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Friday, February 24, 2023

TG Presents on Phase 3 Trials of BRIUMVI™ (ublituximab-xiiy) in Multiple Sclerosis

 TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI™ (ublituximab-xiiy) in adult patients with relapsing forms of multiple sclerosis (RMS), presented at the 2023 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum. Links to each of the presentations are included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to share additional exploratory analyses from the ULTIMATE I & II Phase 3 trials at the ACTRIMS conference this week. We believe these data further support the unique attributes of BRIUMVI which is now commercially available, and we look forward to continuing to share additional analyses throughout the year.”

PRESENTATIONS
Poster Presentation: Early, Transient Shift in Hematologic Parameters Observed with Ublituximab in the ULTIMATE I and II Phase 3 Studies

  • Lead Author: Peiqing Qian, MD, Swedish Neuroscience Institute, Seattle, WA

Poster Presentation: Onset and Maintenance of No Evidence of Disease Activity with Ublituximab: Analyses of the Phase 3 ULTIMATE I and II Studies in Participants with Relapsing Multiple Sclerosis

  • Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

The above presentations are also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

https://finance.yahoo.com/news/tg-therapeutics-announces-presentation-data-120000592.html

Moderna cut to Underperform from Market Perform by SVB

 Target to $93 from $111

https://finviz.com/quote.ashx?t=MRNA&p=d

Childhood obesity is surging: What to know about rising rates, and efforts to curb

 Rates of childhood obesity in the United States have tripled in the past three decades, and early data suggest already surging rates were further exacerbated by the COVID-19 pandemic. 

Experts and advocates warn this could have significant long-term impacts on everything from the toll of chronic disease to military recruitment. 

To help address the crisis, the U.S. Department of Agriculture (USDA) recently updated its nutrition standards for school lunches, and the American Academy of Pediatrics issued new guidelines for treating childhood obesity — its first updated comprehensive guidance on the subject in 15 years.

However, as more children gain weight at younger ages, and racial and economic disparities persist, more action may be needed to prevent rates from rising even further. And experts stress that efforts to treat obesity in children should also take mental health into account to avoid worsening another concern: the risk of developing eating disorders.

What’s causing rates to rise

The Centers for Disease Control and Prevention (CDC) defines childhood obesity as a body mass index (BMI) at or above the 95th percentile. Although BMI, which measures overall weight and not body fat specifically, is an imperfect metric, it is widely used to diagnose obesity. 

In the early 1960s around 5 percent of U.S. children and teens were obese. By 2019, that total rose to 19 percent. 

Should current trends continue, some reports estimate 57 percent of children between the ages 2 and 19 will be obese as adults in 2050. 

More severe levels of obesity are also on the rise, explained Solveig Cunningham, an associate professor of global health at Emory University’s Rollins School of Public health. 

“The average child with obesity is heavier than he or she would have been even 12 years ago,” Cunningham told Changing America. 

The increase seems to have picked up still more momentum in the last three years: Although researchers are still working to get a full picture of the impact of COVID-19 on childhood obesity, some data suggest the rate of BMI increase nearly doubled during the pandemic compared with the period preceding it. The increase was most pronounced among younger children, and those who were already obese or overweight.

There’s no one reason why rates are climbing.

“[Obesity] is a complex, chronic medical condition. There’s lots of factors that are playing a role,” said Crystal Lim, a pediatric psychologist and associate professor at the University of Missouri. 

Researchers have tied an increased risk of childhood obesity to a wide range of factors, from structural racism to a rise in sedentary lifestyles. 

And the COVID-19 pandemic supercharged some of the issues that led to high childhood obesity rates in the first place, explained Erica Kenney, assistant professor of public health nutrition at Harvard’s T.H. Chan School of Public Health.

School closures meant more children were stuck at home, engaging in more sedentary behavior. “A lot of parents, myself included, had to turn to more screen time than they probably would have under normal circumstances,” said Kenney. 

Even high levels of physical activity do not offset obesity risk among youth who spend eight or more hours a day looking at screens, research shows. 

The rise in screen use could have also exposed children to more food advertising, “which we know is associated with extra weight gain in kids and consumption of ultra processed foods and sugary drinks,” Kenney said. 

It’s estimated four in every 10 child-influencer videos on YouTube contain branded food or beverages, with candy brands appearing the most often. 

