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Popular yogurt recalled nationwide due to possible plastic pieces

Popular yogurt recalled nationwide due to possible plastic pieces

Yahoo3 days ago
Danone U.S., the maker of YoCrunch, is recalling the yogurt product due to the potential presence of plastic pieces in the packaging's dome topper, according to federal health officials.
In an alert, the U.S. Food and Drug Administration said the plastic pieces, which were discovered after reported consumer complaints, could potentially cause a choking response if eaten.
"The plastic pieces are transparent, may have sharp edges, and could present a risk to consumers because some pieces are between 7 and 25 mm in length," the FDA noted. "The issue is isolated only to the separately packaged topper and does not impact the separately packaged yogurt."
This recall applies to all flavors and sizes of YoCrunch products currently in market at retail stores nationwide, including those with toppers containing granola, cookie dough, Oreo, M&M, Snickers and Twix pieces. A full list of impacted product names and code dates is on the FDA's website.
"The company is working swiftly with retail partners to remove the impacted product from shelves," the FDA said.
For information on refunds, consumers can contact the YoCrunch consumer care line at 1-877-344-4886.
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ImCheck's ICT01 Receives FDA Orphan Drug Designation for Treatment of Acute Myeloid Leukemia
ImCheck's ICT01 Receives FDA Orphan Drug Designation for Treatment of Acute Myeloid Leukemia

Yahoo

time10 minutes ago

  • Yahoo

ImCheck's ICT01 Receives FDA Orphan Drug Designation for Treatment of Acute Myeloid Leukemia

ImCheck's ICT01 Receives FDA Orphan Drug Designation for Treatment of Acute Myeloid Leukemia Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials Marseille, France, July 18, 2025, 11:00 am CET – ImCheck Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia (AML). AML remains a significant clinical challenge, particularly for older or unfit patients who are not eligible for intensive chemotherapy. 'Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01's innovative therapeutic potential to meet the urgent unmet medical needs of AML patients," said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. "This important regulatory milestone reinforces our confidence that ICT01 will become the first immunotherapy for AML patients and supports our goal of rapidly advancing ICT01 into pivotal studies based on the unprecedented results observed in the clinic to date.' In an oral presentation at the 2025 ASCO Annual Meeting, ImCheck reported results from the Phase I/II EVICTION study, evaluating ICT01 in combination with azacitidine and venetoclax (Aza-Ven) in newly diagnosed AML patients unfit for intensive chemotherapy. Remarkably high remission rates and a positive overall survival signal were observed across a broad range of molecular subtypes, in particular those that are typically less responsive to Aza-Ven. The combination demonstrated a clinically well-manageable safety profile, with Grade ≥3 adverse events consistent with the expected hematological toxicity of Aza-Ven and AML itself. 'Orphan drug designation is a catalyst,' added Pierre d'Epenoux, Chief Executive Officer of ImCheck Therapeutics. 'It validates our regulatory strategy, de-risks and supports clinical development acceleration, and sends a strong signal about the unique potential of ICT01 to transform AML treatment as well as other solid tumor indications.' The FDA's orphan drug designation is granted to drugs and biologics intended for the treatment, diagnosis, or prevention of rare diseases affecting fewer than 200,000 people in the United States. The designation is designed to encourage the development of therapies for underserved patient populations and offers benefits including tax credits for clinical trials, exemption from certain FDA fees, and up to seven years of marketing exclusivity upon approval. Additionally, the designation gives access to regulatory assistance for the drug development process. About the medical need in AML Acute myeloid leukemia (AML) remains a significant clinical challenge, particularly for older or unfit patients who cannot tolerate intensive chemotherapy. While the combination of venetoclax and azacitidine has become the standard non-intensive regimen, it is not curative and relapse rates remain high. Most patients are not eligible for stem cell transplantation, often due to age, comorbidities, or insufficient response, and face limited treatment options and poor overall survival. Despite AML's known sensitivity to immune-mediated control, current immunotherapies targeting PD-1, TIM-3, or CD47 have not delivered meaningful clinical benefit. This underscores the urgent need for novel immuno-oncology approaches. Recently, γ9δ2 T cells, with their cytotoxic activity and unique dual role in both innate and adaptive immunity, have emerged as promising immune modulators. Their association with reduced relapse and prolonged survival, particularly in the post-transplant setting, suggests that enhancing their anti-leukemic potential could offer a meaningful new treatment option for high-risk AML patients. About ICT01 ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. 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Health insurance costs are about to spike again: What to expect in 2026.
Health insurance costs are about to spike again: What to expect in 2026.

