Partial clinical hold placed on Alnylam, Regeneron RNAi Alzheimer's candidate. The US FDA has placed a partial clinical hold on Alnylam Pharmaceuticals (NASDAQ:ALNY) and Regeneron Pharmaceuticals' (REGN) RNAi candidate ALN-APP, under investigation for Alzheimer's disease and cerebral amyloid angiopathy.
Wednesday, April 26, 2023
Make Americans Work Again
I was raised to value a good day’s work and to have pride in what you bring to the table. To be skilled at a craft was an honorable way to make a living whether you were a dishwasher or a surgeon. Work gave each of us a greater self-worth, purpose, and pride.
My father was the youngest master plumber in Montana’s history, and he came from three generations of men who valued and mastered their trade. I still feel pride when an old timer stops me in the street to tell me about the time my dad or grandad helped repair their home.
But now, well outside the global pandemic, our workforce has shrunk to levels not seen since the 1970s, far lower than during the Great Recession of 2008-2009. More than a third of men are out of the work force – the lowest in recorded history – thanks in part to the massive regulatory and welfare state created under COVID and the public health emergency.
Not a day goes by in Montana that you don’t walk down Main St and see a restaurant or shop with a handwritten sign that says “closed today due to staff shortage” or have to wait four months for a vehicle repair.
That is not the sign of a strong economy. It’s the sign of a struggling workforce.
Requiring able-bodied adults who do not have children to work 20 hours a week if they receive government benefits is prudent and hits at our core American value of pulling oneself up by one’s bootstraps.
Plus, it saves taxpayer dollars and grows the economy. According to the Wall Street Journal, “Medicaid work requirement for childless adults ages 18 to 64 could save the federal fisc nearly $170 billion over 10 years.”
You’ll see the president taking victory laps because unemployment is low; well, it’s low because under his policies people are being paid not to work. People are being incentivized with lax unemployment benefits and other welfare to stay at home and not contribute to our community and economy.
That has to end. COVID is over. Our nation is tens of trillions of dollars in debt, facing crippling inflation, a broken supply chain and labor shortage, insolvent senior benefits, and is about to run headfirst into a financial crisis.
House Republicans have put forth a plan to make America work again, reduce the deficit, and put our nation on a healthy fiscal path. It’s called the Limit, Save, Grow Act.
This act, sometimes described in the media as a debt-ceiling plan, addresses the looming Democrat-created debt crisis by cutting excessive COVID spending, cutting regulations, and implementing pro-growth policies like a work requirement and energy permitting reform.
Limit, Save, Grow pulls back unspent COVID funds, saves money in areas where Democrats have continued to be frivolous which has caused spikes in inflation, and increases the flow into programs like Social Security and Medicare.
The work requirement, also known as the America Works Act, which I sponsored, falls under the “grow” area of the bill by incentivizing those who can work to pay into the programs to the caliber of their capability so they can continue to serve the purpose they were created for.
Work requirements aren’t new – they were implemented in 1996 and helped pull people up and out of poverty, lending folks a hand up while giving them the important work experience they need to grow a career and the American Dream.
It encourages independence through employment. It makes able-bodied Americans a part of our economy and feeds the Social Security and Medicare programs until they are at least 65 and are eligible for benefits themselves. Reestablishing and enforcing the original system provide security for those who have continued to persevere and keep those programs alive and gets able bodies on the manufacturing and shop floor and off the couch.
When Americans work, our economy is strong. Our communities prosper and the programs that rely on strong employment like Medicare and Social Security are strong. Not to mention, the quality of life for those who get jobs improves for the long term.
There are a handful of vulnerable Senate Democrats in states that value a good day’s work – Montanans included. Voters in Wisconsin were just asked in a ballot question if able-bodied adults without children should look for work in exchange for benefits. It passed with nearly 80%. The House is set to pass this plan in the coming weeks, and I encourage the Senate to follow our lead.