Additionally, for children who received free or reduced-price meals at school, the transition to a virtual setting could have worsened cost or access barriers to healthy food, explained Lim, the pediatric psychologist. A lack of access to food on a consistent basis is associated with an increased risk of becoming overweight and obese, she added. 

Where a child grows up, household income and structural racism contribute to obesity risk as well.

Childhood obesity tends to be more prevalent in rural and underserved areas of the country with limited access to affordable, healthy food. 

“A lot of families I’ve worked with in rural areas are concerned about kids being more active outside,” said Lim. “There’s no sidewalks, it’s dark. It’s not as safe, maybe, for kids to be active outside.”

Hispanic and Black youth have higher rates of obesity compared with white youth. Although the rate has somewhat plateaued for Hispanic children over the past 15 years “it has continued to go much, much higher for African American kids,” said Cunningham. 

Historic redlining influences the availability of affordable healthy food in certain neighborhoods, along with access to play areas and greenspace for physical activity. 

Genetic and biological factors, like whether a mother has gestational diabetes, can also increase the risk of obesity before a child is born. 

“People who have obesity and diabetes are at higher risk of having children who will also have earlier onset of obesity and diabetes,” explained Cunningham. 

The health toll of obesity 

Obesity raises the risk of diabetes, cardiovascular disease, sleep apnea, certain cancers and other physical and mental health conditions.

The rise in severe levels of obesity means more kids are shifting into areas with “much, much higher risks, especially of diabetes and cardiovascular disease,” said Cunningham.

Earlier development of obesity means longer exposure to its consequences and increased risks of developing other co-morbidities, she added.

And as more people suffer from chronic diseases as a result of high obesity rates, that rise could in turn also rack up health care costs and increase stress on an already strained health care system.

Should the nation fail to adequately address the rise, one of the big concerns from a policy standpoint is that there will be uncontrolled health care costs as a result, Kenney explained. 

It’s estimated obesity already costs the nation’s health system around $173 billion annually

Impact on military readiness 

In addition to costs and disease burden, advocates are raising alarms about the crisis’s impact on the military. 

More than three-quarters of young American adults cannot currently qualify for military service without a waiver. Eleven percent of these individuals are disqualified from serving if they so choose due to being overweight, and it is also a factor for 44 percent who are disqualified for multiple reasons, data from the Pentagon’s 2020 Qualified Military Available Study show. 

According to the CDC, just 2 in 5 young adults meet weight eligibility requirements and are adequately active to prepare themselves for basic training. 

Last year the U.S. Army missed its recruitment goal by 15,000 soldiers thanks to disqualifiers like drug use, mental health and obesity. 

“Physical health challenges, including obesity, prevent far too many young Americans from reaching their dreams. For many young people, those dreams include serving their country in uniform,” said Lt. Gen. Norm Seip, U.S. Air Force, retired, in a Mission: Readiness statement on the Pentagon’s findings. 

The organization, part of the Council for a Strong America, is made up of retired admirals, generals and military leaders advocating for public policy solutions to strengthen national security by investing in the nation’s youth. 

“Investments that bolster the health and nutrition of our children are critical to national security and the future strength of our country,” Seip said. 

Updated nutrition standards

Just as there are many factors that contribute to obesity, experts say a number of different actions will be needed to combat the rising rates.

“We need prevention and treatment at multiple levels,” said Lim.

Cutting back on added sugar, especially the intake of sugary drinks, can make a big difference, experts say. 

A new report from the CDC found that in 2021, more than 30 percent of children did not eat a piece of fruit each day during the preceding week and nearly half did not eat a vegetable daily. However, 57 percent reported drinking a sugar-sweetened beverage at least once during the previous week. 

The latest USDA standards target added sugars and sodium in school lunches, and recommend more whole grains. Boosts in nutrition standards for school lunches have been shown to help curb the rise in obesity among children. 

The standards are “a good step from a policy and implementation standpoint, in terms of increasing access to healthier foods for kids,” said Lim. 

But when it comes to federal policies “the way that they’re implemented in the school setting is really variable and really dependent on resources,” she added.

“I think these policies are important. We also just need to be mindful that they need to have funding tied to them as well, especially for under-resourced settings.” 

New treatment guidelines and mental health concerns

In addressing the rising rates, experts say it’s crucial that intervention and prevention programs take children’s mental health into account to help address the stigma around obesity and to more holistically treat the condition.

The new American Academy of Pediatrics guidelines have raised concerns on that score.

