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Tuesday, January 9, 2024

Elites who funded anti-Israel bridge and tunnel blockage ‘protest’ in NYC must be stopped

 Monday’s antisemitic bridge- and tunnel-blocking “protest” generated a new folk hero, an ordinary man fed up with the protesters’ ugly, narcissistic “activism.” 

Meanwhile, it turns out the “movement” is backed by America’s left-wing, moneyed elites — all too appropriate for goons who feel so comfortable screwing over working Joes just trying to get on with their days. 

A whole laundry list of radical groups joined to produce Monday’s mess, from the Palestinian Youth Movement to the New York Democratic Socialists of America to Jewish Voice for Peace to Al-Awda, accused of ties to terrorists.

And big names in lefty philanthropy provided funding to at least one of them, Jewish Voice for Peace (JVP).  

Like a foundation set up by ice cream titans Ben and Jerry, whose brand posted a hypocritical tweet about land givebacks to the Indigenous over the last 4th of July and caused nationwide scorn and hilarity. 

And the Rockefeller Brothers Fund, an anti-Israel stalwart whose money has reportedly helped bankroll groups linked directly to Hamas.

Heck, even the charitable arm of retail investing behemoth Charles Schwab has given to JVP.

What the heck, Chuck? 

The radical groups portray themselves as innocent, hopelessly outmatched fighters for justice: Ha! Just like the terrorists they support, these cowards have plenty of money and institutional backing.

Pro-Palestinian demonstrators close down the Brooklyn Bridge, one of the main bridges connecting Manhattan to Brooklyn, on January 8.
Pro-Palestinian demonstrators close down the Brooklyn Bridge, one of the main routes connecting Manhattan to Brooklyn, on January 8.Getty Images

In other words, it’s the Black Lives Matter story all over again. (No shock that BLM is a leading voice in the anti-Israel movement, either.) 

The contemporary US left enjoyed until very recently the unalloyed blessing of billionaires, huge corporations, elite universities, and the tip-top American creative class.

Hamas’ Oct. 7 atrocities seem to have begun a reckoning with that

Good. 

Time for the rich and powerful to realize that there’s no “social justice” being built when they fund the lefty equivalents of the Klan or the American Nazi Party.  

https://nypost.com/2024/01/09/opinion/stop-elites-paying-for-anti-israel-brooklyn-bridge-protest/

'Joe Biden will drop out of 2024 presidential race, top JPMorgan strategist predicts'

 President Biden will not run for re-election during a tumultuous year that will see parts of the country suffer rolling blackouts, the release of an inhaled COVID vaccine and a boycott over driverless cars, a top JPMorgan Chase strategist predicted.

Michael Cembalest, who heads the market and investment strategy unit in the Wall Street bank’s asset management division, made the shocking forecasts in his list of ‘Ten Surprises’ for 2024 over the weekend.

Tops among the budding Nostradamus’ prophesies was that 81-year-old Biden will drop out of the race “sometime between Super Tuesday and the November election, citing health concerns.”

“Super Tuesday” refers to the March 5 presidential primaries and caucuses that will be held in more than a dozen states, including California, Texas, Massachusetts, Vermont and North Carolina.

The winner of the “Super Tuesday” contests is considered the heavy favorite to eventually capture the party’s nomination for president.

Cembalest issued his predictions in newsletter as a tribute to former JPMorgan market strategist Byron Wien, who had made 10 prognostications every year for nearly four decades before his death last year at age 90.

A strategist at JPMorgan Chase is predicting that President Biden won’t seek re-election in 2024.SHAWN THEW/EPA-EFE/Shutterstock

Also on Cembalest’s list was that Americans will reject self-driving electric vehicles following several accidents that have roiled San Francisco, and a warning that blackouts will strike New York, Texas, Pennsylvania, Wisconsin and Tennessee due to a natural gas shortage.

He predicted that a new, inhaled COVID vaccine, currently under development, will be available this year and sharply reduce transmission of the virus, that the US dollar would remain stable and that the Russian invasion of Ukraine would drag on this year without a ceasefire.

He also thinks that stocks of US regional banks will do well despite the instability in the lending sector in the past year.

His prediction that Biden would bow out was partly based on the president’s low approval rating — despite “around 10% job creation since his inauguration.”

The strategist noted that Biden’s high job creation figures are “the by-product of his inauguration coinciding with the rollout of COVID vaccines and a reopening US economy.”

Cembalest did not predict who might take Biden’s place as the Democratic candidate.

