Bayer's Nubeqa Meets Key Goal in Late-Stage Prostate Cancer Trial

 Bayer's Nubeqa prostate cancer drug met its main goal in a late-stage trial, which the company said paves the way for regulatory submissions to extend the drug's uses.

The German pharmaceutical company said Wednesday that a Phase 3 clinical study that evaluated Nubeqa in combination with androgen deprivation therapy met its primary objective by increasing radiological progression-free survival in prostate cancer patients with metastasis.

The safety data of the trial confirmed the tolerability profile of the drug in advanced prostate cancer, the company said.

Bayer said it plans to prepare for regulatory submission with health authorities globally to expand the indication of the drug, which is already approved under the brand name Nubeqa for the treatment of patients with prostate cancer who are at high risk of developing metastatic disease and for those with metastatic hormone-sensitive prostate cancer.

https://www.morningstar.com/news/dow-jones/20240717938/bayers-nubeqa-meets-key-goal-in-late-stage-prostate-cancer-trial

Texas AG Appeals Ruling On Nonprofit Accused Of Facilitating Illegal Immigration

 by Aldgra Fredly via The Epoch Times (emphasis ours),

Texas Attorney General Ken Paxton on Monday filed an appeal after a judge dismissed his lawsuit to shut down the nonprofit organization Annunciation House for allegedly facilitating illegal immigration.

District Court Judge Francisco Dominguez blocked the lawsuit in March, saying that Mr. Paxton “acted without regard to due process and fair play” in trying to revoke the registration of the nonprofit organization.

The judge ruled Mr. Paxton’s agency must use the state court system if it wants to investigate the Catholic nonprofit, which has been operating in El Paso, Texas, since the 1970s, offering shelter and other services to illegal immigrants.

Mr. Paxton said Monday he filed an appeal to the Texas Supreme Court against the judge’s decision.

“For too long, Annunciation House has flouted the law and contributed to the worsening illegal immigration crisis at Texas’s border with Mexico,” the Republican attorney general said in a statement.

He said the Office of the Attorney General has been investigating nonprofit organizations in Texas for their involvement in facilitating illegal immigration following Texas Gov. Greg Abbott’s request.

The investigation found Annunciation House was “openly operating in violation of the law without any pretense of trying to comply with the law,” Mr. Paxton’s office said. “According to Annunciation House’s in-court admissions, its employees enter Mexico to retrieve aliens, including aliens who have been denied entry by Border Patrol, to bring them into the United States.”

The Epoch Times has reached out to Annunciation House for comment but has not heard back as of publication time.

Annunciation House describes itself on its website as “a volunteer organization that offers hospitality to migrants, immigrants, and refugees in El Paso,” which is “rooted in Catholic social teaching.”

The Office of the Attorney General issued a Feb. 7 “request to examine” the nonprofit’s records, including documents detailing what services it provides to immigrants who are in the country legally or illegally.

According to Mr. Paxton, Annunciation House refused to turn over documents and sued his office soon after, seeking to halt his efforts to obtain their records. On Feb. 20, Mr. Paxton announced he was asserting a counterclaim, seeking to shut down Annunciation House’s operations within the state entirely.

In his legal filings, Mr. Paxton states his initial request to inspect Annunciation House’s records “was not made in a vacuum.” Rather, he alleged state investigators had been monitoring the “unusually covert way” Annunciation House operates.

Annunciation House’s Previous Response

Annunciation House said on Feb. 23 that Mr. Paxton’s attempt to shut down the organization was “unfounded” and said that it was asking the court to decide which documents the Attorney General is allowed to access.

“There is nothing illegal about asking a Court to decide a person’s rights. The AG has now made explicit that its real goal is not records but to shut down the organization,” it said in a statement.

The organization said it has provided hospitality to “hundreds of thousands of refugees for over 46 years” and that its work was listed in the National Catholic Directory.

“Annunciation House’s work is central to the City of El Paso. El Paso has made it a point of pride to provide humane support for people coming through our community in need,” the organization stated.

“The work helps serve our local businesses, our City, and immigration officials to keep people off the streets and give them a shelter while they come through our community,” it added.

Jane J. Pruet and Ryan Morgan contributed to this report.

https://www.zerohedge.com/political/texas-ag-appeals-ruling-nonprofit-accused-facilitating-illegal-immigration

'Biden eyes major changes to Supreme Court amid outrage over recent decisions'

 President Biden is reportedly planning to endorse major changes to the U.S. Supreme Court, including proposals for legislation to establish term limits for the justices and an enforceable ethics code, as growing outage continues following a series of controversial decisions. 

The Washington Post first reported the changes, citing two people briefed on the plans.

Biden has long resisted changes to the high court, but his supporters have continued to call for reform following ethics scandals surrounding Justice Clarence Thomas and decisions by the court majority on issues including abortion and federal regulatory powers.