USA Today

time12 minutes ago

  • USA Today

Health insurance costs are about to spike again: What to expect in 2026.

Consumers who buy health insurance through the Affordable Care Act marketplace will likely face double-digit rate hikes next year. Insurers plan a median premium increase of 15% for 2026 plans, which would be the largest ACA insurance price hike since 2018, according to a Peterson-KFF Health System Tracker analysis published July 18. And many working-age consumers who get their health insurance through the workplace won't be spared, either. Benefits consultant Mercer said more than half of big employers expect to shift a larger share of insurance costs to employees and their families next year by raising deductibles, copays or out-of-pocket requirements. KFF said the ACA insurers cited factors such as medical cost inflation, the expiration of tax credits instituted during former President Joe Biden's administration that made plans cheaper, and tariffs on prescription drugs and medical device imports. Still unknown is how President Donald Trump's and Congressional Republicans' tax cut and spending law might impact next year's ACA health insurance rates, experts said. Trump's tax cut law has "created a lot of uncertainty," said Matt McGough, a policy analyst for KFF's program on the ACA. "Insurers weren't sure how to handle it." Millions of nondisabled adults are projected to lose Medicaid coverage due to the law's work-or-volunteer requirement, but the law also will impact some who buy ACA plans. Trump's law and a federal rule will end a special sign-up period for people who earned less than 150% of the federal poverty level − a group that had significant enrollment gains in recent years. The enrollment perk allowed low-income Americans to sign up for coverage year-round, making it easier for families to sign up, McGough said. The law also ends automatic ACA enrollment renewals for consumers, who will be required to update income and other information annually. Trump administration officials have said the Biden administration's enrollment policies for Medicaid and the Affordable Care Act allowed fraud and abuse. In a July 17 news release, the Centers for Medicare & Medicaid Services said it discovered 2.8 million Americans were potentially enrolled in Medicaid or Children's Health Insurance Program plans in multiple states, or they were simultaneously enrolled in Medicaid/CHIP plans and subsidized ACA plans. The agency said it initiated steps to ensure people weren't simultaneously enrolled in multiple, taxpayer-subsidized insurance plans. In a statement, U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. said the Trump administration "will no longer tolerate waste, fraud, and abuse at the expense of our most vulnerable citizens." Higher health costs, end of COVID-era tax credits Higher health care spending is the top factor driving health insurance premiums higher - accounting for roughly half of the expected insurance price hikes, McGough said. Another significant factor is Biden's COVID-19 pandemic-era tax credits, which made ACA plans cheaper for consumers and drove record high enrollment, will expire at the end of the year. The nonpartisan Congressional Budget Office estimated about 5 million could lose health insurance after the tax credits expire. KFF said the expiring tax credits will increase ACA consumers' out-of-pocket premium payments more than 75% on average. Healthier enrollees will likely choose to drop their coverage, leaving insurance plans with groups of sicker patients who require more health care, McGough said. KFF's review of 105 ACA insurers in 19 states and Washington D.C. found most are seeking rate hikes of 10% to 20% for coverage next year. Another 28 insurers will seek rate hikes of 28% or more. State and federal insurance regulators must sign off on proposed rate hikes before they are finalized this fall. Most working-age Americans get health insurance through their or a spouse's employer. These large employers will be more willing to pass along a larger share of health insurance costs to workers and their families next year, a July 16 report from benefits consultant Mercer found. Mercer said 51% of large employers say they are likely or very likely to shifts cost to workers through higher deductibles or out-of-pocket maximums. A year ago, 45% of employers were willing to make their workers absorb a higher share of the health bill. Employers health benefits costs are expected to rise 6% in 2025 and could rise even faster in 2026. To curb those cost increases, employers are adjusting insurance plan options for workers and their families, said Beth Umland, Mercer's director of research for health and benefits. Earlier this decade, employers were reluctant to shift significant health costs to workers due to the tight labor market. But with health costs rising faster than inflation, more companies are willing to do so, Umland said. Companies also are increasingly offering plans that encourage workers to get care from narrower networks of doctors and hospitals who have negotiated discounts with the insurance plan, Umland said.

