 2017 - Leave a Response

The race is fully on, now — as to which of the numerous federal District Courts will be the first to enjoin 45’s Muslim Ban 2.0. [In a courtroom, “it is not the loudest voice that prevails, it is the Constitution. . . .”]

Just now, after-hours out West, the Seattle courts set a hearing for no earlier than the one in Hawaii, on Wednesday. And likely for a day or two later than that.

But now the Trump Administration owes Judge Robart some 13 pages by tomorrow afternoon, Pacific. Otherwise, the existing TRO there (already upheld by the Ninth Circuit) will also very-likely be applied to Muslim Ban No. 2.

. . . .The court is in receipt of Plaintiffs’ emergency motion to enforce the court’s February 3, 2017, order preliminarily enjoining certain provisions of the January 27, 2017, Executive Order, entitled “Protecting the Nation from Foreign Terrorist Entry into the United States.” (Em. Mot. (Dkt. # 119); see also Order (Dkt.# 52).) Plaintiffs ask the court to “order a response and set a hearing for March 14.” (Em. Mot. at 12.)

The court hereby ORDERS Defendants to file a response to Plaintiffs’ motion no later than 4:30 p.m., Pacific Daylight Time, on March 14, 2017.

Defendants’ response shall be limited to 13 pages, which is the length of Plaintiffs’ motion. (See generally id.)

The court will defer scheduling a hearing, if any, on Plaintiffs’ emergency motion until after it has reviewed Defendants’ response. In any event, the court will not schedule a hearing prior to March 15, 2017.

If the court schedules a hearing on Plaintiffs’ emergency motion, the court will permit the parties to appear by telephone.

Dated this 13th day of March, 2017. . . .

So — after some day and night snow-carnival festing. . . It’s an early Thursday flight, to the generally-vacant sunshine that is. . . LA. I will keep the readership apprised here on these orders, and the progress of the Wildcats, though — to be sure. Smile.

नमस्ते

Virginia’s “Next Briefings” Schedule Now Defers To Hawaii’s, As Well… On Muslim Ban 2.0 TROs

March 13, 2017 - Leave a Response

Late this afternoon, in the federal District Court for the Eastern District of Virginia (Alexandria), the able Judge Trenga ordered one week’s worth of “slackening“, in the briefing schedule, on the TRO against Muslim Ban 2.0 — originally scheduled to go forward this week. See below — just entered, but this pushes the Virginia TRO hearing back, into next week. [A decision wouldn’t come until later in the week there, then.]

So, once again, we continue expect the hearing in Honolulu will decide it — as a matter of first impression:

. . . .The hearing on Defendants’ Motion currently scheduled for March 13, 2017 be, and the same hereby is, CONTINUED to Tuesday, March 21, 2017 at 10 a.m. . . .

[I]t is further ORDERED that Defendants file their opposition brief no later than Friday, March 17, 2017 at 12 p.m. noon.

Signed by District Judge Anthony J. Trenga on 03/13/2017.. . .

UNRELATED UPDATE: 24 million people may lose insurance (primarily due to cut-backs, and carve-outs from Medicare/Medicaid) under “Trump[No-]Care“, according to the non-partisan CBO. As I earlier opined, this package is. . . DOA. Not really worth discussing — in this flawed form. Not even clear it will have 50 votes in the Senate — let alone the required 60.

Now you know — onward. Off to some snowy night-time fun, here — then LA later in the week, for some warm sunshine!

नमस्ते

Meanwhile, In Brooklyn, On Muslim Ban 2.0…

March 13, 2017 - Leave a Response

This very snowy morning, in Brooklyn, the Trump Administration has filed a letter proposal with Judge Amon, in federal District Court. [Earlier background, here.]

What someone with an experienced eye for such things sees here — is that all the Brooklyn parties are in agreement, that the Hawaii action or the Seattle action (or least probably, the Alexandria, Virginia one) will resolve all these same issues before a hearing is held in Brooklyn. That is, the TROs will all either be extended, or will fail, before March 27. So the parties in Brooklyn won’t duplicate efforts before the able Judge Amon:

. . . .The parties promised the Court that within seven days after the President issued a new Executive Order, they would file a jointly proposed briefing schedule. (ECF No. 169). The President signed the new Executive Order on March 6, 2017, making the proposed briefing schedule due March 13.

After conferring, the parties believe that they may be able to resolve this case without further litigation.

Therefore, they respectfully request that the Court stay this case for fourteen days, until March 27, 2017. At that time, the parties propose filing a status report suggesting how to proceed. . . .

