logo
Recalled baby products still on Nevada shelves, officials warn

Recalled baby products still on Nevada shelves, officials warn

Yahoo28-04-2025

LAS VEGAS (KLAS) — A baby product recalled earlier this year due to a potential choking hazard is still being found on store shelves in Nevada, according to state health officials.
Gerber Products Company issued a recall for all batches of its Soothe N Chew Teething Sticks on Jan. 31 after reports of choking incidents involving babies and young children. Despite the recall, the U.S. Food and Drug Administration (FDA) confirmed this week that some retailers and online sellers are still offering the product for sale.
On Friday, state and local inspectors launched visits to more than 90 grocery and discount stores across Nevada, working to remove the recalled products.
'When inspectors find the product in a store we will ask the operator to remove them from the shelves voluntarily,' Mark Ports, a state environmental health supervisor, said. 'Otherwise, our staff will place a legal hold on the product and remove it from the shelves.'
Parents who have purchased any of the Soothe N Chew® Teething Sticks products are urged not to feed them to their children and can return them to the retailer for a full refund.
For more information about the recall, visit the Food and Drug Administration.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Bavarian Nordic Initiates Phase 3 Study of Chikungunya Vaccine in Children
Bavarian Nordic Initiates Phase 3 Study of Chikungunya Vaccine in Children

Business Upturn

timean hour ago

  • Business Upturn

Bavarian Nordic Initiates Phase 3 Study of Chikungunya Vaccine in Children

First children vaccinated in clinical study seeking to expand the target population for the chikungunya vaccine. COPENHAGEN, Denmark, June 12, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a Phase 3 clinical study of its single-dose, virus-like particle (VLP) chikungunya vaccine, CHIKV VLP in children 2 to 11 years of age. This first trial of CHIKV VLP in a pediatric population aims to expand the target population for the vaccine, currently approved for persons 12 years of age and older in the US, EU and United Kingdom under the trade name VIMKUNYA®. The global, randomized, double-blind, placebo-controlled study (NCT07003984), sponsored by Bavarian Nordic, will evaluate the safety and immunogenicity of CHIK VLP vaccine in 720 children 2 to 11 years of age for two years. Primary results from the study are anticipated in the first half of 2028. Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Upon the successful approvals earlier this year of our chikungunya vaccine for persons aged 12 and older, we are pleased to initiate this Phase 3 study in children for whom there are currently no vaccines available to prevent against chikungunya. This study represents a significant part of our commitment to the further development of the vaccine to help ensure access for people of all ages.' About VIMKUNYA® Chikungunya vaccine (recombinant, adsorbed) VIMKUNYA (CHIKV VLP) is the first and only virus-like particle (VLP) vaccine for the prevention of chikungunya disease in individuals aged 12 years and above. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination. VIMKUNYA is the only single-dose vaccine against chikungunya disease available in a prefilled syringe. VIMKUNYA does not contain viral genetic material and is therefore non-infectious and unable to cause disease, ensuring a broad range of people can benefit from vaccination. The vaccine was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 20251,2 and the United Kingdom in May 20253. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65-year-olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12–64-year-old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain4,5. About chikungunya Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years6. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years7. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide8. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile9. About Bavarian Nordic Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contact investors: Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected], Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600 Contact media: Nicole Seroff, Vice President Corporate Communications, [email protected], Tel: +45 53 88 06 03 1 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 2 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. 3 Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom. 4 Richardson JS, et al. Chikungunya Virus VLP Vaccine: Phase 3 Trial in Adolescents and Adults. medRxiv 2024.10.11.24315179. 5 Tindale LC, et al. Chikungunya Virus VLP Vaccine: Phase 3 Trial in Adults ≥65 Years of Age. medRxiv 2024.10.10.24315205. 6 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 7 European Centre for Disease Prevention and Control. Chikungunya virus disease. 8 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 9 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/ PMID: 38711542; PMCID: PMC11070701. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD
Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Yahoo

time6 hours ago

  • Yahoo

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD). In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing. In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication. Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company's expectations at product launch. Mesoblast has continued to expand coverage for Ryoncil® to over 220 million US lives insured by commercial and government payers. To date, 37 of the 51 States provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process. The remainder will come online July 1, 2025, with mandatory coverage for all 24 million lives. 'We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs,' said Mesoblast Chief Executive Dr. Silviu Itescu. 'We are also encouraged by the strength of the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch. We will be providing an update on sales of Ryoncil® in our quarterly activities report at the end of next month.' About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast's RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@

SNHD identifies 4 cases of salmonella in Clark County linked to multi-state outbreak
SNHD identifies 4 cases of salmonella in Clark County linked to multi-state outbreak

Yahoo

time7 hours ago

  • Yahoo

SNHD identifies 4 cases of salmonella in Clark County linked to multi-state outbreak

LAS VEGAS (KLAS) — The Southern Nevada Health District identified several cases of salmonella in Clark County in connection to a multi-state outbreak linked to brown eggs. The SNHD identified four cases of salmonella in Clark County as of Wednesday as the Centers for Disease Control and Prevention (CDC) leads a coordinated investigation into the outbreak linked to brown cage-free and brown-certified organic eggs. As of Wednesday, at least 50 salmonella-related illnesses have been reported nationwide. Salmonella can cause serious illness and symptoms typically begin six hours to six days after exposure. Symptoms include diarrhea, fever and stomach cramps. Salmonella outbreak tied to eggs sickens dozens across 7 states SNHD said most people recover without medical treatment, but some, especially young children, older adults, and people with weakened immune systems are at greater risk of developing severe illnesses or complications that may require hospitalization. The CDC is advised the following: Do not eat any recalled eggs. Throw them away or return them to where you bought them. Wash items and surfaces that may have touched the recalled eggs using hot soapy water or a dishwasher. Call your health care provider if you have any of these severe Salmonella symptoms: Diarrhea or vomiting lasting more than two days A fever higher than 102°F Bloody diarrhea or bloody urine So much vomiting that you cannot keep liquids down Signs of dehydration, such as not peeing much, dry mouth and throat, and feeling dizzy when standing up For more information about the outbreak, including safety tips and product recall details, is available on the CDC's website or on the U.S. Food and Drug Administration website. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store