Latest news with #USFoodandDrugAdministration
Yahoo
6 hours ago
- Health
- Yahoo
SELLAS' CDK9 inhibitor to advance after 'exceeding expectations' in AML
SELLAS Life Sciences' CDK9 inhibitor, SLS009, for relapsed/refractory acute myeloid leukaemia (r/r AML) is set to advance after it met all endpoints in a Phase Ia/II trial. The open-label Phase Ia/II study (NCT04588922) was evaluating the safety, tolerability, and efficacy of SLS009 (tambiciclib) in combination with Venclexta (venetoclax) and Vidaza (azacitidine) at two dose levels, 45mg and 60mg. In the 60mg dose cohort, patients were treated with either a 60mg dose once per week or a 30mg dose two times per week. The 54 patients enrolled had previously not responded to Venclexta. SELLAS said the study 'exceeded expectations', with a mean overall response rate (ORR) of 33%, exceeding the threshold of 20%. ORR was the study's primary endpoint. When looking at certain arms, some benefited from even higher ORR. For example, AML patients with myelodysplasia-related changes who received 30mg twice weekly had a 44% ORR. The highest ORR was reached by patients with ASXL1 mutations, with an ORR of 50% and acute myelomonocytic leukaemia (AML-M4) and acute monocytic leukaemia (AML-M5) patients, also with 50%. In regard to overall survival (OS), patients with AML MR achieved 8.9 months, and patients with r/r AML who received one prior line of therapy and received twice weekly SLS009 reached 8.8 months. Both these targets surpassed the historical benchmark of 2.4 months and the 3-month target set by investigators. For patients who had received two previous lines of therapy, OS was 4.1 months compared to the 1.8-month benchmark. The treatment was also well-tolerated, with no dose-limiting toxicities across any treatment arm. As a result of the Phase II study, SELLAS will advance SLS009 to a randomised trial that will expand into the newly diagnosed AML populations, as well as patients who are resistant to prior Venclexta and Vidaza treatment. The study will support a potential New Drug Application (NDA) with the US Food and Drug Administration (FDA). CEO of SELLAS Dr. Angelos Stergiou, said: 'The remarkable response rates of 44% among AML MR patients, 50% among ASXL1-mutated AML MR, and 50% among M4/M5 patients at the optimal 30mg twice weekly dose far exceed the targeted 20% benchmark. We believe these data strongly support the potential of SLS009 to meaningfully extend life in patients with otherwise limited options, and we look forward to sharing these findings in more detail in the future.' SELLAS is also investigating SLS009 in r/r diffuse large B-cell lymphoma (DLBCL) and r/r peripheral T-cell lymphoma. Also in SELLAS' pipeline is galinpepimut-S, a cancer vaccine being investigated in the Phase III REGAL study (NCT04229979) in patients with AML second complete remission (CR2) or second complete remission with incomplete platelet recovery (CRp2). The REGAL study is expected to be completed by the end of 2025. "SELLAS' CDK9 inhibitor to advance after 'exceeding expectations' in AML" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Yahoo
a day ago
- Health
- Yahoo
How to make sure you're getting the right supplement. 5 expert tips to help you choose
Editor's note: The podcast Chasing Life With Dr. Sanjay Gupta explores the medical science behind some of life's mysteries big and small. You can listen to episodes here. (CNN) — Take a walk down the supplement aisle of any local drugstore, and you will be confronted with a floor-to-ceiling wall of choices. Not just the usual suspects — vitamins and minerals — but also items as varied as turmeric, fish oil, probiotics and melatonin — as well as combinations that purport to burn fat (not muscle!), cure erectile dysfunction and boost memory. The deluge of options doesn't stop there. Endless social media posts claim a life-changing supplement or regimen will help you eliminate 'cortisol belly,' protect against the flu or 'reset' your hormones. But exactly how many things do we humans need to buy in the race to optimize our health and live our best life? All this noise around supplements generates confusion and anxiety, obscuring what science there is and making it hard to separate fact from wishful thinking. In the most basic sense, these products are meant to supplement the food in your diet with extra added 'dietary ingredients.' You would not be faulted for thinking that the US Food and Drug Administration regulates supplements — and the agency does, but probably not in the way you might think. Thanks to a 1994 law called the Dietary Supplement Health and Education Act, or DSHEA, supplements are regulated more like a subcategory of foods, not a subcategory of medicine. This essentially means that the FDA does not have the authority to approve dietary supplements before they are marketed, unlike pharmaceuticals, which must be shown to be both safe and effective in clinical trials. 'DSHEA is the current framework that all dietary supplements are sold in,' supplement safety advocate Dr. Pieter Cohen told CNN Chief Medical Correspondent Dr. Sanjay Gupta recently on his podcast, Chasing Life. The law, in part, allowed the industry to explode from approximately 4,000 products in 1994, to some 90,000 in 2017, according to estimates in a 2022 AMA Journal of Ethics policy paper. 'Now, that law in 1994 was initially … designed to better regulate vitamins and minerals,' explained Cohen, an associate professor of medicine at Harvard Medical School and an internist at Cambridge Health Alliance, where he leads the Supplement Research Program. 