Search This Blog

Tuesday, October 31, 2023

Centene corp: Bernstein raises the target price from USD 90 to USD 95.

  maintains its outperform rating

https://www.marketscreener.com/quote/stock/CENTENE-CORPORATION-55763517/

A Speaker Unafraid

 Virtually all of the news coverage about the health care positions of newly elected Speaker Mike Johnson have focused on his evangelical advocacy for pro-life, pro-family, and religious liberty principles.

Those are very important but not the whole story.  Speaker Johnson served as the chair of the Republican Study Committee, the largest Republican caucus in the House, where he showed his stripes as a policy wonk who is not afraid to tackle health policy.

He chaired the RSC for two years, starting in 2019 when Republicans were in the minority. The Health Care Task Force, under his leadership, developed policy guidelines that set the stage for many of the health reform bills that are making their way through the House this year.

Chairing the RSC is good training for the speakership because it means getting well over 100 very opinionated members with divergent ideas to agree on a single package of policy recommendations.

The 57-page “Framework for Personalized, Affordable Care” developed under Mr. Johnson’s tenure focused on policies to “protect vulnerable Americans – including those with pre-existing conditions, chronic illness, and serious health issues – while reducing premiums, deductibles, and overall health care costs.”

The Health Policy Consensus Group also provided input to the RSC’s Health Care Task Force, and many of the policy initiatives in the RSC’s framework also are in our group’s Health Care Choices plan. The Consensus Group’s plan also had nearly 100 signatories from leaders in the market-based health policy community.  This is further evidence of the convergence on health policy reforms in the market-based policy community.

A few examples of the common goals:

  1. Loosen federal shackles so states can develop creative risk-sharing models that target better care to the most vulnerable, especially poor pregnant women, children, the elderly, and the disabled
  2. Redirect existing resources and give states more flexibility to reform their individual health insurance markets to provide better coverage options, lowering health insurance costs and expanding coverage
  3. Expand health insurance portability with stronger coverage protections
  4. Expand and improve Health Savings Accounts
  5. Allow consumers to share in savings if they choose lower cost care
  6. Expand access to innovative care arrangements, including direct primary care, health sharing ministries, association health plans, telemedicine, and short-term plans
  7. Provide incentives for states to end anti-competitive practices such as certificate of need laws that drive up prices and reduce consumer choices.

And much more.

The new speaker is facing many challenges, including a Nov.17 government funding deadline, but his past work on health policy gives us renewed hope for action to come on an issue, especially soaring health costs, that will be a top concern of voters in 2024.

Ms. Turner runs the Galen Institute, dedicated public policy initiatives that put doctors and patients at the center of our health sector.  She can be reached at gracemarie@galen.org

https://www.realclearpolicy.com/articles/2023/10/30/a_speaker_unafraid_989363.html

Archives locates 82,000 pages of Joe Biden pseudonym emails, possibly dwarfing Clinton scandal

 Under legal pressure, the National Archives has located 82,000 pages of emails that President Joe Biden sent or received during his vice presidential tenure on three private pseudonym accounts, a total that potentially dwarfs the amount that landed Hillary Clinton in hot water a decade ago, according to a federal court filing released Monday.

The total of Biden private email exchanges was disclosed Monday in a little-noticed status report filed in a Freedom of Information Act lawsuit brought against the National Archives and Records Administration by the nonprofit public interest law firm the Southeastern Legal Foundation.

The foundation brought the lawsuit seeking access to the emails after Just the News revealed a year ago that Joe Biden had used three pseudonym email accounts -- robinware456@gmail.com, JRBWare@gmail.com, and Robert.L.Peters@pci.gov – during the time he served as President Barack Obama’s vice president.

The status report filed Monday in a federal court in Atlanta was the first to provide an estimate of the size and scope of possible government business conducted through Joe Biden’s private email accounts.

“NARA has completed a search for potentially responsive documents and is currently processing those documents for the purpose of producing non-exempt portions of any responsive records on a monthly rolling basis,” the status report stated. “Given the scope of Plaintiff’s FOIA request, which seeks copies of all emails in three separate accounts over an eight-year period, the volume of potentially responsive records is necessarily large.

“NARA has identified approximately 82,000 pages of potentially responsive documents, and it is currently processing those documents and preparing any non-exempt responsive documents for production on a rolling basis,” the filing added.

You can read the full court filing here.

The court filing added that the foundation and NARA are discussing ways to narrow the request for records to get copies of the emails out in a more expeditious manner.

Government officials' use of private email for official business is discouraged under the law, and officials like Biden are required to preserve all government-related emails conducted on their private accounts under the Federal Records Act. The fact that NARA has such a large collection suggests Biden gave those emails to the nation’s history-preserving agency.

