More than 56,000 COVID-19 antigen rapid tests are being recalled because they may provide inaccurate results, according to federal health officials.
Universal Meditech Inc., which initiated the nationwide recall, discovered that the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits were “distributed without appropriate premarket clearance or approval,” according to a notice posted by the Food and Drug Administration.
This “potentially could result in inaccurate test results due to lack of performance evaluation by the FDA,” the notice said.
Consumers are told to “immediately” stop using the recalled product and contact the distributor to return it, according to the notice.
The products were manufactured between October 2021 and December 2021. Universal Meditech sent the products to distributors in California and Texas. They were distributed in January 2022, officials said.
The company has been notifying both distributors and customers about the recall and is arranging for the return of all recalled products.
There haven’t been any injuries related to the recalled product. Still, officials say that any adverse reactions or quality problems that have been experienced with the product can be reported to the FDA’s MedWatch Adverse Event Reporting program.
Universal Meditech discovered that the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits were “distributed without appropriate premarket clearance or approval.”FDA/Universal Meditech Inc. Antigen tests are able to produce test results within 15 to 30 minutes. Although they are rapid, they are less reliable than nucleic acid amplification tests, such as PCR-based tests, “especially for people who do not have symptoms,” according to the Centers for Disease Control and Prevention.
Rep. James Comer, R-Ky., called for an investigation of the Secret Service Monday, accusing the agency of taking part in a "bizarre" ploy to protect Hunter Biden, even when the Biden family did not have Secret Service protection. Comer, the chairman of the House Oversight Committee, joined "Fox & Friends First" to discussa new reporton a trove of emails that raise questions about the Secret Service's role in a 2018 incident involving Hunter Biden's handgun.
JAMES COMER: There are numerous instances where the Secret Service came and tried to bail Hunter out when he was in a jam, when he was in California and getting in all kinds of trouble, getting kicked out of a very exclusive hotel there. The Secret Service showed up to try to see if there was some way they could get him back to Delaware to his family to protect him. And then with this gun application, there's reports that the Secret Service went and visited the gun dealer and wanted a copy of the application. And I don't believe the gun dealer gave the Secret Service a copy of that application, but regardless of the fact at that point in time, Joe Biden did not have Secret Service protection. Joe Biden received Secret Service protection six months after he left the vice presidency and at the point when he declared for president. So there was about a two-and-a-half-year period there where the American people weren't providing Secret Service protection for the Bidens, yet there are numerous instances where the Secret Service always showed up to try to help Hunter Biden. It's bizarre. And this is another set of questions that Joe Biden needs to come forward and be transparent, not just with the American people, but especially with the House Oversight Committee, because we have a major investigation here and the Secret Service should now [be] a part of it.
Americans in January continued to expect high near-term inflation pressures and more modest ones on a longer-term basis, as they trimmed their expectations for future income gains, the New York Federal Reserve said on Monday.
Respondents to the regional Fed bank's latest Survey of Consumer Expectations said they expected inflation one year from now to hold steady at 5%. The expected level of inflation three years from now stood at 2.7%, down from an expectation of 2.9% in December, while inflation five years from now was projected to be 2.5%, versus 2.4% in the prior month.
Fed officials pay close attention to this data because they believe that where the public expects inflation to go strongly influences where it stands today. The projected future path of inflation still remains well above the U.S. central bank's 2% target, as policymakers press forward aggressively with interest rate rises aimed at combating high inflation pressures.
On Tuesday, economists expect the government to report that the Consumer Price Index in January rose 6.2% from the same month in 2022, a slight moderation from the 6.5% year-over-year rise in December.
The New York Fed said in its report that the expected rise in home prices slowed last month and hit its second-lowest reading since May 2020. Respondents projected higher food and energy costs, while they saw steady future gains for rent and medical costs.
The survey also found that respondents in January saw expected future household earnings growth at 3.3%, down from the expected 4.6% rise in the prior month. The New York Fed noted this was the biggest one-month drop ever for this measure. Meanwhile, expected future spending growth moderated to 5.7% last month, from the 5.9% forecast in December.
NATO secretary-general Jens Stoltenberg in a Monday briefing warned that the West is now locked in a race against Russia to get ammunition to the front lines in support of Ukrainian forces. He specificallyaffirmed that NATO countries are in a"race of logistics" regarding ammo and arms supplies at a crucial moment of intensified fighting. This as "Russia seems to havealready launched a large-scale offensive in Ukraine... sending in thousands and thousands more troops," Stoltenberg explained.
"It is clear that we are in the race of logistics. Key capabilities like ammunition . . . must reach Ukraine before Russia can seize the initiative on the battlefield." He also described dramatically that "A war of attrition becomes a battle of logistics," while acknowledging that "Yes, we have a challenge. Yes we have a problem . . . but we have a strategy to tackle that." In some ways, his new words are a belated admission that Russia has already seized the initiative.