'What unfortunately happened — unfortunately, in my opinion — was that that same structure was expanded to include … all nature of botanicals; many different types of extracts, like, let's say, a cow thyroid extract; live microorganisms, like both bacteria and yeast, that are sold as probiotics; protein powders; amino acids. All this was lumped together under that same framework … and all of them were called 'dietary supplements' or 'dietary ingredients.'' You can listen to the full episode here. The FDA does have some power to take action against supplements that are adulterated or misbranded, but only after they are on the market. 'The FDA is in the position of looking for problems out in the marketplace after supplements are being sold, and then working to try to identify the products, which is incredibly difficult, because they don't have an effective system to detect harms, and then to try to remove those dangerous products,' Cohen said. While regulations exist, 'it's companies selling us whatever they choose to declare and identify as a dietary supplement,' he said. He called it 'a system that emphasizes access and minimizes the assurances of safety or at least leaves safety in the manufacturer's court.' What should consumers do before plunking down money at the health food store? Cohen explains what you should know about product claims and offers five tips when deciding which supplements to buy, keep or toss. How the FDA can and can't regulate the supplement industry doesn't even address the issue of what actually works and what you might actually need. Some studies show certain well-known vitamins or minerals can help particular conditions, but often recommendations change after new information comes to light. Good-quality clinical trials are expensive and hard to conduct (or data are gathered through epidemiological studies, so cause and effect can't be definitively proven); they rarely are done on less-well known (or blended) supplements. The label required on US supplements, in essence, occupies a gray zone, and the average consumer might not know that they are expected to read between the lines. A product label is permitted to contain a claim about the effect of the supplement on the body's structure or function (for example, 'helps support flexibility'). But the label 'may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases,' according to DSHEA. The law allows manufacturers to make those gray-zone, health-adjacent claims as long as they include a disclaimer that the claim has not been evaluated by the FDA. The situation is not likely to change any time soon. 'A core concern I have with the current regulatory framework that really inhibits us moving forward is that there is no incentive for manufacturers to conduct carefully done clinical trials,' Cohen said. 'One thing we haven't talked about yet is that one other part of the law is that supplements can claim to have health effects without it being proven in humans,' he noted. 'Since you can do that without doing a clinical trial, what's the incentive to invest in all that money, millions of dollars, to do a clinical trial? 'The only potential outcome is negative — because if you're right, you were already advertising it as it was beneficial to your health and all you did was to prove that your claim is correct,' he said. 'But more likely, if it turns out it doesn't really work like you had hoped it did, and all that money is wasted, and then you've got a problem. But the good news, I guess, is that you can still keep on selling it as if it does work, even when the studies come out negative.' The FDA has certain best practice rules in place when it comes to manufacturing, but it lacks oversight to ensure what is on the label is actually in the supplement, according to Cohen. That's why it's essential to choose supplements with a discerning eye. 'Toss away all supplements that do not include the official stamps from NSF (NSF International) or USP (US Pharmacopeia),' said Cohen said via email, referring to two independent, not-for-profit agencies that test supplements and then certify them. 'The FDA does not test supplements before they are sold,' he said. 'Unless supplements have been certified by a high-quality third-party organization, such as NSF or USP, it is not possible to know what's really inside the bottle.' 'Both those groups do deep dives into the quality of manufacturing,' Cohen told Gupta on the podcast. 'They look at the original ingredients that are coming (so that) when consumers are going in to purchase this online or in a store, that the label accurately represents what's in the product.' Another reputable third-party tester is But remember, none of these organizations test for efficacy, that is whether a supplement does what it claims to do. 'If you say something's good for gut health or will boost your immunity, those claims are not assessed by these companies,' Cohen told Gupta. 'The companies are just looking at — is the powder in the bottle the same as what's on the label?' A good rule of thumb when checking ingredient lists for supplements is less is more. 'Toss away all supplements that list two or more botanical ingredients on the label,' Cohen said. 'Manufacturers are not required to share the details of each ingredient when mixing multiple botanical ingredients in the same supplement,' he said. For example, you might not know the ratio of one ingredient to the others, how fresh each one is, or the process by which each is prepared and then blended together. 'The only way to ensure that sufficient information about the botanical is provided on the label, (is to) select only single-ingredient supplements,' he added. When you shop for dietary supplements, avoid products that claim in vague language to promote health benefits, Cohen said, such as 'boosts immunity' or 'improves cognition.' 