Those who built my little hometown in Montana taught me that the ability to achieve success through hard work and enterprise was a core part of living the American dream; that if you had the ability to work, you should – and to do otherwise was un-American.
* * *
Ryan Zinke is a Republican congressman for Montana’s First District. He previously served as U.S. secretary of the interior and congressman for Montana’s at-large district.
https://www.zerohedge.com/political/make-americans-work-again
US Warns China It Will Ramp Up Military Drills In The Region
The Biden administration has forewarned China that it plans to bolster military drills and the US presence in the region, particularly off the Korean peninsula where it's decided to send nuclear-armed submarines as extra deterrence against North Korean threats aimed at Seoul.
"We are briefing the Chinese in advance and laying out very clearly our rationale for why we are taking these steps," a Biden administration official said. "We believe that non-proliferation efforts in the Indo-Pacific are in the best interest of not just the United States and other leading states, but China as well."
"We'll announce that we intend to take steps to make our deterrence more visible through the regular deployment of strategic assets, including a US nuclear ballistic submarine visit to South Korea, which has not happened since the early 1980s," the US official detailed further as President Biden receives his South Korean counterpart Yoon Suk Yeol in Washington on Wednesday.
China was further briefed on US plans to "strengthen our training, our exercises, and simulation activities to improve the US-ROK [South Korea] alliance's approach to deterring and defending against DPRK [North Korean] threats, including by better integrating ROK conventional assets into our strategic planning."
"To build peace and stability on the Peninsula, during the visit, the alliance will be announcing a Washington Declaration which includes a series of steps that are designed to strengthen US-funded deterrence commitments and strengthen the clarity by which they are seen by the Korean public as well as by neighbors in the face of advancing DPRK [North Korean] nuclear missile capabilities," the official added, previewing the Yoon-Biden talks.
Beijing is unlikely to react positively, given it's also been of late vehemently protesting the US-Australia AUKUS deal to produce and transfer nuclear submarines. China last month warned the countries (including the UK) that they are heading down a "path of error and danger" and that Australia is violating commitments to being a nuclear-free zone.
Elsewhere in the region, China has been closely watching US-Philippine largescale joint exercises...
Despite the US framing its planned heightened nuclear presence in the Korean peninsula as "defensive" and "deterrent" in nature, China will surely see it as yet more provocative expansion of the US military machine it its own neighborhood.
Amazon axes Halo fitness wearable in latest cost-cutting move
will no longer sell its Halo health and fitness tracker, the company announced Wednesday.
Amazon unveiled the health-tracking bracelet in 2020, marking its first foray into wearable devices and a deeper move into the health care space. Halo, in combination with an app, can track users’ activity, body fat and emotional state, and it’s integrated with Amazon’s Alexa digital assistant. Last year, Amazon expanded the Halo lineup with a bedside sleep tracker called the Halo Rise.
Amazon will stop supporting Halo devices and the Halo app on July 31. Users can delete their Halo health data from the app, and any remaining data will be deleted after Aug. 1, the company said.
“At Amazon, we think big, experiment, and invest in new ideas like Amazon Halo in our efforts to delight customers,” the company said. “While we are proud of what we built, we recently made the difficult decision to stop supporting Amazon Halo effective July 31, 2023.”
The company said it will refund any purchases made in the last year of Halo View, Halo Band, Halo Rise and Halo accessory bands. It will also refund any unused Halo subscription fees.
Halo is the latest Amazon product to get axed as CEO Andy Jassy aggressively cuts expenses across the company amid an economic downturn and slowing retail sales. Many unproven bets like the Glow video-calling device and Scout delivery robot were sunset in recent months. The company also shuttered its nascent telehealth program, Amazon Care.