According to more from the Financial Times, despite the West already having poured billions in arms and supplies into Ukraine's military effort over the past year, Ukraine is still being far outgunned:
Ukraine’s ammunition shortages were "acute", a senior western intelligence official told the Financial Times, adding that the speed of western supplies would be critical to the outcome of Russia’s attempt to regain the initiative in the war.
Kyiv’s forces are estimated to be firing more than 5,000 artillery rounds every day — equal to a smaller European country’s orders in an entire year in peacetime. Russia is estimated to be firing four times that amount each day as it seeks to gain territory in the east of the country and deploy tens of thousands of newly trained conscripts in the war.
Urging more immediate production among NATO allies' defense sectors, Stoltenberg said, "The war in Ukraine is consuming an enormous amount of munitions and depleting allied stockpiles. The current rate of Ukraine’s ammunition expenditure is many times higher than our current rate of production. This puts our defense industries under strain."
It was only this past fall that international headlines presented a battlefield picture of a losing Russian side amid a robust West-supported Ukrainian counteroffensive in the east and south. But after Russia's very clear victory over Soledar, and with the strategic Donetsk region city of Bakhmut also now on the verge of falling to the Russians (having been nearly encircled), those prior mainstream media reports have proven premature.
As for Stoltenberg's words saying the major Russian offensive has already started, which was long anticipated headed into spring, he said that Moscow has shown itself willing absorb "a very high rate of casualties". But while taking on "big losses" - the immense pressure being felt by the Ukrainians is evident.
The NATO chief's comments implicitly acknowledge the war has result in significant setbacks for Western countries' own defense readiness, given depleting stockpiles at home...
"What Russia lacks in quality, they try to compensate in quantity," he said, again underscoring the need for more arms and ammo from the Western allies. He said the faster this can be done, the more lives can be saved. He laid out the problem very bluntly and specifically as follows:
Stoltenberg admitted that Nato was facing a "problem" as current waiting times for large-calibre ammunition have grown from 12 to 28 months.
But he still sought to inject some optimism, stressing NATO members are enacting plans to be "on the path that will enable us both to continue to support Ukraine, but also to replenish our own stocks."
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Related to these "plans" in the works for replenishing stocks, Rabobank has highlighted a new scheme cooking in the background as the West apparently "gets creative" over efforts to alleviate the ammo supply crisis...
The UK Telegraph reports ‘Europe rushes to launch Covid-style plan to ramp up shell production for Ukraine’, noting the ECB “could be used to raise funds to place orders large enough to convince defence firms to increase production.” (As long flagged here as a risk by the way.) It notes, “European governments have backed plans to use the EU’s multibillion-euro fast-tracked coronavirus vaccine scheme as a blueprint to produce the ammunition so desperately needed by Ukraine. A number of the bloc’s leaders told the Ukrainian president they “no longer have much in our warehouses to give” after he handed them weaponry wish-lists of weapons during a visit to Brussels earlier this week… Ukraine is firing an estimated 6,000 artillery rounds every day, according to Western intelligence figures, whereas Russia fires 20,000 a day – the same amount manufactured by European defence producers each month.”
Yet this is also about far more than munitions. Foreign Policy magazine underlines the critique that President Biden’s geostrategy lacks an economic vision that brings allies along, making it more reliant on a US military with inadequate funding despite a $848bn defence budget. Indeed, Bloomberg commentator Noah Smith underlines @ElbridgeColby in saying ‘Europe has to stand against Russia: the US is going to get distracted, and Russia isn't going to stop.’ That would change lots of things a very great deal.
While the US government is dispensing millions of dollars in resources to treat balloons as an existential crisis, a small town in Ohio finds itself engulfed in what actually looks like the apocalypse. Perhaps by design, all of the drama surrounding violations of US airspace by Chinese spy initiatives has done well to keep what is becoming one of the worst environmental disasters in recent memory from getting any headlines.
The chaos began early last week when a train of more than 100 cars derailed in East Palestine, Ohio near the state’s border with Pennsylvania with roughly 5,000 residents. The accident launched fifty of those hundred freight cars from the tracks. Twenty of the freight cars on the train were carrying hazardous materials, ten of which were detailed. While the accident had no fatalities, of those ten cars, five contained pressurized vinyl chloride, a highly flammable carcinogenic gas.
In order to address the volatile scenario around the crash site, the Ohio Emergency Management Agency executed its plan of venting the toxic gas with a controlled burn in order to evade an uncontrolled explosion which presented the risk of catastrophic damage. “Within the last two hours, a drastic temperature change has taken place in a rail car, and there is now the potential of a catastrophic tanker failure which could cause an explosion with the potential of deadly shrapnel traveling up to a mile,” Gov. Mike DeWine warned in statement explaining the decision to take action to avert widespread devastation.
