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Tuesday, February 14, 2023

Air Force Jets Intercept 4 Russian Aircraft Off Alaska: NORAD

 NORAD has announced Tuesday that it scrambled jets to intercept four inbound Russian military aircraft near American airspace off Alaska the day prior.

"The Alaskan Region of North American Aerospace Defense Command (NORAD) detected, tracked, positively identified and intercepted four Russian aircraft entering and operating within the Alaska Air Defense Identification Zone (ADIZ) on Feb.13, 2023," an official statement reads.

The response included a pair of US F-16 fighter jets, assisted by two more F-35A fighters, an E-3 Sentry, and two KC-135 Stratotankers, all of which were sent to intercept the Russian aircraft, which included among the the four aircraft a Tupolev Tu-95 "Bear" long range bomber and SU-35 fighter jet. 

But interestingly, NORAD called the incident "routine" - given it has happened an estimated six to seven times a year on average over the past decade or more. Additionally, no breach of actual US airspace was reported by the Russian planes, just the outlying ADIZ.

"Russian aircraft remained in international airspace and did not enter American or Canadian sovereign airspace. This Russian activity in the North American ADIZ occurs regularly and is not seen as a threat, nor is the activity seen as provocative," the statement continued.

However, currently there are heightened tensions with Russia related to the Ukraine war, but also given the unusual spate of 'unidentified object' shootdowns by US fighters over the last week - two of which were in far northern regions, including northeastern Alaska and Canada's Yukon territory.

https://www.zerohedge.com/military/air-force-jets-intercept-4-russian-aircraft-alaska-norad

Border Patrol Encounters With Chinese Nationals At Southern Border Up 719 Percent

 by Samantha Flom via The Epoch Times (emphasis ours),

U.S. Customs and Border Protection (CBP) has encountered 2,999 Chinese nationals at the southern border so far in fiscal year 2023—a 719 percent increase year over year, according to CBP data released on Feb. 10.

The total also exceeds the amount recorded for the entirety of fiscal year 2022 (Oct. 1, 2021, to Sept. 30, 2022), during which 2,176 such encounters were reported.

According to the Department of Homeland Security, CBP encounter data includes illegal immigrants who have been apprehended under Title 8 immigration law, Title 8 “inadmissibles,” and noncitizens processed for expulsion under Title 42.

By this time last year, Border Patrol agents had encountered a total of 366 Chinese nationals at the U.S.–Mexico border.

Nationwide, however, the year-over-year increase in encounters is less dramatic, with the current total for this fiscal year sitting at 10,587 compared to last year’s 9,707. Nonetheless, with national totals increasing month over month since October 2022, the trend has begun to alarm some current and former officials.

We literally apprehend immigrants from China,” former CBP Acting Commissioner Mark Morgan noted at a Feb. 9 press conference. “Do you think we are getting what their background is before we release them? Of course we’re not.”

News of the trend comes amid heightened tensions between the United States and China after the former discovered and subsequently shot down a Chinese spy balloon off the coast of South Carolina earlier this month.

This past weekend, additional unidentified flying objects were sighted over Alaska, Canada, and the Great Lakes region and shot down by the U.S. government.

The Chinese government is spying from above,” House Speaker Kevin McCarthy (R-Calif.) wrote in a Feb. 9 tweet. “Fentanyl from China is killing Americans in every community. More Chinese nationals are crossing illegally at our southern border. This is why I created the select committee on China—to confront these problems head-on.”

Despite the uptick in Chinese nationals illegally entering the country, CBP Acting Commissioner Troy Miller noted on Feb. 10 that January marked a 42 percent decrease in encounters with illegal immigrants of all nationalities between ports of entry at the southern border.

The January monthly operational update clearly illustrates that new border enforcement measures are working, with the lowest level of Border Patrol encounters between Ports of Entry since February of 2021,” Miller said in a statement. “Those trends have continued into February, with average encounters of Cubans, Haitians, Nicaraguans, and Venezuelans plummeting.”

Total southern border encounters also decreased last month to 156,274, down nearly 40 percent from December’s record high of 251,978.