Amazon is in the middle of the largest layoffs in its 29-year history. The company recently wrapped up a round of layoffs impacting 18,000 people, some of which were in its devices and services unit. Last month, Jassy announced the company would lay off an additional 9,000 people, with most of the cuts landing in its cloud computing, advertising, human resources and Twitch livestreaming units.
https://www.cnbc.com/2023/04/26/amazon-halo-fitness-wearable-dead-in-latest-cost-cutting-move.html
Ingestible electroceutical device to control appetite by hormone modulation
A team of researchers at NYU Abu Dhabi (NYUAD), led by Khalil Ramadi, assistant professor of bioengineering at NYU Tandon and the Director of the Laboratory for Advanced Neuroengineering and Translational Medicine at NYU Abu Dhabi, has developed a first-of-its-kind ingestible electroceutical device for the neuromodulation of the gut-brain axis, the signaling pathway between the gastrointestinal tract and central nervous system.
The ingestible capsule is a noninvasive and precise method that could be used to modulate hunger levels and treat metabolic and neurologic diseases. This was developed in collaboration with Professor Giovanni Traverso of MIT, who is a joint senior author of the study and James McRae, a graduate student at MIT, who is first co-author of the paper published in the journal Science Robotics.
The FLASH system uses electrodes on its surface to deliver electrical stimulation to stomach mucosal tissue. The gut-brain axis regulates several physiological functions, including feeding and emotional behavior. The existing pharmaceutical and surgical methods to modulate the axis, including implanting electrodes through surgery, are imprecise, invasive, and have been associated with significant recovery periods and associated risks.
Inspired by the water wicking skin of Moloch horridus, the Australian thorny devil lizard, FLASH features a fluid-wicking capsule coating with grooved patterns and a hydrophilic (water compatible) surface, enabling them to bypass the gastric fluid in the stomach and achieve direct electrode-tissue contact.
Gastric electrical stimulation (GES) directly induces the release of the hormone ghrelin, which stimulates hunger, from the gastric mucosa through endoscopic stimulation. Oral ingestion of the FLASH capsule was shown to modulate levels of the ghrelin hormone significantly and repeatedly.
In the paper, titled "Bioinspired, fluid-wicking, ingestible electroceutical capsules for hunger-regulating hormone modulation," published today (April 26), the researchers report the process of developing the FLASH capsules, which are swallowed. The capsules are powered by ingestible batteries, which were shown to deliver stimulation for 20 minutes. The capsules can then be excreted within two weeks of ingestion in large animals.
Current hormone medications have poor bioavailability when taken orally. This is why medications such as insulin need to be injected. FLASH can be taken orally to specifically target gastric neurohormonal circuits and modulate hormone levels in the blood. It is anticipated that this device could be used for a range of applications to treat metabolic, feeding, gastrointestinal and neuropsychiatric disorders non-invasively, and with minimal off-target effects.
"Electroceuticals, or electrical stimulation therapies, have emerged as the next frontier of neuromodulation," said Ramadi. "FLASH is one of the first ingestible electroceutical that can regulate precise neurohormonal circuits, while avoiding the discomfort patients can experience with invasive treatments. Future ingestible electroceutical systems could be designed and customized for specific applications beyond acute, short-term gastric stimulation."
More information: Khalil Ramadi et al, Bioinspired, ingestible electroceutical capsules for hunger-regulating hormone modulation, Science Robotics (2023). DOI: 10.1126/scirobotics.ade9676. www.science.org/doi/10.1126/scirobotics.ade9676
https://medicalxpress.com/news/2023-04-first-ever-ingestible-electroceutical-device-appetite.html
Chest e-tattoo boasts major improvements in heart monitoring
A new flexible, wearable medical device could provide a major boost in the fight against heart disease, the leading cause of death in the United States.
A team led by researchers at The University of Texas at Austin has developed an ultrathin, lightweight electronic tattoo, or e-tattoo, that attaches to the chest for continuous, mobile heart monitoring outside of a clinical setting. It includes two sensors that together provide a clear picture of heart health, giving clinicians a better chance to catch red flags for heart disease early.
"Most heart conditions are not very obvious. The damage is being done in the background and we don't even know it," said Nanshu Lu, a professor in the Department of Aerospace and Engineering Mechanics and a lead author of the study. "If we can have continuous, mobile monitoring at home, then we can do early diagnosis and treatment, and if that can be done, 80% of heart disease can be prevented."
