First endocrine innovation in more than 20 years which has shown improved efficacy over standard-of-care treatments in patients with advanced breast cancer
ORSERDU is being evaluated in combination with Context’s ONA-XR in the ongoing ELONA trial
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a company developing novel treatments for solid tumors, with a primary focus on female cancers, today announced that its clinical trial collaborator, Stemline Therapeutics, Inc., a wholly owned subsidiary of The Menarini Group (“Menarini”), received approval from the U.S. Food and Drug Administration (FDA) for ORSERDU (elacestrant) for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative (HER2-), Estrogen Receptor 1 gene (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. ORSERDU has shown improved efficacy over the current standard-of-care (SOC) treatment, fulvestrant, in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the Phase 2b clinical trial evaluating MN-166 (ibudilast) for the treatment of alcohol use disorder (AUD) has completed enrollment.
This clinical trial was funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The NIAAA R01 research funding (R01AA026190) was awarded to Principal Investigator Dr. Lara Ray, PhD, ABPP, at the University of California, Los Angeles' (UCLA) Departments of Psychology, and Psychiatry and Biobehavioral Sciences Brain Research Institute. The clinical trial evaluated MN-166 (ibudilast) as a potential treatment to decrease alcohol consumption in treatment-seeking individuals diagnosed with AUD. MediciNova provided drug supply and regulatory support for the clinical trial.
New Internal Revenue Services rules could cause a sizable increase in audits and taxes on Americans, especially those using transaction services like Venmo and PayPal for fantasy sports, according to tax experts.
CPA and Tax expert attorney Bruce Willey told Fox News Digital that the new changes constituted one of the largest “cash grabs” by the IRS in recent memory and were likely to hit taxpayers “like a truck.”
“Most Americans are about to get run over, and they have no idea. If they’re not prepared for it, things could get pretty ugly for people,” he said.
The American Rescue Plan Act (ARPA) of 2021 amended a code section that decreased the minimum threshold for reporting on third-party settlement organizations (TPSOs) from $20,000 and 200 or more transactions to any transaction of $600 or more.
The code change, approved by Democrats and signed by President Biden in March 2021, will require TPSOs like Venmo, PayPal, Etsy, AirBnB and more to send 1099-k forms to the IRS and users if their transactions exceed the amount. If a sports betting application like FanDuel or DraftKings uses these payment systems, you will face taxes there, though sports betting is already included under the current tax code.
If a sports betting application like FanDuel or DraftKings uses these payment systems, you will face taxes there.Bloomberg via Getty Images
“It’s this huge fishing net that’s just going to sweep up a vast amount of people in America,” Willey said.
The code change will likely burden those engaged in sports fantasy leagues and sellers of professional sports tickets with additional obligations come tax season.
BakerHostetler Nationwide Tax Chair Jeff Paravano described a situation in which an individual sells preseason games at a loss but still gets a 1099 for gross proceeds. IRS oversight will not consider what they paid for those tickets or their losses on games and will have to provide further details,
The taxpayer may or may not have taxable income because of that reporting but could get a form for even selling one ticket, depending on the sale amount.
“Somebody that engages in a lot of fantasy sports. You can only deduct the losses to the extent of your winnings. So, you better be keeping receipts of your losses. That’s going to be a deduction for you on the money you received,” Paravano, a former Senior Adviser to the Assistant Treasury Secretary for Tax Policy, said.
Paravano said the changes were also likely to impact fantasy sports leagues with money wagers conducted by coworkers, friends and family members. He suggested the 1099 would be doled out for the gross amount and would not include the wager. Tax penalties are likely for the persons that held onto the money, who will receive a 1099 alongside the third-party payer used by the group.
“The fear is that the 1099 will be sent out for things that are not taxable income and the IRS doesn’t have the capability to easily figure that out,” he said.
Both tax experts suggested that the code changes could result in more audits and taxes for Americans or, at the very least, an increase in correspondence with the IRS.
Government leaders have repeatedly pushed back on the idea that the IRS changes would negatively impact any Americans making under $400,000.
“Legislators are being disingenuous,” Willey said. “This is one of those things where they say one thing while they are taking your campaign donation and then they turn around and go to Washington and do something completely different.”
Tax experts suggested that the code changes could result in more audits and taxes for Americans or, at the very least, an increase in correspondence with the IRS.AFP via Getty Images
“The reality of it is they said nobody making under $400,000 a year was going to have an increased chance of audit or pay more on taxes. That’s a flat lie. That’s not accurate. They’re lying to you,” he added.