ACA insurers propose biggest premium hikes since 2018 as Trump policies take hold
ACA insurers propose biggest premium hikes since 2018 as Trump policies take hold

CNN

time13 minutes ago

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ACA insurers propose biggest premium hikes since 2018 as Trump policies take hold

Affordable Care Act insurers are proposing their steepest premium increases since 2018, driven in part by the looming expiration of Biden-era enhanced premium subsidies and by the Trump administration's tariffs, a new KFF analysis has found. Insurers are asking for a typical rate increase of 15% with more than a quarter proposing hikes of 20% or more. KFF, a nonpartisan health policy research group, looked at 105 Obamacare insurers in 19 states and the District of Columbia that have filed rates so far. Steep rate increases in 2018 were also fueled by Trump administration policies, which were focused on weakening the ACA during the president's first term after Republicans in Congress failed to repeal it in 2017. While rising health care costs account for about half of the coming year's proposed increases, two other forces under the control of President Donald Trump and congressional Republicans are also driving up rates, KFF found. The expiration of the enhanced ACA premium subsidies at the end of this year is prompting many insurers to hike rates by an additional 4%, on average. Insurers are concerned that the disappearance of this beefed-up assistance will prompt many, largely healthier consumers to drop their coverage — leaving sicker, costlier policyholders on the exchanges. Initially created by the Democrats' American Rescue Plan Act in 2021, the enhanced premium subsidies enable lower-income enrollees to sign up for coverage with very low or no monthly premiums. Also, middle-income Americans can qualify for assistance for the first time. The Biden administration repeatedly said the more generous subsidies allow the majority of enrollees to select plans that cost less than $10 a month. The enhanced subsidies helped drive Obamacare signups to a record 24 million people for 2025. Most enrollees qualify for subsidies, which greatly lower their monthly premium payments. But once the beefed-up assistance lapses, those payments are expected to spike by 75%, on average, KFF said. Trump and GOP lawmakers did not include an extension of the subsidies in their 'big, beautiful bill' and it remains to be seen whether they push for it in subsequent legislation. However, the clock is ticking since insurers are currently finalizing their rates, and the Obamacare federal and state exchanges need time to prepare for open enrollment, which starts on November 1. Several states are highlighting the looming loss of the enhanced subsidies as driving up insurers' proposed rates on their exchanges. In Maryland, for instance, carriers have requested an overall average premium change of 17.1%, the highest since 2019. If Congress extends the enhanced subsidies, the rate increases would be 7.9%, on average, according to the Maryland Insurance Administration, which is looking into creating a state-sponsored subsidy to offset some of the premium increases. Also, some insurers are pointing to the tariffs that the Trump administration has promised to impose on pharmaceutical imports, KFF said. Those that cite tariffs say the levies will add 3% to their premium proposals. The rate filings, however, do not mention specific impacts of the 'big, beautiful bill' because insurers generally had to submit their proposals prior to the bill being signed into law on July 4. Those that mention it point to the uncertainty it is causing, said Cynthia Cox, director of KFF's Program on the ACA. 'We're going to be watching over the next few weeks whether insurers come back and say, 'the big, beautiful bill passed, and here's how we think that might affect our premiums,'' she said. The filings also don't take into account the provisions in a rule that the Centers for Medicare and Medicaid Services finalized in late June that will make several changes to Obamacare, including shortening the open enrollment period, increasing verification requirements and limiting the ability of low-income Americans to sign up for coverage year-round. The measures are a 'mixed bag' for insurers in terms of how it might affect premiums, Cox said. One major insurer has already announced its departure from the Affordable Care Act in 2026. Aetna said in May that it would stop selling plans on the individual market because 'it became clear we would not be able to provide the same level of value we've offered in prior years,' the company said on its website. The insurer also left the Obamacare exchanges in 2018 but later returned. Insurers' 2026 rates are preliminary and are subject to change, particularly in states that run their own exchanges, where state regulators have more of a say in setting the final rates. The final rates should be published later this summer, and consumers will be able to view plan premiums shortly before open enrollment starts.

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