The study is published in Advanced Electronic Materials.
As a continuation of an earlier chest e-tattoo project, this new version is wireless and mobile, which is enabled by a series of small active circuits and sensors carefully arranged and linked by stretchable interconnections and conforms to the chest via a medical dressing. The clear devices are far less intrusive than other monitoring systems and more comfortable for patients.
Currently, there isn't a ready solution for long-term, comfortable monitoring outside of the clinical setting. Clinicians can run tests on patients when they visit, but they may not catch some heart issues because signs of disease are not present at that moment.
The e-tattoo weighs only 2.5 grams and runs on a battery the size of a penny. The battery has a life of more than 40 hours and can easily be changed by the user.
It provides two key heart measurements. The electrocardiogram, or ECG, is the electrical signal from the heart. And the seismocardiogram, or SCG, is the acoustic signal from the heart that comes from the heart valves.
ECG can be measured by mobile devices such as an Apple Watch. And the SCG can be monitored via stethoscope. But there is no mobile solution that approximates a stethoscope or takes both measurements.
"Those two measurements, electrical and mechanical, together can provide a much more comprehensive and complete picture of what's happening with the heart," Lu said. "There are many more heart characteristics that could be extracted out of the two synchronously measured signals in a noninvasive manner."
Monitoring those two factors, and synchronizing them, makes it possible to measure cardiac time intervals, which are a major indicator of heart disease and other problems.
The researchers have already tested the device on five healthy patients in their day-to-day environments, with a low error rate in measurements compared with currently available monitoring options. The next step involves further testing and validating the initial results and expanding to different types of patients.
More information: Sarnab Bhattacharya et al, A Chest‐Conformable, Wireless Electro‐Mechanical E‐Tattoo for Measuring Multiple Cardiac Time Intervals, Advanced Electronic Materials (2023). DOI: 10.1002/aelm.202201284
https://medicalxpress.com/news/2023-04-chest-e-tattoo-major-heart.html
SVB's former parent may need new funding after $2bln cash seizure
Silicon Valley Bank's former owner may need to take out a bankruptcy loan amid uncertainty about the U.S. Federal Deposit Insurance Company's seizure of $2 billion in cash from the company, its attorney said Wednesday.
SVB Financial has about $180 million on hand and is not in "imminent danger" of running out of cash attorney James Bromley said at a court hearing before U.S. Bankruptcy Judge Martin Glenn in Manhattan, who is overseeing the company's Chapter 11 proceedings.
SVB Financial filed for Chapter 11 bankruptcy on March 17 after California regulators shuttered Silicon Valley Bank in early March and appointed the FDIC as receiver, making it the largest collapse since Washington Mutual went bust during the financial crisis of 2008. The company replaced its CEO and CFO with turnaround specialists last week.
The company has been forced to consider taking out a bankruptcy loan because the FDIC has not yet said whether it will return any of the $2 billion seized at the time of the bank failure, Bromley said. The FDIC has also not fully explained why the cash was seized, Bromley said.
"There is something fundamentally wrong with taking the money and not saying why," Bromley said.
FDIC's attorney, Derek Baker, told Glenn that SVB Financial's bank accounts were properly seized as part of FDIC's takeover of the failed bank.
The cash is being held as a set-off against the regulator's costs in stepping in to protect SVB customer deposits, and FDIC is working to provide more detail about its claims against SVB Financial, Baker said.
Glenn said he needed more information about the FDIC's authority to seize cash and how disputes related to the seizure should be resolved. He directed Baker to report to the court on those topics within a week.
SVB Financial is also still waiting for the full return of financial records that were seized as part of the bank takeover.
First Citizens BancShares, which bought the failed bank, said that it has hired a specialized financial adviser to speed up the transfer of information necessary to SVB Financial's bankruptcy case.
https://finance.yahoo.com/news/svbs-former-parent-may-funding-190455032.html
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