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Thursday, October 6, 2022

US to Direct Uganda Travelers to Five Airports for Ebola Screening

 The US will begin redirecting travelers from Uganda to five airports to screen for Ebola, as the East African country grapples with an outbreak of a strain of virus for which there is no approved vaccine.

The notice is not a travel ban or suspension on those coming from Uganda, but is being put in place out of an abundance of caution, according to a senior administration official who asked not to be named as the matter has not yet been made public. Earlier this week, the Centers for Disease Control and Prevention raised Uganda’s travel alert level, urging travelers to avoid non-essential travel to the country. 

US health officials believe the current level of risk is low for Ebola spreading in the US, but also plan to alert clinicians and hospitals to be on the lookout for possible cases. A call with thousands of US health-care providers is also planned for Oct. 11. 

The Biden administration is preparing for a surge in cases in Uganda, and believes the current reported number represents a significant undercount, according to a person familiar with the matter who asked not be named discussing matters that aren’t public.

Sudan Strain

The first case in the outbreak caused by the Sudan strain of Ebola, which is less common than the Zaire strain, was found in Uganda in September. Since then, Uganda has reported 63 confirmed and probable cases, with nearly half of the patients succumbing to the illness. The Zaire strain caused more recent outbreaks in West Africa and the Democratic Republic of the Congo, spurring rapid development and approval of a vaccine. The vaccine, called Ervebo, is made by Merck & Co. 

However, that vaccine does not work against the Sudan version causing the outbreak in Uganda. Several shots targeting the strain are in various stages of development, and the World Health Organization said Wednesday that two of the vaccines could begin a human trial in Uganda as soon as this month. The proposed trials are undergoing ethics and regulatory approvals from the Ugandan government, WHO Director-General Tedros Adhanom Ghebreyesus said.

The US government will immediately begin redirecting air travelers from Uganda to JFK International Airport, Washington-Dulles International Airport, Newark Liberty International Airport, Chicago-O’Hare International Airport, and Hartsfield-Jackson Atlanta International Airport for Ebola screening. The process will include a temperature check, risk assessment, visual symptom check, and contact information verification.  US state and local health departments will follow up with travelers 21 days after leaving Uganda.  

https://www.bnnbloomberg.ca/us-to-direct-uganda-travelers-to-five-airports-for-ebola-screening-1.1828979

PureTech buys out Alivio, adding inflammatory disease programs to its pipeline

 Four years after launching Alivio Therapeutics, PureTech Health is bringing the hydrogel player back into the fold by acquiring the remaining 22% of the company.

Through the deal, PureTech will add Alivio’s programs for inflammatory diseases to its own pipeline, including LYT-500, an oral treatment for inflammatory bowel disease (IBD).

There are various IBD treatments, but each comes with its own challenges. Anti-inflammatory drugs may not work for everyone, while systemic immunosuppressive drugs can dial back the body’s immune surveillance even as they reduce inflammation. As for newer biologics, they can be expensive and must be injected, which isn’t exactly attractive to patients.

Alivio, and now PureTech, aims to solve these problems. The technology is based on a hydrogel material that is designed to stick to inflamed tissue but not to healthy tissue. There, it delivers drugs depending on the degree of inflammation. LYT-500 combines the cytokine interleukin-22 and an anti-inflammatory drug to tackle two major causes of IBD: the disruption of the gut’s mucosal barrier and inflammation.

Through the deal, PureTech will also pick up LYT-503/IMB-150 for interstitial cystitis, also called bladder pain syndrome, which Alivio was developing with Imbrium Therapeutics. The companies are positioning it as a non-opioid treatment for the condition.

The Alivio programs join a pipeline of therapies for various ailments like neurological disease, COVID-19, solid tumors and blood cancers. Though PureTech started by spinning out technology into companies like Alivio, the plan was always to develop its own pipeline, said PureTech CEO and founder Daphne Zohar in an interview earlier this year.