The guidelines recommend moving away from a “watch and wait” strategy for children with obesity and say state providers can consider medication interventions for youth as young as 12 and surgery for those as young as 13 in certain cases.

The guidelines have been met with some criticism, as some are concerned they could increase the risk of eating disorders among children. Individuals with higher weights are already at a greater risk of developing eating disorders. 

Explicit focus on weight could also perpetuate stigma around obesity and increase body dissatisfaction among vulnerable youth.

“There’s so much stigma related to overweight and obesity. It’s the number one reason kids are teased and bullied in schools,” said Lim. 

“But they also experience weight stigma in the health care setting and in their own families, by family members. So helping everybody be more sensitive and aware is so important.” 

When it comes to treating children with intensive pharmacological interventions or surgery, “having it paired with mental health support is going to be really important,” said Kenney. 

However, interventions that encourage healthy behaviors for their own sake could improve children’s physical health without focusing on weight loss, experts say.

Healthy nutrition and physical activity are good for everybody, said Kenney. “It isn’t just about weight when you want to eat healthfully or be physically active. It’s about your overall health and well being.” 

Increasing exposure to healthy food options at school can play a big role, while parents and teachers can also model healthy behaviors for children. 

These can include being more positive about their own bodies and asking children what they like about their body. 

“We spend a lot of time talking about things we don’t like or things we want to change [about our bodies],” Lim said. “Helping even parents model [positive behaviors] for their kids is really important.” 

Addressing root causes

The myriad of determinants for childhood obesity creates an opportunity to address root causes that could have meaningful impacts in the future at the population level. 

From a public health perspective, tackling easy access to cheap, ultra-processed food, the lack of physical activity opportunities for kids and overall food insecurity resulting from household income disparities is crucial on a societal level, said Kenney. 

“We should be addressing some of these root causes, so that down the line, everybody can be healthier,” she said. 

https://thehill.com/changing-america/well-being/prevention-cures/3871475-childhood-obesity-is-surging-what-to-know-about-rising-rates-and-efforts-to-curb-them/

Flu experts gather with H5N1 risk on the agenda

 The world's leading experts on influenza met this week to discuss the threat posed to humans by a strain of H5N1 avian flu that has caused record numbers of bird deaths around the world in recent months.

The group of scientists, regulators and vaccine manufacturers meets twice a year to decide which strain of seasonal flu to include in the vaccine for the upcoming winter season, in this case for the northern hemisphere.

But it is also a chance to discuss the risk of animal viruses spilling over to humans and causing a pandemic. At this week's meeting, H5N1 clade 2.3.4.4b was a key topic, the World Health Organization (WHO) and global flu experts told Reuters. They will brief reporters on both the seasonal flu vaccine composition and spillover risks later on Friday.

"We are more prepared (than for COVID), but even if we are more prepared, we are not yet prepared enough," Sylvie Briand, WHO director of global infectious hazard preparedness, said ahead of the meeting. "We need to really continue the efforts for a flu pandemic."

Experts have been tracking H5N1 clade 2.3.4.4b since it emerged in 2020, but recent reports of mass deaths in infected mammals from seals to bears, as well as potential mammal-to-mammal transmission on a Spanish mink farm last year, have raised concern.

However, there have been very few human cases, and the WHO currently assesses the threat to humans as low.

"This is a natural experiment playing out in front of us, and I don't think we are complacent," said Nicola Lewis, director of the WHO Collaborating Centre on Influenza at the Crick Institute in London. Speaking before the meeting, she said it would include assessments of the situation worldwide.

Experts also discussed potential vaccine development.

WHO-affiliated labs already hold two flu virus strains that are closely related to the circulating H5N1 virus, which could be used by vaccine manufacturers to create a human vaccine if needed. One of them was added after the previous WHO flu meeting in September 2022, and labs around the world are currently testing how closely both subtypes match the strain spreading among animals to determine whether any more updates are necessary.

A number of companies that produce seasonal flu vaccines can also make pandemic flu vaccines. For example, GSK and CSL Seqirus are already working with the United States Biomedical Advanced Research and Development Authority (BARDA) to test shots based on one of the closely-related strains.

