
Aqua Illinois unsafe drinking water alert lifted for south suburbs
Aqua Illinois says its water is safe to drink in the south suburbs again.
The utility company initially issued the unsafe drinking water alert on June 7 for Will and Kankakee counties, then expanded it to University Park.
Aqua Illinois said elevated levels of nitrates in the Kankakee River, which may be harmful to infants under 6 months old, prompted the alert, which also warned not to boil the water, as boiling water can actually worsen the elevated nitrate levels.
Friday the utility said customers can now resume normal use of their drinking water as river nitrate levels at the Illinois EPA monitoring location is below the required level and internal data shows all other monitoring locations are also under the nitrate limit.
No more bottle water will be distributed, Aqua Illinois said.
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Associated Press
3 hours ago
- Associated Press
Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 15, 2025-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. Sarepta is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for ELEVIDYS. This panel will evaluate data and assess our proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. Suspending Shipments of ELEVIDYS for Non-Ambulatory Patients: Sarepta is temporarily suspending shipments of ELEVIDYS for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after ELEVIDYS infusion, along with post-treatment monitoring, remains the same. ENVISION Study Paused: Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). FDA concurs with this action. The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume. ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating ELEVIDYS in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy. In the U.S., it serves as the confirmatory trial required under the FDA's accelerated approval pathway for non-ambulatory patients. 'Our paramount priority is the safety and well-being of the patients we serve. We are taking immediate, decisive steps to better understand and mitigate the risk of acute liver failure, including enhancing the immunosuppressive regimen, for those with Duchenne who are non-ambulatory,' said Louise Rodino-Klapac, Ph.D., chief scientific officer and head of research & development, Sarepta. 'We are deeply saddened by the loss of a second patient and extend our heartfelt condolences to the patient's family and his care team during this incredibly difficult time. Duchenne muscular dystrophy is a devastating disease that profoundly affects lives and often cuts them far too short. With more than 900 individuals treated to-date, we know how much hope families place in new treatment options like ELEVIDYS – and we are committed to honoring that hope by acting swiftly, guided by scientific rigor and the insights of leading experts, to strengthen safety for all future patients.' Commitment to Long-Term Safety and Understanding Sarepta remains committed to a thorough approach and the highest standards of patient safety and scientific rigor. The event has been reported to FDA and global health authorities and will inform ongoing discussions around a potential label update to reflect the risk of severe ALF and additional immune management strategies for non-ambulatory patients. While elevated liver enzymes are a known class effect of all AAV-based gene therapies, the exact mechanism behind AAV-related liver toxicity remains unclear. Current evidence suggests it is likely driven by an adaptive immune response. The Company will provide additional updates as appropriate. Investor Conference Call Details Sarepta will be hosting a conference call and webcast to discuss this update and provide an update on the Company's business on Monday, June 16, 2025, at 8:00 am Eastern time. The event will be webcast live under the investor relations section of Sarepta's website at: and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Acute Serious Liver Injury: Immune-mediated Myositis: Myocarditis: Preexisting Immunity against AAVrh74: Adverse Reactions: Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to source version on CONTACT: Investor Contact: Ian Estepan 617-274-4052 [email protected] Contacts: Tracy Sorrentino 617-301-8566 [email protected] Hoeger 617-710-3898 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: INFECTIOUS DISEASES HEALTH GENETICS PHARMACEUTICAL CLINICAL TRIALS SOURCE: Sarepta Therapeutics, Inc. Copyright Business Wire 2025. PUB: 06/15/2025 01:00 AM/DISC: 06/15/2025 01:01 AM
Yahoo
5 hours ago
- Yahoo
My mother-in-law is still driving despite a near miss. How can we stop her?