In its early days, PureTech identified new technology and new potential medicines but didn’t have the capital to develop them on its own, Zohar noted. Over the years, it picked up equity in and, in some cases, royalties from the companies it founded, giving it more capital to work with. “About four years ago … we made the decision we weren’t going to give up ownership in our programs going forward,” Zohar said.

https://www.fiercebiotech.com/biotech/puretech-buys-out-alivio-adding-inflammatory-disease-programs-to-its-pipeline

Statera to deal with listing requirements

 

  • Statera Biopharma (STAB) stock is gaining as it meets with The Nasdaq Stock Market.
  • This has to do with it not meeting listing requirements.
  • The company intends to request an extension to address the exchange's complaints.

Are You Better Off Now Than You Were Two Years Ago?

 In the final weeks of the legendary 1980 campaign that made Ronald Reagan president, Reagan stood before the nation at his sole presidential debate with failing incumbent Jimmy Carter and urged voters to ask themselves a simple question, one that instantly became timeless in American political lore. “Are you better off now than you were four years ago?” Reagan asked.

As Republicans fight to win over the last remaining undecided voters this November, they would do well to reprise Reagan’s iconic question. Are Americans better off now than they were just two years ago, when Joe Biden became president and Democrats took both chambers of Congress? By any relevant metric, the answer is sure to be a definitive “no” – making a clear case for a change in Washington.

Everything Is More Expensive 

Even something as simple as putting a meal on the table has become more difficult under Democrat rule. Since last year, the price of eggs is up 40%, milk is up 17%, and margarine is up about 40%. In total, grocery prices are up roughly 13% – the largest uptick in more than four decades. Even toilet paper prices have soared – the average roll is 6% to 8% shorter but 8% to 10% more expensive than it was two years ago.

Though gas prices have come down somewhat in recent months from record highs last summer, they are still sitting around $3.70 per gallon – up from $2.40 when Biden took office—and in many places, they are much higher than that. Meanwhile, public transportation costs are up more than 20% since last year. And when you get home after that newly-expensive commute and flip on the lights and heating, the electricity will cost you 16% more and the natural gas will cost you 40% more. Home heating costs are set to skyrocket again this upcoming winter.

Even previously comfortable and financially secure Americans are now feeling the pinch. According to a recent Gallup poll, 56% of Americans cite financial hardship due to price increases. Data from the Bureau of Labor Statistics shows that for the past 17 months, inflation has outpaced wages. Nonetheless, despite the fact that their policies have directly led to these financial hardships, Democrats voted in August to raise taxes on the middle class, hire 87,000 IRS agents to harass families and small businesses, and ultimately worsen inflation.

Rents Are Up, Wealth Is Tanking, And Savings Are Depleting

Entering young adulthood and planning for the future is also a far more daunting prospect now than it was two years ago. Median monthly rent is about $1,900 – roughly $200 more than last year. 30-year mortgage rates just hit the highest levels since 2008, dramatically reducing the price of the home a homebuyer can afford. Credit card debt is increasing at the fastest clip in over two decades. Pair this with an April BMO Real Financial Progress survey showing that 60% of young Americans aged 18-34 say they’ve had to reduce contributions to their savings, and it is clear that for many, the American Dream of owning a home and building generational wealth is being destroyed by Democrat policies.

It’s not just young people who are struggling to make ends meet. In the same poll, 1 in 4 Americans say they will need to delay retirement due to skyrocketing prices. Many retirees have even re-entered the workforce because of inflation. Another survey found that about half of Americans 55 and older have dipped into emergency savings as a result of inflationary pressures.

To top it off, the stock market has continued to plummet as new economic numbers hit and investors make quick moves to shore up future losses. The Dow, S&P 500, and Nasdaq have each taken nosedives in recent weeks, crushing public pension funds, retirement accounts, and 401(k)s.

Americans Feel Less Safe as Crime Wave Continues Unabated

According to Gallup, 80% of Americans are worried about crime – the highest figure since 2016. Last year, homicides, robberies, and carjackings spiked across the country, and a number of Democrat-run cities are set to outpace these numbers again this year.

