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Sunday, February 4, 2024

Eisai expects 1,500 Alzheimer's patients in China launch, sees ‘huge’ growth

 Japan’s Eisai aims to roll out its groundbreaking Alzheimer’s drug Leqembi to 1,500 people in China later this year, but expects growth to accelerate significantly in 2025 as diagnosis methods change, a company spokesperson told Reuters.

More convenient Alzheimer's blood tests expected to be ready then could help Eisai reach a bigger share of China’s estimated 17 million people with early-stage disease, the spokesperson said.

“China is one of the fastest-aging countries in the world and is one of the most important countries in the area of Alzheimer’s disease for Eisai,” a company spokesperson said. “The potential growth for Leqembi in China is huge.”

Eli Lilly, which is developing a similar treatment called donanemab, told Reuters it has filed for approval in China. The Indianapolis-based company is now testing its drug in a 1,500-person trial with volunteers in China, Taiwan, South Korea and the EU, a spokesperson said.

The size of Eisai's planned China rollout and the filing of Lilly's approval application have not previously been reported.

Leqembi, which works by removing a toxic protein called beta amyloid from the brain, is the first Alzheimer's treatment proven to alter the course of the fatal, brain-wasting disease. China approved Leqembi in January.

Eisai and U.S. partner Biogen have already rolled out Leqembi in the United States and Japan, and it is under review in Europe.

The treatment, given by infusion twice a month, slowed progression of the disease by 27% for patients in the earliest stages of Alzheimer's in a clinical trial.

Current treatments available in China have limited effect, and Eisai's trial results give patients "a lot of hope," said Alzheimer's expert Dr. Liu Zhou of Guangdong Medical University.

Eisai said it expects to start using the drug in China by September, and forecast a total of 1,500 patients there by March 2025, a number limited by the country's diagnostic capabilities.

Leqembi's sales could "increase significantly" in 2025, the company said, with the expected introduction of blood tests to assess a patient's amyloid burden rather than PET scans or invasive lumbar punctures, which require access to specialists.

“If treatment were to become possible based solely on blood tests, we think it would generate significant interest,” Citi analyst Hidemaru Yamaguchi said in a research note. He did not have an estimate for China but expects Leqembi sales outside of Japan and the U.S. to peak in 2030 at 126 billion yen ($1.08 billion).

Rates of Alzheimer's diagnosis and treatment in Asia's biggest economy remain low, and medical specialists and public awareness of the disease is limited, according to The China Alzheimer Report 2022, published in BMJ General Psychiatry.

China's health ministry did not respond to a request for comment by the time of publication.

Experts said the country has been ramping up imaging capacity.

Siemens Healthineers, which sells imaging equipment in China, said the market in China for molecular imaging has grown more than 45% over the past four years.

'ILL PREPARED'

Initially, Eisai plans to launch Leqembi on China's private market, where it is priced at about 200,000 yuan ($28,180) per year, about $2,000 more than in the U.S.

Eisai said it will decide whether to seek government coverage after it assesses private market demand.

Inclusion on China’s National Reimbursement Drug List typically means a steep price cut. A 2023 analysis estimated the average negotiated price cut ranged from 44% to 61%.

To be eligible for treatment, patients undergo cognitive testing, genetic testing to assess whether they carry a gene that increases the drug's adverse side effects, and testing to confirm abnormal levels of amyloid, the sticky substance in the brain targeted by Leqembi.

Once on treatment, suitable patients undergo a series of MRI scans to monitor for potentially fatal swelling and bleeding in the brain.

Economist Dr. Soeren Mattke, director of the University of Southern California Brain Health Observatory who has consulted for both Eisai and Biogen, said China lacks a system of primary care physicians to do preliminary testing and refer appropriate candidates to specialists.

Mattke and colleagues published an assessment of China's readiness for disease-modifying treatments in July in the Journal Alzheimer's & Dementia that concluded that China is “ill prepared to provide timely access to an Alzheimer’s treatment.”