However, that operation sent large plumes of smoke containing vinyl chloride, phosgene, hydrogen chloride, and other gases into the air as the flames from the controlled burn raged on for days. Phosgene in particular is a highly toxic gas that can cause vomiting and respiratory trouble. The toxicity of phosgene gas is so potent that it was previously used as a chemical weapon during the First World War.
The hazardous airborne chemicals prompted officials to issue mandatory evacuation and shelter-in-place orders within a one-mile radius of where the train derailed. Those orders forced nearly 2,000 residents of East Palestine out of there homes. Despite the public safety risk in proximity to the crash site, over 500 people within the parameters of the evacuation order refused to leave their homes. However, those orders were lifted on February 8th, allowing residents to return to the area adjacent to the disaster.
Following the controlled burn, local authorities received multiple concerning reports from residents outside of the mile-long radius of the evacuation area conveying that the emergency posed by the disaster was far from over. One local farmer reported the sudden deaths of many of the animals on the premises of his farm, Park Dairy. The farmer, Taylor Holzer, also works with the Ohio Department of Natural Resources as a registered foxkeeper. Following the disbursement of chemical agents into the air from the controlled burn, many of the foxes on Holzer’s farm experienced fatal effects from the air quality surrounding the area.
“Out of nowhere, he [a fox] just started coughing really hard, just shut down,” Holzer recalled to local media outlet WKBN 27 News. “This is not how a fox should act. He is very weak, limp. His eyes are very watery and weepy. Smoke and chemicals from the train, that’s the only thing that can cause it, because it doesn’t just happen out of nowhere,” he added.
“The chemicals that we’re being told are safe in the air, that’s definitely not safe for the animals…or people.”
Holzer’s concerns were echoed by reports from other residents who described similar conditions near their own properties. One of those residents was Katlyn Schwarzwaelder, the operator of a local dog kennel in nearby Darlington, Pennsylvania. The catastrophe caused her to leave her home despite the fact that it lies more than 10 miles away from the site of the controlled burn. After fleeing to Boardman, Ohio, 15 miles away from the derailment, Schwarzwaelder stated she received multiple reports of dead chickens, fish, and other animals from friends and acquaintances. One affected resident told Schwarzwaelder that they let their 2-year old dog out to use the bathroom only for it never to return. When they embarked upon a search for their missing pet, they found it dead in their yard.
Testimony from Holzer, Schwarzwaelder, and others paints a drastically different picture than the official narrative tailored by officials who assured residents that the situation was under control. The poor air quality presents short and long term health risks to the public considering the carcinogenic effects of the chemicals. Carcinogens like vinyl chloride can cause cancer in organs including the liver, according to Kevin Crist, a professor of chemical and biomolecular engineering who also serves as the Director of Ohio University’s Air Quality Center.
Although officials in charge of the emergency response utilized techniques like dispersion modeling in order to calculate and mitigate the risk of airborne chemicals, the chemicals disbursed following the derailment pose other significant risks of contamination. Chemicals also spilled into the Ohio River toward West Virginia, prompting officials from the neighboring state to shut down water production in the area and turn to alternative sources for water supply. Soil contamination is another significant risk that leaves officials weary of broader implications affecting public health than those associated with the air pollution alone.
However, the magnitude of those risks hasn’t been apparently recognized by the leadership across various states affected by the disaster. According to Pennsylvania Governor Josh Shapiro, there were no concerns regarding the air and water quality in the area. Nevertheless, the governor reiterated that a shelter-in-place order remained in effect for Pennsylvanians within two miles of East Palestine. Officials from the Environmental Protection Agency took a similar tone, stating nothing unexpected was seen following the controlled burn. James Justice of the EPA summed up his agencies position by saying “So far, so good and we’re going to continue to monitor until the fire’s out,”.
While the immediate risks presented by a possible explosion following the train’s derailment may have been averted, the emergency response may become an instance of a cure being worse than the disease it seeks to remedy. The accidents also brings the state of safety regulations surrounding rail transport of hazardous freight into a new light. Over the last five years alone, eight train derailments have occurred in the Pittsburgh metro area, leading to calls for increased oversight over the industry.
Despite the inherent risk that comes with transporting chemicals like vinyl chloride, the US Department of Transportation approved a rule to expand the scope of what hazardous materials can be transmitted by rail. The rule made it permissible for liquefied natural gas to be shipped by train without additional safety regulations. This enables freight trains to transport 100 more tank cards with up to 30,000 gallons of the natural gas extracted from shale fields.