National Taxpayer Advocate Erin Collins projected last week that the number of 1099s being filed would double once the code change goes into effect.
The Joint Committee on Taxation estimated that the new provision will raise 8.1 billion in revenue over a 10-year budget window.
Calling it a “stealth tax increase,” Willey said it is a “fantasy world” to think that the move will not increase audits and taxes.
If a transaction provider like Venmo or PayPal is being used and the amount compounds to over $600 within a year, a 1099 will likely follow.AP
“If it didn’t increase anybody’s taxes and didn’t increase their chances of an audit, then what are the 87,000 new employees going to do, where’s’ the 9.1 billion that the estimated it’s going to recover—where’d that number come from? It’s going to affect the fabric of American life,” he said.
Outside of fantasy sports, Willey and Paravano also asserted that the IRS changes would impact Americans in various other ways.
For example, sending money to a kid in college can be considered a gift under the current US tax code unless it exceeds $17,000. However, both parents and the student will still receive a 1099 to ask for proof.
“The horror is that a parent who pays rent to a college student every month, guess what, they may get a 1099,” Pavalano said.
The code changes will also cover transactions on Facebook marketplace, lending money to a friend, reimbursing a roommate for rent, paying a colleague for going out to dinner, repaying a bar tab, a mother sending a child gas and raising money to get a coach a gift.
If a transaction provider like Venmo or PayPal is being used and the amount compounds to over $600 within a year, a 1099 will likely follow.
Interestingly, taxpayers will not get a 1099 if they use Zelle because of the technical definitions of third-party settlement organizations. Generally, a check is the safest option to avoid triggering a 1099.
The new system is expected to increase the paperwork and cause more instances of mismatch between the IRS and the taxpayer.Getty Images/iStockphoto
The IRS’ current information return volume is 4 billion annually, with 99% filed electronically. They just rolled out a 1099 electronic information return portal.
The new system is expected to increase the paperwork and cause more instances of mismatch between the IRS and the taxpayer.
“In a vacuum, one of those transactions doesn’t seem bad, but if we’ve got 4 billion information returns now, and we think that might double, there’s just going to be a lot of compliance burdens,” Paravano said.
“The thing that comes up in my mind is the image of the dog catching bus. You caught the bus, what do you do with it. You’ve got all this information out, and you’ve got all the reporting. What will the IRS do with it,” he added.
There is support in the House and Senate from both parties to raise the threshold to $5,000.
Republicans, according to Paravano, would prefer to go back to the previous threshold of 20,000 and 200 transactions, but it will be challenging to put old rules back in place given the concern around spending.
Willey described the situation as an “enforcement nightmare” for the IRS and a nightmare for the taxpayer.
“You should be calling your legislature and complaining if they voted for this bill to all ends,” he added.
A 2022 IRS tax audit data study found that a taxpayer in the lowest income bracket is five times more likely to face an audit than a member of the highest income bracket.
“The IRS correspondence audit process is structured to expend the least amount of resources to conduct the largest number of examinations – resulting in the lowest level of customer service to taxpayers having the greatest need for assistance,” taxpayer advocate Collins said of the report during an annual report to Congress.
The IRS in December said that it is the new tax reporting requirement by one year and would likely impact tax filings occurring in early 2024.
The IRS said the change was intended to home in on Americans evading taxes by not reporting their full gross income. However, critics have labeled it as government overreach likely to hurt middle-class Americans and small businesses.
Medications like dextromethorphan, used to treat coughs caused by cold and flu, could potentially be repurposed to help people quit smoking cigarettes, according to a study by Penn State College of Medicine and University of Minnesota researchers. They developed a novel machine learning method, where computer programs analyze data sets for patterns and trends, to identify the drugs and said that some of them are already being tested in clinical trials.
Cigarette smoking is risk factor for cardiovascular disease, cancer and respiratory diseases and accounts for nearly half a million deaths in the United States each year. While smoking behaviors can be learned and unlearned, genetics also plays a role in a person's risk for engaging in those behaviors. The researchers found in a prior study that people with certain genes are more likely to become addicted to tobacco.
Using genetic data from more than 1.3 million people, Dajiang Liu, Ph.D., professor of public health sciences, and of biochemistry and molecular biology and Bibo Jiang, Ph.D., assistant professor of public health sciences, co-led a large multi-institution study that used machine learning to study these large data sets -- which include specific data about a person's genetics and their self-reported smoking behaviors.
