Federal government no longer accepting orders for free Covid-19 tests
It's not clear whether the program has shut down permanently. The US Department of Health and Human Services has not responded to CNN's questions about why the program is no longer taking orders.
The testing website says orders placed before 8 p.m. ET Sunday, March 9, will still be shipped. Home tests are also sold at grocery stores and pharmacies.
Ordering on Covidtests.gov has been suspended off and on since it started in the winter of 2021. Last year, the Biden administration stopped the program as virus numbers fell in the spring but restarted it last fall ahead of the respiratory virus season.
The coronavirus is still making people sick in the United States, but the number of cases has been falling.
As of March 1, the number of people testing positive for Covid is down slightly from the week before, with nearly 4% of those who take a test showing up as positive, according to the US Centers for Disease Control and Prevention. Hospitalizations and deaths are also down slightly from the week before, according to the CDC.
The US Food and Drug Administration recommends that people who have Covid-like symptoms test repeatedly to determine whether they have the virus. Prices for tests can range from $10 to $35 each. Some insurance plans may cover the tests, and local health programs sometimes offer free tests.
Last March, ASPR said it had delivered over 1.8 billion free Covid-19 tests through its Covidtests.gov website.
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Time Magazine
an hour ago
- Time Magazine
The Clashing Advice Over COVID-19 Shots for Kids
Should you give your baby a COVID-19 shot? The answer isn't as straightforward or as much of a consensus as it used to be: In an unusual move, the American Academy of Pediatrics (AAP) is recommending a different approach to childhood vaccination than the U.S. Centers for Disease Control and Prevention (CDC). Both groups agree that families should make individual decisions in consultation with their doctors about whether kids should be vaccinated. But the AAP has a stricter stance for the youngest eligible children in the U.S., recommending that all of them get COVID-19 shots. The CDC stopped recommending COVID-19 vaccines for healthy children older than six months following guidance from the Secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., in May. The CDC does, however, recommend the shot for children who are moderately or severely immunocompromised. A day after the AAP released its recommendations, Kennedy fired back at the organization on social media, accusing them of allowing pharmaceutical-company donors to guide their recommendations. AAP maintains that its recommendations are based on science. Here's what to know about the clashing advice regarding COVID-19 vaccines for kids. What does the AAP recommend in terms of COVID-19 shots for children? Whether most children should get a COVID-19 vaccine should be based on their particular risk, the AAP says—taking into account their underlying conditions, such as asthma, obesity, or diabetes, as well as whether they live in a household with people at high risk for developing severe disease. That risk is higher for the youngest eligible age group—ages 6 months to 23 months—which is why the AAP recommends that all kids in this age group get vaccinated. 'For the youngest kids, the hospitalization rate is similar to that for adults 50 to 64 years old,' says Dr. Sean O'Leary, chair of the AAP Committee on Infectious Diseases. 'It's not nothing. And that's for something that can be prevented by a vaccine, which has been better studied than any medical product in our history. We have a very strong level of confidence in the safety of the vaccine.' HHS did not respond to TIME's request for comment. Why are the recommendations different? Generally, the CDC sets the schedule for which vaccines people should get and at which ages. The CDC makes its decision based on advice from its Advisory Committee on Immunization Practices (ACIP). ACIP is made up of independent experts who volunteer to review data, discuss their findings, and make recommendations to help guide the CDC. But Kennedy—a longtime vaccine-skeptic who now oversees the CDC as head of HHS—fired all members of ACIP in June, accusing them of following industry interests. Kennedy replaced them days later with people he had selected, 'many of them with strong anti-vaccine views,' says O'Leary. Read More: How Having a Baby Is Changing Under Trump After ACIP was replaced, AAP—which typically works closely with the advisory committee and other liaison groups in setting vaccination schedules—decided not to attend ACIP's first meeting under the new administration in the spring. 'We saw from that meeting that ACIP has gone off the rails, essentially, in terms of the way they are operating and the messaging from the new members, which is very much around sowing distrust about vaccines and not making evidence-based vaccine recommendations,' says O'Leary. Weeks later, the AAP and other liaison groups were asked to discontinue their participation in ACIP work groups, O'Leary says. 