"In China," Mattke said, "specialty care is almost absent in the rural areas."

https://news.yahoo.com/exclusive-eisai-expects-1-500-230243104.html

Zelenskiy says he might replace several Ukraine officials, not just military

 Ukrainian President Volodymyr Zelenskiy, in an interview broadcast on Sunday, said he was considering replacing several senior officials, and not just in the military, to determine who is to lead the country.

Speculation has gripped Ukraine over suggestions that the president is about to dismiss the commander of Ukraine's military, Valery Zaluzhnyi. The two have been at odds over the conduct of the nearly two-year-old Russian invasion of Ukraine.

"It is a question of the people who are to lead Ukraine," Zelenskiy told Italian state RAI television when asked about Zaluzhnyi. His comments were voiced over in Italian.

"A reset is necessary, I am talking about a replacement of a number of state leaders, not only in the army sector. I am reflecting on this replacement. Is a question for the entire leadership of the country."

He said that to introduce the necessary changes, "I have in mind something serious that does not concern a single person but the direction of the country's leadership".

"If we want to win we must all push in the same direction, we cannot be discouraged, we must have the right and positive energy, negativity must be left at home. We can't take on giving-up attitudes."

Differences have come to the fore since a Ukrainian counteroffensive launched last year made only limited gains against Russian forces well dug in along the 1,000-km (600-mile) front line in Ukraine's south and east.

Zaluzhnyi gave an interview to a Western media outlet in November in which he said the war had entered a new phase of attrition. That drew a rebuke from the president.

Last week as speculation over his dismissal intensified, he set out his case in a commentary for broadcaster CNN for new electronic means of warfare.

He also said some Ukrainian institutions were preventing the country from achieving its objectives, including efforts to build an effective fighting force to match Russian numerical superiority.

https://news.yahoo.com/ukraines-zelenskiy-says-considering-replacing-215259773.html

Denver Starts Booting Migrants From Shelters As City Nears 'Breaking Point'

 Denver, Colorado is reaching a breaking point as migrant arrivals continue to overwhelm the self-proclaimed sanctuary city.

As a result, Mayor Mike Johnston (D) suggested that the city may stop accepting more, while officials begin the process of booting them from overcrowded shelters.

"I think our city is very close to its breaking point now," he told Fox & Friends last week. And we’ve been talking to leaders in D.C. around the country about why we need them to take action here. I think we have successfully welcomed almost 40,000 migrants in the last year and — and we know what it takes to do this successfully, we just need that help."

Last year the city helped over 38,000 migrants. As of Friday night, 3,895 were staying in city shelters.

"That’s an incredible number of people to shelter, support, feed, help with transportation, deal with case management," said Jon Ewing of Denver Human Services.

According to Johnston, more needs to be done to address the influx of migrants at the southern US border.

"And the things we need are — yes, we need federal dollars, but the most important thing is we need, you know, work authorization for folks when they arrive, and we need those resources at the border so you can add more security at the border and so you can help process those asylum claims so the folks that do arrive here can work," he said.

Perhaps preventing them from entering the country in the first place is the way to go, Mike?

On Friday, Johnson told KOA news that the city is exploring options to pause taking in more people.

"We are considering it. We have to consider all options, particularly if there isn’t any help from the federal government," he said.

Denver is clearing out migrant shelters

According to Fox31, Denver is clearing out shelters used by the migrants.

Starting on Monday, 150 migrants in city shelters will be discharged. Then that number will fluctuate between 50-100 every day until all 3,800 are out of the 10 shelters currently run by the city.

The hope and goal is that we are able to connect the vast majority with housing, or at least as many of them as we possibly can,” Ewing said.

The number of migrants arriving in Denver is coming down — 48 arrived on Thursday and 64 on Friday, a significant drop from the beginning of January, when that number was 200-300 daily. -Fox31

"4,000 people when you have limited budget, when you have limited resources … very difficult to find enough housing as is, affordable housing as is, in the city of Denver — that’s going to be difficult," said Ewing.

Denver is one of several Democratic strongholds across the United States which pledged maximum virtue by signaling themselves as sanctuary cities - only to be completely unprepared for the surge of migrants that followed the Biden administration's open invitation to them on day one.