President Biden has been dealt several setbacks by the Supreme Court, including with respect to his student loan handout plan. Biden is set to announce support for major changes to the U.S. Supreme Court. (Alex Wong/Getty Images)

"I’m going to need your help on the Supreme Court, because I’m about to come out — I don’t want to prematurely announce it — but I’m about to come out with a major initiative on limiting the court … I’ve been working with constitutional scholars for the last three months, and I need some help," Biden said, according to a transcript of a call obtained by The Washington Post.

Many of the changes would need congressional approval. The Post also reported that Biden was weighing whether to call for a constitutional amendment to eliminate broad immunity for presidents and other constitutional officeholders.

Days after Biden debated former President Trump last month, the high court ruled that Trump was immune from prosecution for official acts during his first term in office.

Justices of the U.S. Supreme Court in the House Chamber for a State of the Union address at the Capitol in Washington, D.C., on March 7, 2024. (Julia Nikhinson/Bloomberg via Getty Images)

"This decision today has continued the court’s attack in recent years on a wide range of long-established legal principles in our nation, from gutting voting rights and civil rights to taking away a woman’s right to choose, to today’s decision that undermines the rule of law of this nation," Biden said in public remarks later that day.

https://www.foxnews.com/politics/biden-announce-support-major-changes-supreme-court-outrage-recent-decisions-report

UnitedHealth sticks to 2024 outlook despite strong quarter

 UnitedHealth topped second-quarter forecasts but remains cautious about the year as it continues to eat costs from a massive cyberattack and deals with rising medical expenses.

The health care giant on Tuesday said it was sticking with an earnings forecast for 2024 it first laid out last fall that includes some costs from the attack earlier this year on its Change Healthcare business.

Hackers gained access in February to Change’s system and unleashed a ransomware attack that encrypted and froze large parts of it. Change provides technology used to submit insurance claims, and the attack disrupted payments and claims processing around country.

UnitedHealth booked $1.1 billion in total costs from the cyberattack in the second quarter.

The company said it has restored most of the Change services affected by the attack. Estimated direct costs for its response to the attack have climbed as it started notifying customers who were affected and continued to provide financial support to care providers.

The company says it has provided more than $9 billion in advance funding and no-interest loans.

UnitedHealth provides health insurance for more than 49 million people in the United States. Its Optum segment also provides care, runs one of the nation’s largest pharmacy benefits management businesses and offers technology services.

In the second quarter, UnitedHealth’s net income slumped 23% to $4.22 billion. It reported adjusted earnings of $6.80 per share on $98.85 billion in total revenue.

Analysts expected earnings of $6.66 per share on $98.73 billion in revenue, according to FactSet.

Medical costs, the company’s largest expense, climbed more than 8% to $65.46 billion in the quarter.

UnitedHealth’s U.S. medical enrollment climbed 3% in the quarter even as it lost nearly a million customers with Medicaid coverage over the past year. Enrollment in the government-funded program for people with low incomes has fallen nationally as states redetermine eligibility after a pause during the COVID-19 pandemic.

Company executives told analysts on Tuesday that they expect Medicaid enrollment to stabilize in the year’s second half.

For the full year, UnitedHealth said it still projects adjusted earnings between $27.50 and $28 per share. UnitedHealth typically raises its initial forecast at least once this far into the year.

That outlook includes estimated business disruption costs like lost revenue of between 60 cents and 70 cents per share from the cyberattack.

UnitedHealth Group Inc. stock climbed more than 5% to $543.49 Tuesday while the Dow Jones Industrial Average climbed about 1%. UnitedHealth is a Dow component.

https://apnews.com/article/unitedhealth-change-healthcare-medicare-advantage-2f998375043dc810f4037454f0881e9a

'Palliative care is underutilized in nursing homes, says study'

 Palliative care, specialized medical care focusing on providing relief from the symptoms—including pain—and the stress of serious illness, is underutilized in nursing homes, despite the large number of nursing home residents living with a serious illness such as cancer, dementia, Parkinson's disease, heart failure or chronic obstructive pulmonary disease.

A qualitative study, published in the Journal of the American Geriatrics Society, analyzes lack of palliative care referrals for nursing home residents and proposes ways to address this health care gap. In addition to examining existing referral patterns, the authors explore recommendations for ideal criteria and create a substantive framework for palliative care referrals in nursing homes.

Palliative care is not the same as, nor is it limited to, hospice care. Palliative care, a broader term, can be delivered to anyone with serious illness, often along with other therapies and treatments.

Depending on the needs of the nursing home resident, one palliative care consultation may be all that is needed to review medications to establish a plan of care. Other residents who have ongoing symptom-management needs or who experience multiple changes in status, may need ongoing palliative care support.

