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The Science Behind Fertility: Exploring Fertility Awareness for Family Planning

The Science Behind Fertility: Exploring Fertility Awareness for Family Planning

Family planning allows individuals to decide when and if they wish to have children. In support of this goal, it encompasses various methods.

These methods span a broad array of options from contraceptive pills and barrier methods like condoms to implants and intrauterine devices. Surgical procedures that limit fertility also fall under this umbrella.

Then there are the non-invasive strategies — abstinence and the calendar method.

Understanding fertility can support effective decision-making when it comes to family planning.

What’s Fertility Awareness?

Fertility awareness, as it is called, is a natural method of tracking various physiological signs to identify a menstruator’s fertile window, i.e. the days in a cycle when conception is most likely to occur.

These signs include:

  • A slight temperature shift in the Basal Body Temperature (BBT), or the body’s resting temperature.
  • Changes to cervical mucus that occur throughout the menstrual cycle. It becomes clear and stretchy during ovulation, letting the sperm easily pass through the cervix.

How To Do It Right?

Like many family planning methods, fertility awareness isn’t foolproof. Commitment and consistency in tracking are important for it to work, which can be difficult for those with busy lifestyles.

Also, since the menstrual cycle can be impacted by stress, illness, and lifestyle changes, the presence of these factors might make the prediction of the fertile window harder.

Indeed, getting in touch with your body’s internal calendar isn’t as straightforward as many people think.

Working with a fertility awareness educator can help you address these challenges and enhance the effectiveness of this method. With their expertise, they can provide you with a personalised education that would help you:

  • Use the most effective charting methods
  • Troubleshoot irregularities in your cycle
  • Recognize your body’s signals

Benefits of Fertility Awareness

There are several advantages to fertility awareness that make it appealing to many menstruators:

  • It’s cost-effective and doesn’t have the side effects associated with hormonal contraception.
  • It helps menstruators understand their bodies and reproductive health better.
  • It helps in both achieving or avoiding pregnancy.
  • It helps improve the connection between partners, making family planning a shared responsibility.

It is aligned with various cultural and personal beliefs about contraception and family

4 Tips for Handling Family Conflict

Family Conflict

In a world with endless ways to customize your life, there’s one glaring component you can’t choose: your family. While there are some slight caveats to this claim, for the most part, your family is inherited, not selected. As you grow into your own, you might find that your family dynamic is at odds with your beliefs. In other cases, family members might bring tension, conflict, and unwelcome energy into your otherwise happy dynamic. No matter the source of the conflict, how you manage them in the moment and after will impact your well-being.

1. Strengthen Your Mental Wellness

We exist in a universe full of differences, challenges, and conflicts that are outside of our control. However, one thing we can control is our response to external forces, even if they are out of alignment with our beliefs. Cultivate your ability to protect your wellbeing and strengthen your mental tenacity by caring for your mental health. Engage in therapy where you explore your current state, learn coping skills, and work through challenges in a safe space. Everyone benefits from therapy, even if your life situation is without turmoil.

Individuals who already manage mental illness or are in a season of significant change should invest time in their wellness. Make lifestyle adjustments to manage stress, eat a healthy diet, and exercise to care for your body and mind. Step away from the hustle and begin mental health rehab to dedicate time with a support system to guide you. By prioritizing your mental wellbeing, you’ll establish a foundation of mental wellness that has you prepared for whatever life brings.

2. Assess the Situation Before You Act

Tune into your spatial awareness and get a read on any situation before you respond to conflict. Pull back from the noise and be aware of the room, its inhabitants, and the mood. If you’re at a holiday gathering, chances are many people are together for the first time in several months. There’s a lot of catching up to do, and if there’s conflict, now is when it’s put to the test. Get a read on if you’re in a good place to converse and similarly, if they are, too.

Consider the time and place and determine if it’s best to lay low, de-escalate, or engage in challenging conversations. In some cases, avoiding conflict or specifically triggering people can be the healthiest choice to make. If you, they, or both of you are on edge, it’s likely to cause more harm to butt heads. Other times, setting differences aside is the most mature thing to do, especially if an argument could harm others. Conflict or not, escalating a long-held argument doesn’t need to take place at a wedding, child’s birthday, or grandma’s 100th.

3. Come from a Place of Curiosity

You likely already know not to start a statement with “you,” which innately directs blame or assigns responsibility to others. Instead, place yourself in a state of constant curiosity, asking why others interact how they do. Think about this yourself, digging deep into what you know about your family member. Generational differences, life experiences, and traumatic events play a major role in how we live long after the events.