CBP attributed the decrease to the “success” of the new immigration measures announced by President Joe Biden last month, which included the expansion of a parole program that grants illegal immigrants from Venezuela, Cuba, Haiti, and Nicaragua authorization to work and live in the United States with the sponsorship of a U.S. resident after a background check.

Others, however, have criticized the program as a means of granting amnesty to illegal immigrants.

This unlawful amnesty program, which will invite hundreds of thousands of aliens into the U.S. every year, will only make this immigration crisis drastically worse,” Texas Attorney General Ken Paxton said last month.

The Republican, along with 19 other attorneys general, has filed a lawsuit against the Biden administration challenging the legality of the program.

https://www.zerohedge.com/political/border-patrol-encounters-chinese-nationals-southern-border-719-percent

U.S. proposes Medicare, Medicaid programs to cut drug costs, including $2 generics

 The U.S. health department proposed on Tuesday three new pilot projects aimed at lowering prescription drug prices for people enrolled in government health insurance plans, including offering some essential generic drugs for $2 a month.

The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor.

The proposed models would lower the out-of-pocket cost of commonly used generic drugs for chronic conditions, such as hypertension, to $2 a month for people on Medicare, improve access to expensive lifesaving cell and genetic treatments for those on Medicaid, and get CMS better deals for expensive new therapies that lack complete clinical trial data, CMS said.

The first model sees CMS encouraging Medicare Part D plans, which cover most prescription drugs, to offer a monthly $2 fixed co-payment for a standard list of around 150 generic drugs targeting conditions common among Medicare beneficiaries, such as hyperlipidemia and hypertension. It is voluntary.

The second voluntary model allows state Medicaid agencies to pay for cell and gene therapies by delegating authority to CMS so it can facilitate contracts and payment models as well as structure and coordinate multi-state arrangements with manufacturers.

The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP).

CMS has raised concerns about covering drugs under the pathway such as those for Alzheimer's disease because it does not require the same degree of drug efficacy data as the FDA's regular approval process.

The model would address the high cost and lack of confirmed effectiveness of drugs that receive accelerated approval through providing drugmakers with incentives to speed up the completion of confirmatory clinical trials, CMS said, and would be developed in consultation with the FDA.

CMS will announce the first model's start date "as soon as operationally feasible", it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.

https://finance.yahoo.com/news/u-proposes-medicare-medicaid-programs-233748255.html

Unanswered questions over Ohio train derailment, toxic spill

 Residents of the small town of East Palestine, Ohio, are back in their homes this week following their evacuations over looming explosion fears after a train carrying 20 cars of hazardous materials derailed.

The contents of the rail cars have since been burned to prevent an explosion, while officials conducted a “controlled release” of toxic chemicals. Noxious odors have also largely dispersed from town, though still remain near some streams, according to local reports.

Questions have swirled in recent days around the root causes of the accident and whether residents should be concerned about a continued threat to land and water. The accident has also raised scrutiny over safety regulations.

Here are five lingering questions about the spill:

What was on the train — and what got out?

Immediate coverage of the Norfolk Southern train derailment focused on an urgent threat — five leaking cars of vinyl chloride, a cancer-causing, explosive chemical ingredient used to make hard plastic such as PVC pipe.

Faced with the risk of an explosion, emergency responders diverted the leaking vinyl chloride into a trench and burned it off — converting it into phosgene gas, used as a lethal chemical weapon in World War I.

Officials urged residents to quickly evacuate, with Ohio Gov. Mike DeWine (R) saying at a media briefing, “You need to leave. You just need to leave. This is a matter of life and death.”

Two days later, with the gas dispersed, state and local health officials declared that “it is now safe for community members to return to their residences.”

But those five train cars — each potentially holding thousands of gallons of vinyl chloride — were not the only hazardous material, according to documents the train company provided to the Environmental Protection Agency (EPA).

During the wreck, EPA investigators said they found other hazardous material-containing cars “derailed, breached and/or on fire.”

