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Sun Pharmaceutical Announces FDA Approval of LEQSELVI™ for Severe Alopecia Areata

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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.

LEQSELVI
Sun Pharma Headquarters

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.

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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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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.

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selective focus photo of three eggs on tray
Photo by Monserrat Soldú on Pexels.com

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.

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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.

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

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Lifestyle

Fall Respiratory Virus Vaccines: What pregnant people need to know

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virus vaccines

(Family Features) Fall brings cooler days and more time indoors. This makes it easier for viruses like influenza (flu), COVID-19 and respiratory syncytial virus (RSV) to spread. These illnesses can be especially risky for pregnant people and newborns. Getting vaccinated for flu, COVID-19 and RSV during your pregnancy lets you pass protection to your baby. Your immunity helps keep them from getting very sick from one of these viruses in their first few months of life.

Virus Vaccines

Vaccines for flu and COVID-19 also protect expectant parents from serious symptoms. Pregnant people are more likely to need medical care or hospitalization for flu and COVID-19 than people their age who are not pregnant, according to the Risk Less. Do More. Public Education Campaign.

“It makes sense that people are very careful about the health choices they make during pregnancy,” said Manisha Patel, MD, MS, MBA, Chief Medical Officer of the National Center for Immunization and Respiratory Diseases. “The good news is that flu and COVID-19 vaccines are the best way to protect you and your baby against serious disease. RSV vaccines cut by more than half the risk of your baby being hospitalized for severe RSV disease, the leading cause of hospitalization for infants in the United States.”

Here are some key facts about pregnancy and vaccination:

Getting vaccinated protects you during and after pregnancy.
Common respiratory viruses can be dangerous for people who are pregnant or have recently been pregnant. This is because respiratory illnesses during pregnancy are more likely to be severe. Studies show that the flu and COVID-19 vaccines are the best protection for pregnant people. They lower the risk of serious illness, hospitalization and death. Like medications, vaccines can cause side effects, but side effects from flu and COVID-19 vaccines are almost always mild and brief. The benefits of these vaccines outweigh the risks for most people.

The Centers for Disease Control and Prevention also recommends an RSV vaccine during pregnancy. Vaccination during pregnancy cuts the risk of a newborn being hospitalized with RSV by half.

Getting vaccinated protects your unborn or nursing child.
Flu, COVID-19 and RSV viruses are dangerous for both unborn and newborn children. About 20,000 children under age 5 in the U.S. are hospitalized with flu each year. Infants under 6 months are at the highest risk of serious complications. Infants are also at higher risk for RSV. In fact, it’s the top reason babies in the U.S. are hospitalized.

When a pregnant person gets vaccinated for flu, COVID-19 or RSV, they share their immunity with their child. Recent studies also show that some breastfeeding parents maintain infection-fighting antibodies in their breastmilk after vaccination. This immunity can also help protect their baby.

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Timing for vaccinations is important.
Getting vaccinated for flu, COVID-19 and RSV during pregnancy builds antibodies that can help protect the baby. Get the yearly COVID-19 and flu vaccines this fall season. For RSV, it is recommended that pregnant people get vaccinated between 32-36 weeks of pregnancy during the RSV season, which is from September-January in most parts of the United States.

If you have questions or concerns, talk to your doctor. Knowing the facts about vaccination and pregnancy can offer confidence and comfort. Visit cdc.gov/RiskLessDoMore to learn more and talk with your doctor about getting your flu, COVID-19 and RSV vaccines.

Photo courtesy of Shutterstock


SOURCE:
United States Department of Health and Human Services

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

What Ophthalmologists Want You to Know About Eye Color-Changing Drops

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Newswise — SAN FRANCISCO, Calif.  The American Academy of Ophthalmology is sounding the alarm on over-the-counter eye drops advertised as eye color-changing solutions. These products are not FDA approved, have not been tested for safety or efficacy, and could potentially damage the eyes.

“Consumers seeing these products on TikTok or elsewhere online need to know that they are not FDA approved,” said JoAnn A. Giaconi, MD, clinical spokesperson for the American Academy of Ophthalmology. “The ads show dramatic before-and-after shots and vague information on how the drops actually work to change eye color. But here’s the reality, there’s no evidence that they do anything at all, and no evidence that they’re safe.”

Because the products are not FDA approved, they have not undergone rigorous safety and efficacy testing, and it’s unclear if Current Good Manufacturing Practice regulations were followed during production. Unregulated manufacturing facility conditions can lead to contaminated products that can cause dangerous eye infections

Eye Color-Changing Drops

Potential safety risks of using unregulated eye drops include:

  • Inflammation
  • Infection
  • Light sensitivity
  • Increased eye pressure or glaucoma
  • Permanent vision loss

Manufacturers claim that the drops include an ingredient that adjusts natural levels of melanin in the iris, the colored part of the eye. But there is no evidence that the formula can target the iris pigment. And if the drops did destroy the pigmented cells in the iris, it could potentially harm the eye, causing light sensitivity, eye inflammation, and eventually vision loss. It’s also unclear how other parts of the eye that rely on melanin to function properly, such as the retina, would react to this ingredient.

“Social media and the internet are full of potentially dangerous eye health claims. Bottomline, the Academy advises the public to never put anything in the eye that isn’t made to go in the eye,” Dr. Giaconi said. “You’re putting yourself at risk for painful eye conditions or even blindness.”

The safest way to change eye color is with colored contact lenses, but only if the lenses are prescribed, dispensed, and fitted by a qualified eye health professional.

For more information about eye health and how to protect your eyes, visit the Academy’s EyeSmart website.

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About the American Academy of Ophthalmology

The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org.

Source: American Academy of Ophthalmology (AAO)

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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