If your uncle is incredibly crass, bordering on abusive with his remarks, think about why that may be. This exercise isn’t to give him a free pass, rather, it’s a way to practice empathy and understanding. Try to gauge how his life experiences have informed him to think that his behavior is acceptable. Maybe that’s how his father spoke or perhaps that behavior was common among his generation.

The next time he makes a crude remark, ask questions like, “what did you mean by that?” He’ll be forced to come up with a why, which oftentimes sparks realization about how inappropriate it is. As he’s attempting to explain, he might end up apologizing or sharing more about his reason. While it may not be a good one, you’ll make your boundary known, and he’ll have something to chew on. Another prompt is to ask, “can you say that again?” which might squash an otherwise embarrassing remark to repeat.

4. Learn and Set Your Boundaries

As you learn more about yourself, you discover what is OK with you and what isn’t. However, articulating those things can be a bigger hurdle than looking inward. First, explore your individuality and establish what you’re comfortable with. Some people enjoy spicy jokes, political debates, and curse words, while others prefer more conservative, neutral conversations. There’s no wrong answer for you, or anyone for that matter — we enjoy freedom of speech and opinion.

No matter your preferences, you can set boundaries regarding what you’re comfortable with and you can expect others to respect them. There’s no need to put out an all points bulletin about your boundaries, but you can prepare your responses. If conversations about the political climate are off limits for you, kindly request another topic.

Respond with, “politics aside, I’d love to catch up with you on what else you’re up to these days.” This shift establishes the limit while putting your interest on them, not the political drama of the day. Most people enjoy talking about their interests, and it feels good for someone to ask. Shift the conversation toward something you both can enjoy and leave the conflict out of it. This way, you can make family engagements more enjoyable for everyone and protect your wellbeing.

Strike a Balance that Protects Your Wellbeing

Focus on understanding yourself and what you need to feel safe in any situation. By nurturing your mental wellbeing, establishing boundaries, and practicing articulating these things, you can navigate nearly any dynamic. Empathize with others and be curious about their perspective while setting your boundaries clearly. When you do, you’ll be able to handle any family conflict that life brings your way.

Enhancing Patient Safety with Hospital at Home Initiatives: Proactive Strategies for Fall Prevention | By Amy Hester, PhD, RN, BC, FAAN, chairwoman and CEO, HD Nursing

Patient safety is a fundamental priority in healthcare and fall prevention is a critical component in achieving this goal. Hospital at Home (HaH) initiatives, which bring hospital-level care to patients’ homes, offer innovative solutions to improve patient safety, reduce costs and decrease unnecessary hospital stays.

The Joint Commission reports that patient falls are the most frequently reported sentinel event, making proactive fall prevention strategies essential. Falls can have severe consequences for patients, leading to injuries, extended recovery times and even death. Statistics indicate that 18% of fall-related incidents result in death and 57% cause severe temporary harm.

The World Health Organization (WHO) states that falls are the second leading cause of accidental injury deaths globally, with 684,000 fatal falls occurring each year. In the United States, preventable medical errors, including falls, rank as the third leading cause of death.

Falls not only result in physical injuries but also lead to prolonged hospital stays and a greater risk of subsequent falls. This can erode patient confidence and independence, complicating their overall recovery process. Thus, effective fall prevention measures are vital to enhancing patient safety and improving health outcomes.

The Importance of Proactive Strategies

Proactive strategies in fall prevention involve anticipating and addressing risks before they lead to incidents. These strategies offer several benefits:

  • Reducing Injuries: Early identification and intervention significantly lower the likelihood of fall-related injuries.
  • Boosting Confidence and Mobility: Patients who feel secure are more likely to engage in physical activities and rehabilitation, leading to better health outcomes.
  • Cost Savings: Fewer falls mean reduced need for additional treatments; shorter hospital stays and lower legal liabilities.

Hospital at Home initiatives provide comprehensive medical care within the comfort of patients’ homes. This model has demonstrated potential in enhancing patient safety, particularly through fall prevention programs. By reducing the need for hospital admissions, these initiatives help minimize healthcare costs and improve patient satisfaction.

Key Components of Hospital at Home Fall Prevention Programs

Comprehensive Risk Assessments

Effective fall prevention starts with thorough risk assessments. This involves evaluating patients for factors such as mobility issues, medication side effects and cognitive impairments. High-risk patients receive customized interventions and close monitoring. Regular updates to these risk assessments ensure that new risks are quickly identified and addressed.

Adapting the home environment to minimize fall risks is essential. This can include installing grab bars, ensuring adequate lighting, using non-slip mats and removing tripping hazards. These modifications help create a safer space for patients to move around.

