'VP Harris to unveil nursing home rules in battleground state of Wisconsin'

 U.S. Vice President Kamala Harris will travel to the political battleground state of Wisconsin on Monday to announce two final rules aimed at improving access to long-term care and ensuring the quality of care-giving jobs, a White House official said.

The White House said Monday's announcements finalized two rules first announced in September as part of U.S. President Joe Biden's pledge to crack down on nursing homes that endanger resident safety, and to improve access to high-quality care.

Harris will announce the rules in a meeting with nursing home care workers in La Crosse, Wisconsin, marking her third trip to the state this year and her seventh since taking office.

Biden visited Wisconsin last month after clinching the Democratic Party's nomination as he focused on securing votes among suburban women, Black voters and Latinos across the Midwest ahead of the November presidential election.

A new Reuters/Ipsos poll released earlier this month showed Biden leading his Republican rival former president Donald Trump by 4 percentage points, up 1 percentage point from March.

Wisconsin and Michigan are part of the "blue wall," along with Pennsylvania, that Biden will need to hold to secure a second term. In 2016, Trump flipped all three to win the White House, but Biden took them back four years ago.

One of the rules would set federal minimum staffing levels for nursing homes, addressing longtime complaints about abuse and neglect in the industry that were highlighted during the COVID-19 pandemic.

It requires all nursing homes that receive federal funding through Medicare and Medicaid to have 3.48 hours per resident per day of total staffing. That means a facility with 100 residents would need at least two or three RNs and at least 10 or 11 nurse aides as well as two additional nurse staff to meet the minimum staffing standards, the White House said.

The second final rule will help improve access to home care services for the 7 million seniors and people with disabilities who rely on these serves, while improve the quality of care-giving jobs, many held by women of color, the White House.

It will ensure adequate compensation for home care workers by requiring that at least 80% of Medicaid payments for home care services go to workers’ wages.

States will also be required to be more transparent in how much they pay for home care services and how they set those rates, and set up advisory panel including beneficiaries, home care workers and other key stakeholders.

https://www.yahoo.com/news/vp-harris-unveil-nursing-home-090314365.html

Akero and Madrigal Face Off in the MASH Space

 Last month, the FDA approved Madrigal’s Rezdiffra as the first therapy for metabolic dysfunction-associated steatohepatitis, or MASH (formerly known as NASH). It was one of the most anticipated regulatory actions of the year and a win for MASH patients, who, to this point, have had no treatment options. But Madrigal may soon have competition in this space.

The week before Rezdiffra’s approval, Akero Therapeutics reported updated data from its Phase IIb HARMONY trial examining the effects of efruxifermin (EFX) 28 mg and EFX 50 mg versus placebo in patients with F2-F3 liver fibrosis, or precirrhotic MASH. While it's still too soon to tell, early signs indicate that EFX could challenge Rezdiffra in this population of patients. 

In Phase III trials, the FDA asks MASH drug developers to show a one-stage improvement in fibrosis (ranked on a scale from F0, or the absence of fibrosis, to F4, full-blown cirrhosis) with no worsening of MASH, or the resolution of MASH with no worsening of fibrosis.

In the HARMONY trial, 46% of those treated with EFX 28 mg and 75% of patients treated with EFX 50 mg achieved at least one stage of improvement in fibrosis and no worsening of MASH after 96 weeks, compared to 24% of the placebo arm. 

Although the results for EFX 28 mg were not statistically significant, those for EFX 50 mg were, demonstrating sustained long-term benefits with this dose. 

While EFX is currently being studied in multiple clinical trials, these preliminary results are already a sign of efficacy that Madrigal will need to consider in moving forward with Rezdiffra. According to Akero’s updated competitive intelligence reporting, its clinical trials give it some compelling advantages over Rezdiffra. 

For instance, by enrolling MASH patients with F2-F3 liver fibrosis scores in HARMONY, Akero is targeting a more complicated population than the broader F1-F3 liver fibrosis patients targeted by Madrigal in its MAESTRO-NASH Phase III trials. By focusing on F2-F3 liver fibrosis, Akero is positioning itself to maximize the evidence for EFX’s use in reducing liver fat, given that patients with F2-F3 liver fibrosis have hepatic fatty scars that are absent in earlier stages of liver fibrosis.

