Novartis Cosentyx nod ends 10-year drought in new biologics for HS

 Novartis’ IL-17 inhibitor Cosentyx has become the first new biological therapy for the painful skin condition hidradenitis suppurativa (HS) in nearly a decade, following its approval by the European Commission.

Cosentyx (secukinumab) will become a treatment option for the approximately 200,000 people with HS in Europe who are currently living with moderate to severe HS, said the drugmaker in a statement. A decision on the new indication is due later this year in the US.

Cosentyx is already approved to treat psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis and is one of Novartis’ top products, generating $4.8 billion in sales last year.

The approval gives the drug another indication that for the moment has only one other biologic therapy, AbbVie’s TNF inhibitor Humira (adalimumab), and according to Novartis, represents a “sizable” market in its own right.

However, a number of rivals are coming through the pipeline, including IL-17 inhibitors such as UCB’s Bimzelx (bimekizumab) and Acelryn’s izokibep, Boehringer Ingelheim’s IL-36 inhibitor Spevigo (spesolimab) and oral JAK inhibitors from the likes of Pfizer, AbbVie, Incyte and Priovant.

HS is a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. In the phase 3 SUNSHINE and SUNRISE trials, Cosentyx was found to provide a significant reduction in pain and other HS symptoms at 16 weeks that was maintained over a full year.

The full results – recently published in The Lancet – showed that at the primary endpoint more than 70% of patients were flare free and more than 65% had solid pain control, with what Novartis has described as a rapid and lasting improvement in quality of life scores.

“With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional burden and help partially avoid invasive surgery, if treating early,” said Prof Christos Zouboulis, president of the European Hidradenitis Suppurativa Foundation.

“This expanded approval offers physicians an additional effective and, for dermatologists, familiar treatment choice that we can feel confident in prescribing for this complex and challenging disease,” he added.

Novartis is also working on extending the indications for Cosentyx into giant cell arteritis, lupus nephritis, polymyalgia rheumatica and rotator cuff tendinopathy.

https://pharmaphorum.com/news/cosentyx-nod-ends-10-year-drought-new-biologics-hs

SpaceX Gets Pentagon Ukraine Starlink Contract

 by Dave DeCamp via AntiWar.com,

The Pentagon said Thursday said it’s awarded a contract to Elon Musk’s SpaceX to ship Starlink satellite internet terminals to Ukraine.

"Satellite communications constitute a vital layer in Ukraine’s overall communications network and the department contracts with Starlink for services of this type," the Pentagon said in a statement to CNBC

The Pentagon refused to share any details about the contract, and it’s not clear how many terminals will be purchased. "For operational security reasons and due to the critical nature of these systems — we do not have additional information regarding specific capabilities, contracts or partners to provide at this time," the Pentagon said.

SpaceX began shipping thousands of Starlink terminals to Ukraine shortly after the Russian invasion, and the internet service is said to have been vital for Ukraine’s war effort, both for communication and helping with targeting.

Earlier this year, the president of SpaceX, Gwynne Shotwell, said the Starlink terminals were never meant to be "weaponized," referring to reports of Ukraine using Starlink to acquire targeting data with drones. Shotwell said that SpaceX took steps to "limit" Ukraine’s ability to use the internet service in that way. 

She had explained February of this year--

"However, Ukrainians have leveraged it in ways that were unintentional and not part of any agreement," she said.

Speaking later with reporters, Shotwell referred to reports that the Ukrainian military had used the Starlink service to control drones. Ukraine has made effective use of unmanned aircraft for spotting enemy positions, targeting long-range fires and dropping bombs.

"There are things that we can do to limit their ability to do that," she said, referring to Starlink’s use with drones. "There are things that we can do, and have done."

The US Agency for International Development (USAID) said it was cooperating with SpaceX to get Starlink terminals to Ukraine in the early days of the war. Last fall, Musk said that SpaceX couldn’t continue paying for the service for Ukraine and asked the Pentagon to foot the bill.

