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Galderma announces FDA approval of Differin for OTC acne use

This approval makes Differin Gel the first and only OTC acne product containing a full prescription-strength retinoid. It also marks the first new, FDA-approved active ingredient to be introduced to the OTC acne category in over three decades.

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Galderma announced that its US affiliate, Galderma Laboratories, received approval from the US Food and Drug Administration (FDA) for Differin Gel (adapalene gel 0.1%) as an over-the-counter (OTC) treatment for acne. This approval makes Differin Gel the first and only OTC acne product containing a full prescription-strength retinoid.  It also marks the first new, FDA-approved active ingredient to be introduced to the OTC acne category in over three decades.

Differin

“We believe bringing Differin Gel over-the-counter will be a game-changer for consumers and for the acne category,” said Miles Harrison, president and GM of Galderma Laboratories. “We’re excited to deliver this new level of efficacy without a prescription to consumers, and to bring the first new active ingredient to the category in over 30 years. As the research and development leader of medically proven dermatologic solutions, Galderma is proud to announce this innovation will be available for people with skin health needs.”

Acne is the most common skin condition in the US alone, affecting up to 60 million teens and adults annually, however, only one-third seek out the help of a healthcare provider to address these issues2. In fact, 45 percent of adults are not satisfied with their current products, with nearly half of people using three or more acne products. With a growing trend among consumers to self-treat, many turn to the skincare aisle at their local drugstore. Until now, there have been only two active ingredients on the over-the-counter market*, leaving many people dissatisfied and searching for better options. With the Rx to OTC switch of Differin Gel, millions of people will have easier access to a full prescription-strength product containing a retinoid.

“This landmark approval was years in the making at Galderma and demonstrates our ongoing commitment to individuals with dermatologic concerns such as acne,” said Philip Brown, MD, JD, SVP, Medical and Regulatory Affairs, Galderma Laboratories. “Galderma will continue to partner with healthcare professionals and invest in Rx, OTC and Aesthetic & Corrective medical innovations to enhance skin health.”

Differin Gel containing 0.1% adapalene is specially formulated for efficacy and tolerability. It is a full prescription-strength, once-a-day topical containing a retinoid, which is clinically proven to treat current and future breakouts.  An innovation from Galderma R&D, the dermatologist-developed and tested Differin Gel contains adapalene, a safe and effective retinoid, which doctors have prescribed to over 40 million people globally for more than 20 years.  According to the American Academy of Dermatology’s therapeutic treatment guidelines, topical retinoids are recommended as first-line therapy for all acne cases.

Differin Gel is clear, fragrance-free, oil-free and alcohol-free. Differin® Gel is applied once daily, directly to the full-face or other affected areas. It is approved for use by people 12 years and older with acne.

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Telling people they might lose motivates more than telling them they might win, research shows

How managers choose to frame problems directly influences employees’ motivation to speak up at work. For managers, this is an insightful approach for building more open and collaborative teams.

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Athletes say they hate to lose more than they love to win. New research finds the same sentiment is shared in organizations.

A Virginia Tech researcher and his colleagues discovered that when managers frame work problems as a potential loss, employees are more likely to take action than when those problems are framed as potential gains. The research also revealed that when the potential loss impacts a larger group, employees are more likely to take action in the form of speaking up to a supervisor in hopes of finding a solution. The findings were recently published in the Journal of Applied Psychology.

For managers, this research suggests that framing work problems as potential losses can influence employees to speak up more.

“Employee voice occurs when suggestions are made to improve organizational functioning,” said Phil Thompson, associate professor in the Pamplin College of Business Department of Management. “From an organizational perspective, the positive outcomes of employee voice include improved performance, effectiveness, and workplace safety. From an employee level, speaking up is positively related to creativity, innovation, engagement, and ethical behavior.”

At its core, this research shows that how managers choose to frame problems directly influences employees’ motivation to speak up at work. For managers, this is an insightful approach for building more open and collaborative teams.