In addition, Madrigal’s clinical trial design was less rigorous. HARMONY is a completer trial, which enforces rigid adherence to treatment by only including in its analysis those patients who stuck with their assigned regimen, while MAESTRO-NASH is an intention-to-treat (ITT) trial, which allows for real-world dosing frequency deviations. Rigid adherence maximizes clinical trial efficacy by ensuring patients are taking EFX as scheduled and not missing doses. 

Given that Madrigal only has Phase III data up to 52 weeks for Rezdiffra, Akero’s drug has demonstrated long-term efficacy that could be a positive tiebreaker for those looking at alternative investigational treatments for MASH.

On the other hand, while Akero’s achievements are noteworthy, there are limitations to its competitive intelligence comparisons.

Because Akero has not investigated EFX in MASH patients with F1 liver fibrosis scores in HARMONY, Rezdiffra appears to be the drug of choice for the first-line treatment of early-stage MASH, while EFX may be relegated to second-line or alternate therapy.

Additionally, as an Fc‐FGF21 fusion protein, EFX is an investigational once-weekly subcutaneous injection administered to the abdominal area, while Rezdiffra is an FDA-approved orally administered tablet taken once daily. Compared to an oral tablet, ensuring the stability of a subcutaneous formulation will potentially entail more significant costs and quality control issues.

Finally, the relatively small number of patients enrolled in HARMONY means that comparing Madrigal’s data with Akero’s head-on is not straightforward. Because MAESTRO-NASH enrolled approximately 1,750 patients while HARMONY enrolled only 128, it is too early to tell how Akero will fare statistically in Phase III trials as the number of participants increases.

Therefore, although Akero’s data appears to be more efficacious than Madrigal’s, whether the data will hold in real-world scenarios remains to be seen. Keep an eye on the MASH market as this therapeutic area continues to heat up in the coming years.

https://www.biospace.com/article/opinion-akero-and-madrigal-face-off-in-the-mash-space/

'Ukraine arms makers held back by lack of cash'

 Since Russia launched its war on Ukraine over two years ago, hundreds of businesses making weapons and military equipment have sprung up in the country.

But now the budding private arms sector is facing setbacks – as funding dries up and Russian missile strikes intensify.

Owners say they have pumped in their own cash to survive, and have moved locations at their own expense to stay ahead of Russian intelligence.

Reuters spoke with Ukraine’s strategic industries minister Oleksandr Kamyshin.

“At the moment, the general capacity of Ukraine’s military-industrial complex is $18-20 billion per year. The Ukrainian government can only fund only a third of the capacities.”

According to his ministry, the number of private defense manufacturers has more than doubled since the invasion.

To resolve cash shortages, Ukraine is asking foreign partners to fund its arms production.

Denmark became the first to answer the call on April 16 when it pledged $28.5 million.

Some manufacturers say their financial woes are compounded by red tape:

"The first threat that makers come up against when they start working is the bureaucracy of the military sphere and of purchases."

Vladyslav Belbas heads one of the few Ukrainian manufacturers making armored vehicles and artillery shells.

He cited the fact that the defense ministry only places orders for the current year, hampering makers' ability to plan for the long term.

Some manufacturers also want to be allowed to export, though that has so far been barred for fear it could undermine Ukraine's pleas for military aid from abroad.

Aside from financial difficulties, making weapons during a full-scale war is an inherently risky business.

Some manufacturers move locations as often as every three months for security.

And Belbas said that Russia’s strikes on Ukraine’s energy infrastructure had hurt production.

"In 2022-2023, we did not have electricity for two-thirds of our working hours – of course, under such conditions it is very difficult to manufacture anything."

A government source, who spoke on condition of anonymity, denied that manufacturers had issues with power supply.

In the event of power cuts, they said the arms sector would quote “be switched off last.”

https://www.yahoo.com/news/ukraine-arms-makers-held-back-114129620.html

Papua New Guinea leader responds to Biden comment, saying nation undeserving of cannibalism label

 Papua New Guinea Prime Minister James Marape says his nation does not deserve to be labelled cannibals, and urged the U.S. to clear up the remnants of World War Two littered across the Pacific, after comments by President Joe Biden about his missing serviceman uncle.

