Merck Says It Wins US Approval for Shot to Prevent Infant RSV
Merck & Co. said it won US approval for a shot that protects against RSV, the most common cause of hospitalization among infants.
The Food and Drug Administration was considering Merck's preventative for RSV, or respiratory syncytial virus, for children under the age of 1. In clinical trials, Merck's treatment reduced the rate of RSV infection by 60% compared with placebo over five months.
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Health Line
an hour ago
- Health Line
What to Know About Aluminum in Deodorant and Antiperspirant
Unlike antiperspirants, deodorants don't contain aluminum. There's no link between aluminum and cancer or most other health conditions, but those with severe kidney ailments shouldn't use antiperspirants. A lot of people use deodorant or antiperspirant every day. These two products are both effective ways to manage sweating, but they work differently: Deodorants deodorize, or make sweat smell better. Antiperspirants make you sweat, or perspire, less. The article explores the differences between deodorants and antiperspirants and the potential risks of products containing aluminum. Is aluminum in deodorant or antiperspirant? Aluminum isn't found in deodorants. Most antiperspirants, on the other hand, do contain aluminum. Two-in-one products — meaning they're both a deodorant and an antiperspirant — will also include aluminum. Antiperspirants help you sweat less by blocking your pores. Pores are the tiny openings in your skin which sweat comes out of. Antiperspirants contain many ingredients, including aluminum salts. These salts dissolve on your skin and 'melt' into your pores, helping to plug up your pores and stop some of your sweat. Doctors and dermatologists use prescription antiperspirants to help treat health conditions that cause too much sweating, like hyperhidrosis. These antiperspirants can contain 10 to 30% aluminum chlorohydrate, a common type of aluminum salt. This is much higher than the amount of aluminum in over-the-counter (OTC) antiperspirants. Does aluminum stop you from sweating out cancer-causing toxins? Some proponents of aluminum-free products claim that aluminum prevents you from sweating out toxins that could potentially cause cancer. But cancerous toxins aren't removed from the body through the axillary (underarm) lymph nodes. The kidneys and liver help remove these toxins from the body, and they're eventually expelled through the urine and feces. What does the research say about the risks of aluminum? The most common concern about aluminum in antiperspirants and other topical products is that it's linked to breast cancer. However, there's little evidence that typical exposure to aluminum causes cancer or any other health condition. Breast cancer The American Cancer Society notes that there's no scientific evidence that using antiperspirants causes or worsens breast cancer. But some research has suggested that aluminum, at least in large amounts, may be harmful. A study from 2017 asked hundreds of women how often they used antiperspirants and for how long. The group with breast cancer self-reported that they used antiperspirants several times a day, beginning before the age of 30 years. The group of women without breast cancer self-reported that they used antiperspirants less often. Both groups had aluminum salts in their breast tissue. But the women who had breast cancer in the upper outer quadrant and used aluminum products more frequently had higher levels of aluminum in their breast tissue than women without cancer. The researchers were unable to rule out a reverse causation effect. This means it's possible that aluminum simply accumulates in breast tumors and doesn't necessarily cause or increase your risk for breast tumors. A 2018 study suggests that too much aluminum may change how the body makes or responds to the female hormone estrogen. Changes in the endocrine (hormone) system can be harmful to your body over time. On the other hand, other research also shows that the skin absorbs very little (0.01–0.06 percent, according to one literature review) of the aluminum applied to it via products like antiperspirant. More conclusive research into aluminum's effect on cancer is needed. Kidney disease The Food and Drug Administration (FDA) requires manufacturers of antiperspirant products to add a warning to their label that states: 'Ask a doctor before use if you have kidney disease.' This has led some people to believe that the aluminum in these products may also increase the risk of kidney disease. But aluminum in antiperspirant poses no kidney-related risk to the average person. Your kidneys help get rid of aluminum and other waste products in your body. In addition, the National Kidney Foundation (NKF) confirms that it's not possible to absorb enough aluminum through your skin to damage your kidneys. Should you avoid antiperspirants if you have chronic kidney disease (CKD)? The NKF advises people to avoid skin care products with aluminum if they already have stage 4 kidney disease. At this stage, the kidneys are working at a level of only 30% and can't clear out aluminum (also present in kidney medications and dialysis fluid) fast enough. This may allow it to build up in your body and trigger health problems. Bone disease Elevated aluminum levels from chronic dialysis can lead to weakened bones in people with kidney disease, according to a 2018 study. This bone disease is known as osteomalacia. Memory disorders According to a 2016 literature review, chronic exposure to aluminum may increase your risk of developing Alzheimer's disease. A 2018 literature review found that adults with Alzheimer's disease had higher levels of metals like aluminum, mercury, and cadmium in their blood. But these metals were thought to be from their environment. More research is needed to find out whether aluminum or other metals in the body are linked to memory disorders. Do aluminum-free antiperspirants exist? Aluminum-free antiperspirants don't exist, but if you're looking to reduce body odor, you can do so without using an antiperspirant. Deodorants are aluminum-free. Avoid aluminum by trying one of these options: perfume-free or fragrance-free deodorant hypoallergenic deodorant baking soda deodorant, which you can make at home Other products and ingredients to consider include: How to read labels for aluminum The FDA requires manufacturers of antiperspirant products to list aluminum on their product labels. Check deodorant and skin care product labels for aluminum. You may see it under any of these names: aluminum salts aluminum compounds aluminum chlorohydrate aluminum zirconium tetrachlorohydrex gly What happens when you stop using aluminum antiperspirant If you decide to switch from a perspirant that contains aluminum to an aluminum-free deodorant, you may initially experience or notice more sweating. This is because when your sweat glands are no longer blocked by aluminum, more sweat will come out of those glands. An aluminum-free deodorant can minimize underarm odor, and frequent underarm toweling can help soak up sweat. The takeaway Antiperspirants contain aluminum to help you sweat less. Deodorants don't use aluminum as an ingredient. The research is mixed on whether the aluminum from antiperspirants can build up in your body. You're probably more likely to get aluminum from other sources, like medications. That said, there's no scientific evidence that directly links aluminum to cancers or other health conditions. Still, some of this research has led experts to advise that antiperspirant use isn't a good idea for everyone, like people who have severe kidney disease.