These substances included industrial solvents such as ethylene glycol monobutyl ether — which can be absorbed through the skin and is toxic to the liver and kidneys — and ethylhexyl acrylate, another known carcinogen that is toxic to the lungs and nervous system. 

According to the EPA, about 20 rail cars in the wreck were listed as carrying hazardous materials, and after the spill chemicals were seen running into storm drains. Other chemicals were buried on site.

These chemicals did not stay in place — all of those listed are still being released “to the air, surface soils, and surface waters,” the EPA reported.

What’s in the water?

Sulphur Run, the chemical-smelling creek that runs through East Palestine, connects through a number of waterways down to the Ohio River, snaking through a densely populated countryside dotted with towns, cities and fields

Last week, officials in the Ohio River community of Weirton, W.Va., detected butyl acrylate — another chemical listed among the burning cars — though they aren’t sure if it came from the spill upriver, The Weirton Daily Times reported.

Further downstream in Cincinnati, officials were monitoring water intakes to see if the chemicals make it to them. If detected, officials told local station WLWT they could shut off intake valves to allow the chemical plume to drift by.

Other residents don’t have the benefit of water treatment facilities to insulate them from spills. Fish kills proliferated along Ohio River tributaries in the days after the East Palestine spill, including Little Beaver Creek, a National Scenic River, WKBN reported.

Those streams are an important site for the reintroduction of the hellbender salamander, an endangered species in Ohio — and a creature that, like other amphibians, is at particular risk from water pollution.

“We really don’t know any of the effects on the hellbender population where we’ve done the reintroduction of those in the streams. It’s gonna take time to know what the effects are,” Matthew Smith, an official with the Ohio Department of Natural Resources, told WKBN.

In a statement to The Hill, Ohio Sen. Sherrod Brown (D) called on the state and federal environmental protection agencies to ensure local families receive complete testing and cleanup and continued health monitoring — and to ensure Norfolk Southern pays for cleanup.

Norfolk Southern said on Monday it has performed 340 in-home air tests and thousands of outdoor tests as well as water testing in municipal drinking water and public and private wells — results it will release next week. 

It also announced plans to create a new monitoring system and task force to keep tabs on contamination of local water supplies. 

Did lax regulations help cause the crash?

Railroad safety experts and union members have reiterated calls for more stringent federal oversight of the rail industry following the derailment.

One area of constant tension has been brakes. Investigators from the National Transportation Safety Board (NTSB) received reports that crews of the Norfolk Southern train pulled the emergency brake, and a mechanical issue with one of the railcar axles was discovered, CNN reported.

The possibility of a brake failure points to a behind-the-scenes battle in American railroad regulation — and a place where critics say that both parties have resisted reforms that would make Americans safer.

Most trains run on a system where wheels stop one at a time using a compression system, left-leaning news outlet The Lever reported. By contrast, electronically controlled pneumatic brake technology halts all the cars simultaneously — dramatically reducing stopping time.

While Norfolk Southern initially touted these advances, it was also part of a coalition of rail companies that successfully fought the regulations, winning a reprieve from the Obama administration and a repeal under the Trump administration, according to The Lever.

The outlet reported that the Norfolk Southern train wasn’t regulated as a “high-hazard flammable train” even though its crash triggered a fireball.

“Railroads should not use their lobbyists to block or weaken commonsense safety measures that protect workers and communities,” Brown told The Lever. 

In his statement to The Hill, the Ohio senator called on the NTSB, which is investigating the derailment, to tell Congress and the Department of Transportation what can be done “to avert future derailments involving hazardous materials.” 

One such measure is before the agency now. Members of multiple railroad unions are fighting a potential rule that would allow trains using the new electronic brakes to travel 2,500 miles — up from 1,500 — without stopping to have their brakes tested. 

While these trains would have electronic logs, such a ledger “cannot justify reducing the frequency of inspections and repairs to train brakes in the field,” Rich Johnson of the Brotherhood of Railway Carmen said in a statement.

“Such changes will almost certainly reduce the overall safety of trains operating across the country,” Johnson added.

Will it lead to railroad reforms?

