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FDA grants priority review for Lilly’s abemaciclib for breast cancer treatment

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) accepted and filed its New Drug Application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and given the NDA a Priority Review designation.

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Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) accepted and filed its New Drug Application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and given the NDA a Priority Review designation.

The NDA includes the company’s submission of abemaciclib for two indications: abemaciclib monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy. This submission is based on the MONARCH 1 and MONARCH 2 studies, respectively.

“We are pleased that the FDA has granted abemaciclib Priority Review, both as a potential monotherapy and combination therapy [with fulvestrant] for patients with advanced breast cancer,” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. “Breast cancer is a complex disease, and the need still exists for new treatment options as patients face a significant disease burden. We look forward to working with the FDA and bringing this important potential treatment option to patients as soon as possible.”

In 2015, the FDA granted abemaciclib Breakthrough Therapy Designation based on data from the breast cancer cohort expansion of the company’s Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. A drug that receives Breakthrough Therapy Designation may be eligible for Priority Review, which aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment. With Priority Review of a new drug, the FDA’s goal is to take action within eight months of receiving an application, compared with the standard review timeframe of 12 months. Lilly is working with the FDA and anticipates agency action on this application in the first quarter of 2018.

In addition, Lilly intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of 2017.

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A Woman leader’s journey to health, empowerment

As a woman who believes in the power of preventive care, Rebecca Bustamante shares her story of health challenges and triumphs—all fueled by her trust in Fullerton’s executive health screening facility.

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Rebecca Bustamante, CEO of Asia CEO Events, has always been a force to be reckoned with among key industries and businesses in the Philippines. As an inspirational keynote speaker and organizer of the largest business forums and summits in the country, she has paved the way for empowering professionals to take charge of their careers and create their path to success. 

She is, indeed, one of the best examples of what it truly means to be an empowered woman—one who helps others achieve success while fueling and creating change. But beyond her professional triumphs, Bustamante knows that true empowerment starts with taking charge of one’s health, and for her, partnering with Fullerton Health has been a crucial part of that journey. 

With the intention of taking control of her health, she turned to Fullerton Health, a leading vertically integrated healthcare platform in Asia with a proven track record of providing enterprise healthcare solutions.

As a woman who believes in the power of preventive care, she shares her story of health challenges and triumphs—all fueled by her trust in Fullerton’s executive health screening facility. 

A Wake-Up Call to Prioritize Health

Bustamante’s journey to prioritizing wellness began with a moment that changed everything. In 2005, at just 38 years old, she was diagnosed with a brain tumor and only given six months to live. The news was devastating. 

“I was paralyzed, I couldn’t function,” she recalls. “It was the biggest turning point of my life.” 

Against all odds, Bustamante survived. But the experience left a lasting impact, reshaping her entire perspective on health. She realized that no matter how successful one becomes, it all means nothing if one’s health is compromised.

That wake-up call made her more intentional about wellness, sparking a lifelong commitment to proactive healthcare and preventive measures. Since then, taking care of her health has been at the forefront of her priorities. She knew that while she had achieved great success, maintaining her well-being was just as important as building her career. 

Discovering Fullerton Health

In her search for a healthcare provider that aligned with her commitment to long-term wellness, she was introduced to Fullerton Health by her colleague and friend, Carmie De Leon, who happens to be Radlink Philippines’ Country General Manager and EHS Lead. Fullerton’s executive health screening offered a seamless, thorough, and personalized approach—something Bustamante knew was essential in maintaining her well-being. 

“Upon learning about it, my husband and I were excited to experience Fullerton Health because we wanted to see if we were really looking after ourselves properly,” Bustamante explains.

She added that her first executive check-up exceeded all expectations. 

“It’s truly a five-star experience,” Rebecca shares. “We didn’t have to wait for the whole day just to get our results because Fullerton Health is efficient and personalized. In just three hours, we completed a full-body assessment. It felt like a business-class health experience.” 

Taking Charge of Her Health with Fullerton

Through Fullerton’s comprehensive executive check-up, Bustamante, along with her husband, gained valuable insights into her health—all consolidated into one detailed report and thoroughly explained by Fullerton Health’s doctors. These results served as a guide for her wellness journey, helping her make necessary lifestyle adjustments. 

“Fullerton doesn’t just give you test results—they guide you on what to improve and maintain,” Bustamante says. “It’s not just about diagnosing problems but about taking control of your health before issues arise.” 

She also emphasized the convenience and efficiency of Fullerton’s services, which allowed her to focus on making meaningful lifestyle changes while balancing the demands of being a CEO and a mother. She shared how her experience with Fullerton Health made her realize the importance of treasuring time with family. 

“If you love your family, you owe it to them to stay healthy. You don’t want to be a burden. Instead, you want to be present for your children and grandchildren,” she emphasizes. 

When asked what advice she would give to others looking to take charge of their health, she states: “Don’t wait for a wake-up call. Your health is your greatest investment.

Fullerton Health has given me clarity, confidence, and control over my well-being—and that’s priceless.” 

A Commitment to a Healthier Future

Through Fullerton Health, Bustamante proves that true success begins with taking care of yourself. Her story is a testament to how prioritizing health can lead to a fuller, more empowered life. 

More than just an executive check-up, her experience with Fullerton Health reinforced her belief that preventive care is the best care. Now, she eagerly anticipates her annual check-ups, seeing them not as a task, but as an essential step in her journey to a healthier, more empowered life.

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High dietary fish intake may slow disability progression in MS

The anti-inflammatory and neuroprotective properties of the nutrients found in fish may be key, underscoring the potential importance of diet in managing MS.

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A high dietary intake of lean and oily fish may slow the progression of disability in people with multiple sclerosis (MS), suggests a comparative population based study, published online in the Journal of Neurology Neurosurgery & Psychiatry.