New York is facing a similar overload, as Mayor Eric Adams (D) has repeatedly called on the Biden administration to lend a hand in dealing with the migrants. The Big Apple has seen a surge of more than 160,000 asylum seekers since last year.

https://www.zerohedge.com/political/denver-starts-booting-migrants-shelters-city-nears-breaking-point

Democrats Create an Alice in the Looking Glass World

 By Clarice Feldman

Like Alice dropped into an illogical world, I’m looking at the past week and seeing a chaotic, topsy-turvy, irrational series of policies, events, and outcomes. There are many possible examples to choose from. I’ve chosen four: The open border, the inexplicable disparities in the handling of crimes by Democrat district attorneys, the Administration’s song and dance with Iran and UNRWA, and China, and there’s a degree of overlap in some of these.

North of the Border

Millions of people -- mostly military-age men -- from almost every country on the globe are being processed by the Borden Patrol and released with orders to show up for hearings, many not set for several years distant, during which time the Democrats will certainly seek an electoral advantage. Since districting for voting and disbursement of federal funds is based on the number of residents, regardless of their legal status, districts with lots of illegals will get a weighted advantage. Most of the asylum applications are groundless, but most likely, the Democrats will seek amnesty for these millions. President Trump had begun wall construction and set in place policies to stop this. Within 100 days of taking office, Biden took 94 executive actions which smoothed the way for the massive influx of illegal immigrants. Legalizing them will effectively create a one-party state. Secretary Alejandro Mayorkas, who is now facing impeachment proceedings, worked to make deportation of these people nearly impossible. Elon Musk on X:

“Homeland Security Secretary Mayorkas issued written guidance making it clear that: 1. Illegal presence alone is not grounds for deportation. 2. Criminal charges, convictions or gang membership alone are not enough for deportation. You basically have to be a convicted axe murderer to be deported!“

The Supreme Court has made it nearly impossible for states to act when the federal government will not stem the invasion. Jonathan Turley:

[T] his crisis is the result of decades of court rulings expanding executive powers while limiting the ability to challenge those policies. The court’s decisions narrowing standing have been deleterious, limiting those who can challenge unlawful or unconstitutional acts by the federal government.

States such as Texas are absolutely correct that this is a breach of the original understanding with the federal government. The combination of the sweeping preemption by the courts and diminishing enforcement by the agencies has left states as mere observers to their own destruction. It is like watching your house burn down as the fire department works primarily to prevent anyone else from putting it out.

The Biden fire department is claiming that, just as it has the authority to put out fires, it has the authority to let them burn . 

Irrational Democrat Law Enforcement

A pack of illegal migrants attacked New York City policemen. Videos captured the assault, and several of the men were arrested. District Attorney Alvin Bragg arranged for them to be released on bail, and they were photographed laughing and flipping off photographers.  Then, using  false names, they persuaded a sympathetic-to-illegals charity to give them bus transportation to California, where they will receive “free health  care, housing, food 

subsidies, scholarships for illegal aliens in Gavin Newsom’s $ 68-billion-in-the-red state.”  Confronted by a reporter concerning the no-bail policy for illegal criminals, New York's Governor Kathy Hochul suggested they be deported, contrary to sanctuary cities in both states. 

Questioned why he chose to arrest and demand $100,000 bail for Daniel Perry, who saved a subway car full of passengers from a violent man threatening them, while at the same time seeking no bail for illegals who beat up cops, Bragg said he lacked evidence to hold them, this despite all the passengers who supported Penny and thanked him, and the assault of law enforcement officers being on videotape. The message is this -- in Bragg’s NYC jurisdiction, we’re going to allow people to brutally attack you with little consequence, and you dare not defend against that.

A congressional aide engaged in anal intercourse in a Capitol hearing room, videotaped it, and made it public. The U.S. Capitol Police declined to charge him, though imprisoned Jacob Chansley and most of the other January 6 defendants engaged in no misuse of government property when they walked through rope lines in the Capitol and engaged in friendly exchanges with the Capitol Police while there. Instead of prosecuting felonies in the District of Columbia, the U.S. attorney for D.C. is still directing massive amounts of manpower to track down January 6 trespassers who reside around the country to prosecute them.