'We received an email un-inviting us,' he says. The reason provided, he says, was that the organizations represented 'special interest groups,' which O'Leary says is a 'poor interpretation of the rules. All of the organizations at the table have expertise, and there are a lot of reasons to have representation from professional societies.' Which advice will doctors and pharmacists follow? O'Leary says pediatricians are anticipating having to have more conversations with families about the conflicting vaccine advice, and that the AAP is providing guidance to help inform those discussions on its website and via emails to its members. 'Politics has entered the exam room in a way that it never has before,' he says. 'These discussions will be contextual, depending on how well the pediatrician knows the family, what relationship they have, and how frank they can be with them in the discussion.' Ultimately, he says, the message from pediatricians should be this: 'We are committed to the health of children, and our recommendations are based on the best available science.' Read More: What the New COVID-19 Vaccine Guidance Means For You Pharmacists must take a slightly different approach, since they are only allowed to vaccinate according to the CDC's recommendations, while doctors can vaccinate outside of strictly approved conditions or populations in so-called 'off-label' use. Since current CDC recommendations say that families should make their own decisions about whether their children receive the shot, pharmacists will vaccinate kids if parents want them to have the shots, but won't specifically recommend that people get them. 'Our guidance is to always follow what the CDC or HHS recommends,' says Rick Gates, chief pharmacy officer at Walgreens. If families come in with questions about whether their child should get the COVID-19 shot, pharmacists will probably refer them back to their pediatrician or family physician. Will insurance cover COVID-19 vaccines for kids if the CDC doesn't recommend them? It's still not clear how insurers will respond to the differing recommendations. 'This is a real concern,' says Dr. David Higgins, an infectious-disease expert at AAP. Traditionally, a recommendation from ACIP means that a shot will be covered, since any vaccines recommended by the committee have to be reimbursed by insurers under the Affordable Care Act. It's not clear how insurers will interpret the individual choice of families when it comes to vaccinating children. The AAP is urging insurers to continue covering the COVID-19 vaccine for infants six to 23 months, despite the fact that ACIP does not recommend the vaccine for all kids in this age group. 'The AAP is already engaging with private insurers and policymakers to ensure our evidence-based recommendations are covered,' Higgins says, 'and we will continue to advocate to make vaccines accessible to every child in every community.'
Yahoo
an hour ago
- Yahoo
Hamlet BioPharma Announces the Completion of the Alpha1H Phase II Study in Non-Muscle Invasive Bladder Cancer
LUND, Sweden, Aug. 21, 2025 /PRNewswire/ -- Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, announces the completion of the successful Phase II clinical trial of the company's drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and efficacy were reached. The final clinical report has been completed and submitted to the FDA (Food and Drug Administration, USA). "The final clinical report's consistent efficacy outcomes and favorable safety profile are highly encouraging. The strength of the data provides compelling evidence of Alpha1H's potential to become a much-needed proactive treatment option, and we look forward to advancing it in our regulatory discussions. We are committed to bringing this innovative therapy to patients as quickly and safely as possible. These results mark a major milestone for Hamlet BioPharma and for people with cancer in the urinary bladder. The study was made possible through close collaboration with leading universities and medical centers, including Lund University, Sweden, Motol University Hospital, Czechia and Linnane Pharma AB, whose combined expertise ensured robust design, execution, and analysis," said Catharina Svanborg, MD, PhD and CEO Hamlet BioPharma. Summary from the Clinical Study Report Efficacy was formally confirmed – 80% of tumors responded to Alpha1H, with 59% average tumor size reduction in the high-dose group Molecular and cellular secondary endpointsAlpha1H reaches tumor tissue, triggers tumor cell apoptosis, and causes rapid shedding of tumor cells into the urine. Durable effect shown across repeated treatment cyclesPatients who received a second round of instillations maintained clinical benefit, showing continued tumor cell death and reduction — demonstrating the treatment's lasting efficacy, even with repeated dosing. BCG-like immune activation confirmed – but fasterCytokine profiling shows Alpha1H activates a broad immune response overlapping with BCG, the current standard of care. However, Alpha1H triggers this response more rapidly and without lasting side effects. Suppression of cancer genes and pathways Advanced RNA sequencing revealed Alpha1H downregulated over 700 of ~800 cancer-related genes, including key oncogenes like RAS and