The anti-inflammatory and neuroprotective properties of the nutrients found in fish may be key, say the researchers, who add that their findings underscore the potential importance of diet in managing the disease.

Emerging evidence indicates that diet may have a role in the development of inflammatory diseases, including MS, explain the researchers. 

While previously published research has linked fish consumption with lower levels of disability among those with MS, few studies have looked at whether it might slow or lessen the progression of disability, they point out. 

To explore this further, they drew on 2719 newly diagnosed participants (average age 38) in The Epidemiologic Investigation of Multiple Sclerosis (EIMS) study, a Swedish nationwide population based case-control study, all of whom were recruited between April 2005 and June 2015.

On entry to EIMS, all participants provided information on environmental exposures and lifestyle habits, including their consumption of lean and oily fish, which was categorised as: never or seldom; 1 to 3 times a month; and weekly, and scored from 2 to 6, depending on whether they ate lean or oily fish, or both. 

Their disease progression, measured using the Expanded Disability Status Scale (EDSS), was tracked for up to 15 years through the Swedish MS Registry.

Confirmed disability worsening was defined as an increase in the EDSS score of at least 1 point from baseline, sustained between two further check-ups, at least 6 months apart.

The highest fish consumption at diagnosis was associated with a 44% lower risk of confirmed disability worsening as well as a 45% lower risk of progressing to EDSS 3 and and a 43% lower risk of progressing to EDSS 4 compared with those who ate none or very little.

And the more lean and oily fish that was consumed, the lower was the risk of confirmed disability worsening and progression to EDSS 3 and 4, trends analysis indicated.

In 2021, 1719 participants completed an online follow-up questionnaire which assessed changes in fish intake over time. Some 412 (24%) had altered their fish consumption: 288 had increased it; 124 had decreased it. 

Those who increased their score from 2–3 to a score of 5–6 within 5 years after diagnosis (133) had a 20% lower risk of confirmed disability worsening, compared with those who continued to eat little or no fish (400). 

Only 16 participants increased their fish consumption from a baseline score of 2 to a score of 5–6, but they had a 59% lower risk of confirmed disability worsening, compared with those who remained at the lowest level of consumption (101).

The findings held true even when the potentially influential factors of physical activity, weight (BMI), smoking, alcohol intake, and sun exposure were accounted for. They also remained similar when further adjustment was made for vitamin D level.

This is an observational study, and as such, no firm conclusions can be drawn about cause and effect. And further research to validate the findings and investigate the underlying biological mechanisms is required, say the researchers.

But they suggest: “While omega-3 fatty acids, predominantly found in oily fish, may contribute to reduced disability progression, the beneficial effects observed from lean fish consumption suggest that other factors may also play a significant role. One such factor is taurine, an amino acid found in significant amounts in fish and seafood.”  

They explain: “Taurine is the most abundant free amino acid in the brain and, although there are endogenous mechanisms for its production, an exogenous supply is necessary to meet physiological needs.”  

They add: “Taurine has diverse cellular functions, including cytoprotective actions through antioxidative and anti-inflammatory effects, making it a potential therapeutic agent for neurological disorders.” 

And they conclude: “The results underscore the potential role of diet, particularly fish consumption, as a modifiable factor that could complement existing therapeutic strategies for MS.” 

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Myth busted: Healthy habits take longer than 21 days to set in

Planning and intending to complete a new behaviour can also help solidify a new habit, so make sure you continue to make time to include your new healthy habits into your everyday activities. This could be as easy as laying out your gym clothes the night before a morning walk or having a healthy lunch ready to go in the fridge.

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We’re nearly two months into 2025, but if you’re struggling to hold onto your New Year’s resolution, stay strong, as University of South Australia research shows that forming a healthy habit can take longer than you expect.

In the first systematic review of its kind, UniSA researchers found that new habits can begin forming within about two months (median of 59–66 days) but can take up to 335 days to establish.

It’s an important finding that could inform health interventions to promote healthy behaviours and prevent chronic disease.

In Australia, chronic disease contributes to a large portion of the disease burden. Many conditions, including type 2 diabetes, heart disease, lung diseases and stroke, can be prevented by changing unhealthy habits or lifestyle factors. 

University of South Australia researcher, Dr Ben Singh, says that contrary to popular belief, healthy habits take far longer than three weeks to lock down.

“Adopting healthy habits is essential for long-term well-being but forming these habits – and breaking unhealthy ones – can be challenging,” Dr Singh says.

“At the beginning of the year, many of us are setting goals and making plans for the months ahead –things like being more active, cutting back on sugar, or making healthier food choices – but while common wisdom suggests that it takes just 21 days to form such habits, these claims are not evidence-based.

“In our research, we’ve found that habit formation starts within around two months, but there is significant variability, with formation times ranging from four days to nearly a year.

“So, it’s important for people who are hoping to make healthier habits not to give up at that mythical three-week mark.”

The study of more than 2600 participants also found that certain factors can influence successful habit formation.

“When trying to establish a new healthy habit, success can be influenced by a range of things including how frequently we undertake the new activity, the timing of the practice, and whether we enjoy it or not,” Dr Singh says.

“If you add a new practice to your morning routine, the data shows that you’re more likely to achieve it. You’re also more likely to stick to a new habit if you enjoy it.

“Planning and intending to complete a new behaviour can also help solidify a new habit, so make sure you continue to make time to include your new healthy habits into your everyday activities. This could be as easy as laying out your gym clothes the night before a morning walk or having a healthy lunch ready to go in the fridge.

“Tailoring habit-building strategies into our day and making plans on how we can achieve them, will put you in a position for success.”

While more research is needed, researchers say that these findings can guide public health initiatives and personalised programs that support sustained and healthy behaviour change.

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