As of October 2022, SpaceX donated 20,000 terminals to Ukraine. Musk said at the time that it cost his company "$80 million and will exceed $100 million by the end of the year."

https://www.zerohedge.com/military/spacex-gets-pentagon-ukraine-starlink-contract

Fed Shocking Seasonal Adjustments Convert $28B Bank Deposit Outflow Into $102B Inflow

 The Fed reportts that domestic (large and small) commercial banks saw NSA flows of -$28.4 billion, while SA flows were +$102.5 billion!

As if it needs to be said, non-seasonally-adjusted deposit flows are 'actual flows'? And why do we care about 'seasonally-adjusted' deposits - they aren't real assets?

For some more context, the deposit delta (between real outflows and SA outflows) since March 1 is now $150BN+

It seems The Fed is using the 'fog of banking crisis war' - knowing this data drops late on a Friday night - to pull the wool over depositors and investors eyes.

*  *  *

Following yesterday's ugly money-market fund (accelerating inflows) and Fed balance sheet (another jump to a record usage of the Fed's Bank Term Funding Program emergency bailout cash), expectations are that bank deposits continued to leave US commercial banks (despite last week's unexpected rise in deposits and loans by small bank to real estate borrowers - hhmm).

Regional bank shares have risen for three straight weeks - but the context for where they are is key...

And if you wondered what's driving that - take a look at bank exec's insider buying (hint).

And if everything's so awesome, why are banks still using The Fed's emergency bank bailout facilities so much?

Source: Bloomberg

And so, according to the latest H8 report from The Fed, on a seasonally-adjusted basis, total US Commercial Bank deposits (including large time deposits) increased by $86.5 billion during the week ended 5/24...

Source: Bloomberg

That is the biggest (seasonally adjusted) weekly inflow since June 2021 (and $116 billion of deposit inflows in 2 weeks).

One can't help but wonder if this giant surge is 'seasonal-only' given the timing of the prior jump.

And this inflow occurred as money-market fund inflows hit a new record high (note that deposit data is one-week lagged to MM flows). So where is all this 'cash' coming from..

Source: Bloomberg

Under the hood, Large Banks saw a massive $85.6 billion seasonally-adjusted inflow (biggest weekly inflow since May 2020) as Foreign Banks saw outflows (-$159 billion) which were offset by $16.9 billion in inflows to Small Banks...

Source: Bloomberg

So - money flowed into bank deposits, money-market funds, and tech stocks...

Sure!

On a non-seasonally-adjusted basis, all bank cohorts saw OUTFLOWS

Source: Bloomberg

Here's the direct comparison of real NSA flows and 'fake' SA flows...

On the other side of the ledger, despite MASSIVE INFLOWS, large banks pulled back on credit extension (loans -$4.405 billion) while Small bank loans rose 7.9 billion...

Source: Bloomberg

As we noted last week, despite this 'fake' inflow data, this is far from over as former Dallas Fed head Robert Kaplan dropped some uncomfortable truth bombs on the US banking system:

Phase one was an asset/liability mismatch at several banks

Phase two began with the stock market deciding to do its own supervisory scrubbing

We are now heading into the third phase.

Bank leadership at small and midsize banks are considering how to shrink their loan books in order to address the mark-to-market loss of capital, as well as to guard against potential deposit instability in the future.

Bank leadership is very aware that the economy is slowing, and that we are likely about to enter a challenging credit environment.

While asset/liability mismatches are relatively easy to spot, assessing the quality of loan portfolios is much more complicated.

CEOs of many small and midsize banks are in a tough position.

They can't easily raise equity because their stock prices are down.

As a result, they are turning to shrinking their loan books, finding places to pull back on existing loans and future loan commitments.

This is making it much harder for small and midsize businesses to get and keep their bank loans.

It is a quiet phase that won’t make headlines but is nevertheless relentlessly going on beneath the surface.

Read the full interview here...

Free to speak his mind, Kaplan concludes rather ominously, "the recent banking turmoil has highlighted the disparity between too-big-to-fail banks and smaller and midsize banks. I worry that increasing the Fed funds rate from here may create further strains on the deposit base for those smaller banks. I’m concerned that, as the Fed raises rates, it is tightening the vice on small and midsize banks and the small and midsize businesses that rely on those banks for funding."

