Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine

  Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ®, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

The Company will hold an analyst call and a webcast at 3:00pm CET or 9:00am EDT on Monday, November 13, 2023. The link will be available on the Company’s investor page. Please refer to this link Investors - Valneva.

https://www.globenewswire.com/news-release/2023/11/10/2778039/0/en/Valneva-Announces-U-S-FDA-Approval-of-World-s-First-Chikungunya-Vaccine-IXCHIQ.html

Philippines denounces China for 'unprovoked acts of coercion' to block resupply mission

 The Philippines on Friday condemned China's coast guard for "unprovoked acts of coercion and dangerous manoeuvres," including its use of a water cannon against one of its boats, in an attempt to disrupt a resupply mission in the South China Sea.

China's actions, the Philippines said, has not only "put the lives of our people at risk," but have "put into question and significant doubt the sincerity of its calls for peaceful dialogue".

The regular resupply missions support the Philippines' troops stationed in an intentionally grounded dilapidated warship on Second Thomas Shoal, a hotly disputed atoll in the South China Sea that Manila calls Ayungin and is known as Renai Reef in China.

China claims almost the entire South China Sea, which includes the Second Thomas Shoal, and has deployed hundreds of vessels to patrol there, including what Manila refers to as "Chinese maritime militia", which it said were involved in the latest attempt to obstruct the resupply mission.

China's coast guard on Friday said two small Philippine transport ships and three coast guard ships entered the waters without the permission of the Chinese government and urged the Philippines to stop infringing on Beijing's sovereignty.

"The China coast guard has followed Philippine vessels in accordance with the law, taken control measures, and made temporary special arrangements for the Philippine side to transport food and other necessary daily necessities," Beijing's coast guard said in a statement.

The Philippines' government said the resupply mission was completed, even as its boats were "subjected to extremely reckless and dangerous harassment at close proximity" by the Chinese coast guard's inflatable boats inside the shoal.

For years, Manila and Beijing have been embroiled in on-off confrontations at the Second Thomas Shoal as China has become more assertive in pressing its maritime claims, alarming rival claimants and other states operating in the South China Sea, including the United States.

Washington has thrown its support behind a 2016 ruling by the Permanent Court of Arbitration in the Hague, that said Beijing's expansive claims had no legal basis, delivering a historic legal victory for the Philippines. Under the ruling, the shoal is inside the Philippines' exclusive economic zone.

"The Philippines has acted responsibly, consistent with a rules-based international law, on the basis of UNCLOS and the 2016 Arbitral Award," the task force said. "Peace and stability cannot be achieved without due regard for the legitimate, well-established, and legally settled rights of others."

China's use of water cannons followed a series of incidents in the South China Sea, including the collisions between China's vessels and two Manila ships on Oct. 22. The Philippines accused China coastguard of "intentionally" colliding with its vessels.

https://news.yahoo.com/china-coast-guard-urges-philippines-033556262.html

US appeals court calls Biden's 'ghost gun' limits unlawful

 A federal appeals court on Thursday ruled that the Biden administration lacked authority to adopt a regulation aimed at reining in privately made firearms called "ghost guns" that are difficult for law enforcement to trace.

A three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals sided with a group of firearm owners, gun rights groups and manufacturers in declaring the Bureau of Alcohol, Tobacco, Firearms and Explosives' 2022 rule "unlawful."

The panel, comprised entirely of judges appointed by Republican former President Donald Trump, largely upheld a Texas judge's ruling against the rule, which targeted the rapid proliferation of such homemade weapons.

The rule updated the definition of a "firearm," "frame" and "receiver" under the Gun Control Act of 1968 to address the rise of ghost guns that can be assembled from kits that can be bought online or at a store without a background check.

U.S. Circuit Judge Kurt Engelhardt, writing for the 5th Circuit panel, said ATF's rule "flouts clear statutory text and exceeds the legislatively-imposed limits on agency authority in the name of public policy."

"ATF, in promulgating its final rule, attempted to take on the mantle of Congress to 'do something' with respect to gun control," he wrote. "But it is not the province of an executive agency to write laws for our nation."

The U.S. Department of Justice and ATF did not respond to requests for comment. But the administration is likely to appeal, after already seeking the U.S. Supreme Court's intervention in the case.