Biden had "appeared to imply his uncle was eaten by cannibals after his plane was shot down over PNG during WWII", Marape's office said in a statement late on Sunday.

"President Biden's remarks may have been a slip of the tongue; however, my country does not deserve to be labelled as such," Marape said in the statement.

"I urge President Biden to get the White House to look into cleaning up these remains of WWII so the truth about missing servicemen like Ambrose Finnegan can be put to rest."

The U.S. signed a defence cooperation agreement with Papua New Guinea last year, amid competition for influence in the region with China, which has a security pact with neighbouring Solomon Islands.

China's Foreign Minister Wang Yi met with Marape in the capital Port Moresby on Sunday to build closer economic ties, while Australia's Prime Minister Anthony Albanese arrives this week to commemorate World War Two history.

Biden has previously cited his personal connection with Papua New Guinea's wartime history on visits to Australia, telling the story of his uncle who died in a plane crash in May 1944.

Biden last week raised the possibility his uncle might have fallen victim to cannibals, after visiting a missing-in-action war memorial in Pennsylvania.

Historians say Papua New Guinea was crucial to the United States drive across the Pacific to liberate the Philippines in World War Two, while Australia has said the wartime history showed the renewed strategic importance of its northern neighbour.

The impact of the war remains sensitive among Pacific Islanders, however.

Marape said his nation was "needlessly dragged into a conflict that was not their doing".

Papua New Guinea and Solomon Islands remain littered with wartime human remains, plane wrecks, ship wrecks and tunnels, as well as leftover bombs which were still killing people, he said.

https://www.yahoo.com/news/papua-guinea-leader-responds-biden-002347508.html

Deepfakes of Bollywood stars spark worries of AI meddling in India election

 In fake videos that have gone viral online, two of India's A-lister Bollywood actors are seen criticizing Prime Minister Narendra Modi and asking people to vote for the opposition Congress party in the country's ongoing general election.

In a 30-second video that shows Aamir Khan and another 41-second clip of Ranveer Singh, the two Bollywood actors purportedly say Modi failed to keep campaign promises and failed to address critical economic issues during his two terms as prime minister.

Both AI-generated videos end with the Congress election symbol and slogan: "Vote for Justice, Vote for Congress".

The two videos have been viewed on social media more than half a million times since last week, a Reuters review shows.

Their spread underlines the potential role such AI (artificial intelligence)-generated content can play in the mammoth Indian election that started on Friday and will continue until June. AI and AI-generated fakes, or deepfakes, are being increasingly used in elections elsewhere in the world, including in the U.S., Pakistan and Indonesia.

Campaigning in India has long focused on door-to-door outreach and public rallies, but extensive use of WhatsApp and Facebook as campaigning tools started in 2019. This year's general election - in which Modi is expected to secure a rare third term - is the first in which AI is being used.

A Congress spokesperson, Sujata Paul, shared actor Singh's video with her 16,000 followers on X on April 17 and by Saturday afternoon, her post had been reshared 2,900 times, liked 8,700 times and received 438,000 views.

Paul told Reuters by telephone she was aware the video was marked "manipulated media" by X, but she did not want to delete it as, while posting, she thought the person was a look alike of Singh and "it has creativity for sure".

The post was no longer visible on X on Sunday, hours after Reuters sent a request for comment to Congress' head of social media cell, who did not respond.

Both actors have said the videos are fake. Facebook, X and at least eight fact-checking websites have said they are altered or manipulated, which the Reuters digital verification unit has also confirmed.

Reuters could not ascertain who created the videos. Khan was "alarmed" by the viral "fake" video and Singh's team was looking into the matter, according to a spokesperson for both actors. Singh wrote on X on Friday: "Beware of deepfakes, friends".

https://finance.yahoo.com/news/deepfakes-bollywood-stars-spark-worries-025652212.html

US-Funded Experiments In China Could Secretly Manipulate Viruses: Email

 by Zachary Stieber via The Epoch Times (emphasis ours),

Experiments in China funded by the U.S. government could manipulate coronaviruses and leave no trace, according to newly disclosed emails.