The District of Columbia is the site now of a really horrendous crime wave, including many brutal carjackings. The D.C. attorney general Brian Schwalb claims we can’t stop this by arresting the young men engaged in these crimes.

Fani Willis, who seeks to convict Donald Trump under some notion of RICO, now admits that she has a “personal relationship” with the man she hired to prosecute the case, a man with no experience in such prosecutions. Her paramour’s friends bankrolled her campaign and, in return, received lucrative contracts, and she is charged with having misused federal funds.

Iran and UNRWA

Either Biden is stupid or he thinks we are. After repeated aggression by Iranian proxies, including the killing of three U.S. servicemen and women, the Administration said it was going to take countermeasures. It announced six days before acting where it was targeting and unsurprisingly, by the time it did so, the targets certainly had moved to safety. This is in line with its policies of giving Iran a free pass.

While Robert Malley was placed under FBI investigation and was removed from office as Biden’s Iran envoy, the administration has not deviated from the never-disclosed policy he set in 2016 while he was with the non-governmental agency, the International Crisis Group -- a Memorandum of Understanding with the Iranian Foreign Ministry. Biden will not enforce sanctions against Iran, has instituted no arms embargo against Iranian drone purchases, and has not interfered while Iran builds up its nuclear arsenal. Those drones Iran purchased are apparently the very ones the Iranian proxy Houthis are firing at vessels in the Red Sea. We keep announcing that we are shooting down those drones, but it’s a costly “victory.” The drones are worth about $50 thousand each, and the cost of destroying them before they damage our ships is in the millions. Certainly, reason suggests it’s time to destroy the drone launch pads and launchers and abandon Malley’s plan.

As to UNRWA, in the face of its proven collaboration with Hamas and participation in the attacks on Israel, a significant number of countries and the European Union have announced suspension of further contributions to the organization. Biden did as well. But -- hold on a minute -- we only suspended $300,000 of our contributions. So far this year, we have contributed $121 million dollars to UNRWA, doubtless a good deal of it after October 7. Remember, Trump suspended contributions to UNRWA, and Biden reinstated them.

The Great Afghan Folly

Regarding our disastrous fast-footing out of Afghanistan, leaving a fortune in military equipment behind, a new Department of Defense IG report indicates that, in 2022 and 2023, we spent a total of $5.1 billion in fiscal years 2022 and 2023 to house, feed, transport, and resettle Afghan evacuees, and here’s the kicker: the beneficiary of all our labors, lost troops, and fortune expended in Afghanistan will be – guess who -- China.

“The Taliban has asked to join China’s Belt & Road initiative and has already signed contracts with China allowing the Communist regime to drill for oil and gas in Afghanistan and to mine lithium and copper in the mineral-rich country” per a Pentagon IG report.“ 

I wish, like Alice, we could all realize this was some kind of weird dream, but I know it isn’t.

https://www.americanthinker.com/articles/2024/02/the_democrats_create_an_alice_in_the_looking_glass_world.html

Attkisson: Eagle Pass Being Closed To Journalists, Still Open For Illegal Border Crossers

 "Full Measure" host Sharyl Attkisson investigates the border crisis playing out in Eagle Pass, Texas. She speaks with the local sheriff and other law enforcement officials and tours the site where many thousands of unchecked illegal border crossings are taking place each day. She also looks at the effort by the state of Texas to halt the flow of migrants and the role of the Biden administration and Mexican cartels.



SHARYL ATTKISSON: We begin with the border crisis that some officials say has turned into a catastrophe. Right now, there is an epic battle in Texas over whether states have the right to protect their own borders from illegal foreigners entering when the federal government won't do it.

Three years into the Biden administration, illegal border crossings continue to shatter all-time records with well over 7 million southwest border encounters in three years. The House is moving to impeach Biden's Homeland Security secretary over the chaos, and today, we were returned to Eagle Pass, Texas, ground zero for the controversy, and where we find big changes since our last visit a year and a half ago. As the crisis has worsened, Texas has increasingly crossed swords with the Biden administration.