The Supreme Court had twice before in August and October acted following rulings by the Texas judge and granted requests by the administration that have allowed the regulations to remain in effect while litigation continues.

The administration has said that ghost guns are attractive to criminals and others prohibited from lawfully buying firearms, including minors.

There were about 20,000 suspected ghost guns reported in 2021 to the ATF as having been recovered by law enforcement in criminal investigations - a tenfold increase from 2016, according to the White House.

Cody Wisniewski, a lawyer for the plaintiffs at the Firearms Policy Coalition Action Foundation, in a statement called Thursday's ruling a "massive victory against ATF and a huge blow to the Biden administration's gun control agenda."

https://news.yahoo.com/us-appeals-court-calls-bidens-015832550.html

World’s Largest Bank Hit By Ransomware Gang Linked to Boeing, Ion Attacks

 Industrial & Commercial Bank of China Ltd. is suspected of being hacked by the same group that has — just in the past year — also hit Boeing Co., ION Trading UK and the UK’s Royal Mail.

The prolific gang known as Lockbit is suspected to have orchestrated a ransomware attack against the US unit of ICBC, the world’s largest lender by assets, according to people familiar with the situation, who asked not to be identified because the information isn’t public. The attack has resulted in disruptions across the US Treasury market, with some transactions failing to clear and traders being asked to reroute their deals.

Read More: ICBC Hit by Cyberattack, Tells US Clients to Reroute Trades

Lockbit, a criminal gang with ties to Russia, specializes in using malicious software known as ransomware to encrypt files on its victims’ computers, then demanding payment to unlock the files. Earlier this year, it took credit for an attack against ION that paralyzed derivatives trading across markets for everything from commodities to bonds and forced several banks and brokers to process trades manually.

On Thursday, ICBC confirmed in a statement on its website that a ransomware attack at its ICBC Financial Services unit resulted in disruption to some of its systems. The bank said it’s conducting a thorough investigation and progressing its recovery efforts. The lender said systems at its head office and other domestic and overseas affiliates, including its New York branch, weren’t affected.

A week ago, Boeing disclosed a cyberattack that took down the website where it sells spare aircraft parts, software and services. Lockbit threatened to release “sensitive data” belonging to Boeing if it didn’t pay a ransom by Nov. 2. The hackers placed the company’s name on its website, with a countdown to the day last week. The name later disappeared from the site.

https://finance.yahoo.com/news/icbc-hit-ransomware-gang-linked-225423225.html

Marijuana Use Tied to Heart Failure, MI, Stroke

 Daily marijuana use was associated with a 34% increased risk for heart failure within 4 years compared with nonuse, in new observational research.

In a separate study, cannabis use disorder (CUD) was linked with a 20% increased risk for major adverse cardiac and cerebral events (MACCEs) during hospitalization in older patients with cardiovascular risk who were tobacco nonsmokers.

The studies will be presented on November 13 at the upcoming American Heart Association (AHA) 2023 Scientific Sessions.

These were observational data, so they can show only association and not causation, the researchers stress, but they build on other recent findings.

Despite the study limitations, "Is this a signal? Absolutely," said Robert L. Page II, PharmD, MSPH, in an interview with theheart.org | Medscape Cardiology.

Page is a professor in the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado and chaired the writing group for the 2020 AHA Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health. He was not involved in either of the current studies.

Marijuana Use and Risk for Heart Failure

Marijuana use in the United States has increased exponentially with increasing state-level legalization, but its effect on cardiovascular health is unclear, Yakubu Bene-Alhasan, MD, MPH, and colleagues write.

In their study, the researchers assessed the association between marijuana use and risk for incident heart failure compared with the risk in nonuse on the basis of survey data and medical records from participants in the National Institutes of Health–sponsored All of Us research program.

They identified 156,999 adults aged 18 years or older who did not have a diagnosis of heart failure at baseline. Participants had a mean age of 54 years, and 61% were women.

About one quarter had hypertension (24%) or hyperlipidemia (23%), 9.2% had type 2 diabetes, and 9% had coronary artery disease (CAD). They had a median body mass index (BMI) of 28; 17% were current smokers, and 22% were former smokers. Almost all had insurance (95%).