In January, a poll found that about 70% of Philadelphia residents cited crime, drugs, and safety as the top issue facing the city – a drastic 30 point jump from August 2020. As crime levels continue to worsen, this tracks with a more recent Siena poll showing that 70% of New York City residents feel less safe now than they did before the pandemic.

The crosstabs in the Siena poll should be of particular interest for Republicans running in districts that are competitive or lean Democratic: 70% of Democrats, 78% of Republicans, and 73% of Independents said they felt “less safe,” indicating a broad bipartisan consensus on the need to address crime. Moreover, the most notable spread occurred between sexes, not races: 63% of men said they feel less safe whereas 77% of women said the same – providing Republicans a critical opportunity to win back the women voters they lost ground with in 2020.

Radical Leftism Running Amok in Education as Achievement Dips

Measurable outcomes for K-12 learning show student test results are falling disastrously. The first national test results of nine-year-olds comparing scores before and after school closures show a five-point drop in reading levels, and a seven-point drop in math – the first drop recorded in the test’s history.

A growing number of parents of all political persuasions are also waking up to the reality that their children’s schools have become breeding grounds for toxic left-wing ideologies like Critical Race Theory and gender theory. It is no surprise that student achievement in math and reading is lagging considering schools are teaching sex-ed to kindergartners and replacing traditional instruction with lessons on “Whiteness Theory.”

Confidence in the Future Is Falling

There is perhaps no clearer sign that Americans are worse off than they were two years ago than the fact that measures of national confidence in the future have tumbled in recent months. According to a recent ABC/Ipsos poll, 69% of Americans say the economy is getting worse. Additionally, a recent AP-NORC poll shows 85% of Americans say the country is headed in the wrong direction (78% of Democrats said this – a 56-point jump from when Biden first took office).

This would imply that not only are Independent voters persuadable, but even some Democrats are primed for a change in direction. Now, it will be up to Republicans to make the right arguments – and ask the right questions – to capitalize on voter frustrations and take back control of Congress this November.

https://amac.us/the-question-that-terrifies-democrats-are-you-better-off-now-than-you-were-two-years-ago/

Criminal Neglect

 Confirming widespread perceptions, the nation’s largest crime survey finds that violent crime in urban areas rose dramatically from 2020 to 2021. The Bureau of Justice Statistics (BJS), the statistical arm of the Department of Justice, recently released findings from the 2021 National Crime Victimization Survey. According to the NCVS, which dates to the Nixon administration, the rate of violent crime rose only in urban areas. It did not change to a statistically significant degree in suburban or rural areas.

The NCVS involves about a quarter of a million interviews each year with a nationally representative sample of U.S. residents. The federal government’s field agents ask respondents whether they were the victim of a crime within the past six months. According to the NCVS, violent crime in urban areas rose 29 percent from 2020 to 2021, from 19.0 to 24.5 victimizations per 1,000 persons aged 12 or older.

From 2018 through 2020, the NCVS found that the violent-crime rate in urban areas was between 29 percent and 42 percent higher than the rate in rural areas. In 2021, however, the violent-crime rate in urban areas was 121 percent higher, more than doubling the rate in rural areas (24.5 victimizations in urban areas, versus 11.1 in rural areas, per 1,000 persons). In addition, the violent-crime rate in urban areas was 48 percent higher in 2021 than in suburban areas, more than tripling any difference in urban and suburban rates registered from 2018 to 2020. The property-crime rate in urban areas was nearly twice as high in 2021 as in suburban areas (157.5 to 86.8 victimizations per 1,000 households) and nearly three times as high as in rural areas (157.5 to 57.7 victimizations per 1,000 households).

These statistics do not include murder, as murder victims obviously can’t answer a crime survey. In 2020, according to FBI statistics, the nationwide murder rate rose 27 percent, the largest percentage increase in at least 100 years—higher even than during the surge of violence at the start of Prohibition (see page 414 in this census report, page 83 in the PDF). In cities such as Minneapolis, Portland, and New York, the increase was even greater, as former attorney general Jeff Sessions has noted.