Having these strains ready could save around two months in the development of a vaccine, said the WHO's Briand. But getting enough vaccine developed quickly would still remain a challenge in a pandemic situation, the experts said.

https://www.yahoo.com/now/flu-experts-gather-h5n1-risk-060000461.html

Moderna target cut by Morgan Stanley

 Moderna: Morgan Stanley lowers PT to $185 from $205. Maintains equal-weight rating.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/

CMS accused of discrimination over Alzheimer’s drug verdict

 The US Centers for Medicare and Medicaid Services (CMS) has rejected broader coverage of new amyloid-targeting Alzheimer’s disease treatments, a decision branded “pernicious” by patient organisation the Global Alzheimer’s Foundation (GAP).

The CMS was responding to a request by the Alzheimer’s Association to reconsider its national coverage determination (NCD) for FDA-approved antibodies targeting amyloid – i.e. Biogen and Eisai’s Aduhelm (aducanumab) and Leqembi (lecanemab) – which effectively restricts their use to clinical trials.

“We recognise that these medications are a unique, new class of drugs, and we regret that the decision could not be more favourable,” said the CMS in a statement, in which it confirmed it would not be revisiting the NCD for the time being.

Both Aduhelm and Leqembi have been granted accelerated approval by the regulator, and Leqembi has also been filed for full approval, with a decision due later this year - potentially as early as the summer.

Even if that outcome is positive, however, CMS currently recommends that reimbursement coverage would still be limited to use within real-world, registry-based studies, rather than allowing unrestricted access.

“After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration,” said the CMS.

However, it will “expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCD.”

The Alzheimer’s Association said the decision was “unjust”, given “significant new evidence” published since it first drew up the NCD in the wake of the chaotic approval and launch of Aduhelm last year.

“CMS’ role is to provide health care coverage,” it continued. “Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate.”

It said that, for each day CMS leaves the policy in place, more than 2,000 people aged 65 or older may transition from mild dementia due to Alzheimer’s to a more advanced stage of the disease.

The GAP has slammed the CMS in even more strident tones, saying it has “outrageously discriminated against 1.2 million Americans with Alzheimer’s who can benefit from a class of disease-modifying therapies that can help extend their life, memory, and independence.”

“This decision continues the agency’s unprecedented and pernicious actions against the Alzheimer’s community, which take treatment options – and hope – away from people with this heinous disease,” added the organisation.

In the absence of Medicare coverage, Eisai is limited to providing Leqembi – which launched at a price of $26,500 per year – to patients who can pay for treatment out-of-pocket or are eligible for its patient assistance programme. It recorded its first sales of the drug last month.

https://pharmaphorum.com/news/cms-accused-discrimination-over-alzheimers-drug-verdict

US Black Hawk Helicopter Appears In Use By Ukraine's Military Intelligence

 by Kyle Anzalone & Will Porter via The Libertarian Institute, 

Ukraine’s military intelligence agency has shared photos of a Black Hawk helicopter. The American-made aircraft was painted with a Ukrainian flag, and the intel org suggested it was used in military operations

Two photos showing a Black Hawk were posted on the Twitter account and website of Ukraine’s Main Directorate of Intelligence on Tuesday. A press release accompanying the images said the agency had recently completed military missions.

"Military intelligence aviation of Ukraine continues its work on the front line of the defense of our country. Reconnaissance pilots have just returned from another combat mission," it said, adding that "Combat helicopters significantly increase the capabilities of the special units of the Main Directorate of Intelligence and the effectiveness of special operations."

Another aircraft seen in the photos was identified by the Drive as a Ukrainian Mi-24 Hind.

It is unclear how Kiev obtained the American helicopter or whether it has been used in combat operations. Officially, the White House has approved sending Soviet-era Mi-17 Helicopters – aircraft formerly owned by the Afghan government prior to its collapse in 2021 – though it has made no mention of Black Hawks to date

In June, the assault and reconnaissance wing of the Intelligence Directorate, known as the 'Shaman battalion,' claimed to have carried out operations inside Russian territory, according to the Times of London. The outlet said the commandos were flown into the country via helicopter, but did not specify what type.

Despite repeated demands from Kiev, President Joe Biden has resisted sending long-range weapons over concerns they could be used for attacks on Russian soil.

However, the White House has nonetheless authorized increasingly heavy arms shipments, including the ground-launched small-diameter bomb (GLSDB), which can strike targets more than 90 miles away, as well as dozens of advanced HIMARS multi-launch rocket platforms, a Patriot missile battery and a number of other systems.

https://www.zerohedge.com/military/us-black-hawk-helicopter-appears-use-ukraines-military-intelligence