Concerns about Biden’s age and mental acuity as well as high inflation have put a damper on his re-election chances.AFP via Getty Images

The Post has sought comment from the White House.

Vice President Kamala Harris is unpopular with the public — with more than half (55.5%) disapproving of her job performance, according to the FiveThirtyEight data and statistics news site.

Rep. Dean Phillips (D-Minn.) and self-help author Marianne Williamson are the only other Democrats who have declared their candidacies.

The two long-shot candidates will debate one another in New Hampshire on Monday.

Biden will not participate.

Recent polls show former President Donald Trump defeating Biden in a rematch of the 2020 election.AFP via Getty Images

Another Democrat, Robert F. Kennedy Jr., intends to run as an independent candidate.

Despite concerns over Biden’s age and mental acuity, the incumbent remains the overwhelming favorite to recapture his party’s nomination, with polls showing three in four Dems favoring him over Williamson and Phillips, according to FiveThirtyEight.

Former President Donald Trump remains the overwhelming front-runner in a race against GOP hopefuls Nikki Haley, Florida Gov. Ron DeSantis and biotech mogul Vivek Ramaswamy.

If the presidential election were held today, Biden would lose to Trump, according to the most recent public opinion surveys.

https://nypost.com/2024/01/08/business/joe-biden-will-drop-out-of-2024-presidential-race-top-jpmorgan-strategist-predicts/

Gene Therapy Approvals Expected to Ramp Up in 2024 Amid Manufacturing, Cost Challenges

 2023 was a breakthrough year for cell and gene therapies, with seven FDA approvals in the U.S. and one in the European Union, according to the Alliance for Regenerative Medicine. Looking to 2024, the Washington, D.C.–based advocacy organization predicted on Monday in its annual Cell & Gene State of the Industry Briefing that the sector could see up to 17 approvals in the U.S. and EU.

Regulators in the U.S. gave the greenlight in 2023 to five gene therapies for rare genetic diseases and in 2024 could see an additional five approved by the FDA, as well as the first-ever approval of adoptive cell therapy for solid tumors and the first U.S. approval of an allogeneic T-cell therapy.

Other notable milestones expected in 2024 include additional therapies to treat hemophilia A and hemophilia B and dystrophic epidermolysis bullosa.   

“We’re optimistic that we’ll see a lot of these pulled through to the finish line,” Tim Hunt, CEO of the Alliance for Regenerative Medicine (ARM), said at the Biotech Showcase 2024 investor conference in San Francisco, co-located with the 42nd Annual J.P. Morgan Healthcare Conference.

Hunt called last month’s respective FDA approvals of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia, competing gene therapies for sickle cell disease, the “seminal moment in the history of biotechnology.”

Casgevy got the regulatory go-ahead for the first CRISPR-based gene editing therapy. However, it is an approval unlikely to be followed up by another such drug anytime soon, according to GlobalData.

“Given the relative immaturity of the CRISPR drugs pipeline, which features very few late-stage products alongside a low likelihood of approvals, it is unlikely to see another drug approval in the near future,” Jasper Morley, drugs intelligence analyst at GlobalData, said in a statement.

Speaking at Monday’s ARM event, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that gene therapy is currently at a “critical juncture” due to a combination of factors, including manufacturing challenges, issues with clinical development timelines and different global regulatory requirements.

Marks contends that current manufacturing platforms limit gene therapy production. “The problem is the setup cost for these small gene therapies is just way too high in proportion to the return on investment—so we have to figure out a way to get over that,” he said.

The Cost of Gene Therapies

The National Bureau of Economic Research estimates that more than 1 million patients will receive treatment with gene therapies, costing more than $25 billion annually by the end of 2034, raising concerns about how the U.S. healthcare system could support these growing costs.

The prices for the two latest FDA-approved gene therapies drive the point home. Casgevy has a U.S. list price of $2.2 million per patient, while the wholesale acquisition cost of Lyfgenia in the U.S. is $3.1 million.

Despite their multimillion-dollar price tags, gene therapies have the potential to save the U.S. healthcare system money, according to ARM’s Hunt.

“This can be a little controversial. I know there’s sticker shock when you price the product at $2 million to $3 million. But if you look at the data, take the emotion and set it aside, it tells a very compelling story,” Hunt said. “We believe that these gene therapies are clearly affordable.”

According to Hunt, the lifetime cost of the standard of care for most rare diseases is more expensive than those of approved gene therapies. He noted that the lifetime cost for patients with severe Hemophilia A is over $21 million, those with severe sickle cell disease pay between $4 million to $6 million and patients with transfusion-dependent thalassemia $5.4 million.  

