health and wellness
Sun Pharmaceutical Announces FDA Approval of LEQSELVI™ for Severe Alopecia Areata
Sun Pharmaceutical Industries Limited is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. This approval is a significant milestone, particularly for the roughly 300,000 Americans living with this challenging condition.
Alopecia areata is an autoimmune disorder marked by significant hair loss, often resulting in severe emotional and psychological distress. The journey to finding effective treatment options has been fraught with challenges, as the condition could be unpredictable and resistant to previous therapies.
Groundbreaking Clinical Trial Results
The FDA’s approval of LEQSELVI™ was supported by robust evidence from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which collectively enrolled 1,220 patients. These studies demonstrated that LEQSELVI™ delivered substantial hair regrowth: at 24 weeks, approximately one-third of the patients achieved 80% or more scalp hair coverage, a significant improvement from an average baseline scalp hair coverage of just 13%.
How LEQSELVI™ Works
LEQSELVI™ is a cutting-edge, twice-daily oral medication that selectively inhibits Janus Kinases (JAK) JAK1 and JAK2. This mechanism targets the immune pathways believed to contribute to the hair loss seen in severe alopecia areata, offering a new hope to those who have had limited success with existing treatments.
Safety and Efficacy
The treatment has been carefully tested for safety across several studies. While the medication is generally well-tolerated, it does carry warnings for serious infections, malignancies, thrombosis, and gastrointestinal perforations, similar to other treatments in its class. Patients and healthcare providers are advised to monitor for symptoms and manage them accordingly.
Support and Accessibility
Understanding the challenges associated with treatment access, Sun Pharma is initiating a comprehensive access program. This initiative will help eligible patients begin and adhere to their treatment, ensuring that LEQSELVI™ reaches those who need it the most. More details about this program are available on the official LEQSELVI™ website.
A Step Forward for the Alopecia Community
The approval of LEQSELVI™ represents a significant advancement for the alopecia community. Abhay Gandhi, CEO North America Business, Sun Pharma, shared his enthusiasm about bringing this innovative treatment to the market, stating it “offers a new and effective solution that will significantly enhance the options for patients and their physicians.”
Moreover, organizations such as the National Alopecia Areata Foundation (NAAF) have welcomed this new treatment option. Nicole Friedland, President and CEO of NAAF, highlighted the importance of this development, underscoring the profound impact alopecia areata can have on individuals’ lives.
Looking Ahead
With the introduction of LEQSELVI™, Sun Pharma continues to cement its position as a leader in dermatological treatments. The company’s commitment to addressing complex medical conditions through innovative solutions is evident in their rapidly expanding dermatology portfolio.
For patients suffering from severe alopecia areata, LEQSELVI™ represents not merely a new treatment option but a new hope—a possibility of regaining not just their hair, but also their confidence and quality of life.
For further details on LEQSELVI™ and patient support initiatives, visit www.LEQSELVI.com.
View the full multimedia release.
Disclaimer:
This content may include forward-looking statements, which are based on current expectations and projections about future events. Readers should not place undue reliance on these statements, as actual results may vary.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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Lifestyle
Mac and Cheese Recall: Potential Spoilage Concerns Affect Products at Major Retailers
Mac and Cheese Recall
In a recent announcement by the Food and Drug Administration (FDA), two types of macaroni and cheese products sold at major retailers have been recalled due to concerns over potential spoilage. The recall affects Reser’s American Classics Macaroni & Cheese and Reser’s American Classics Macaroni & Cheese White Cheddar, as part of a broader recall of Reser’s Fine Foods deli salads and refrigerated items.
Scope of the Recall
The affected macaroni and cheese varieties were distributed across five states: California, Illinois, Minnesota, North Dakota, and South Dakota. The specific “use by” dates for the recalled products are as follows:
- Reser’s American Classics Macaroni & Cheese: Use by dates of September 14 and September 16, 2024.
- Reser’s American Classics Macaroni & Cheese White Cheddar: Use by date of September 11, 2024.
In addition to the macaroni and cheese products, the recall includes a variety of other items such as potato salad, scalloped potatoes, pasta salad, corn, egg salad, spinach dip, gravy, and various desserts.
Cause of the Recall
According to the FDA, the potential spoilage was linked to “temperature abuse” during transportation, specifically due to a malfunctioning refrigeration unit on a trailer. A representative from Reser’s Fine Foods confirmed to FOX Business that the issue was isolated to a single truckload of product delivered to only one distributor location.
“The recall was initiated on July 29, 2024, and no affected products ever made it to the store shelves,” the representative stated. They further reassured consumers that any items purchased from stores are safe to consume.
Retailer Responses
Major retailers, including Safeway, Stop & Shop, and Walmart, which stock Reser’s macaroni and cheese products, have stated that their stores were not impacted by the recall. However, Target, another retailer selling the products, did not provide a comment when contacted by FOX Business.