'Supplement claims are not vetted by the FDA, and manufacturers do not need to perform studies of the supplement to demonstrate any benefit before selling the product,' he noted. Cohen said it's best to avoid supplements with these types of claims and instead 'obtain information about benefits and risks of supplements from a reliable, independent source, such as the National Institutes of Health's Office of Dietary Supplements.' Supplements can lose potency or, like fish oil, even go bad. 'Toss away all supplements that are past their expiration date,' Cohen said. 'Supplements past their expiration date are unlikely to have the correct amount of active ingredients as listed on the label,' he explained. It's important to incorporate any supplements prescribed by your doctor in your routine on a consistent basis. Following your annual wellness visit, your physician might say, for example, that you need more iron or vitamin B12 or vitamin D based on bloodwork. 'Take all the supplements that your doctor recommends,' Cohen said. 'Many vitamin and mineral supplements are key to treating a variety of health conditions, so if your doctor recommends one or more supplements, remember to take them regularly,' he said. Most healthy people probably don't need to take even a multivitamin, according to Cohen. 'My clinical experience is that regardless of how people are eating, as long as people are not on a highly restrictive diet, that they are going to get sufficient vitamins and minerals,' he told Gupta. 'Even if they're eating mainly manufactured or processed foods, or they're growing everything in their own garden, because of supplementation (in the food system), I'm not seeing serious vitamin deficiencies in my practice.' Of course, it is not a bad idea to check with your doctor before you start a new supplement, and certainly let them know during your annual exam what you are currently taking. Some supplements can interact with certain medications, while others shouldn't be used by people with certain health conditions. We hope these five tips help you make better sense of supplements. Listen to the full episode here. Join us next week for a new episode of the Chasing Life podcast. CNN Podcasts' Madeleine Thompson and Kyra Dahring contributed to this report.
Yahoo
a day ago
- Business
- Yahoo
Takeda Pharmaceutical (TAK) Gets GAMMAGARD LIQUID ERC Approved by FDA
Takeda Pharmaceutical Company Limited (NYSE:TAK) is one of the 13 Best Japanese Stocks to Buy According to Hedge Funds. On June 30, Takeda Pharmaceutical Company Limited (NYSE:TAK) announced that it has received US Food and Drug Administration (FDA) approval for AMMAGARD LIQUID ERC with less than or equal to 2 micrograms per milliliter in a 10% solution. AMMAGARD LIQUID ERC is the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content that is approved for use as a replacement therapy for people aged two years and older who have primary immunodeficiency (PI). A scientist studying a DNA sample under a microscope in a laboratory. As a ready-to-use liquid, GAMMAGARD LIQUID ERC can be administered intravenously or subcutaneously. This can help make treatment easier for patients and healthcare providers by removing the need for reconstitution. Takeda Pharmaceutical Company Limited (NYSE:TAK) expects the commercialization of GAMMAGARD LIQUID ERC to start in the US in 2026. The company expects to launch it in the European Union in 2027, where it has already been approved by the European Medicines Agency (EMA) as DEQSIGA. Takeda Pharmaceutical Company Limited (NYSE:TAK) is a Japanese multinational biopharmaceutical company that discovers and develops a range of treatments. The company's core therapeutic and business areas include gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. While we acknowledge the potential of TAK as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best American Semiconductor Stocks to Buy Now and 11 Best Fintech Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Time of India
a day ago
- Health
- Time of India
Trump admin's healthy push: Ice-cream to go dye-free; plant-based colours to be used instead
In what the Trump administration called a 'major announcement', the US dairy industry has agreed to voluntarily remove synthetic dyes from ice-cream products, a shift officials say could lead to healthier options, especially for children. 'This is relevant to my favorite food, which is ice-cream,' said US health secretary Robert F Kennedy Jr. 'Since we came in about five and a half months ago and started talking about eliminating dyes and other bad chemicals from our food, we've had this extraordinary response from our industry,' The Guardian quoted the official. More than 40 ice-cream manufacturers have reportedly signed on to the voluntary agreement, according to representatives from the dairy sector. Kennedy also hinted at upcoming dietary guidelines that will 'elevate' dairy, including full-fat products, to reflect their contribution to children's health. Dr Marty Makary, head of the US Food and Drug Administration (FDA), also revealed that the agency has approved a new plant-based dye, 'gardenia blue', which may serve as a natural alternative. The health benefits of full-fat dairy remain contested. While longstanding guidance has warned against excessive intake of saturated fats, sugars and refined grains, a growing number of researchers argue that full-fat dairy may not be as harmful as once believed. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Providers are furious: Internet access without a subscription! Techno Mag Undo This view is echoed by the dairy industry, which has invested heavily in nutrition research and pushed back on government restrictions on dairy in school meals since the Obama era. In rural farming communities, the debate is more than academic. Farmers have displayed hand-painted hay bales with slogans such as 'Drink whole milk 97% fat free,' underlining the cultural and economic importance of dairy in these regions. The Trump administration's close ties with the dairy sector are well-documented. Back in 2019, former agriculture secretary Sonny Perdue famously toasted dairy lobbyists with chocolate milk to mark the return of flavoured milk to school cafeterias. 