In the aftermath of the crash, railroad union leaders were quick to connect it to an issue they’ve warned about for years: that railroad layoffs and reliance on clockwork, inflexible scheduling were running them ragged and leading to disaster.

These policies, rolled out under a broader model in 2015, “pose real threats to workers and public safety,” Greg Regan, president of the Transportation Trades Department of the AFL-CIO union, wrote the head of the Federal Railroad Administration last week.

“In fact, derailments per train mile and incidents at rail yards have significantly increased on several major freight railroads since they adopted the Precision Scheduled Railroading,” Regan added.

The question of scheduling is a particularly divisive one. Last year, Congress voted to force union workers to accept a deal with railroad companies that gave them virtually no ability to take unscheduled sick time — and then narrowly voted down a plan that would have forced the companies to give sick time anyway.

Unions and progressive politicians see the recent derailment and leak as added proof that this was a bad decision that benefited railroad carrier balance sheets over public safety.

Last week, Sen. Bernie Sanders (I-Vt.) linked the Ohio crash to railroads’ record 2022 profits and what he characterized as chronic underinvestment in both infrastructure and staffing.

Sanders joined with Sen. Mike Braun (R-Ind.) to demand rail companies give workers at least seven days of paid sick time.

He had reason to be optimistic: CSX Transportation — one of the country’s largest railroad companies — reached a deal last week with two railroad unions to provide that number of sick days.

In a speech, Braun framed this as a commonsense measure. “In this day and age you don’t know when you’re going to get sick. It’s going to be an issue on keeping employees long term. Where I come from, most of this stuff should be natural,” he said. 

Sanders was more pugnacious. He suggested the rest of the major rail carriers reach voluntary deals of their own. “If not, I look forward to seeing them right here,” he said, gesturing at the Senate chambers. 

Will it happen again?

About 4.5 million tons of toxic chemicals are transported through U.S. communities every year by rail, and 12,000 trains carrying hazardous materials cross through towns and cities each day, The Guardian reported.

“The Palestine wreck is the tip of the iceberg and a red flag,” Ron Kaminkow, a former Norfolk Southern freight engineer and secretary for the Railroad Workers United, told The Guardian. “If something is not done, then it’s going to get worse, and the next derailment could be cataclysmic.”

Railway safety advocates also point to reporting around near-disaster events.

The NTSB operates a confidential “close call” reporting system — which allows employees to report unsafe events and near-misses so they can be fixed. 

“Not one of the seven major U.S. freight railroads voluntarily use this program,” Regan, the AFL-CIO official, wrote in his letter to the Federal Railroad Administration.

Regan called on Congress to force rail carriers to participate in the reporting program, which he said would “create a safer freight rail system and identify potential safety issues before they lead to dangerous catastrophes.”

Without meaningful reform, he wrote, “we fear that these safety incidents will unfortunately keep happening.”

https://thehill.com/policy/energy-environment/3857172-five-lingering-questions-over-ohio-train-derailment-toxic-spill/

Actinium to Present Full Results from Pivotal Phase 3 Trial on Call Following Presentation

  Late-breaker presentation at 5:00 PM EST on Saturday, February 18, 2023, to feature Iomab-B SIERRA Pivotal Trial results

-  Investor call at 6:00 PM EST on Saturday, February 18, 2023, to highlight full results from the Phase 3 SIERRA trial

Actinium Pharmaceuticals, Inc.,  (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies, today announced its presence at the upcoming Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held February 15 – 19, 2023 at the World Center Marriott in Orlando, Florida. Actinium will host an investor conference call and webcast to present full topline results from its pivotal Phase 3 SIERRA trial of Iomab-B at 6:00 PM EST on Saturday, February 18, 2023. The investor conference call will follow the late-breaker presentation of the full Phase 3 SIERRA trial results. In addition, Iomab-B will be highlighted in a CME Event titled, "The Convergence of Innovative Therapy and AlloHCT in AML: Applying Current Evidence to Improve Outcomes Across Patient Populations.