Consumer Safety First
The FDA and Reser’s Fine Foods have stressed the importance of consumer safety in this situation. While the affected products have not reached store shelves, customers who may have purchased any items from the recalled batch are encouraged to check the packaging for the specified “use by” dates.
As always, consumers are advised to be vigilant about food safety and to report any concerns to their local health department or the FDA. For those who may have questions or require further information regarding this recall, contacting Reser’s Fine Foods directly or checking the FDA’s website can provide additional clarity.
In conclusion, while the recent recall raises concerns over food safety, companies and regulatory agencies are working diligently to ensure that consumers remain informed and protected. As the situation develops, staying updated through reliable sources is essential for maintaining food safety standards in your household.
Read the story on Fox Business.com: https://www.foxbusiness.com/lifestyle/mac-cheese-sold-major-retailers-recalled-potential-spoiling
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health and wellness
The First Suicide and Self-Harm Cross-Industry Signal Sharing Program to be Established Under the Leadership of The Mental Health Coalition
The Mental Health Coalition
NEW YORK, Sept. 12, 2024 /PRNewswire/ — The Mental Health Coalition (MHC) announced today a new program called Thrive, the first cross-industry signal sharing program designed to help stop the spread of suicide and self-harm content across different internet platforms. The goal is to increase industry collaboration, prevent online challenges from spreading virally, and help improve early detection of content that could potentially pose a safety risk.
Suicidal and self-harm content online can manifest in diverse forms, including viral challenges, text posts, visual media (images and livestreams), etc. While approaches employed by internet companies to mitigate harmful content differ, they are crucial for safeguarding user and viewer wellbeing. The expeditious identification and removal of suicide and self-harm content through Thrive will enable companies who are part of Thrive to investigate, take action and prevent similar content from being disseminated on their platforms fostering a safer online environment. While the technological infrastructure underpinning Thrive is not new (provided by Meta, it is already used by the Tech Coalition’s Lantern program), this initiative marks the first industry-wide endeavor to address suicide and self-harm content comprehensively across different platforms.
“We at MHC are excited to work with Thrive; a unique collaborative of the most influential social media platforms that have come together to address suicide and self-harm content. Meta, Snap and TikTok are some of the initial partners to join “the exchange” committing to make an even greater impact and help save lives,” said Kenneth Cole, Founder of The Mental Health Coalition.
“The integration of signal sharing, coupled with cross-industry collaboration and moderated by an independent and neutral intermediary, represents a major breakthrough in industry collaboration and public protection on the global, public health crisis of suicide and ultimately save lives,” said Dr. Dan Reidenberg, Director of Thrive.
Thrive will leverage a centralized technology platform, enabling the aggregation of information from diverse sources (platforms), where participating companies can receive alerts of content that raises concerns or contravenes their respective company policies or community standards against suicide and self-harm. Platforms are then able to independently assess whether to take action on the content. This new signal sharing program will be underpinned by a technical infrastructure provided by Meta which allows tech companies to securely share signals about content that breaks their suicide and self-harm policies. This approach addresses harmful content while respecting the autonomy of each organization’s moderation strategies, reduce the risk of contagion or content becoming viral across platforms and ensure measures exist and only share de-identified signals to protect the users privacy. There will be no personally identifiable information shared through Thrive.
“At Meta, we have strict rules against content that encourages, glorifies or shows graphic suicide or self-harm, and remove it whenever we become aware of it. Unfortunately this content isn’t limited to any one platform – especially when it comes to viral challenges – and it’s imperative that the technology industry works together to help prevent it from spreading. That’s why we’re proud to partner with the Mental Health Coalition and our peers to launch Thrive, and help keep people safe across the many apps they use.” Antigone Davis, VP of Global Safety at Meta.
“The safety and well-being of the Snapchat community is a top priority. Our dedicated teams, technologies, policies, and partnerships help keep our community safe, healthy, and informed, and our well-being features are designed to educate and empower individuals who might be struggling with their own social and emotional well-being. We are honored to be founding members of the Thrive initiative – an opportunity to continue to work industry-wide on approaches that strengthen capabilities to halt the spread of self-harm content.” Jacqueline Beauchere, Global Head of Platform Safety, Snap
“TikTok is an uplifting and entertaining part of many people’s day, and we continually invest in protecting and securing our community’s experience. By becoming a founding member of The Mental Health Coalition’s Thrive, we’re strengthening how we prevent harmful suicide and self-harm content online. Through this important collaboration and collective action, we hope to keep people safe on TikTok and beyond.” Valiant Richey, Global Head of Outreach and Partnerships, Trust and Safety, TikTok
Thrive’s Director will oversee operational aspects of the program, ensuring its effective functioning through convening, facilitating, moderating, and monitoring activities. Participating companies will assume responsibility for uploading, reviewing and taking the appropriate action on the content shared through Thrive and leveraging the platform to share insights and best practices. Dr Reidenberg will collaborate with other signal sharing exchange directors on optimal moderation strategies, lessons learned, and transparency protocols. An annual report will be issued to provide insight into the exchange’s use and impact.