On the basis of the participants' reported marijuana use, defined as unprescribed use or use beyond prescribed doses over the previous 3 months, they were classified as never-users (107,976 participants); former users (33,816); or less than monthly (7292), monthly (1686), weekly (2326) or daily (3903) users.

During a median follow-up of 45.3 months, there were 2958 incident heart failure events.

Compared with never-users, daily marijuana users had a 34% increased risk for heart failure after adjusting for age, sex, race, ethnicity, alcohol use, smoking, education, employment, income, health insurance, type 2 diabetes, hypertension, hyperlipidemia, and BMI (hazard ratio [HR], 1.34; 95% CI, 1.04-1.72).

However, after further adjusting for CAD, the risk for heart failure was no longer significant (HR, 1.27; 95% CI, 0.99-1.62), suggesting that CAD is a pathway through which daily marijuana use may lead to this outcome.

"Given that this is an observational study, we can't say that marijuana use causes heart failure," Bene-Alhasan, a resident physician at Medstar Health, in Baltimore, Maryland, told theheart.org | Medscape Cardiology.

Still, "over the years there have been more and more reports of negative effects associated with marijuana use," he noted. "This study and most studies suggest that marijuana use has detrimental effects, especially in the cardiovascular system.

"Given the increasing use of marijuana," he said, "it's something that every physician will come across."

It would be difficult and probably unethical to examine these risks in a randomized controlled trial, Bene-Alhasan said. "But as more and more [observational] studies show association between marijuana and other conditions," he added, "the evidence will be one day overwhelming towards one direction or the other, and then clinicians can make informed decisions with their patients."

Page pointed out that both of these studies show association and not causation, but nevertheless, "these data are a signal of potential cardiovascular issues," he said.

"I don't want people to think, 'Well, if I smoke it once a month I won't have that issue,'" Page said. "Don't get a false sense of security," he warned, because other observational data have show cardiovascular effects even when people were using marijuana weekly.

Other limitations of both studies include that they are abstracts and have not been peer reviewed, he noted.

Of importance, the studies did not distinguish between cannabis smoking or vaping vs edibles. "When you're smoking or vaping a cannabis product," particularly one that is higher in tetrahydrocannabinol or cannabidiol, he said, "you get more acute cardiovascular effects, which you may not see with the edibles."  

CUD and Risk for MACCEs

In a separate report, Avilash Mondal, MD, and colleagues examined the risk for in-hospital MACCEs, defined as a composite of all-cause mortality, acute myocardial infarction (MI), cardiac arrest, or stroke, in older tobacco nonsmokers with established cardiovascular disease (CVD) risk (hypertension, type 2 diabetes, or hyperlipidemia) who had CUD, defined as using cannabis and being dependent on it compared with those without this disorder.  

The investigators analyzed data (including ICD-10 codes) from the National Inpatient Sample (2019) in individuals aged 65 years or older with established CVD risk factors (hypertension, type 2 diabetes, or hypercholesterolemia) when they were admitted to hospital.

Of 10,680,280 patients, 28,535 had CUD; they were generally younger and more likely to be men than were those without CUD. During a median hospitalization of 4 days, 13.9% of the patients with CUD reported MACCE episodes.

Compared with other patients, those with CUD had higher rates of acute MI (7.6% vs 6.0%) and stroke (5.2% vs 4.8%), similar rates of cardiac arrest (1.1% each), but lower rates of all-cause mortality (1.7% vs 3.3%) and dysrhythmia (25.9% vs 34.9%).

Patients with CUD were more likely to have MACCEs (odds ratio, 1.20; 95% CI, 1.11-1.29), after adjusting for baseline demographics, comorbidities, and hospital characteristics.

Study limitations include that the information comes from a national database and that different clinicians may have defined CUD differently, Mondal, a resident physician at Nazareth Hospital in Philadelphia, Pennsylvania, noted in an interview with theheart.org | Medscape Cardiology.

The data did not indicate whether the cannabis was smoked or vaped vs edibles or whether it was medicinal vs recreational, he noted.

Cannabis was legalized in 1996 in California for medicinal use, and then, this was expanded to recreational use, so it "has been in circulation for 20 plus years now," he said, "and now we can see a few of its effects in the older population."