Investor Conference Call and Webcast Details:

Time / Date:

6:00 PM EST on Saturday, February 18, 2023

Presenters:

Sandesh Seth, Chairman & CEO, Madhuri Vusirikala M.D., Vice President, Clinical Development – Transplant & Cellular Therapy, Avinash Desai, M.D., Chief Medical Officer, Caroline Yarbrough, Chief Commercial Officer

Dial-in:

1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) or by clicking on this link and requesting a return call

Live webcast:

To access the live webcast of the call with slides please visit the Investors section of Actinium's website https://ir.actiniumpharma.com/presentations-webinars or https://viavid.webcasts.com/starthere.jsp?ei=1590226&tp_key=580722640c

An archived webcast will be available on the Actinium's website (click here) after the event.

https://www.biospace.com/article/releases/actinium-to-present-full-results-from-pivotal-phase-3-iomab-b-sierra-trial-on-investor-call-following-the-late-breaker-presentation-at-the-2023-transplantation-and-amp-cellular-therapy-tandem-meetings-on-saturday-february-18-2023/

FSD Launches R&D Targeting Unmet Medical Needs for Alcohol Misuse

 FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory, and metabolic disorders, today announced the launch of a new research and development program focused on unmet medical needs for alcohol misuse.

Inebriated people with high blood alcohol levels often present to hospital emergency rooms in a variety of contexts. Management of these patients often consumes significant staff time and other resources, because their behaviour can be dysregulated, and judgement is impaired.

“Alcohol intoxication is a common presentation in many patients who visit hospital emergency rooms, and I see this during every one of my shifts. These presentations can require substantial time and effort to manage. Anything that could accelerate recovery from alcohol-intoxication would free up valuable health care resources and provide additional treatment options for alcohol use disorders,” said FSD Pharma’s Expert Advisory Committee Member Dr. Albert Wong, a psychiatrist who works in the emergency department at the Centre for Addiction and Mental Health in Toronto, Canada.

Substance misuse is one of the most pervasive challenges in many countries, including Canada. According to US Substance Abuse and Mental Health Services Administration’s 2021 National Survey on Drug Use and Health (“NSDUH”) alcohol consumption, a ubiquitous part in most societies, is the biggest contributor to substance misuse disorders. Among the estimated 46.3 million people aged 12 or older who met the criteria for having a substance use disorder in 2021 in the United States, 29.5 million people were classified as having an alcohol use disorder.

https://www.biospace.com/article/releases/fsd-pharma-launches-a-new-research-and-development-program-targeting-unmet-medical-needs-for-alcohol-misuse/

Vaxart Doses First Subject in Phase 2 Trial of Bivalent Norovirus Candidate

 Vaxart, Inc. (NASDAQ: VXRT) today announced that it has dosed the first subject in the Phase 2 clinical trial of its oral tablet bivalent norovirus candidate. The dose-ranging study is designed to identify a vaccine dose for a potential Phase 3 clinical trial.

“Initiating the Phase 2 clinical trial of this candidate is an important achievement toward our goal of developing an oral tablet vaccine that may reduce the significant global health threat that norovirus poses to children and seniors,” said Dr. James F. Cummings, MD, Chief Medical Officer at Vaxart. “Results from the Phase 1b clinical trial in healthy adults demonstrate that this candidate stimulates robust IgA antibody secreting cells against the prevalent strains of two norovirus genotypes that cause the majority of norovirus disease. Data from the Phase 2 trial will inform our further clinical development strategy for this promising vaccine candidate targeting a market estimated at more than $10 billion in the United States alone.”

As previously reported, Vaxart’s bivalent vaccine candidate demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain, with no interference observed.

This Phase 2 clinical trial is expected to enroll approximately 135 healthy adults at three sites in the United States. The first 10 subjects will receive open label high-dose vaccine and the remaining subjects will be randomized to high- or low-dose vaccine (N=50 for each arm) or placebo (N=25). The primary endpoints are safety and immunogenicity with the objective of determining dose levels for Phase 3 development.

Vaxart expects to report topline data from the Phase 2 study in mid-2023.

https://www.biospace.com/article/releases/vaxart-doses-first-subject-in-the-phase-2-clinical-trial-of-its-bivalent-norovirus-candidate/