Medscape
an hour ago
- Medscape
Kennedy Dismisses Entire US CDC Vaccine Panel, Replacing All 17 Members
WASHINGTON (Reuters) -Health Secretary Robert F. Kennedy Jr. has fired all members sitting on a U.S. Centers for Disease Control and Prevention panel of vaccine experts and is reconstituting the committee, his department said on Monday. Kennedy removed all 17 members of the Advisory Committee on Immunization Practices, the Department of Health and Human Services said in a statement, and is in the process of considering new members to replace them. The ACIP panel is tasked with recommending which vaccines get placed on the CDC immunization schedule and who should get them, which helps determine insurance coverage. "Today we are prioritizing the restoration of public trust above any specific pro- or anti-vaccine agenda," Kennedy said. "The public must know that unbiased science — evaluated through a transparent process and insulated from conflicts of interest — guides the recommendations of our health agencies." All 17 sitting ACIP members were appointed under former President Joe Biden's administration, including 13 in 2024, HHS said. Not removing them would have prevented President Donald Trump's administration from choosing a majority of the committee until 2028. "That's a tragedy," former Food and Drug Administration Chief Scientist Jesse Goodman said of the firings. "This is a highly professional group of scientists and physicians and others... It's the kind of political meddling that will reduce confidence rather than increase confidence." Kennedy, who for many years has questioned the safety and efficacy of vaccines, making claims contrary to scientific evidence, said the change was necessary because the committee is rife with conflicts of interest and most members receive funding from drugmakers. But ACIP members are required to declare any potential or perceived conflicts of interest that arise in the course of ACIP tenure and any relevant business interests, positions of authority or other connections with organizations relevant to the work of the ACIP. "Our worst fears have been realized," said one expert with close ties to the committee, adding that the vetting of ACIP members "is very, very rigorous." Kennedy and HHS provided no specific evidence of industry conflicts of interest among departing ACIP members. The CDC's web page for conflicts of interest, last updated in March, showed that one current member had recused herself from votes on a handful of vaccines because she had worked on clinical trials for their manufacturers. ACIP will convene its next meeting June 25-27 at CDC headquarters in Atlanta, the department said. The change was first announced in an editorial written by Kennedy for the Wall Street Journal. At least one ACIP member who spoke on the condition of anonymity learned that they were being retired from the committee from the editorial and they believe none of the members had been notified by the CDC. ACIP members were required to disclose everything as part of the application process, including investments and all sources of income, the member said. Once the FDA approves vaccines for sale to the public, the ACIP role is to review data in a public meeting and vote on vaccine recommendations, which are then sent to the CDC director to sign off. The Affordable Care Act generally requires insurers to cover vaccines that are listed on the CDC vaccine schedule. (Reporting by Ahmed Aboulenein in Washington, Michael Erman in New York, and Julie Steenhuysen in Chicago; Additional reporting by Puyaan Singh in Bengaluru; Editing by Lisa Shumaker and Bill Berkrot)
Miami Herald
an hour ago
- Miami Herald
Jaguar Health Provides Update on Meeting with FDA Discussing Statistically Significant Results of Responder Analysis of Breast Cancer Patients in Phase 3 OnTarget Trial and Potential Approval Pathway for Crofelemer
Productive and collaborative discussion on proposed pathway by the company to bring crofelemer to approval for cancer therapy-related diarrhea (CTD) in patients with metastatic breast cancer receiving selected targeted therapies The currently estimated US metastatic breast cancer population would qualify as an orphan population, which aligns with company's core focus on orphan diseases Company plans to promptly pursue authorization to initiate expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer SAN FRANCISCO, CA / ACCESS Newswire / June 9, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided a recap on the company's assessment of the in-person Type C Meeting on May 28, 2025 with the Division of Gastroenterology of the U.S. Food and Drug Administration (FDA) to discuss the statistically significant responder analysis results for adult patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial. "We were very happy to take part in the face-to-face Type C Meeting, the catalyst for which was the positive data in the subpopulation of breast cancer patients from our OnTarget trial," said Lisa Conte, Jaguar's founder, president, and CEO. "Napo proposed two simultaneous potential pathways during the meeting for making crofelemer available to metastatic breast cancer patients with the significant unmet medical need of CTD: conducting a pivotal treatment trial to facilitate approval of crofelemer for CTD in this focused patient population; and the prompt pursuit of authorization to initiate