The total revealed by the Archives, however, is stunning in size, even dwarfing the total from the most infamous private email scandal in American history involving former Secretary of State Hillary Clinton, which also involved government business on Obama’s watch.

A State Department inspector general report in summer 2016 found Mrs. Clinton improperly used a private email server stored in her family’s home in Chappaqua, N.Y., to regularly conduct government business and later deleted many of the emails she considered to be private.

“Secretary Clinton produced to the Department from her personal email account approximately 55,000 hard-copy pages, representing approximately 30,000 emails that she believed related to official business,” the final report noted. Those totals are significantly smaller than the amount of pages the National Archives says it has from Biden’s personal account.

The IG noted there was a lax record-keeping system at State and across government that needed modernizing and impacted several prior secretaries.

You can read that full report here.

Internal investigations concluded that about 100 emails Clinton moved through her private server contained information that should have been deemed classified at the time they were sent, including 65 emails at the "Secret" level and 22 at "Top Secret" security clearance.

Eventually, the government recovered even Mrs. Clinton's personal emails that had been deleted and released all of them under FOIA, totaling about 52,000.

To date, there is no indication from the National Archives in the court case that any of Biden’s email contain classified information. However, the president is under criminal investigation by Special Counsel Robert Hur for taking classified documents from his time as vice president and as a senator and storing them improperly in insecure locations in the garage of his Delaware home and a think tank office he kept in Washington D.C.

Hur recently spent two days interview Biden in that investigation.

Former President Donald Trump has already been indicted by Special Counsel Jack Smith for mishandling classified documents the FBI recovered from his Mar-a-Lago estate in Florida or that Trump returned to the Archives belatedly.

https://justthenews.com/accountability/political-ethics/archives-locates-82000-pages-joe-biden-pseudonym-emails-possibly

T cell discovery offers hope to treat and reverse osteoarthritis

 Current osteoarthritis treatment manages symptoms rather than addressing the underlying disease, but a new University of Adelaide study has shown the condition may be treatable and reversible. The research is published in the journal Nature Communications.

Osteoarthritis is the degeneration of  and other tissues in joints and is the most common form of arthritis in Australia, with one in five people over the age of 45 having the condition.

It is a long-term and progressive condition which affects people's mobility and has historically had no cure. Its treatment cost the Australian health system an estimated $3.9 billion in 2019-20.

Often described as a 'wear and tear' condition, factors such as aging, obesity, injury and  contribute to the progression of .

University of Adelaide researchers discovered a novel population of stem cells—marked by the Gremlin 1 gene—responsible for the progression of osteoarthritis.

Treatment with fibroblast growth factor 18 (FGF18) stimulated the proliferation of Gremlin 1 cells in  in mice, leading to significant recovery of cartilage thickness and reduced osteoarthritis.

Gremlin 1 cells present opportunities for cartilage regeneration and their discovery will have relevance to other forms of cartilage injury and disease, which are notoriously challenging to repair and treat.

It challenges the categorization of osteoarthritis as wear and tear.

"The findings of our study reimagine osteoarthritis not as a 'wear and tear' condition but as an active, and pharmaceutically reversible loss of critical articular cartilage stem cells," said the University of Adelaide's Dr. Jia Ng from the Adelaide Medical School, who co-led the study.

"With this new information, we are now able to explore pharmaceutical options to directly target the stem cell population that is responsible for the development of articular cartilage and progression of osteoarthritis."

While Dr. Ng describes current treatments for osteoarthritis as a "Band-Aid approach", this new understanding could lead to a pharmaceutical treatment that reverses osteoarthritis and helps to address health outcomes associated with the disease.

"Known comorbidities of osteoarthritis include heart, pulmonary, and , mental and behavioral conditions, diabetes, and cancer," said Dr. Ng.

"Our study suggests that there may be new ways to treat the disease rather than just the symptoms, leading to better health outcomes and quality of life for people who suffer from osteoarthritis."

Though this discovery is limited to animal models, Dr. Ng said there are genetic similarities to human samples, and  are ongoing.

"We look forward to the outcome of these trials and to contribute to the better understanding of a pharmaceutical mechanism to treat osteoarthritis," she said.

Results of a five-year clinical trial study using FGF18, known clinically as Sprifermin, were published in 2021 with potential long-term clinical benefit and no safety concerns.

Phase 3 of the Sprifermin trial is ongoing, and researchers envision  to this treatment soon.

More information: Jia Q. Ng et al, Loss of Grem1-lineage chondrogenic progenitor cells causes osteoarthritis, Nature Communications (2023). DOI: 10.1038/s41467-023-42199-1


https://medicalxpress.com/news/2023-10-gremlin-cells-discovery-reverse-osteoarthritis.html

'Next-gen flu B vaccines provide broad and long-lasting protection against flu viruses in preclin'

 Recent preclinical results indicate novel next-generation vaccine candidates developed at Cleveland Clinic protect against multiple strains of influenza and last longer than vaccines currently in use.