While the Census Bureau does not officially distinguish urban areas from suburban areas, BJS does. As is explained in detail in Classification of Urban, Suburban, and Rural Areas in the National Crime Victimization Survey, BJS classifies most cities that stand at the center of a major metropolitan area, as well as many other densely populated places, as urban. BJS delineates urban and suburban areas using a measurement called “weighted housing-unit density,” essentially a measure of how closely people live to one another. The overall weighted housing-unit density for the United States is 2,396 housing units per square mile (based on the 2010 Census). Among cities with populations of at least 50,000 people (as of 2010), the 15 U.S. cities (or Census-designated places) with the highest levels of urban density—based on weighted housing-unit density—are as follows:

  1. New York, N.Y. (weighted housing-unit density of 29,345 housing units per square mile)
  2. Hoboken, N.J. (25,870)
  3. Union City, N.J. (20,477)
  4. San Francisco, Calif. (17,316)
  5. Miami Beach, Fla. (17,063)
  6. Jersey City, N.J. (13,837)
  7. Honolulu, Hawaii (13,756)
  8. Boston, Mass. (12,708)
  9. Chicago, Ill. (11,429)
  10. Arlington, Va. (10,485)
  11. Cambridge, Mass. (10,377)
  12. Washington, D.C. (10,115)
  13. Miami, Fla. (9,887)
  14. Somerville, Mass. (9,770)
  15. Philadelphia, Pa. (9,706)

    (Note: Los Angeles, at 6,961, is 30th.)

Beyond providing geographical breakdowns on crime, the NCVS asks crime victims about the demographics of those who committed the crimes against them. For violent crimes in which the victim could identify the race or ethnicity of the offender, 66 percent of white victims said that the person who perpetrated the crime against them was also white. That’s similar to (1.1 times) the percentage of the overall (over-12) population that is white (61 percent). In comparison, 34 percent of Hispanic victims said that the perpetrator of the crime against them was also Hispanic, which is nearly double (1.9 times) the overall percentage of the (over-12) population that is Hispanic (18 percent). Most strikingly, 71 percent of black victims said that the perpetrator of the crime against them was also black—5.9 times the overall percentage of the (over-12) population that is black (12 percent).

While black Americans are often the victims of intra-racial crime, white or Hispanic offenders commit comparatively few violent crimes against black victims. According to the 2021 NCVS, 6.9 times as many violent crimes were committed by black offenders against white victims (480,030) as by white offenders against black victims (69,850). In comparison, essentially the same number of crimes were committed by whites against Hispanics as vice versa (1.0 times as many in either direction). Again, that’s according to the victims.

Like the 2020 Census, the 2020 NCVS was at least somewhat compromised by Covid policies (outside of BJS’s control) that kept the federal government’s field agents from going door-to-door and interviewing people for most of that spring, all that summer, and part of that fall. Some of the unfortunate effects of these policies likely carried over to the 2021 NCVS. Thus, comparisons between overall pre-2020 NCVS crime rates and the 2020 and 2021 crime rates are probably not as reliable as one might hope. But comparisons across the past few years of where crimes most often occurred were likely not as affected—as the impact of not being able to go door-to-door was not limited to one type of area (urban, suburban, or rural). The same is likely true for the demographics of victims and offenders, as the inability to go door-to-door affected all races and ethnicities.

The rise in crime in urban areas hasn’t resulted from random chance. It’s a product of the powers that be in major cities having willfully ignored the lessons across the decades that Broken Windows policing works, and that indulging general disorder leads not only to squalor but also to rising violent crime. At some point, cities’ residents will demand that their fellow citizens be held accountable for their actions and for upholding basic human expectations, instead of indulging in the fantasy that everyone but the victims is a victim. Until then, expect more statistics on urban crime like those in this year’s NCVS.

Bill aims to limit CMS’ 'overreach' on Alzheimer’s drugs

 A bipartisan bill has been introduced in the US Congress that will try to block Centers for Medicare and Medicaid Services (CMS) restrictions on Biogen’s Alzheimer’s therapy Aduhelm being extended to newer drugs for the disease.