GJA1. This provides a mechanistic explanation for its unique tumor-killing profile. Strong safety profile confirmed over longer follow-up – no serious side effectsNo drug-related serious adverse events occurred, even after higher or repeated dosing. Mild local side effects were comparable to placebo, and no systemic effects were observed, consistent with Alpha1H's local mechanism of action. Why This Matters Clinical Value The results reinforce Alpha1H as a potential breakthrough therapy for NMIBC patients. Unlike current treatments that are often given after surgery, Alpha1H is used before surgery to reduce tumor burden, potentially allowing for less invasive procedures and improved outcomes. Importantly, Alpha1H achieved these effects without the toxic side effects associated with chemotherapy or systemic immunotherapy. Differentiated Mechanism and Positioning Alpha1H works through a unique mechanism: it enters tumor cells, causes programmed cell death (apoptosis), and activates the body's own immune response. Unlike BCG, which is limited by supply issues and safety concerns, Alpha1H is a well-tolerated, synthetic compound with strong stability and safety – even after repeated dosing. It acts locally in the bladder, without systemic exposure, making it easier to deliver and better suited for broader clinical use. Commercial Opportunity Each year, more than 500,000 patients globally are diagnosed with non-muscle invasive bladder cancer. Many do not respond to BCG or other interventions and experience relapses. With Fast Track designation from the FDA and patent protection in key markets, Alpha1H is well positioned to meet this urgent unmet need. The global NMIBC market is estimated at over USD 3 billion[1] annually. If approved, Alpha1H could serve as a neoadjuvant treatment, an add-on to standard of care, or a standalone therapy – representing a strong commercial opportunity. The results from the final clinical report will also strengthen our position in our dialogue with potential partners. About the Study The Phase II/III trial was designed to evaluate the efficacy and safety of Alpha1H in about 60 subjects. Participants were randomized to receive either Alpha1H or placebo of care over about one month. The primary endpoints were Adverse Events, Characteristics of papillary tumors, Quantification of cell shedding in urine and the secondary endpoints included Induction of apoptosis, Histopathology scoring, Tumor response to Alpha1H by gene expression analysis, Proteomic analysis of immune markers in urine. Safety was assessed for all patients, who received treatment with investigational product or placebo. These achievements were made possible by close collaborations with leading universities and medical centers. The trial brought together leading researchers and clinicians from Lund University in Sweden, Motol University Hospital in Czechia and Linnane Pharma AB in Sweden. By combining expertise across disciplines and geographies, the partnership ensured rigorous study design, high-quality data collection, and robust analysis. This collaborative approach not only advanced the development of Alpha1H but also contributed valuable insights to the broader scientific community working to improve outcomes for patients with bladder cancer. Next Steps Hamlet BioPharma is engaged with FDA to discuss submission requirements and timelines for a Phase III study. The clinical study data and other progress is regularly published in international, peer-reviewed journals. About Alpha1H The drug candidate Alpha1H kills tumor cells quickly and selectively and shows strong anti-cancer effects in animal models of and patients with bladder cancer. Hamlet BioPharma announced that the drug candidate Alpha1H showed potent treatment effects in patients with cancer of the urinary bladder. The extensive data analysis of the complete study material, which includes safety, clinical data and advanced molecular and tissue analyses has now been completed and final clinical report prepared for regulatory purposes. About Hamlet BioPharma Hamlet BioPharma is an innovative biotechnology company that develops scientific discoveries into drugs for the treatment of cancer and infections. The goal is to address unmet medical needs in large patient groups in need of improved cancer treatments or alternatives to antibiotics. The company is leveraging highly innovative scientific discoveries and an extensive IP portfolio, to take these innovative drugs through mechanistic and preclinical phases, through the development of drug production technology to the clinic. Three projects in clinical development are in Phase II trials. The company is listed on Spotlight Stockmarket, ticker HAMLET. For more information, please contactCatharina Svanborg, CEO and founder, +46 709 42 65 Testad, CFO, Hamlet BioPharma AB, +46 70 84 84 210, [1] Transparency Market Research; This information was brought to you by Cision The following files are available for download: Release 4221183_0.png View original content: SOURCE Hamlet BioPharma AB (publ) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


Miami Herald
an hour ago
- Miami Herald
US Bankruptcies Hit Highest Level Since COVID