The researchers identified more than 400 genes that were related to smoking behaviors. Since a person can have thousands of genes, they had to determine why some of those genes were connected to smoking behaviors. Genes that carry instructions for the production of nicotine receptors or are involved in signaling for the hormone dopamine, which make people feel relaxed and happy, had easy-to-understand connections. For the remaining genes, the research team had to determine the role each plays in biological pathways and using that information, figured out what medications are already approved for modifying those existing pathways.
Most of the genetic data in the study is from people with European ancestries, so the machine learning model had to be tailored to not only study that data, but also a smaller data set of around 150,000 people with Asian, African or American ancestries.
Liu and Jiang worked with more than 70 scientists on the project. They identified at least eight medications that could potentially be repurposed for smoking cessation, such as dextromethorphan, which is commonly used to treat coughs caused by cold and flu, and galantamine, which is used to treat Alzheimer's disease. The study was published in Nature Genetics today, Jan. 26.
"Re-purposing drugs using big biomedical data and machine learning methods can save money, time and resources," said Liu, a Penn State Cancer Institute and Penn State Huck Institutes of the Life Sciences researcher. "Some of the drugs we identified are already being tested in clinical trials for their ability to help smokers quit, but there are still other possible candidates that could be explored in future research."
While the machine learning method was able to incorporate a small set of data from diverse ancestries, Jiang said it's still important for researchers to build out genetic databases from individuals with diverse ancestries.
"This will only improve the accuracy with which machine learning models can identify individuals at risk for drug misuse and determine potential biological pathways that can be targeted for helpful treatments."
Other College of Medicine authors on the project include Fang Chen, Xingyan Wang, Dylan Weissenkampen, Chachrit, Khunsriraksakul, Lina Yang, Renan Sauteraud, Olivia Marx and Karine Moussa. They declare no conflicts of interest.
This research was supported by The National Institutes of Health (grants R01HG008983, R56HG011035, R01HG011035, R56HG012358, R01GM126479, R21AI160138 and R03OD032630) and Penn State College of Medicine's Biomedical Informatics and Artificial Intelligence Program in the Strategic Plan. The views of the authors do not necessarily represent the views of the funders.
Journal Reference:
Fang Chen, Xingyan Wang, Seon-Kyeong Jang, Bryan C. Quach, J. Dylan Weissenkampen, Chachrit Khunsriraksakul, Lina Yang, Renan Sauteraud, Christine M. Albert, Nicholette D. D. Allred, Donna K. Arnett, Allison E. Ashley-Koch, Kathleen C. Barnes, R. Graham Barr, Diane M. Becker, Lawrence F. Bielak, Joshua C. Bis, John Blangero, Meher Preethi Boorgula, Daniel I. Chasman, Sameer Chavan, Yii-Der I. Chen, Lee-Ming Chuang, Adolfo Correa, Joanne E. Curran, Sean P. David, Lisa de las Fuentes, Ranjan Deka, Ravindranath Duggirala, Jessica D. Faul, Melanie E. Garrett, Sina A. Gharib, Xiuqing Guo, Michael E. Hall, Nicola L. Hawley, Jiang He, Brian D. Hobbs, John E. Hokanson, Chao A. Hsiung, Shih-Jen Hwang, Thomas M. Hyde, Marguerite R. Irvin, Andrew E. Jaffe, Eric O. Johnson, Robert Kaplan, Sharon L. R. Kardia, Joel D. Kaufman, Tanika N. Kelly, Joel E. Kleinman, Charles Kooperberg, I-Te Lee, Daniel Levy, Sharon M. Lutz, Ani W. Manichaikul, Lisa W. Martin, Olivia Marx, Stephen T. McGarvey, Ryan L. Minster, Matthew Moll, Karine A. Moussa, Take Naseri, Kari E. North, Elizabeth C. Oelsner, Juan M. Peralta, Patricia A. Peyser, Bruce M. Psaty, Nicholas Rafaels, Laura M. Raffield, Muagututi’a Sefuiva Reupena, Stephen S. Rich, Jerome I. Rotter, David A. Schwartz, Aladdin H. Shadyab, Wayne H-H. Sheu, Mario Sims, Jennifer A. Smith, Xiao Sun, Kent D. Taylor, Marilyn J. Telen, Harold Watson, Daniel E. Weeks, David R. Weir, Lisa R. Yanek, Kendra A. Young, Kristin L. Young, Wei Zhao, Dana B. Hancock, Bibo Jiang, Scott Vrieze, Dajiang J. Liu. Multi-ancestry transcriptome-wide association analyses yield insights into tobacco use biology and drug repurposing. Nature Genetics, 2023; DOI: 10.1038/s41588-022-01282-x
Whether you call them comfort foods, highly processed foods, junk foods, empty calories or just some of Americans' favorite foods and drinks, a sizable percentage of older Americans have an unhealthy relationship with them, according to a new poll.