Meta, Snap, and TikTok have pledged their support and participation as founding members, with other companies expected to join.
The Mental Health Coalition relies on donations. If you want to help support Thrive and the lifesaving work of the Coalition, please contact Dr Dan Reidenberg.
About The Mental Health Coalition
The Mental Health Coalition (www.thementalhealthcoalition.org), is a coalition of the Nation’s leading mental health organizations, brands, and individuals who have joined forces to end the debilitating stigma surrounding mental health and to change the way people talk about, and care for, mental illness. Our mission is to catalyze like-minded communities to work together to destigmatize mental health and empower access to vital resources and necessary support for all.
The Mental Health Coalition was formed with the understanding that the mental health crisis is fueled by a pervasive and devastating stigma, preventing millions of individuals from being able to seek the critical treatment they need. We will not relent until mental health is no longer associated with stigma, shame or judgment and all people feel empowered to openly discuss and address their individual mental health needs.
SOURCE The Mental Health Coalition
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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FDA CDC News
Important Recall Alert: Milo’s Poultry Farms and Tony’s Fresh Market Eggs Potentially Contaminated with Salmonella
Milo’s Poultry Farms, LLC has recalled eggs under the “Milo’s Poultry Farms” and “Tony’s Fresh Market” labels in Wisconsin, Illinois, and Michigan due to Salmonella contamination, advising consumers to discard or return products.
As of September 6, 2024, Milo’s Poultry Farms, LLC, headquartered in Bonduel, Wisconsin, has issued a voluntary recall of all its egg products due to possible contamination with Salmonella. This recall applies to both “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs, spanning across various retail stores and foodservice distributors in Wisconsin, Illinois, and Michigan.
What You Need to Know
Salmonella is a bacteria that can cause serious and occasionally fatal infections, particularly in young children, the elderly, and individuals with weakened immune systems. Healthy individuals infected with Salmonella often experience fever, diarrhea (potentially bloody), nausea, vomiting, and abdominal pain. In severe cases, the infection can result in the bacteria entering the bloodstream and causing more critical conditions such as infected aneurysms, endocarditis, and arthritis.
Scope of the Recall
The recall encompasses:
- All carton sizes and types of eggs under the “Milo’s Poultry Farms” label, across all expiration dates.
- All carton sizes of “Tony’s Fresh Market” branded eggs, applicable to all expiration dates.
- All cases of eggs intended for retail foodservice distribution, regardless of expiration dates.
Reason for the Recall
The recall was triggered after environmental samples collected by the FDA tested positive for Salmonella. Further investigations through whole genome sequencing linked these samples to an ongoing outbreak of Salmonella, prompting immediate action by Milo’s Poultry Farms.
Consumer Safety Measures
Milo’s Poultry Farms, LLC has temporarily halted production and distribution of the affected products to conduct necessary testing and sanitization processes at their facilities.
What Should Consumers Do?
Customers who have purchased any of the recalled eggs are strongly advised not to consume them. These products should be discarded immediately or returned to the place of purchase for a full refund.
Consumers with additional questions or concerns can reach out directly to Milo’s Poultry Farms, LLC at (715) 758-6709 for further guidance and support.
Stay Informed
Salmonella is an ongoing risk in uncooked poultry and eggs. Consumers are reminded to cook eggs thoroughly before consumption to kill bacteria and prevent illness. Stay updated with food recall alerts and safety guidelines to ensure the health and safety of you and your family.
Remember, food safety is paramount. Keep abreast of the latest FDA warnings and manufacturer recalls to safely navigate any potential health risks associated with contaminated products.
About the FDA
The Food and Drug Administration (FDA) is a U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA also regulates the nation’s food supply to safeguard against contamination and prevent foodborne illnesses. One of its key functions is monitoring and managing food recalls when potential risks are identified, ensuring that hazardous foods are quickly and effectively removed from the market. The FDA issues alerts to inform the public about foodborne illness outbreaks, working collaboratively with manufacturers to recall affected products and maintain the safety and integrity of the food supply chain.
Follow FDA
- Follow@US_FDA on X
- FollowFDAon Facebook
- Follow@FDArecallson X
- Recent Recalled Product Photos on FDA’s Flickr Photostream
Read the FDA release here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/milos-poultry-farms-llc-recalls-eggs-because-possible-health-risk
Source: FDA
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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