Walmart Recalls Shrimp From Indonesia Over Radioactive Contamination Fears
The U.S. Food and Drug Administration asked Walmart to pull three lots of Great Value brand frozen shrimp from stores after federal officials detected Cesium-137, a radioactive isotope, in shipping containers and a sample of breaded shrimp imported from Indonesia.
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Tivic Receives Two Investigational New Drug Applications for Entolimod™ for the Treatment of Acute Radiation Syndrome (ARS) and Advanced Cancers
INDs Transferred from Statera Biopharma Advance Entolimod for ARS Along Regulatory Pathway and Enable Pursuit of Clinical Trial Program in Neutropenia and Lymphocyte Exhaustion FREMONT, Calif., August 20, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead candidate, Entolimod™. The two INDs cover the use of Entolimod to treat acute radiation syndrome, including both hematopoietic (ARS-H) and gastrointestinal (ARS-GI) sub-syndromes, and the use of Entolimod to treat advanced cancers, including as an anti-tumor agent and for conditions resulting from cancer treatments. "Transfer of these INDs to Tivic allows us to formally engage the FDA regarding Entolimod's regulatory pathway and enables clinical trials in neutropenia, lymphocyte exhaustion, and other cancer-related conditions," stated Tivic CEO, Jennifer Ernst. "While the IND for advanced cancers allows exploration of Entolimod's anti-tumor activity, building on prior developments, we remain focused in the near-term on Entolimod's first indication--acute radiation syndrome." About Entolimod Entolimod is a novel TLR5 agonist that triggers NF-kB signaling, activating antiapoptotic and cell protective mechanisms. Under the FDA's Animal Rule, Entolimod has been the subject of extensive trials for the treatment of acute radiation syndrome (ARS), and has demonstrated robust survival, enhanced GI tract recovery and improved hematopoiesis in animal models. Entolimod has been granted Fast Track Designation for ARS. Tivic also holds the exclusive rights for Entolimod for the treatment of neutropenia and has the option to license additional indications, including lymphocyte exhaustion, immunosenescence, and chronic radiation syndrome. About Tivic Tivic's dual platform strategy utilizes the body's biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system. Tivic's biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track designation and is in late-stage development. Tivic's bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with the its partners; timing and success of clinical trials and study results; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; regulatory requirements and pathways for approval; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading "Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. View source version on Contacts Investor Contact: Hanover International, Media Contact: Deanne Eagle or Laura Min Jacksonmedia@ Error while retrieving data Sign in to access your portfolio Error while retrieving data
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Vivani Medical CEO Adam Mendelsohn to Present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025
ALAMEDA, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) ('Vivani' or the 'Company'), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that CEO Adam Mendelsohn, Ph.D., will present a company overview and conduct partnering meetings at the H.C. Wainwright 27th Annual Global Investment Conference, taking place from September 8-10, 2025 in New York, New York. Details of Dr. Mendelsohn's presentation are as follows: Date: Wednesday, September 10, 2025Time: 1:00 PM - 1:30 pm, Eastern TimeLocation: Lotte New York Palace Hotel, Holmes I - 4th Floor Dr. Mendelsohn will highlight Vivani's portfolio of miniature, ultra long-acting drug implants, powered by its proprietary NanoPortal™ drug implant technology. These innovative implants are designed to address poor medication adherence and improve patient outcomes in chronic disease management. The Company is prioritizing the advancement of NPM-139, a novel semaglutide implant, with clinical development expected to begin in 2026, pending regulatory clearance. More information about the H.C. Wainwright 27th Annual Global Investment Conference can be found at About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Today, medication non-adherence affects approximately 50% of patients. Vivani's priority product candidate, NPM-139, is a miniature, six-month, subdermal, GLP-1 (semaglutide) implant under development for chronic weight management in obese or overweight subjects. NPM-139 has the added potential for once-yearly dosing. Vivani's emerging pipeline also includes NPM-115 (exenatide implant) for chronic weight management in obese and overweight individuals, and NPM-119, an exenatide implant program for the treatment of type-2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability and loss of efficacy. Forward-Looking Statements This press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that in this press release, including statements regarding Vivani's business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 Phase 1 study and reporting of study results, Vivani's emerging development plans for NPM-139, NPM-115, NPM-119 or Vivani's plans with respect its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani's current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani's control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani's products, including NPM-139, NPM-115, and NPM-119; delays and changes in the development of Vivani's products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani's development activities, including Vivani's ability to commence clinical development of NPM-139; risks related to the initiation, enrollment and conduct of Vivani's planned clinical studies and the results therefrom; or Vivani's history of losses and Vivani's ability to access additional capital or otherwise fund Vivani's business. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business Officerinfo@ 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@ 506-8462 Media Contact:Mark CorbaeICR 682-8288
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Elysium Therapeutics Completes Pre-IND Meeting with FDA for First-Ever Technology Designed to Combat Oral Fentanyl Overdose
Reports alignment with FDA on next steps to progress clinical program for SOOPR™ as a potentially novel rescue therapy for oral fentanyl overdose LYONS, Colo., Aug. 20, 2025 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to prevent and reverse overdoses caused by highly potent, synthetic opioids especially when ingested orally, today announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) focused on a planned first-in-human clinical trial investigating SOOPR™ (Synthetic Opioid Overdose Protection and Reversal) as a rescue treatment for overdoses brought on by synthetic opioids, including fentanyl. "We are grateful for the productive conversation with the FDA and are confident that we have a clear path forward for our SOOPR clinical program," said Greg Sturmer, CEO of Elysium Therapeutics. "We look forward to receiving the formal minutes from our meeting, completing IND-enabling studies, and filing the IND application in the coming year." SOOPR is a rapid-onset, long-acting rescue agent specifically designed to prevent and reverse overdoses from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 12 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization and severe withdrawal symptoms commonly associated with nalmefene and high-dose naloxone products. SOOPR is also designed to provide protection from same-day re-use of opioids. Data from in vivo proof-of-concept studies of SOOPR demonstrated a more rapid onset of action versus naloxone and a significantly longer duration of action. This profile is especially useful in counteracting oral fentanyl overdoses associated with prolonged fentanyl absorption and exposure that often outlast the short-acting profile of Narcan. Sturmer added: "Improved rescue therapies designed specifically to address fentanyl overdose are urgently needed as currently available short-acting opioid agonists, such as Narcan, do not align with the long-acting profile of synthetic opioid drugs and often induce severe withdrawal symptoms. As a result, 20 to 45% of fentanyl overdose victims initially rescued with naloxone experience a re-narcotization event, which can lead to brain damage and death, and approximately 40% of decedents from an opioid overdose have received Narcan." About Elysium Therapeutics Elysium is an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral synthetic opioids, including fentanyl. Elysium is working to establish new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead technology, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), is a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. In addition, Elysium is developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain. For more information, please visit ContactTiberend Strategic Advisors, Media David Irish Casey McDonald (231) 632-0002 (646) 577-8520 dirish@ cmcdonald@ View original content to download multimedia: SOURCE Elysium Therapeutics 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