“When managers say, ‘If we don’t get this done, not only will you lose the $5,000 bonus, but everybody in this work group is going to lose a $5,000 bonus,’ it magnifies an employee’s motivation to act in a proactive way,” said Thompson. “This suggests that framing work problems as what will be collectively lost – compared to what can be individually lost – makes employees want to speak up more.”

Thompson was part of a research team led by Jeffery Thomas and Jonathan Booth from The London School of Economics and Mark Bolino from Oklahoma University. Together they analyzed responses from nearly 2,000 full-time employees, MBA students, and employee-supervisor pairs for their experience in situations where work problems were framed as either a gain or a loss. Across three different studies, framing something as a loss yielded employees to voice a work suggestion more.

For example, a manager dealing with a reputational crisis of their team, such as a product quality issue, can frame the problem in a way to spark helpful employee suggestions on how to resolve the issue. For example, instead of saying “if this product has great quality, our company will look really good” a manager saying “if this product is not up to quality standards, our reputation will be damaged” carries more weight for the team. When this reputational risk is shared by everyone, employees are more willing to step forward to help the problem.

In the first study, participants were asked to think about a problem at work that was significant for them. From there, they were randomly assigned to write about the potential losses or gains from that problem. They were also asked to indicate how likely they were to talk about these problems to their supervisor. Participants who reflected on their potential losses showed a 16 percent higher willingness to speak up compared to those who focused on the potential gains.

When it came to the MBA students, they read a fictional performance review scenario where a workplace problem was described. They then rated how willing they would be to speak up about that scenario if they were in the situation. One example suggested that the entire team might fall short of its goals if an issue was not addressed. This specific scenario yielded the most likelihood of speaking up 35 percent more than the scenario’s suggesting that only they would miss their goal, supporting the research’s findings that an employee is more likely to speak up when the loss impacts more people.

The third study looked at employee-supervisor pairings to understand how these relationships play out in the real world. Using pairings from across three industries, employees reported a workplace problem they encountered and their supervisor rated how often that employee spoke up on the job. While the first two studies involved hypothetical scenarios, this real-world evidence showed that employees were 8-10 times more likely to speak up when issues were framed as a potential collective loss compared with a potential collective gain. 

“This research is really geared toward managers so they can facilitate and understand how and why their employees will speak up,” said Thompson. “You can talk about the issue, but it always ends in terms of how we frame things.” 

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Yoga practice could reduce blood pressure in people with obesity

People who practiced yoga had a significant decrease in blood pressure, with systolic blood pressure lowered by an average of 4.35 mmHg and diastolic blood pressure by 2.06 mmHg.

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Practicing yoga could help people with overweight or obesity improve their cardiometabolic health, according to a study in the open-access journal PLOS Global Public Health by Widya Wasityastuti from the University of Edinburgh, Scotland, and colleagues.

Yoga is a popular form of exercise around the world, and is a gentle and accessible form of exercise for many people. To better understand the potential health benefits of yoga, the authors of this study performed a meta-analysis, examining 30 studies of yoga for its cardiometabolic benefits. They focused on studies which examined outcomes for blood pressure, lipid profiles, glucose homeostasis, markers of inflammation, and measures of antioxidants, and those which examined people with body-mass index over 23 for Asian countries, and 25 for other countries, indicating that participants had overweight or obesity. Of the 30 studies considered, 23 were conducted in Asian countries, while the remaining studies were from the United States, Germany, and Australia.

Across the 30 studies and a total of 2,689 participants, the authors found that people who practiced yoga had a significant decrease in blood pressure, with systolic blood pressure lowered by an average of 4.35 mmHg and diastolic blood pressure by 2.06 mmHg. They also found modest beneficial effects on low- and high-density lipoproteins, types of cholesterol that have been linked to an increased risk of stroke. 

The authors note that the studies analyzed were not specifically recruiting people with obesity, and there was no dose-response measured, so it is unknown how much yoga is needed to produce these effects, though the studies they analyzed favored practice of at least 180 minutes per week.

The studies also focused heavily on Asian participants, and practitioners with comorbidities were excluded from analysis. Finally, it’s important to note that due to the nature of this study, causality cannot be confirmed here despite the correlations found.