Caregivers and family members play a crucial role in preventing falls. Educating them about best practices and potential risk factors helps create a supportive environment for patients. Ongoing training and regular competency assessments ensure caregivers are well-prepared to maintain high standards of care.

Leveraging Technology for Fall Prevention

Technological advancements have introduced innovative tools to enhance patient safety and prevent falls. These tools include sensor-based monitoring systems, wearable devices and data analytics with predictive risk modeling.

Sensor-based systems use motion sensors, bed alarms and wearable devices to monitor patient movements and alert caregivers to potential fall risks in real-time, allowing for timely interventions.

Wearable devices can detect falls as they occur and automatically notify healthcare providers, ensuring immediate responses that can mitigate the severity of injuries.

Through the analysis of patient data, healthcare providers can identify patterns and predict fall risks, facilitating more accurate risk assessments and targeted interventions.

Cost Savings and Reducing Hospital Days

Along with the benefit of enhanced patient safety, Hospital at Home (HaH) initiatives offer significant cost savings and reduced number of hospital days. By implementing effective fall prevention strategies, HaH programs help avoid the need for additional medical treatments that would otherwise be required after a fall. This includes costly extended hospital stays and potential legal expenses associated with fall-related injuries. Consequently, healthcare facilities and patients experience substantial financial savings.

Moreover, by delivering high-quality care in the comfort of patients’ homes, HaH initiatives reduce the necessity for prolonged hospital admissions. This not only decreases overall healthcare costs but also alleviates the burden on hospital resources, making it easier for healthcare facilities to allocate attention and care to more critical cases.

By minimizing the time patients spend in the hospital, these programs promote a more efficient and effective healthcare system while ensuring patients receive the personalized care they need in a familiar environment.

A Path to Continuous Improvement Through Precision and High Reliability

Precision nursing involves customizing prevention and screening programs based on individual genetic and lifestyle factors, which enhances the effectiveness of preventive measures by addressing specific risk factors early. High reliability in nursing ensures consistently safe and high-quality care, even in complex situations, through standardized, evidence-based protocols and data-driven methods that identify vulnerabilities and track intervention effectiveness.

To maintain the efficacy of fall prevention strategies, healthcare providers must regularly evaluate their impact and strive for continuous improvement. This involves tracking metrics such as fall rates, injury rates, patient satisfaction scores, and cost savings.

By conducting regular reviews and updates of fall prevention protocols, informed by the latest research and feedback, healthcare providers can adapt their strategies to meet evolving challenges and uphold high standards of care.

Commitment to Excellence in Fall Prevention

Proactive fall prevention strategies are essential for enhancing patient outcomes and advancing healthcare excellence. Comprehensive risk assessments, environmental modifications, staff education, and the use of technology allow healthcare providers to significantly reduce fall-related injuries and improve patient safety. Involving patients and their families in these efforts also contributes to better outcomes.

Continuous evaluation and refinement of fall prevention measures ensure their long-term effectiveness and sustainability. As healthcare evolves, prioritizing proactive fall prevention will remain vital for delivering high-quality, patient-centered care.

Hospital at Home (HaH) initiatives, coupled with comprehensive fall prevention programs, significantly improve patient safety and healthcare quality. By proactively addressing fall risks and utilizing technology and data, healthcare providers can reduce unnecessary hospital days, achieve cost savings, and enhance patient outcomes. These initiatives will continue to play a crucial role in the future of patient-centered care.

About Dr. Amy Hester, PhD, RN, BC, FAAN, Chairwoman and CEO, HD Nursing.

Amy has 25 years of nursing experience including over a decade of med/surge and neuro nursing followed by unit management and hospital administration. In 2015, she earned a Doctor of Philosophy in Nursing Science and has since published and spoken extensively on the subject of falls and injury prediction and prevention. She retired from UAMS in 2018 after 26 years of service to dedicate her time fully to HD Nursing. She is adjunct faculty at UAMS College of Nursing. As an entrepreneur, she mentors others to help them with their own endeavors. Amy also serves as the Chair of the HD Nursing Board of Directors. View previous article here.

 

 

Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA

(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company submitted the fourth and final module of its Premarket Approval (PMA) application for Genio to the U.S. Food and Drug Administration (FDA).

Genio is a different approach to hypoglossal nerve stimulation (HGNS). Genio offers patients a leadless, fully-body MRI compatible, non-implanted battery solution, powered and controlled by a wearable. Thanks to the fully upgradable wearable component, Genio patients can always have access to the most advanced technology without needing another surgery. In March 2024, Nyxoah announced the DREAM U.S. pivotal study data achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an intent-to-treat basis, and that Genio is the only HGNS solution to show similar outcomes in supine and non-supine sleep.