Now that the younger generation is using cannabis more, users need to be more aware of the long-term repercussions on health. There is a lot that is not currently known about cannabis, Mondal said, adding that it would not be ethical to do a randomized trial with cannabis.

Given what is known though, he said, "we as providers — physicians, nurse practitioners — should all be more vigilant" in obtaining information about a patient's cannabis use, when taking their medical history.

"We should be more careful, and ask 'Do you use weed or marijuana? How frequently? Is it medicinal? Why do you use it?'"

About one third of the patients with CUD in this study also had drug abuse. Page observed, which "kind of muddies the water a little," because drugs such as cocaine and methamphetamine can lead to increased risk for atherosclerotic cardiovascular disease (ASCVD).

Nevertheless, both studies add to "the overwhelming evidence that has been generated over the last 5 years that maybe cannabis is going to be a potential risk factor for ASCVD disease or contributing to it," Mondal said.

Cigarette smoking was completely acceptable in the 1940s and 1950s, but how long did it take before it was realized that it led to stroke, heart attack, cancer, he asked rhetorically.

"The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide), and tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions," he said in a press release from the AHA.

"Because something is natural doesn't always make it safe," Page added. "There are risks and we're starting to see that. As healthcare providers we need to make sure that patients are aware of that." At the same time, he added, it is very important for clinicians to have a nonjudgmental approach.

The study authors and Page have no relevant financial disclosures.

https://www.medscape.com/viewarticle/998288

NHS will pilot blood tests for Alzheimer’s

 A large-scale study that will pilot the use of blood tests to diagnose Alzheimer’s disease has been announced in the UK, in the hope of finding ways to spot people in the earliest stages of the illness.

The five-year Blood Biomarker Challenge project will be led by Alzheimer’s Research UK, the Alzheimer’s Society, and the National Institute of Health and Care Research (NIHCR), with £5 million ($6.1 million) in funding provided by the People’s Postcode Lottery.

Currently, there is no approved blood test for this form of dementia cleared for use by the NHS, which means that Alzheimer’s is typically diagnosed with the help of time-consuming and expensive PET brain scans or invasive spinal fluid analysis carried out by lumbar puncture, coupled with cognitive testing.

All of these tests can be hard to access for patients, which contributes to the current situation where almost four in 10 people with dementia do not have a diagnosis, according to the Alzheimer’s Society. NHS England data indicates that people can wait up to four years for a diagnosis if they are aged under 65.

Recent figures published by the Alzheimer’s Society found that around 34,000 people under 65 in England have been diagnosed with young-onset dementia, but it reckons the true figure could be much higher, with an estimated 19,000 living without a diagnosis and support.

There are a number of groups around the world working on blood tests for Alzheimer’s, generally looking for traces in the blood of proteins like amyloid and tau that aggregate in the brains of people with Alzheimer’s and are a hallmark of the disease.

Earlier this year, for example, Roche and Eli Lilly – which are both developing drugs that target amyloid in the central nervous system as potential Alzheimer’s therapies – started a two-year trial of a new test that will look for the biomarker in blood.

Early diagnosis has become increasingly important now that drugs have started to become available that target amyloid, with Eisai and Biogen’s Leqembi (lecanemab) now approved in the US and Japan and filed in Europe, and Lilly’s donanemab going through regulatory review, with first decisions expected before the end of this year.

Diagnosis early in the course of the disease is thought to be critical to getting the most benefit from these therapies, which would be made much easier with a reliable and simple blood test. Moreover, testing will be important to rule out other forms of dementia that would not be helped by these drugs.

“We’re sitting on the cusp of a new era of dementia treatments, and doctors are likely going to see more people coming forward for a diagnosis. But the NHS doesn’t possess the required levels of diagnostic infrastructure to cope with this growing demand,” said Dr Susan Kohlhaas, executive director of research and partnerships at Alzheimer’s Research UK.

“Low-cost tools like blood tests that are non-invasive and simpler to administer than current gold standard methods are the answer to this” she added.