Details of the experiments showed that changing the viruses could be done and “would leave no signatures of purposeful human manipulation,” an unknown person told the FBI on April 23, 2020, one of the emails showed.

The details were outlined on a webpage for a grant funded by the U.S. National Institute of Allergy and Infectious Diseases, the agency headed by Dr. Anthony Fauci until late 2022. The government has funded $4.3 million for the grant. A portion of the funds were sent to the Wuhan Institute of Virology, a laboratory located in the same Chinese city in which the first COVID-19 cases appeared in 2019.

An FBI official forwarded the email to another FBI official about an hour after receipt. “Hey are you going to be in office tomorrow? We just interviewed our person from [redacted] again and he provided us with some alarming new info,” the official wrote. “Give me a call if you can.”

The identities of the source and FBI officials were redacted in the messages, which were obtained by the nonprofit Judicial Watch through a Freedom of Information Act request.

The FBI and EcoHealth did not immediately respond to requests for comment.

“These smoking gun documents showed the FBI quickly understood that Fauci’s agency funded the gain-of-function research that could disguise the resulting coronavirus as ‘natural,’” Judicial Watch President Tom Fitton said in a statement. “These new documents further demonstrate the need for a comprehensive criminal investigation into Fauci’s gain-of-function scandal.”

Robert Garry, who has a doctorate in microbiology and also studied virology, said in private messages that genetic manipulation doesn’t leave signatures. One could “synthesize bits of the genes ... with perfect provision and then add them back in without a trace,” he wrote in early 2020 while analyzing COVID-19.

Mr. Garry and others later wrote in a paper called Proximal Origin that the available evidence showed COVID-19 “is not a laboratory construct or a purposefully manipulated virus.” Two of the authors defended the change during a hearing in Congress.

Records previously obtained by Judicial Watch showed that the FBI opened an inquiry into the research in Wuhan, which was done under a grant called “Understanding the Risk of Bat Coronavirus Emergence.”

It’s not clear what specific actions the FBI took but the bureau has since determined that COVID-19, a coronavirus, likely originated at the Wuhan lab.

“You’re talking about a potential leak from a Chinese government-controlled lab that killed millions of Americans,” FBI Director Christopher Wray said in 2023.

The U.S. intelligence community as a whole is divided on the matter, with at least one other agency also assessing a lab origin as likely while others are undecided or lean towards the natural origin theory.

COVID-19 is believed to have come from bats. The grant gave money to scientists to gather bat coronaviruses and experiment on them in labs in Wuhan and elsewhere. China has largely blocked investigations into the origins of COVID-19 and declined to make information from the lab public. Similarities between COVID-19 and a virus on which experiments were proposed in a separate EcoHealth funding application are among the evidence pointing to the lab leak theory, experts say. Others say the available evidence, including early cases at a wet market in Wuhan, suggest a natural origin.

Experiments funded through the U.S. grant did result in a bat coronavirus that made mice sicker than those infected with the original version, government officials have disclosed. Concerns about work at the lab were raised prior to the pandemic, according to an internal report viewed recently by a U.S. senator. Officials renewed EcoHealth’s grant in 2023 but have barred funding to the Wuhan lab after lab leaders stopped sharing information with EcoHealth and U.S. overseers.

https://www.zerohedge.com/political/us-funded-experiments-china-could-secretly-manipulate-viruses-email

Ipsen, Skyhawk in RNA targeting research collaboration in rare neurological diseases

 

• Ipsen enters into an option agreement to receive exclusive global rights to two candidates pursued under the collaboration
• Following development candidate validation, Ipsen will assume responsibility for further development and commercialization, leveraging existing neuroscience expertise in movement disorders
• This promising platform technology created by Skyhawk allows for the exploration of previously undruggable RNA targets with small molecules, expanding the disease target landscape

https://www.biospace.com/article/releases/ipsen-and-skyhawk-therapeutics-announce-rna-targeting-research-collaboration-in-rare-neurological-diseases/