“I am proud to achieve this important milestone, which brings us one step closer to offering Genio to obstructive sleep apnea patients in the U.S. I would like to congratulate our entire team on their hard work in completing the PMA submission. I could not be more excited for the remainder of 2024, which includes presenting the complete DREAM data at the International Surgical Sleep Society meeting in September and preparing for a U.S. launch by the end of the year,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer.

FDA Approves PYZCHIVA ® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara

Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA® (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Stelara1 (ustekinumab). PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Additionally, a provisional determination was granted for PYZCHIVA’s interchangeability.

“The FDA approval of PYZCHIVA as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments,” said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “In addition, biosimilars have a potential to reduce the financial burden of healthcare systems, especially in the US where biologics account for more than 46% of the annual drug spending. We will continue to reinforce our commitment to widen access to medicines by advancing our biosimilar pipeline for the benefits of patients, healthcare providers, and healthcare systems around the world,” she added.

The FDA’s approval of PYZCHIVA is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating biosimilarity to Stelara, with no clinically meaningful differences in terms of safety, purity and potency: The randomized, double-blind, three-arm, parallel-group, single-dose Phase 1 clinical study (NCT04772274) demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity profiles between PYZCHIVA (SB17) and Stelara in healthy volunteers. The randomized, double-blind, multicenter Phase 3 clinical study (NCT04967508), conducted in patients with moderate to severe plaque psoriasis, demonstrated biosimilarity of SB17 with Stelara through equivalent efficacy and comparable safety and PK profiles up to Week 28 and these primary results were published in the Journal of the American Academy of Dermatology.2 In addition, the Phase 3 study demonstrated biosimilarity of SB17 to Stelara up to week 28 in terms of efficacy, safety, pharmacokinetics, and immunogenicity, and these data were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in March 2024.3

PYZCHIVA, developed by Samsung Bioepis, will be commercialized by Sandoz in the United States. Samsung Bioepis and Sandoz entered into a commercialization agreement for SB17 (PYZCHIVA) in September 2023 for the US, Canada, European Economic Area (EEA), Switzerland, and United Kingdom (UK). In the US, the license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.

Samsung Bioepis has a total of 11 biosimilars in its products and pipeline portfolio across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Samsung Bioepis has seven biosimilars approved in the US and four commercially available as of June 2024.

About PYZCHIVA® (ustekinumab-ttwe) injection, for subcutaneous (45 mg/0.5 mL and 90 mg/mL) or intravenous (130 mg/26 mL solution) use

PYZCHIVA (ustekinumab-ttwe) is indicated for:

  • Plaque Psoriasis: PYZCHIVA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • Psoriatic Arthritis: PYZCHIVA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
  • Crohn’s Disease: PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
  • Ulcerative Colitis: PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

SELECTED IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
PYZCHIVA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in PYZCHIVA.

WARNINGS AND PRECAUTIONS

Infections
Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.

Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical studies included the following:

  • Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections.
  • Psoriatic arthritis: cholecystitis.
  • Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
  • Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.

Avoid initiating treatment with PYZCHIVA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of PYZCHIVA in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with PYZCHIVA and discontinue PYZCHIVA for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances).

Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis infection prior to initiating treatment with PYZCHIVA.

Avoid administering PYZCHIVA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering PYZCHIVA. Consider anti-tuberculosis therapy prior to initiation of PYZCHIVA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving PYZCHIVA for signs and symptoms of active tuberculosis during and after treatment.

Malignancies
Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical studies. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.

The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving PYZCHIVA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment

Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue PYZCHIVA.

Posterior Reversible Encephalopathy Syndrome (PRES)
Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.

Monitor all patients treated with PYZCHIVA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue PYZCHIVA.

Immunizations
Prior to initiating therapy with PYZCHIVA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with PYZCHIVA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with PYZCHIVA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving PYZCHIVA because of the potential risk for shedding from the household contact and transmission to patient.

Non-live vaccinations received during a course of PYZCHIVA may not elicit an immune response sufficient to prevent disease.

Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue PYZCHIVA and institute appropriate treatment.

Most common adverse reactions are:

  • Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
  • Crohn’s Disease, induction (≥3%): vomiting.
  • Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
  • Ulcerative colitis, induction (≥3%): nasopharyngitis
  • Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea

Please see Full Prescribing Information for PYZCHIVA™ (ustekinumab-ttwe) HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ ®

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva’s single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA)1.

The EC decision marks the third approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023 and Health Canada last month2. The Company expects to deliver the first doses in Europe in the fourth quarter of 2024.