"People in nursing homes may receive care there for years. They often have serious and advanced medical illnesses and have the need for the symptom management and supportive care that palliative care provides. Many nursing home residents with advanced disease, particularly those with advanced dementia, have goals of care consistent with comfort care," said study co-author and Regenstrief Institute Research Scientist Kathleen Unroe, M.D., MHA.

"While it is typically available in hospital and cancer center settings, unfortunately, palliative care is not consistently and widely available in every nursing home in the United States. It really depends on where you live. Non-hospice palliative care in nursing homes is hard to come by," she added. Dr. Unroe is also an associate professor of medicine at the Indiana University School of Medicine—Indianapolis.

"Primary care providers, which I am in the nursing home setting, can do a lot in terms of supportive care. There are some cases, however, where we need palliative care consultants to support us to provide specialized palliative care," Dr. Unroe noted.

"Despite documented unmet needs for palliative care in nursing homes, we struggle to deliver these services. It is, however, happening in some markets and some facilities. The goal of this study was to interview people who are doing this work, learning how they're doing it, so that we can create a best practice model and help define what the standard of care should be."

To expand palliative care utilization in nursing homes, the research team indicates it is imperative that staff members be aware of the significance of palliative care and that they also be equipped with tools to identify when this care is needed,

Laying the foundation for the development of evidence-based referral criteria, the researchers propose the exploration of five domains or themes for identification of nursing home residents with unmet palliative care needs:

• goals of care support
• uncontrolled symptoms
• serious illness
• global indicators of decline
• end of life

"We need to keep figuring out creative solutions for frontline staff and primary care providers to have palliative care training so that we can meet many of the care needs of residents. We also need to have systematic processes to identify who needs a higher level, more specialized palliative care," added Dr. Unroe.

"If you or a loved one transitions into a nursing facility, it is absolutely appropriate to ask what they do for palliative care in that facility. Even if you or your loved one do not need those services today, you may in the future, and it's good to know the resources that are available."

The research team continues to evaluate current practice and to develop and test new evidence-based best practice tools and models of care with the goal of creating and applying scalable models to disseminate palliative care practice in nursing homes.

"Our study highlights the need for the implementation of standardized referral criteria to ensure equitable access to palliative care in nursing homes," said Connie S. Cole, Ph.D., DNP, of the University of Colorado, the study's lead author. "Providing important education about palliative care allows residents and families to make informed decisions regarding their care preferences."

More information: Connie S. Cole et al, Palliative care in nursing homes: A qualitative study on referral criteria and implications for research and practice, Journal of the American Geriatrics Society (2024). DOI: 10.1111/jgs.18938

https://medicalxpress.com/news/2024-07-palliative-underutilized-nursing-homes.html

Repurposed CF drug improves outcomes for patients with severe COVID-19 pneumonia

 A drug commonly used to treat cystic fibrosis improved outcomes for patients with severe COVID-19 pneumonia and could be used to treat other respiratory infections, according to clinical trial results from researchers at UCL, UCLH and the Francis Crick Institute.

The study, published in eLife, found that the drug dornase alfa reduced hyper-inflammation in COVID-19 pneumonia patients, which occurs when the body's immune system reacts too strongly and can lead to tissue damage and death.

The next step will be to conduct larger clinical trials, with the ultimate goal of approving dornase alfa for wider use. As well as COVID-19, dornase alfa has the potential to treat other respiratory infections such as those caused by influenza or bacterial pneumonia, and even other lung diseases such as pulmonary fibrosis.

Since the beginning of the COVID-19 pandemic, the proportion of SARS-CoV-2 infections that result in death has fallen from a high of almost 1,400 deaths on 19 January 2021 to 143 deaths on 21 June 2024. This is partly down to increased immunity from prior infection or vaccination, as well as improved treatments for those who become seriously ill such as dexamethasone, a steroid that helps to tackle the hyper-inflammation that was a key factor in many COVID-19 deaths. But this treatment isn't suitable for some patients and is not always successful in severe cases.

In this study, researchers from UCL, UCLH and the Francis Crick Institute set out to assess whether dornase alfa could be used to improve outcomes for patients admitted to hospital with severe COVID-19 pneumonia who required oxygen.

Out of a total of 39 participants, 30 were randomized to receive twice-daily treatment with nebulized dornase alfa in addition to best available care (BAC) which included dexamethasone, with nine patients randomized to BAC only.

Patients treated with dornase alfa had a 33% reduction in systemic inflammation on top of the reduction provided by dexamethasone, as measured by C-reactive protein (CRP) levels in the blood over seven days or until they were discharged from hospital.