As the sun rises on Eagle Pass, Texas, one of the first changes we discover is, it's now harder for the media to get a front-row seat to the historic border chaos. Since our last visit to Eagle Pass, authorities and cut off access to the place where many of the illegal border crossings happen, under that bridge. To be clear, they haven't cut off access to the legal border crossers. They have cut off access to the media.

So while foreigners can still cross at will, the credentialed press are restricted from public property where we can see it. The local Maverick County sheriff agrees to get us into the restricted area bordering the Rio Grande. Barbed wire put up by the state is another new feature since our last visit. Tattered clothes mark a popular route.

Like most of America's border towns, Maverick County, Texas, is dominated by Democrats who don't see eye to eye with President Biden on this issue.

MAVERICK COUNTY, TEXAS SHERIFF: In the Trump years, I know he kept them on the other side in Mexico and it was stopped. When this administration came in, it's like they opened the borders. Now we have this new precedent that's going to open up the borders and open arms and they're going to start crossing.

SHARYL ATTKISSON: This group tells us they have just come in from Honduras and Venezuela. They are bound for Houston... The sheriff shows us another recent feature in the border crisis under Biden -- too many unidentified bodies to bury, and a trailer to store them.

...

Another addition to the landscape... A giant federal facility built to hold and process masses of foreigners... The attendants asked us to leave.

Next, we meet up with Sergeant Remi Cordova from the Texas Department of Public Safety. Even before we can start our interview, we see a group waiting across the frigid river from Mexico. Two head back, probably guides we're told, they will probably return with more.

...


Up the river, he shows us new state additions, besides coils of barbed wire, new open spaces where they used to be brush.

...

The Texas border initiative is called Operation Lone Star. As part of it, Governor Greg Abbott has ignited criticism and praise by busing a fraction of the millions of illegal immigrants to sanctuaries that invite and protect them from deportation. About 100,000 have been taken to L.A., Philadelphia, Washington D.C., Denver, Chicago, and New York City.

But this dynamic is heading for a dramatic shift on March 5th. A new Texas law will make illegal immigration a state crime. Local police will be able to make arrests rather than having to turn people over to Border Patrol, and the courts can order them back to Mexico.

...

Even before the new law took effect, Texas began flexing its muscles. The week we visited Eagle Pass, the Texas National Guard took control of this same area, shutting out federal border patrol, which is been letting more and more foreigners come in illegally, even opening gates in the border fence.

The Department of Justice and other advocates for illegal border crossers are arguing Texas's actions and the new law are unconstitutional. Meanwhile, it's hard not to notice that everywhere you look, someone is making a lot of money off the border crisis. Billions of dollars are going to federal and local agencies, nonprofits, and contractors for security, transportation, facilities, fencing, labor, processing, and supplies. The Mexican cartels are getting rich, too. They collect thousands of dollars from most every illegal border crosser, according to Border Patrol. That adds up to somewhere around $14 billion over three years. That doesn't count the money they are making from all of the drugs they are moving across the porous southern border.

The Biden administration blamed Texans for the drowning death of a woman and two children crossing illegally last month, claiming the Texas National Guard wouldn't let border patrol rescue them. But it turns out, the three victims were already deceased long before Border Patrol notified the guard and tried to get access to the river. The Justice Department and other advocates for illegal immigrants are suing Texas over the new law that will let local police arrest, saying that law violates the Constitution.

https://www.realclearpolitics.com/video/2024/02/04/sharyl_attkisson_eagle_pass_texas_is_being_closed_to_journalists_still_open_for_illegal_border_crossers.html

'Don't forget about East Palestine'

 Feb. 3, marks the first anniversary of the Norfolk Southern train derailment, which spewed carcinogenic chemicals across the town of East Palestine and its nearly 5,000 residents, displacing and sickening hundreds. A year later, residents still don’t know whether to trust that their community, and its environment, has been healed.

One milestone may finally be reached: After reneging on his promise a year ago, President Joe Biden has announced a visit to the Ohio hamlet in the coming days — though which day has not yet been announced. It is essential, needless to say, that the president not stiff East Palestine once again.