So, believe what you want America - did deposits soar last week or did they continue their trend of outflows (as evidenced by money-market fund inflows)?

Source: Bloomberg

And finally, the piece de resistance of Fed fuckery - for domestic (large and small) commercial banks, NSA (actual) flows were -$28.4 billion, while SA (magic) flows were +$102.5 billion!

Are non-seasonally-adjusted deposit flows 'actual flows'? And why do we care about 'seasonally-adjusted' deposits - they aren't real assets?

For some more context, the deposit delta (between real outflows and SA outflows) since March 1 is now $150BN+

It seems The Fed is using the 'fog of banking crisis war' - knowing this data drops late on a Friday night - to pull the wool over depositors and investors eyes.

https://www.zerohedge.com/personal-finance/bank-deposits-see-biggest-inflow-2-years-despite-massive-mm-fund-equity-inflows

Hunter Biden Reportedly Planning A Second Amendment Defense

 by Jonthan Turley,

“This... should deeply trouble us all.”

Those words from President Joe Biden was his response to the Supreme Court reaffirming the individual rights under the Second Amendment in New York State Rifle & Pistol Association v. Bruen in 2022. Now, according to the New York Times, Hunter Biden is preparing a possible Second Amendment defense to gun charges under that very case. The idea of the Bidens going Bruen is only the latest glaring contradiction for the First Family as it struggles to contain the scandals surrounding the son of the President. It appears that “The only thing that stops a bad guy with a [Second Amendment claim] is a good guy with a [Second Amendment claim].”

When the Supreme Court handed down Bruen, it was heralded as a great civil liberties victory for gun owners and a great tragedy by gun control advocates.

One of the loudest critics was President Biden who expressed his “deep disappointment” and denounced a ruling that he insisted “contradicts both common sense and the Constitution.”

Those nonexistent rights, however, may now benefit his son who is facing clearly false statements contained on a gun form.

Form 4473 is required for gun purchases like the one of Hunter in 2018. It asks:

Are you an unlawful user of, or addicted to, marijuana or any depressant, stimulant, narcotic drug, or any other controlled substance?

Warning: The use or possession of marijuana remains unlawful under Federal law regardless of whether it has been legalized or decriminalized for medicinal or recreational purposes in the state where you reside.

Hunter reportedly lied and said “no.”

The Bureau of Alcohol, Tobacco and Firearms maintains this ban applies to people who have admitted to using illegal drugs in the 12 months before buying a gun. Hunter Biden was using drugs before, during, and after that period.

We previously discussed the issue which became even greater news when it was learned that the gun was tossed into a trash bin in Wilmington by Hallie Biden, widow of the deceased brother of Hunter. After the death of his brother Beau, Hunter began a sexual relationship with Hallie and she apparently became concerned about what he might do with the gun.

President Biden has demanded “red flag” enforcement that would also appear to target the conduct of his own son.

Now, Hunter Biden could be arguing against some of these laws as unconstitutional under a more expansive view of the Second Amendment. While most courts have upheld the ban on drug users, Hunter’s lawyers reportedly told the Justice Department that they will challenge the law under Bruen where a six-justice majority declared that such limitations must be consistent with the practices during the founding period.

This is not the first glaring contradiction to arise under the Hunter Biden scandals. President Biden has long campaigned against “deadbeat Dads,” but did not utter a word of concern when his son spent years resisting recognizing or supporting his daughter until a settlement was raised with the help of a court. He is now trying to reduce those payments.  The President and First Lady continue to refuse to acknowledge their granddaughter, Navy, as Hunter opposes her use of the family name.

Biden’s arguments in Arkansas, to paraphrase his new found allegiance, appears to be that Navy “I’ll give you my [more child support] when you pry (or take) it from my cold, dead hands.”

Given his father’s call for greater enforcement of red flag laws and gun controls (including permitting requirement), it will be interesting to see how the Justice Department deals with what appears an knowing violation of the federal gun laws. While this is not the charge that most concerns the White House, it is still a charge that can come with a sentence of up to 15 years in prison.