Hunt pointed to an Institute for Clinical and Economic Review (ICER) report which found that gene therapies—including BioMarin’s Roctavian (Valoctocogene roxaparvovec) and CSL Behring’s Hemgenix (etranacogene dezaparvovec)—for hemophilia A and B showed the potential for substantial cost offsets due to elimination of the need for expensive prophylactic treatment.

“In the case of these two gene therapies, more than 99% of the traditional cost-effectiveness ‘value’ is generated by cost offsets of eliminating prophylactic treatment that itself is widely considered to be far too expensive to be cost-effective,” according to ICER.

Hunt asserts that ICER “confirmed the high-cost offsets from durable gene therapies in hemophilia, sickle cell and other rare diseases.” He acknowledged that the ICER report is “one data point, but a lot of commercial payers are there as well,” adding that “these products are ultimately digestible by healthcare systems even before taking into account cost offsets.”

https://www.biospace.com/article/gene-therapy-approvals-to-ramp-up-in-2024-amid-manufacturing-cost-challenges/

'CAR T Cell Therapy Is a Comparatively Low-Risk Cancer Treatment'

 CAR T cell therapy is lower risk than other cancer treatments, according to a prominent group of cancer and cell therapy leaders who published their commentary in Nature Tuesday, a little more than a month after the FDA announced it was investigating the “serious risk” of T cell malignancies in patients who received such treatments. But more information is still needed, the authors stressed.

Specifically, current and past presidents of national and international cell therapy organizations collectively stated that “the benefits of CAR-T therapies continue to outweigh the potential risks in the vast majority of cases.”

The question remains whether the CAR T cell therapy caused the secondary cancers reported, but FDA Center for Biologics Evaluation and Research Director Peter Marks noted that it’s likely. “It does look like there’s a causal relationship,” he said during the Alliance for Regenerative Medicine’s annual Cell & Gene State of the Industry Briefing at the 42nd J.P. Morgan Healthcare Conference. However, he hastened to add that “it’s not overly concerning to us in this malignant setting right now.”

Lead author of the Nature commentary Bruce Levine, like many in the oncology community, emphasized this point as well. “We have to remember who the patients are who are receiving CAR T,” said Levine, founding director of the Clinical Cell and Vaccine Production Facility at Penn Medicine’s Center for Cellular Immunotherapies. “These are patients who are relapsed/refractory who have very few, if any, options.”

Is the FDA’s concern warranted?

On Nov. 28, the FDA stated it was investigating 20 reports of T cell lymphoma in patients who had previously received CAR-T therapies, STAT News reported. And this week, Marks said the number had grown to 22 by the end of 2023. According to the authors of the Nature paper, more than 34,400 patients have received these therapies. The commentary references post-authorization safety studies, recorded by the Center for International Blood and Marrow Transplant Research. Of 8,060 recipients of commercial CAR-T cells followed for a median of 13 months, three had documented T cell malignancies as of Dec. 14, 2023.

However, Levine told BioSpace that the two voluntary reporting databases, the FDA Adverse Event Reporting System (FAERS) and the Center for International Blood & Marrow Transplant Research (CIBMTR), contain “only a fraction” of outcomes from the total patients known to be treated. “We have some information, but not nearly enough,” he said.

The authors note that much is still unknown about the T cell lymphoma cases; they list age, prior therapies, immune status and time from CAR-T infusion to the development of the lymphoma as important patient characteristics to consider in assessing the therapy’s risk.

Levine said he wants to know how many of the cancers are CAR-positive—and if they are CAR-positive, where the insertion is—and whether the CAR is a passenger or a driver of the subsequent malignancy. Such information “tells us how we might think about screening and treating patients” and could potentially inform the use of vectors or vector design, he said.  

The Path Forward

The authors estimate that long-term side effects, including potentially cancerous mutations, occur at “a much higher rate” with standard chemotherapy and radiotherapy than with CAR T cell therapy. Levine said he couldn’t rank the relative risk of CAR T cell therapy compared to other immunotherapies until additional data are gathered.

With so much still unknown, Levine said the group decided to put out the commentary now “to encourage reporting to the voluntary databases and to the FDA, and when cases are discovered, to proceed with very thorough investigations to get out the potential causes.”