My mother-in-law is still driving. After a near miss a few months ago, we told her she was no longer to drive with our children in her car, and we were grateful that she immediately agreed – but also puzzled that she didn't consider stopping altogether. A year ago she developed cataracts and was told to stop driving. She coped well, using her free bus pass and walking, which she doesn't mind doing and knows is good for her health. However, when the cataract had been treated, the doctor told her she could drive again. Recently, her car insurance was renewed, and she paid a hefty sum that we felt would have been better spent on taxis. All her life my mother-in-law has been 'useful', and she is very proud that her four children have grown up to also be kind, helpful people. She continues to drive because it is useful, and she offers lifts to elderly friends which we fear is an accident waiting to happen. I love her dearly and would hate her to come to any harm. We live slightly farther away than her other children, who help her the most with finances and some practical things. We realise that if she stopped driving she might need more help, which we don't have the capacity to provide. However, we feel the risks to herself and the community outweigh any inconvenience to the wider family. Please give us a script we can use to express ourselves in a new way. Her other children continue to be dismissive of our concerns, and I don't know what to say to convince her that it's her turn to be looked after and chauffeured about by others. This has become an increasingly common problem. I remember some years ago, talking to psychotherapist Chris Mills about a friend's mum who had dementia and was no longer safe to drive. He said something I never forgot: 'If we were talking about a gun, no one would hesitate over taking it off her. Yet a car can also kill.' So I went to Mills again with your letter. 'Your request for a 'script' is the easy bit,' he said 'as it doesn't sound as if you've yet said to your mother-in-law words to the effect of, 'We don't believe your driving is safe any more, and we'd like you to give up your car now and use other ways of getting around, before someone gets hurt.' It is absolutely your business to say this, because it is your own concerns that you're reporting.' I'm not clear why you are taking this on, rather than your husband – why you have written this letter, not him Realising you are at the stage of life where you can no longer do things is a huge deal. So you're right to tread carefully. I would stress how much you care about her and the help she is still able to give you. 'But,' continued Mills, 'before going ahead with this, I'm not clear why you are taking this on, rather than your husband – why you have written this letter, not him. He is her son and his siblings' brother. There is usually someone in the family who is the 'canary' and sees things before others can. But might you run the risk of being cast as the over-fussy interfering in-law?' Related: My mother says she'll disinherit me unless I split with my partner. What should I do? Mills suggests your husband could contact her GP to request a reassessment of her driving ability. 'There's no guarantee that your mother-in-law or your husband's siblings will approve of any of this, but that shouldn't prevent him from doing what he believes is the right thing – ie in the absence of his mother's agreement, ensuring that the decision about her potentially dangerous driving is passed to the relevant authority.' In England and Wales, the DVLA issues licences and can revoke them or ask for medical confirmation that someone is fit to drive. You can also report your concerns to the DVLA via their website. Remember that this will be about so much more than just driving, so please reassure your mother-in-law about how much she is still needed. • Every week, Annalisa Barbieri addresses a personal problem sent in by a reader. If you would like advice from Annalisa, please send your problem to Annalisa regrets she cannot enter into personal correspondence. Submissions are subject to our terms and conditions. The latest series of Annalisa's podcast is available here. • Comments on this piece are pre-moderated to ensure the discussion remains on the topics raised by the article. Please be aware that there may be a short delay in comments appearing on the site.
Yahoo
11 hours ago
- Yahoo
Dollarama-sold Oracare Baby Brush toothbrush recalled for choking hazard
Health Canada has recalled a baby toothbrush sold in Dollarama stores across the country due to a possible choking hazard. The federal health agency says the Oracare Baby Brush toothbrush has a manufacturing defect that can cause the toothbrush to break into two pieces. It says Dollarama has received one consumer complaint about the manufacturing defect but there have not been choking incidents reported to the company or Health Canada. Dollarama also says it will no longer import or sell the product. Health Canada advises consumers to stop using the toothbrush immediately and to seek immediate medical attention if injury from using the product occurs. The agency says it will continue to monitor the situation. This report by The Canadian Press was first published June 14, 2025. The Canadian Press Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data