Further studies will be needed to understand whether yoga can provide similar benefits to other populations, as well as people with co-morbidities such as diabetes or heart disease.

The authors suggest that while more high-quality trials are needed, the meta-analysis supports potential benefits of yoga for cardiometabolic health in people with overweight and obesity.

The authors summarize: “Our review suggests that yoga may offer a helpful additional option for improving some aspects of cardiometabolic health in adults with overweight or obesity, particularly blood pressure.”

They add: “Yoga is often seen mainly as a wellbeing practice, but our findings suggest it may also support certain cardiometabolic health outcomes in adults with overweight or obesity.”

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Stress, BMI, and hormones linked to earlier puberty in girls

Higher levels of key steroid hormones—combined with elevated stress and body mass index (BMI)—are associated with earlier onset of puberty in girls.

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Higher levels of key steroid hormones—combined with elevated stress and body mass index (BMI)—are associated with earlier onset of puberty in girls, according to a new study at Columbia University Mailman School of Public Health.

The findings are published in The Journal of Clinical Endocrinology & Metabolism.

 Elevated prepuberty urinary levels of glucocorticoids, androgens, and progesterone were strongly linked to accelerated breast development (thelarche). Girls with high glucocorticoid levels alongside high BMI and stress entered puberty an average of seven months earlier than peers with lower levels.

“While stress and BMI have long been recognized as independent predictors of puberty, few studies have examined how they interact with a girl’s hormones,” said Lauren Houghton, PhD, assistant professor of Epidemiology at Columbia Mailman School, and first author. “Our findings challenge conventional research that has largely focused on estrogen and body size, highlighting instead the role of stress and androgens – typically thought of as male hormones– in shaping pubescent development.”

The strongest associations were observed for progesterone, androgens, and glucocorticoids, indicating that multiple hormonal pathways—not just estrogen—play a critical role in the timing of puberty.

For example:

  • Higher glucocorticoid, androgen, and progesterone metabolites were associated with earlier onset of puberty
  • Elevated androgens and progesterone were also linked to a longer duration of puberty
  • Estrogen metabolites were associated with delayed onset, not acceleration
  • The effects of hormones on puberty timing were significantly modified by BMI and stress levels.

 Notably, the associations were consistent regardless of family history of breast cancer.

“Our objective was to identify the full set of hormonal patterns linked to accelerated puberty and test whether BMI and stress modify this relationship,” said Houghton, who is also assistant professor at the Herbert Irving Comprehensive Cancer Center at Columbia. “We predicted that girls with elevated BMI and stress would experience the earliest onset—and that the stress response shifts during this key time for girls.”

The researchers drew on data from the LEGACY Girls Study, a cohort of 1,040 girls ages 6 to 13 recruited across the U.S. States and Canada. Participants were followed every six months with clinical assessments, questionnaires, and biospecimen collection.

The analysis included 327 girls who were at the pre-puberty stage at baseline and provided urine samples at least one year before the onset of puberty. Houghton and colleagues measured a comprehensive panel of steroid metabolites using first-morning urine samples and tracked puberty development using validated clinical scales.

Mothers of the girls completed an Internalizing Composite Scale, which includes subscales for anxiety, depression, and other at-risk status. They also provided information on girls’ family history of all cancers as well as on pregnancy and infancy, including birth weight and their child’s race and ethnicity. Trained research staff measured height and weight twice every 6 months. 

“Unlike prior research, this study simultaneously examined hormonal patterns, BMI, and psychosocial stress—captured through standardized behavioral assessments—within the same cohort,” said senior author Mary Beth Terry, PhD, professor of Epidemiology at Columbia Mailman School, and the Herbert Irving Cancer Center, and Silent Spring Institute.  “Interestingly, we also learned that the associations were consistent regardless of family history of breast cancer.”

The findings may help explain the ongoing trend toward earlier puberty and point to actionable prevention strategies, observed the authors.

 “Stress-reducing interventions and healthy lifestyle changes may help delay early puberty and improve long-term health outcomes,” said Houghton. ‘Because early puberty is linked to increased breast cancer risk later in life, the results have important implications for both pediatric care and public health.”

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