The NHS Blood Biomarker Challenge aims to recruit at least 1,000 NHS patients to help put potential tests through their paces, according to the partners, who say more details from the programme – including the researchers who will be involved – will be made available in January.

https://pharmaphorum.com/news/nhs-will-pilot-blood-tests-alzheimers-disease

China Unveils Plan To Mass Produce Human-like Robots, Calling It 'New Engine' For Growth

  by Eva Fu via The Epoch Times (emphasis ours),

China is setting out to mass produce human-like robots in two years, an ambitious plan that, according to a blueprint issued by the Ministry of Industry and Information Technology (MIIT), it hopes will make the regime in Beijing the leader in the field of robotics.

The goal is to establish an innovation framework for humanoid robots and ensure that the country can make core parts of the robots on its own.

The products, under the MIIT plan, will meet advanced international standards in quality, for use in harsh environments, manufacturing, and service sectors, according to the directive. Like smartphones, computers, and new energy vehicles, humanoid robots have the “disruptive” potential to “revolutionize” people’s lives, the document said.

The ministry told local officials to take advantage of China’s market size and its “whole-of-nation system” to accelerate humanoid robot development as a pillar industry to advance China’s manufacturing and digital dominance.

Beijing hopes that by 2025 it will have two to three companies with global influence and will nurture more smaller businesses dedicated to the field. In another two years, the aim is to create a “safe and reliable supply chain” for the technology and make the country competitive globally. At that point, it said, such products will be deeply integrated into the economy and become a “new engine” for economic growth.

The “brain,” “cerebellum,” and “limbs” of the robots should be the focus, and the industry should aim at creating “highly reliable” robots for harsh or dangerous conditions, the guideline said. When monitoring and safeguarding “strategic locations,” robots need to be able to move in “highly complicated terrains,” size up the situation, and make intelligent decisions, it said, adding that robots will need greater ability to protect themselves and work with higher precision in scenarios such as rescue work or where explosives are involved.

Relevant authorities need to deepen international cooperation, encourage foreign companies to create research centers in China, and bring Chinese products to the international market, according to the document.

Eager to partake in setting the global standard for emerging technology, Beijing said it’d like to get “deeply involved in the international rules and standard setting” and “contribute Chinese wisdom” to the industry’s development, the document said.

The directive is China’s latest attempt to boost technological self-reliance as the United States tightens its ban on China’s access to advanced U.S. chips. Expanding on chip controls on China from October last year, the Bureau of Industry and Security of the Commerce Department in mid-October required more U.S. firms to obtain a license before they could export advanced semiconductor chips to China, a step they said is necessary to prevent Beijing from using these chips for their military ends. On Oct. 23, the U.S. government told Nvidia to stop shipping most of its key artificial intelligence chips to China.

Without citing those actions by the United States, the document asked the industry to design AI chips for humanoid robots that would allow for self-learning and other capabilities.

Half a dozen Chinese intelligence firms saw their shares jump by as much as 20 percent the day after the announcement, and stock value for other robotic electronics also surged.

The Beijing regime's roadmap means it will be competing with international firms such as Samsung, Microsoft, and Tesla that are investing in the field.

Tesla CEO Elon Musk has been trying to build a humanoid robot called Optimus or Tesla Bot. After much hype last year, though, the display of the robot walking slowly on the stage and waving to the crowd fell short of expectations.

A man takes a picture of robots during the World Artificial Intelligence Conference in Shanghai, on July 7, 2023. (Wang Zhao/AFP via Getty Images)

There seems to be optimism about the technology among Chinese media.

Lu Hanchen, director of the Gaogong Industry Research Institute, told the state-owned Securities Times that while China is some distance away from producing humanoid robots at scale, that goal isn't far off.

More than 10 Chinese companies this year have revealed innovations related to humanoid robots, he noted, adding that China already has some supporting facilities from developing industrial robots.

Beijing has set aside about 10 billion yuan (about $1.4 billion) to fund the robotic development. On Nov. 6, China opened the first provincial-level innovation center on humanoid robots in the country’s capital to work on solving pressing “key common problems,” including an operation control system, open source software, and robot prototypes.

At least one Chinese company, Jiangsu Miracle Logistics System Engineering Co., has promised to introduce its first humanoid robot by the end of the year. Chinese securities brokerage firm Zheshang Securities estimates that the humanoid robot market will have a demand for 1.77 million machines by 2030.

https://www.zerohedge.com/technology/china-unveils-plan-mass-produce-human-robots-calling-it-new-engine-growth