It was a harrowing few days, with pictures of giant black plumes rising above a model small town dominating the news. Train cars filled with vinyl chloride spilled and were eventually burned to avoid a catastrophic explosion, blanketing the area in a cloud of hydrogen chloride and phosgene.

Since then, Norfolk Southern has paid nearly $21 million directly to residents and invested over $100 million overall to atone for its negligence. That’s still only about 1% of its annual earnings: While cash can’t heal all wounds, we wish Pennsylvania and Ohio had extracted more direct payments.

Residents are divided. Some believe the worst is over, and that Norfolk Southern has done its duty to clean and revitalize the village it blighted. Others, many of whom still have unidentified health issues, don’t believe EPA reports that the air and water are clean. They have questions about sediment sampling and the long-term safety of their children.

Experts haven’t formed a consensus about the hazard, either. Studies contradict one another: One by the Texas A&M University Superfund Research Center and Carnegie Mellon University sided with the EPA that air quality is satisfactory, but another from Purdue University found lingering, dangerous health threats inside buildings near the derailment site and along the nearby creek, Sulfur Run.

The unknowns dwarf the knowns. Though some chemicals may test below technical danger thresholds, it’s simply impossible to know the effects of low-level exposure to them, in all their combinations, over long periods of time. Even now, the water of Sulfur Run has an oily sheen as it winds its way to the Ohio. Nobody knows what’s causing it.

This is consistent with many environmental disasters through history: There are always effects that cannot be predicted or understood using current knowledge and methods. And at some point in the future, everyone in charge looks foolish.

A year later, the recovery is still a work in progress. Crews have hauled over 44 million gallons of wastewater and 176,000 tons of solid waste from the derailment site, and are now backfilling new stone and gravel. Seventy-five to 100 trucks shuttle through East Palestine daily.

The worst fate that could befall the town now is to be forgotten. Hopefully Mr. Biden’s visit will ensure a renewed focus on East Palestine, on the people who still call it home, and on the lessons that still need to be learned from last year’s disaster.

https://www.msn.com/en-us/news/us/editorial-dont-forget-about-east-palestine/ar-BB1hHZm3

CPAC royalty: Trump’s 14th appearance tops Reagan record

 Former President Donald Trump has penned in his next appearance and speech at the annual Conservative Political Action Conference, breaking former President Ronald Reagan’s seemingly unbeatable record string of 13.

“President Trump will break the Reagan record by appearing at our major conference for a 14th time,” said Matt Schlapp, the chairman of CPAC.

“Thanks Mr. President #47,” Schlapp said with a reference to how Trump, the 45th president, would be the 47th president elected should he beat President Joe Biden, No. 46, in the fall elections.

CPAC takes place Feb. 21-24 at the Gaylord National Harbor Resort & Convention Center, which sits on the Capital Beltway and just up the Potomac River from George Washington’s Mount Vernon plantation.

Reagan attended the conferences long before they became the flashy stage for conservative superstars that it is now. The conference gave Reagan a chance to meet with conservative youth and discuss ideas. The conference’s major dinner is called the Ronald Reagan Dinner. This year, former GOP candidate Vivek Ramaswamy is the speaker.

Trump started the same way as Reagan at the conferences, but he has turned his appearances into major headline events and images, such as when he hugged the American flag in 2019 and 2020.

Just a month ago, Schlapp and CPAC endorsed Trump’s bid to win back the presidency.

Schlapp told us Friday: “This is a big deal. America is falling apart, and it has become clear that one man can get us back on track. Donald Trump will break Reagan’s record appearing at 14 national conferences, even though the South Carolina primary is the same weekend. President Trump has earned the loyalty of the grass roots because he shows up and never forgets who is there for him. It’s why he will be our 47th president.”

The list of confirmed speakers at the conference is already loaded with well-known conservatives and lawmakers. They include former British Prime Minister Liz Truss, possible Trump running mate Rep. Elise Stefanik (R-NY), and top conservative talker Mark Levin.

https://www.washingtonexaminer.com/news/washington-secrets/2833952/cpac-royalty-trumps-14th-appearance-tops-reagan-record/