Dr. Venizelos Papayannopoulos, senior author of the study from the Francis Crick Institute, said, "Dexamethasone has been highly successful in treating patients with severe COVID-19 pneumonia and is now standard care in the UK. But it isn't suitable for some patients, such as those with diabetes, those that do not require oxygen, and in very severe cases it may not be enough. Dornase alfa can be used to treat a wider variety of patients and gets right to the heart of the inflammatory response. Based on these results, we think it will be a valuable tool for tackling severe COVID-19 illness."

Patients treated with dornase alfa were also more likely to need less oxygen and be discharged sooner compared to patients who received BAC. These additional benefits could help to free up beds and resources in the UK's busy hospitals.

The next step will be to conduct larger clinical trials to ensure dornase alfa is safe and effective for treating severe COVID-19 pneumonia. There is also potential for the drug to be trialed for other respiratory infections and conditions, such as acute exacerbations of pulmonary fibrosis, where inflammation of already scarred lung tissue affects how well oxygen can be absorbed.

Professor Joanna Porter, first author of the study from UCL Medicine and UCLH, said, "Given that we observed a significant further reduction in C-reactive protein in patients who were already receiving dexamethasone, which also reduces inflammation, this trial is proof-of-concept that dornase alfa can be used to treat severe COVID-19 pneumonia. If we can help patients recover more quickly and get home sooner, this would be great for them and also help to reduce pressure on the NHS.

"I'm optimistic that dornase alfa will have applications for treating other respiratory infections, and acute exacerbations of other chronic lung diseases, such as pulmonary fibrosis, that may share mechanisms with severe COVID-19."

Catriona Crombie, Associate Director of Technology Transfer and Philanthropic Fund at LifeArc, said, "We were delighted to support this study that has demonstrated how repurposing of a treatment commonly used for cystic fibrosis can be effective in improving outcomes for patients with severe COVID-19. LifeArc is committed to helping take scientific ideas out of the lab and into medical breakthroughs for patients, especially where there is an unmet medical need. To date, we have provided more than £27 million to fund the search for new medicines and diagnostics to address COVID-19."

More information: Joanna C. Porter et al, Anti-inflammatory therapy with nebulised dornase alfa in patients with severe COVID-19 pneumonia A Randomised Clinical Trial, eLife (2023). DOI: 10.7554/eLife.87030.1

https://medicalxpress.com/news/2024-07-clinical-trial-repurposed-drug-outcomes.html

Supplements slow disease progression in late stage 'dry' age-related macular degeneration

 In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision.

Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.

"We've known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD," said Tiarnan Keenan, M.D., Ph.D., of NIH's National Eye Institute (NEI) and lead author of the study. "These findings support the continued use of AREDS2 supplements by people with late dry AMD."

In their new analysis, the researchers reviewed the original retinal scans of participants in the AREDS (total 318 participants, 392 eyes) and AREDS2 (total 891 participants, 1,210 eyes) trials who developed dry AMD, calculating the position and expansion rate of their regions of geographic atrophy.

For those people who developed geographic atrophy in their central vision, the supplements had little benefit. But for the majority who developed geographic atrophy far from the fovea, the supplements slowed the rate of expansion towards the fovea by approximately 55% over an average of three years.

n early and intermediate AMD, the light-sensing retina at the back of the eye develops small yellow deposits of fatty proteins called drusen. When the disease progresses to the late stage, people can develop leaky blood vessels ("wet" AMD) or can lose regions of light-sensitive cells in the retina ("dry" AMD). The geographic atrophy in these regions slowly expands over time, causing people to progressively lose their central vision.

The original AREDS trial found that a supplement formula containing antioxidants (vitamin C, E, and beta-carotene), along with zinc and copper, could slow progression of intermediate to late-stage AMD. The subsequent AREDS2 trial found that substituting the antioxidants lutein and zeaxanthin for beta-carotene improved the efficacy of the supplement formula and eliminated certain risks. At the time, neither trial detected any further benefit once participants had developed late-stage disease.

However, that original analysis did not account for a phenomenon in the dry form of late AMD called "foveal sparing." While all regions of the retina are sensitive to light, the region that gives us the highest acuity central vision is called the fovea. Many people with dry AMD first develop geographic atrophy outside this foveal region, and they only lose their central vision when the geographic atrophy regions expand into the foveal area.

"Our high acuity central vision is essential for tasks like reading and driving. Given that there are few therapeutic options for people with late-stage dry AMD to retain or restore their vision, antioxidant supplementation is a simple step that may slow central vision loss, even for those with late disease," Keenan said. "We plan to confirm these findings in a dedicated clinical trial in the near future."

More information: Tiarnan Keenan et al, Oral antioxidant and lutein/zeaxanthin supplements slow geographic atrophy progression to the fovea in age-related macular degeneration, Ophthalmology (2024). DOI: 10.1016/j.ophtha.2024.07.014. www.aaojournal.org/article/S01 … (24)00425-1/abstract

https://medicalxpress.com/news/2024-07-supplements-disease-late-stage-dry.html