So — all eyes are on Hawaii, and the very capable US District Court Judge Derrick Walker, there. [For what it is worth (i.e., not much), here is the government’s latest (March 13, 2017) — mostly specious — set of arguments as to why Hawaii cannot enjoin Muslim Ban 2.0. It is 68 pages. Ugh.] Tune in on Wednesday evening, local time. That Honolulu court has issued lots of real time blogging credentials to various major media outlets, for that afternoon. We should know in nearly real time how it all turns out. Onward.

नमस्ते

O/T: Yep. I’m A Goof For It — Pi Day 2017, Tomorrow…

March 13, 2017 - Leave a Response

Well, I suppose it belongs here — because of its importance to all of the life sciences, generally. And — as someone I once loved told me exactly two years ago, today (on the once a century “epic” Pi day!) — I’m a goof for it. True — but my adoration of pi (and pie!) remains. . . shameless.

From The New York Times opinion page, two years ago, this afternoon, then:

. . . .Early mathematicians realized pi’s usefulness in calculating areas, which is why they spent so much effort trying to dig its digits out. Archimedes used 96-sided polygons to painstakingly approximate the circle and showed that pi lay between 223/71 and 22/7. By the time Madhava (in India, around 1400) calculated pi to over 10 decimal places using his groundbreaking infinite series (which regrettably bears Leibniz’s name), it was already more than accurate enough to address all practical applications. Pursuing pi further had essentially become a mathematical challenge. . . .

Here in the waning moments of our final 2017 Spring snowstorms, tomorrow at late-lunch, I’ll go have a big slice of warm pecan pie, literally swimming in dollops of whipped cream. . . so my celebration and observance will then be. . . complete!

Have you. . . had yours?

O/T First Time In Its 78 Year-History — NCAAs — Wanna’ Lose A Bet?

March 13, 2017 - Leave a Response

If there is anyone out there, willing to take the southern side of this bet, I’ll give points — but I will see my Wildcats win their first appearance in the Big Dance, in the 78 year history of the tourney.

With 44 no longer publishing a bracket, I’ll no longer post all of my picks (for a comparison), but I will have NU going through the second round. Vandy just won’t be up to it, here — in my estimation — come Thursday at 4:30 PM EDT. Here’s a bit:

. . . .NU coach Chris Collins was not worried.

“We’re going West,” he told his players.

And he was right.

At 5:32 p.m., CBS put a halt to agonizing NU fans.

“The No. 8 seed, out of the West,” Greg Gumbel said. “There they are … the Northwestern Wildcats … 78 years in the making.”

And the gym went nuts, with NU players leaping from their chairs. . . .

Hey — the Cubs did it, right? So, feel free to come wearing purple on Thursday, one and all. It will indeed be a great day to be a Wildcat. . . Smile. . . .

नमस्ते

Unless Earlier Settled, The Merck vs. Merck Name Spat Will Be Tried One And One Quarter Years From Now…

March 12, 2017 - Leave a Response

As ordered by the federal District Court in Newark, the German Merck and the US Merck have agreed to a pre-trial schedule in this contract enforcement action, and federal Lanham Act suit.

They are also putting the finishing touches on an agreed choice of laws memo, for the court, now. Here are some salient dates from the agreed schedule (a three page PDF):

. . . .Next status conference: May 8, 2017

All document production: July 31, 2017

All fact discovery and witnesses: October 31, 2017

All expert discovery completed: March 23, 2018. . . .

The time frames allotted here greatly exceed the complexity of the issues involved, so (as I’ve repeatedly suggested) I expect this “slack-time” will allow for settlement discussions — and at a languid pace, to boot. Onward we go, with that sweet lil’ baby girl, in tow. . . . smile.

नमस्ते

More On This, In The Coming Week — By Wednesday Night…

March 11, 2017 - Leave a Response

The very able Judge Robart in Seattle informed the government that its latest “notice” is essentially of no legal effect, on Friday — while also telling the plaintiffs that they need to get a formal motion on file by Wednesday, in order to extend the TRO nationwide.

All of which means that US District Court Judge Derrick Watson, in Honolulu, will almost certainly be the first to enter a new nationwide TRO against 45’s Muslim Ban 2.0. Stay tuned at mid-week.

[A judge in Wisconsin has enjoined it, but solely as to one Syrian family in transit to America — and their specific circumstances, already — but there is no nationwide order enjoining it, yet.]

I expect to be able to report to you about that occurrence, by St. Patrick’s Day 2017. Onward, and goodnight. . . with a grin. . . .

नमस्ते