The Mandating Exclusive Review of Individual Treatments (MERIT) Act – co-sponsored by Representatives Nanette Barragán (D-CA) and Vern Buchanan (R-FL) – has been tabled shortly after Eisai and Biogen reported positive top-line data for their Aduhelm follow-up lecanemab, which is heading for an FDA accelerated approval decision in January.

Rep Nanette Barragán

As its name indicates, the new bill seeks to ensure that decisions on reimbursement of late-stage anti-amyloid drugs like lecanemab, Eli Lilly’s donanemab, and Roche’s gantenerumab are made on their own merits, and to prevent the CMS from restricting coverage of similar drugs on a class basis in future.

Earlier this year, the CMS limited reimbursement of Aduhelm (aducanumab) to patients enrolled in clinical trials in its national coverage determination (NCD) decision for the drug – effectively ending any hope of broad access for patients and commercial viability.

Drug developers were appalled, saying the move was tantamount to the CMS overruling an FDA approval decision, but most concerning to the industry was CMS’ decision to extend Aduhelm’s restriction to all amyloid-targeting drugs, placing them all in the same basket.

The final NCD wording states, however, that the agency is prepared to provide “broad access” via Medicare “if a drug in this class shows evidence of clinical benefit through the traditional FDA approval process.”

That would deny new drugs the accelerated approval route by which Aduhelm was approved, meaning that a positive FDA decision on lecanemab in January would not be enough to ensure access, and Eisai/Biogen would have to wait for a full review by the agency.

That will depend on the full data from the Clarity AD trial, due to be reported at the Clinical Trials on Alzheimer’s Congress (CTAD) in November, and a standard filing in the US scheduled for the first quarter of 2023.

“By requiring CMS to review each drug individually, the MERIT Act will undo the actions taken by CMS that would otherwise unnecessarily limit access to drugs like Aduhelm for seniors,” said Buchanan in a statement.

“With additional drugs to treat Alzheimer’s preparing to come to market soon, this bill will ensure those drugs receive fair and accurate consideration for coverage, rather than requiring onerous additional steps before CMS will make them available to Medicare beneficiaries.”

A number of patient organisations have voiced their support for the bill, including the Alzheimer’s Association, UsAgainstAlzheimer’s, and the Global Alzheimer’s Platform Foundation.

Robert Egge, Alzheimer’s Association chief public policy officer commented that “no two treatments are the same, even if they are in the same class of drug, and CMS should not determine coverage based on type of treatment.”

https://pharmaphorum.com/news/bill-aims-to-limit-cms-overreach-on-alzheimers-drugs/

Senti Bio: Preclinical Data on Cancer-Killing Allogeneic CAR-NK Cells at SITC Annual Meeting

 Abstracts highlight Senti Bio’s continued progress in applying gene circuits to improve the cytotoxicity and persistence of allogeneic CAR-NK cells for the potential treatment of solid tumors

Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company innovating next-generation cell and gene therapies using its proprietary gene circuit platform, today announced two poster presentations at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held November 10-12, 2022, in Boston, MA.

Information about the poster sessions is as follows:

Title: Multi-Arming and Regulator Dial Gene Circuits Tackle Key Challenges in Solid Tumors

Abstract Number: 228
Location: Poster Hall C
Date and Time: November 10, 2022, 9:00 am - 9:00 pm EDT

Title: SENTI-401, an Allogeneic Logic-Gated and Multi-Armed CAR-NK Cell Therapy for the Treatment of CEA-Expressing Solid Tumors with Enhanced Selectivity and Efficacy
Abstract Number: 221
Location: Poster Hall C
Date and Time: November 10, 2022, 9:00 am - 9:00 pm EDT

Following the presentations, copies of the posters will be available on the Scientific Presentations & Publications section of the Senti Bio website.

https://finance.yahoo.com/news/senti-bio-present-preclinical-data-120100559.html