The U.S. saw a sharp increase in corporate bankruptcy filings in July, according to a recent report, reaching a post-COVID peak and placing 2025 on track to surpass last year's total. S&P Global Market Intelligence, the research and data arm of the credit-rating agency, found that filings by large public and private companies rose to 71 last month from 66 in June, marking the highest monthly tally since July 2020. So far in 2025, meanwhile, the total of 446 bankruptcy filings is the highest for this seven-month stretch since 2010. Experts told Newsweek that, when factoring in things like currency depreciation and corporate structures, statistics such as these are less alarming than they may initially appear. However, the notable increase in both business and personal bankruptcies in recent months has exacerbated existing concerns about the overall health of the U.S. economy. In its report, S&P Global cited the impact of high interest rates and "uncertainty" created by tariffs; but the economy is also grappling with elevated inflation, a precarious labor market and other headwinds that have prompted some economists to warn of an impending recession. Through the first seven months of the year, bankruptcies were heavily concentrated in the industrial and consumer discretionary sectors, totaling 70 and 61, respectively. Among high-profile bankruptcies, S&P Global noted three that had over $1 billion in assets and liabilities at the time of their July filings: Glucose-monitoring company LifeScan Global; canned goods company Del Monte Foods; and Genesis Healthcare, the Pennsylvania-headquartered nursing home and long-term care provider. With 446 bankruptcies recorded within the first seven months, 2025 is on track to surpass 2024's full-year total of 688. This compares to 634 in 2023, 373 in 2022, 405 in 2021 and 638 in 2020. For its tracking purposes, S&P Global defined "large" firms as public companies with at least $2 million in assets or liabilities, and private companies with at least $10 million at the time of the bankruptcy filings. However, Robert Lawless, a professor of law at the University of Illinois and co-author of Debt's Grip: Risk and Consumer Bankruptcy, said that this benchmark may result in comparisons that are not quite "apples-to-apples." "A dollar has lost 19 percent of its value since December 2020," he told Newsweek. "Similarly, a $2 million bankruptcy today is the same as approximately a $1.4 million bankruptcy in 2010." "Inflation over time will make it seem like there are more 'big' bankruptcies if an adjustment is not made," Lawless said. Newsweek has contacted S&P Global via email for clarification on its methodology. Lawless added that the report avoids a crucial issue by tracking bankruptcy filings rather than the number of entities filing for bankruptcy, as others have done recently. Earlier this month, bankruptcy information services platform Epiq AACER reported that commercial bankruptcy filings had jumped 78 percent year-over-year to 911 in July. However, as Lawless noted in a blog post, nearly a third of these filings were the result of the Genesis Healthcare bankruptcy. "The narrative focused on the number of entities filing for bankruptcy is not quite right," Melissa Jacoby, a law professor of the University of North Carolina at Chapel Hill, told Newsweek. "Many of those separate corporate entities are part of a common corporate group-companies partition themselves into separate business associations under state law, but they typically are an integrated whole in terms of thinking about a bankrupt business and are managed together in the bankruptcy process," she said. S&P Global, in the report, wrote: "Companies are contending with elevated interest rates as uncertainty from U.S. tariff policy pressures costs and supply chain resilience." "Companies could benefit from the [Federal Reserve] rate cut if such a move impacts U.S. Treasury yields or market sentiment," it said, adding that: "Treasury yields influence corporate debt interest rates more directly than the Fed rate." Moody's chief economist Mark Zandi, said earlier this month: "It's no mystery why the economy is struggling; blame increasing U.S. tariffs and highly restrictive immigration policy. The tariffs are cutting increasingly deeply into the profits of American companies and the purchasing power of American households." Despite rising bankruptcies, other signs point to resilience among large U.S. corporations. According to recent analysis by Goldman Sachs strategists, cited in Bloomberg, aggregate second-quarter earnings per share for S&P 500 companies are up 11 percent compared to last year, surpassing previous forecasts of a 4 percent gain. The Federal Reserve will make its next interest rate decision following the mid-September meeting. According to CME FedWatch, which predicts moves by the central bank based on interest rate trades, there is an 81 percent chance of a 25-basis points cut at this meeting. Related Articles Bed Bath & Beyond's 'Never Expire' Coupons to Be Accepted at New StoreMC Hammer Faces Financial Trouble After LawsuitClaire's Faces Stores Closing Across US As Retailer Files for BankruptcyAt Home Stores Closing: Full List of Locations 2025 NEWSWEEK DIGITAL LLC.