an expanded access program for breast cancer patients with CTD who may not be eligible for this study, including breast cancer patients in the adjuvant and neoadjuvant settings. We are pleased with the constructive and productive discussion that took place with the FDA during the meeting. Last week the FDA formally acknowledged both of these key discussion points in correspondence to Napo. We plan to submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer." Patient advocates participated in the Type C Meeting to share their raw and personal experience with CTD, including a metastatic breast cancer patient with uncontrollable diarrhea who received a prescription for crofelemer. "The design of the protocol for OnTarget was based on a survey of cancer patients. Today there are close to 100 approved targeted cancer agents. Thanks to these amazing drugs, metastatic cancer patients are living longer, frequently rendering cancer, and CTD, chronic ailments with which to live. To deepen our understanding of the current population of metastatic cancer breast with CTD, and ensure the clinical meaningfulness of the design of the anticipated pivotal treatment trial, we plan to conduct a new survey of this cancer patient population," Conte said. The currently estimated US metastatic breast cancer population potentially qualifies as an orphan population, in alignment with the company's core focus on orphan diseases. The company therefore intends to request orphan drug designation from the FDA for the CTD indication in this population. Given crofelemer's novel and paradigm-shifting mechanism of action, the company also plans to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory approval in the US for crofelemer for CTD in metastatic breast cancer patients. "Embracing a sharp strategic focus on orphan indications seems to fit with the new administration's efforts and philosophy," said Conte. "Dr. Marty Makary, the new Commissioner of the FDA, commented in April 2025 that the agency will open a new regulatory pathway based on what he called a 'plausible mechanism,' focusing mainly on rare or incurable diseases." As expressed during the Type C Meeting, the data from the first-of-its-kind prophylactic OnTarget study is invaluable, providing new insights into the natural history of the important and debilitating side effect of CTD. Diarrhea is a common side effect of targeted cancer therapies and can lead to dose changes, treatment delays, and often cessation of lifesaving cancer therapy. The benefit to risk ratio of crofelemer is well-documented, as the active agent has been commercialized for the approved indication of HIV-related diarrhea since 2012, with no crofelemer-related reported serious adverse events. In both the US and European Union, crofelemer has been granted orphan drug designation for the orphan diseases of short bowel syndrome with intestinal failure and microvillus inclusion disease. Crofelemer has been granted orphan drug designation for treatment of diarrhea in cholera in the US, where cholera is an orphan disease. Orphan drug designation in the US qualifies the sponsor of a drug for various development incentives, including tax credits for qualified clinical testing and relief of filing fees. Additionally, orphan drug designation in the US provides a seven-year period of marketing exclusivity to the first sponsor who obtains marketing approval for the designated orphan drug. While the multicenter, double-blind, placebo-controlled OnTarget pivotal trial did not meet its primary endpoint, the subgroup of adult breast cancer patients achieved statistically significant results in the responder analysis. In the responder analysis of patients with breast cancer on targeted therapies, crofelemer CTD prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial of crofelemer for diarrhea in adults with 10 solid tumor types receiving targeted therapy with or without standard chemotherapy. The OnTarget results in breast cancer patients were the subject of a poster presentation on December 11, 2024, at the San Antonio Breast Cancer Symposium, and additional significant results in adult breast cancer patients from the OnTarget study have been accepted for presentation as an oral rapid e-poster at the Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting in June 2025 in Seattle, Washington. About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the currently estimated US metastatic breast cancer population qualifies as an orphan population, Jaguar's expectation that the company will submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer, Jaguar's expectation that it will promptly pursue authorization to initiate an expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer patients, and that the expanded access program would potentially include breast cancer patients in the adjuvant and neoadjuvant settings, Jaguar's expectation that Napo will conduct a clinical trial of crofelemer for treatment of CTD in patients with metastatic breast cancer, Jaguar's plans to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory approval in the US for crofelemer for CTD in metastatic breast cancer patients, and Jaguar's expectation that additional significant results in adult breast cancer patients from the OnTarget study will be presented at the 2025 MASCC Annual Meeting. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc.