In fact, about 13% of people aged 50 to 80 showed signs of addiction to such foods and beverages in the past year, the new data from the National Poll on Healthy Aging suggest.
The percentage is much higher among women than men -- especially women in their 50s and early 60s. It was also higher in older adults who say they are overweight, lonely, or in fair or poor physical or mental health.
The poll is based at the U-M Institute for Healthcare Policy and Innovation and supported by AARP and Michigan Medicine, U-M's academic medical center.
The poll team and U-M psychologist Ashley Gearhardt, Ph.D., used a set of 13 questions to measure whether, and how often, older adults experienced the core indicators of addiction in their relationship with highly processed foods such as sweets, salty snacks, sugary drinks and fast food. These addiction indicators include intense cravings, an inability to cut down on intake, and signs of withdrawal.
Based on their findings, Gearhardt suggests that the same set of standard questions should become part of screening at doctors' offices. This could help identify older adults with addictive eating habits who could benefit from referrals to nutrition counseling or programs that help people address addictive eating or get affordable access to healthier foods.
Gearhardt, an associate professor in the U-M Department of Psychology and member of IHPI, co-developed the standardized questionnaire used in the poll, called the Yale Food Addiction Scale.
"The word addiction may seem strong when it comes to food, but research has shown that our brains respond as strongly to highly processed foods, especially those highest in sugar, simple starches, and fat, as they do to tobacco, alcohol and other addictive substances," says Gearhardt.
"Just as with smoking or drinking, we need to identify and reach out to those who have entered unhealthy patterns of use and support them in developing a healthier relationship with food."
In order to meet the criteria for an addiction to highly processed food on the scale used in the poll, older adults had to report experiencing at least two of 11 symptoms of addiction in their intake of highly processed food, as well as report significant eating-related distress or life problems multiple times a week. These are the same criteria used to diagnose addiction-related problems with alcohol, tobacco and other addictive substances.
By these criteria, addiction to highly processed foods was seen in:
17% of adults age 50 to 64, and 8% of adults age 65-80
22% of women age 50 to 64 and 18% of women age 50 to 80,
32% of women who say their physical health is fair or poor, and 14% of men who say the same -- more than twice as high as the percentages among those who say their physical health is excellent, very good or good
45% of women who say their mental health is fair or poor, and 23% of men who say the same -- three times as high as the percentages among those who say their mental health is excellent, very good or good
17% of men who self-report they are overweight, compared with 1% of men who indicate they're around the right weight
34% of women who self-report they are overweight, compared with 4% who indicate they're around the right weight
51% of women who say they often feel isolated from others, and 26% of men who say the same -- compared with 8% of women and 4% of men who say they rarely feel isolated
The most commonly reported symptom of an addiction to highly processed foods in older adults was intense cravings. Almost 1 in 4 (24%) said that at least once a week they had such a strong urge to eat a highly processed food that they couldn't think of anything else. And 19% said that at least 2 to 3 times a week they had tried and failed to cut down on, or stop eating, these kinds of foods.
Twelve percent said that their eating behavior caused them a lot of distress 2 to 3 times a week or more.
"Clinicians need a better understanding of how food addiction and problematic eating intertwines with their patients' physical and mental health, including chronic conditions such as diabetes, heart disease and certain types of cancer," says poll director Jeffrey Kullgren, M.D., M.P.H., M.S., an associate professor of internal medicine at Michigan Medicine and physician and researcher at the VA Ann Arbor Healthcare System. "We need to understand that cravings and behaviors around food are rooted in brain chemistry and heredity, and that some people may need additional help just as they would to quit smoking or drinking."
The poll report is based on findings from a nationally representative survey conducted by NORC at the University of Chicago for IHPI and administered online and via phone in July 2022 among 2,163 adults aged 50 to 80. The sample was subsequently weighted to reflect the U.S. population. Read past National Poll on Healthy Aging reports and about the poll methodology.