Ironically, when he committed the alleged violation, the penalty was 10 years. The Bipartisan Safer Communities Act raised the maximum penalty for that offense to 15 years. The president who enthusiastically signed that law was Joe Biden.

https://www.zerohedge.com/markets/should-deeply-trouble-us-all-hunter-biden-reportedly-planning-second-amendment-defense

CIA Chief Made Secret Visit To China To Salvage Spiraling Relations

 CIA director Bill Burns recently made a secret trip to China in an attempt to rescue deteriorating relations between the two powerful rivals. The clandestine trip was revealed Friday by the Financial Times, which wrote "Five people familiar with the situation said Burns, a former top diplomat who is frequently entrusted with delicate overseas missions, travelled to China for talks with officials." It happened last month.

Burns was dispatched as President Biden reportedly sees him as among the most "trusted" senior US officials, and it demonstrates the urgency with which Washington is trying to stabilize the relationship with China

Neither the White House nor CIA have issued official comment, but FT cites one US officials to confirm that "Burns met Chinese intelligence officials during the trip", and further--

"Last month, director Burns travelled to Beijing where he met with Chinese counterparts and emphasized the importance of maintaining open lines of communications in intelligence channels," said the US official. Burns’ mission took place in the same month US national security adviser Jake Sullivan met Wang Yi, China’s top foreign policy official, in Vienna. The White House did not announce that meeting until it had concluded.

As we've detailed previously, military as well as intelligence channels of communications between the US and Chinese governments, used especially to avoid inadvertent conflict in places like the South China Sea or related to the Taiwan issue, have almost entirely ceased. 

The last time a high-level Biden admin official visited China was all the way back in July 2021, when deputy secretary of state Wendy Sherman traveled to Tianjin for official dialogue.

But relations and communications were severely damaged in the last months going back to the early February Chinese 'spy balloon' shootdown incident over the US east coast. Its flight over North America grabbed headlines and consumed the world's attention for days.

American officials used the whole saga to highlight Chinese spying and malfeasance on US soil - something which Beijing officials vehemently denied. It angered the Chinese government to the point of tit-for-tat vows of retaliation and heated statements which persisted for weeks.

According to more from FT: 

The incident derailed an effort to set "a floor" under the relationship that Biden and Chinese president Xi Jinping had agreed was necessary when they met at the G20 in Bali in November. Biden last month said he expected an imminent “thaw” in relations without providing any detail. Burns travelled to China before Biden made the comment at a G7 summit in Hiroshima. 

Months prior to Russia's Feb. 24, 2022 invasion of Ukraine, Burns was dispatched on an at that time secret trip to Moscow to warn Putin's government over the military build-up near the Ukrainian border. Burns was later in Kiev to warn Zelensky that US intelligence indicated Russia was about to kickstart a major military offensive.

At this point, it remains unclear the degree to which Burns made headway with China, but there are signs of positive economic and bilateral dialogue of late. Military-to-military dialogue has continued to decline, however.

https://www.zerohedge.com/geopolitical/cia-chief-made-secret-visit-china-salvage-spiraling-relations

Vanda gets orphan designation for Charcot-Marie-Tooth Disease treatment

 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VCA-894A for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within IGHMBP2.

CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy for which there is no available treatment. The estimated prevalence of CMT is 1 in 2,500 individuals, with varying clinical features dependent on the various genetic variants of CMT.1,2 The prevalence of CMT2S is estimated to be less than 1 in 1,000,000 worldwide.3

Onset of CMT2S begins in early childhood.2 CMT2S is characterized by slowly progressive distal muscle weakness and atrophy, affecting the upper and lower limbs in a child's first decade of life, leaving patients with decreased reflexes and sensory impairment.1,2 Because CMT2S is a progressive disease, most patients become wheelchair bound.

https://finance.yahoo.com/news/vanda-pharmaceuticals-announces-orphan-drug-013100973.html

FDA revokes emergency use authorization for J&J's COVID vaccine

 The U.S. Food and Drug Administration said on Thursday it has revoked the emergency use authorization for Johnson & Johnson's COVID-19 vaccine. 

https://finance.yahoo.com/news/us-fda-revokes-emergency-authorization-222406748.html