For now, Levine said that at the University of Pennsylvania, they will continue to prescribe CAR-T therapy to patients as they have in the past, “keeping in mind what’s going on in the background with these cases.”

https://www.biospace.com/article/car-t-cell-therapy-is-a-comparatively-low-risk-cancer-treatment-industry-experts-/

Western Allies Met Secretly With Ukraine On Peace Plan, Attempt To Woo Global South

 Despite the continued 'steadfast' rhetoric on 'not backing down' to Russian forces which has persisted from Zelensky's office, the consensus among realists has been that Ukraine's only way out at this point is through negotiated settlement. On a public level at least, the White House has continued to back Kiev in rejecting negotiations as the bloodshed continues. 

Yet there has for many months been the suspicion that even the Biden administration sees the proverbial writing on the wall, and is quietly pressing for President Zelensky to engage in negotiations. Kiev has presented its own peace plan to allies, but which Moscow has already long rejected as an impossibility, given it would require that Russian troops simply march back home, handing Crimea and the four annexed territories back to Ukraine. For example, here is Point 6 of Zelensky's ten point peace plan:

To cease the hostilities, Russia must withdraw all its troops and armed formations from the territory of Ukraine, plain and simple. Ukraine’s full control over its state border, recognized internationally, needs to be restored.

Without this, no long-lasting peace can be achieved. Each day Russian soldiers remain on Ukrainian land, Ukrainians have to fight and die to protect their homes and to shield the world from the long-lasting consequences of this aggression.

Obviously, President Putin won't negotiate for the demise or 'loss' of his whole two-year long operation, especially when by all accounts Russia has the upper-hand, also as Kiev struggles for lack of manpower and steady ammo supplies. Tragically, there have likely been hundreds of thousands of lives lost, and possibly just as many severely wounded from the war.

On Tuesday Defense Minister Sergei Shoigu announced the Kremlin assessment that Ukraine has lost over 200,000  of its troops in 2023. "Groupings of Russian troops are methodically reducing the combat potential of the Ukrainian armed forces. Over the past year, enemy losses exceeded 215,000 servicepeople and 28,000 weapons systems. We maintain the strategic initiative along the entire line of combat contact," Shoigu told a meeting of military leaders. Of course, there's no way to verify this figure, and both sides have kept military losses a tightly guarded secret. Zelensky too has recently said the other side has suffered "heavy losses".

At this point, even Ukraine's most ardent supporters acknowledge a hopelessly stalemated situation along the front lines. The war is now spiraling into senseless cross-border aerial attacks where civilians on either side bear the brunt of suffering.

It appears Washington is ramping up diplomatic efforts toward kick-starting a negotiation process on a track that's favorable to Ukraine. But persuading Moscow will be a different story, also as it has the backing or at least tacit support (or 'neutral' silence from) large economies like China and India. Bloomberg on Tuesday has reported on a secret meeting recently held in Saudi Arabia:

A secret meeting took place last month between Ukraine, its Group of Seven allies and a small group of Global South countries to try to rally support for Kyiv’s conditions for holding peace talks with Russia, according to people familiar with the matter.

The previously undisclosed Dec. 16 meeting of national security advisers was held in Saudi Arabia and followed larger, publicized gatherings aimed at countering Moscow’s attempts to divide and paint Ukraine and its allies as unwilling to negotiate an end to the war.

It remains that many of these Global South countries have been key in helping Russia navigate and endure past the US-EU sanctions storm targeting Moscow.

Bloomberg says that the secrecy aspect was to make other countries feel more comfortable to speak and act freely without having to worry about potential blowback or repercussions from Moscow. Of course, Russia wasn't invited, and crucially China didn't go. Among major participants included senior representatives from Turkey, Indian, and Saudi Arabia - yet notably absent were Brazil (which apparently submitted a written statement), China, and the UAE, according to sources cited in the report.

"There was no major progress at the latest meeting, held in Riyadh, according to people familiar with the session who asked for anonymity to discuss matters that aren’t public," Bloomberg writes. "Ukraine and its G-7 allies continued to resist calls from the Global South nations to engage directly with Russia, they said."

China is seen as key to getting Russia to make significant compromise, yet both Xi and Putin know that Russian military success in Ukraine means Kiev has no cards to play. Ultimately, without China being on board with such initiatives to woo Global South countries to take a firmer anti-Russian line, there's little that will come out of it.

Still, it seems each side is at least inching toward future talks. "Liu Jianchao, head of the International Department of the Communist Party of China Central Committee, told an event in the US that Russia has showed enthusiasm to have peace talks with Ukraine, when Chinese officials talked with them," according to the latest from Bloomberg.

https://www.zerohedge.com/geopolitical/western-allies-met-secretly-ukraine-peace-plan-attempt-woo-global-south