“The risks of catastrophic liquefied natural gas releases in accidents is too great not to have operational controls in place before large blocks of tank cars and unit trains proliferate,” the National Transportation Safety Board wrote in a comment if support of the proposed rule. In response to that comment, critics of the rule highlighted how a potential explosion of just twenty-two tank cards filled with liquefied natural gas holds the same amount of explosive energy as the atomic bomb dropped on Hiroshima in the waning days of the Second World War.
The ongoing crisis in East Palestine represents an environmental and humanitarian disaster that hasn’t been seen in the United States in recent memory. The scenes from East Palestine look as if they’re taken straight out of a horror film depicting nuclear winter.
In spite of that, the magnitude of this story has been seemingly scrubbed from the public view as national media outlets continue to run sensationalist headlines about issues that look innocuous in comparison. It is an instance of history being rewritten in real time, setting a precedent that would allow victims of other widespread devastation to be swept under the rug. However, the scenes of the horror engulfing this small town in America’s heartland may prove to make this disaster impossible to ignore, rightfully putting the spotlight on the shortcomings of state and federal agencies tasked with emergency response management whose continued lack of accountability enables them to fail the American public time and time again.
Shares of Sorrento Therapeutics are lower by nearly 50% in pre-market trading on Monday after the company filed for Chapter 11 bankruptcy protection in Texas.
An 8-K from the company on Monday morning read: "To protect the Company’s business and maximize its value, on February 13, 2023, the Company and its wholly-owned direct subsidiary, Scintilla Pharmaceuticals, Inc. (together with the Company, the “Debtors”), commenced voluntary proceedings under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas (the “Bankruptcy Court”)."
"The Debtors have requested that the Chapter 11 proceedings be jointly administered under the caption In re Sorrento Therapeutics, Inc., et al. (the “Chapter 11 Cases”). The Debtors continue to operate their business in accordance with the applicable provisions of the Bankruptcy Code and orders of the Bankruptcy Court. The Debtors intend to seek approval of a variety of 'first day' motions containing customary relief intended to assure the Debtors’ ability to continue their ordinary course operations during the Chapter 11 Cases," it continues.
The company was well known for making bold claims at the beginning of the Covid pandemic in an exclusive with Fox News, suggesting a "cure" for Covid was forthcoming:
A California-based biopharmaceutical company claims to have discovered an antibody that could shield the human body from the coronavirus and flush it out of a person’s system within four days, Fox News has exclusively learned.
Later Friday, Sorrento Therapeutics will announce their discovery of the STI-1499 antibody, which the San Diego company said can provide "100% inhibition" of COVID-19, adding that a treatment could be available months before a vaccine hits the market.
"We want to emphasize there is a cure. There is a solution that works 100 percent," Dr. Henry Ji, founder and CEO of Sorrento Therapeutics, told Fox News. "If we have the neutralizing antibody in your body, you don't need the social distancing. You can open up a society without fear."
The comments drew the ire of short seller Hindenburg Research, who pointed out in May of 2020 that it was skeptical of the company's claims. "We see significant downside from these levels and believe the company is already in the process of severely diluting its new unsuspecting investor base. We believe regulators should closely scrutinize the company’s actions over the last several weeks," the firm said almost 3 years ago.
The company then claimed in August of 2020 it was going to "take action" against Hindenburg.
"I am giving them a fair warning shot. Just cover yourself, don't ruin your family," CEO Henry Ji said in August 2020. "Sorrento will collaborate with law enforcement and regulators to ensure that any criminal activity is investigated and rectified," the company added at the time.
Vallon Pharmaceuticals Inc (NASDAQ: VLON) stock price spiked 51.4% today, adding to Friday’s 72.57% rally as investor interest in the firm remained high following Friday’s regulatory filing highlighting its planned merger with GRI Inc.
The company’s stock price closed 72.6% higher on Friday after the firm filed an amended S4 registration statement detailing its merger with GRI Inc, which was first announced via a press release on December 13, 2022.
The merger is expected to be completed this quarter, and investors are excited about the tie-up of the two businesses to form a much larger and financially robust business. Unlike in December, Vallon Pharma did not issue a press release after the latest update, instead choosing to issue the update via a regulatory filing silently.
The enlarged company will trade as “GRI Bio, Inc.” on the Nasdaq Capital Market under the ticker symbol “GRI”. Investors’ optimism about the merger is warranted, given that Altium Capital agreed to invest $15 million in the combined company after closing.
GRI Bio Inc. will be flush with cash once the merger is completed. Altium Capital has committed to investing a further $10 million in the combined company once the terms and conditions outlined in the securities purchase agreement are met.
The new company will be a clinical-stage biotechnology firm focused on fundamentally changing how inflammatory diseases are treated by targeting NKT immune cells earlier in the inflammatory chain compared to the current standard of care to interrupt disease progression more effectively.