'This is a great day for dairy and a great day for 'make America healthy again,'' said Michael Dykes, president and CEO of the International Dairy Foods Association. 'We're so happy with the voluntary industry-led commitment.' Still, the administration's preference for voluntary deals has met resistance elsewhere. Kennedy's efforts to secure similar commitments from confectionery giant Mars, maker of Skittles and M&M's, fell flat. Health experts have also raised doubts on whether voluntary pacts with private health insurers will deliver meaningful change for Americans. Stay informed with the latest business news, updates on bank holidays and public holidays . AI Masterclass for Students. Upskill Young Ones Today!– Join Now
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Business Standard
4 days ago
- Health
- Business Standard
US aid cuts pause HIV vaccine research in S Africa, to have global impact
Just a week had remained before scientists in South Africa were to begin clinical trials of an HIV vaccine, and hopes were high for another step toward limiting one of history's deadliest pandemics. Then the email arrived. Stop all work, it said. The United States under the Trump administration was withdrawing all its funding. The news devastated the researchers, who live and work in a region where more people live with HIV than anywhere else in the world. Their research project, called BRILLIANT, was meant to be the latest to draw on the region's genetic diversity and deep expertise in the hope of benefiting people everywhere. But the $46 million from the US for the project was disappearing, part of the dismantling of foreign aid by the world's biggest donor earlier this year as President Donald Trump announced a focus on priorities at home. South Africa hit hard by aid cuts South Africa has been hit especially hard because of Trump's baseless claims about the targeting of the country's white Afrikaner minority. The country had been receiving about $400 million a year via USAID and the HIV-focused PEPFAR. Now that's gone. Glenda Grey, who heads the Brilliant program, said the African continent has been vital to the development of HIV medication, and the US cuts threaten its capability to do such work in the future. Significant advances have included clinical trials for lenacapavir, the world's only twice-a-year shot to prevent HIV, recently approved for use by the US Food and Drug Administration. One study to show its efficacy involved young South Africans. We do the trials better, faster and cheaper than anywhere else in the world, and so without South Africa as part of these programs, the world, in my opinion, is much poorer, Gray said. She noted that during the urgency of the COVID-19 pandemic, South Africa played a crucial role by testing the Johnson & Johnson and Novavax vaccines, and South African scientists' genomic surveillance led to the identification of an important variant. Labs empty and thousands are laid off A team of researchers at the University of the Witwatersrand has been part of the unit developing the HIV vaccines for the trials. Inside the Wits laboratory, technician Nozipho Mlotshwa was among the young people in white gowns working on samples, but she may soon be out of a job. Her position is grant-funded. She uses her salary to support her family and fund her studies in a country where youth unemployment hovers around 46 per cent. It's very sad and devastating, honestly," she said of the US cuts and overall uncertainty. We'll also miss out collaborating with other scientists across the continent. Professor Abdullah Ely leads the team of researchers. He said the work had promising results indicating that the vaccines were producing an immune response. But now that momentum, he said, has all kind of had to come to a halt. The BRILLIANT program is scrambling to find money to save the project. The purchase of key equipment has stopped. South Africa's health department says about 100 researchers for that program and others related to HIV have been laid off. Funding for postdoctoral students involved in experiments for the projects is at risk. South Africa's government has estimated that universities and science councils could lose about $107 million in US research funding over the next five years due to the aid cuts, which affect not only work on HIV but also tuberculosis another disease with a high number of cases in the country. Less money, and less data on what's affected South Africa's government has said it will be very difficult to find funding to replace the US support. And now the number of HIV infections will grow. Medication is more difficult to obtain. At least 8,000 health workers in South Africa's HIV programme have already been laid off, the government has said. Also gone are the data collectors who tracked patients and their care, as well as HIV counselors who could reach vulnerable patients in rural communities. For researchers, Universities South Africa, an umbrella body, has applied to the national treasury for over $110 million for projects at some of the largest schools. During a visit to South Africa in June, UNAIDS executive director Winnie Byanyima was well aware of the stakes, and the lives at risk, as research and health care struggle in South Africa and across Africa at large. Other countries that were highly dependent on US funding including Zambia, Nigeria, Burundi and Ivory Coast are already increasing their own resources, she said. But let's be clear, what they are putting down will not be funding in the same way that the American resources were funding," Byanyima said.