The vaccines are part of Cleveland Clinic's global  research program, led by Ted Ross, Ph.D., Global Director of Vaccine Development at Cleveland Clinic. Published in Scientific Reports, the study credits the preclinical success of the influenza B vaccines to  called Computationally Optimized Broadly Reactive Antigens (COBRAs).

Current vaccines use small, non-infectious parts of the virus or bacterium called antigens to train the  against infection. Keeping that immunity current can require yearly updates as the pathogen mutates, like for the . COBRAs are antigens designed to train the immune system's response more broadly to anticipate any changes.

"Seasonal influenza vaccines are mostly effective against pathogens with antigens matching the vaccine formulation," says study first author Michael Carlock, program manager in Dr. Ross's lab and Ph.D. student at the University of Georgia. "Viruses like to mutate constantly. If their antigens change too much, our immune system won't recognize them as the pathogen that the vaccine trained them to fight. We constantly need to update our vaccines to keep up with these new variants and mutations."

Further complicating the issue, a strain can mutate into multiple variants, and multiple strains of the same virus can break out at the same time. Vaccines made using an antigen specific to one strain or variant aren't always as effective against another.

Vaccine developers currently use a combination of statistics and  to predict what flu strains will be the most common that year. They use antigens from those strains to make their vaccines. However, often by the time vaccines are manufactured and distributed, strains can mutate and render the vaccines less effective, Carlock says.

"Between 2001 and 2012, the influenza B strain used to make the flu shot matched the main influenza B strain infecting the population about 50% of the time," he says, "The vaccines weren't as effective as they could have been. That's part of why some flu seasons are worse than others."

The COBRA technology, says Carlock, eliminates the guesswork from antigen selection to protect against multiple diverse strains of the . The technology uses public databases of sequences and bioinformatic programs to analyze hundreds of flu strains over years' worth of flu seasons. The analysis identifies conserved regions of  most likely to be present in many viral strains and least likely to mutate over time.

The computer models behind COBRA can be used in multiple viruses, including influenza, SARS-CoV-2, HIV,  (RSV) and many insect-borne viruses. Carlock and Dr. Ross say the success of their influenza B vaccine candidates serves as a proof-of-concept for COBRA as a whole.

When the influenza B COBRA vaccines were tested in preclinical models, they performed even better than expected. They protected against multiple strains of influenza B and even protected against strains between the two different lineages of influenza B. There was also evidence that the COBRA vaccines are longer-lasting than current technology.

"We used old strains isolated prior to 2013 to design these vaccines, but they protected against new strains circulating in 2023," says Carlock. "The vaccines that public health officials actually made from and used against those strains ten years ago cannot protect against modern viruses. Our COBRA vaccines provide broad, long-lasting protection against many viruses over many years."

Clinical trials are planned to test the effectiveness of COBRA-based influenza vaccines against  in humans.

"The preclinical success of these vaccines is exciting because it shows our platform's promise in addressing public health threats effectively and proactively," Dr. Ross says. "As we continue to expand Cleveland Clinic's global vaccine research, technologies like COBRA are critical to serving the communities we reach all over the world."

More information: Michael A. Carlock et al, A computationally optimized broadly reactive hemagglutinin vaccine elicits neutralizing antibodies against influenza B viruses from both lineages, Scientific Reports (2023). DOI: 10.1038/s41598-023-43003-2


https://medicalxpress.com/news/2023-10-next-generation-influenza-vaccines-broad-long-lasting.html

Tonix depression drug trial ended after endpoint miss

 The study did not achieve statistical significance on the primary endpoint

Tonix is discontinuing development of TNX-601 ER based on the efficacy results of this study

Tonix expects topline data results in December 2023 for its Phase 2 study of TNX-1900 in chronic migraine and Phase 3 study of TNX-102 SL in fibromyalgia

https://www.globenewswire.com/news-release/2023/10/31/2770686/28908/en/Tonix-Pharmaceuticals-Announces-Topline-Results-from-Phase-2-Proof-of-Concept-Study-of-TNX-601-ER-for-the-Treatment-of-Major-Depressive-Disorder.html

FDA approves Novartis Cosentyx biologic treatment option for hidradenitis suppurativa

 

  • FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21

  • As the only IL-17A inhibitor approved for HS, Cosentyx offers a meaningful new treatment option that demonstrated reductions in inflammatory nodules and abscesses, and flares2

  • HS is a chronic, progressive and often painful disease that may affect 1 in 100 people worldwide