IXCHIQ® is the world’s only licensed chikungunya vaccine available to address this unmet medical need. In accordance with the International Recognition Procedure (IRP)3, Valneva has also submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA). An additional marketing authorization application is under review by the Brazilian Health Regulatory Agency (ANVISA) to make the vaccine available in certain Low- and Middle-Income Countries (LMIC), with potential approval in 2024.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “The EC approval marks a crucial milestone toward making this vaccine available to as many European citizens as possible. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected. It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks. We would like to thank our partner, CEPI, for supporting us in this endeavor.”

Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), commented, “Supported by CEPI and EU funding, IXCHIQ is the world’s first vaccine offering protection against the debilitating Chikungunya virus. The EU’s rapid approval of the vaccine, following recommendation by the European Medicines Agency, is a historic moment to help protect the lives and livelihoods of European populations against Chikungunya outbreaks, which are becoming more frequent and widespread in the region. But the fight is not over – as a matter of priority CEPI is working with Valneva and the EU to expand access to the vaccine to those living in endemic countries who are greatest risk from the disease.”

The EC marketing authorization follows the European Medicines Agency’s (EMA) positive opinion a month ago4 and is supported by data from the pivotal Phase 3 study which were published in The Lancet, and showed a 98.9% seroresponse rate at 28 days with a single vaccination. This immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults5. Last month, Valneva reported further positive pivotal data in adolescents six months after a single vaccination, which are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years6. The data are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in an endemic population.

Valneva partnered with CEPI 7 and Instituto Butantan in Brazil8 to make the vaccine more accessible to LMIC. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 20199, which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

OSE Immunotherapeutics Announces Publication of Preclinical Efficacy Results with Lusvertikimab in Acute Lymphoblastic Leukemia in the Journal ‘Blood’

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced the publication of an article on latest preclinical efficacy data on the use of its anti-IL-7 receptor (IL-7R

A&io) antagonist Lusvertikimab (OSE-127) for the treatment of B- and T-Cell Acute Lymphoblastic Leukemia (B- and T-ALL) in ‘Blood’, a peer-reviewed medical journal published by the American Society of Hematology.

The preclinical data on Lusvertikimab published in ‘Blood’ was generated from a collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany). This collaboration is using patient-derived samples and in-vivo xenograft models to evaluate the therapeutic potential of anti-IL-7R antagonist Lusvertikimab in targeting and blocking the high and dysregulated IL-7R-expression observed in nearly 85% of B- or T-Acute Lymphoblastic Leukemia (ALL) patients.

Pr. Denis Schewe (newly appointed Head of Pediatric Hematology/Oncology, University Hospital Dresden and National Center for Tumor Diseases, Partner Site Dresden, and formerly from the University Medical Center Schleswig-Holstein of Kiel) and Dr. Lennart Lenk (Department of Pediatrics I, Christian-Albrechts University Kiel and University Medical Center Schleswig-Holstein, Kiel), leading the research program in collaboration with OSE Immunotherapeutics, comment: “Treatment options for T-ALL remain very limited and there is an urgent need for novel immunotherapy approaches to reduce toxicity and to target relapsed or refractory disease in ALL patients. Through its dual mode of action comprising both IL-7R signaling blockade and antibody-dependent cellular phagocytosis induction, Lusvertikimab may represent a promising novel immunotherapy option for CD127 positive ALL patients, particularly in combination with polychemotherapy standard of care. When translated into the clinic, Lusvertikimab could significantly improve ALL-therapy and the outcome of relapsed/refractory disease.”

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: “We are very pleased with this publication on Lusvertikimab in ‘Blood’, a high-level journal within the field of hematology whose manuscripts are reviewed by prominent specialists. Novel targeted immunotherapy options are urgently needed for B-ALL and T-ALL patients and we are happy to collaborate with the research leaders in hematology from the University of Kiel to face this clinical challenge.”

The abstract, titled: “The IL-7R antagonist Lusvertikimab reduces leukemic burden in xenograft-ALL via antibody-dependent cellular phagocytosis” reported that IL-7R immunotherapy with Lusvertikimab shows significant in vivo efficacy in preclinical models using samples from B-ALL and T-ALL. Mechanistically, Lusvertikimab targeted ALL cells via a dual mode:

  • On one hand it blocks IL-7 receptor signaling and hence block proliferative and pro-survival signals induced by Interleukin-7.
  • In parallel, it induces leukemic cells elimination by macrophages (antibody-dependent phagocytosis), in particular with strong correlation with the level of IL-7R surface expression on leukemic cells.

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is a heterogeneous group of lymphoid disorders resulting from clonal proliferation of immature lymphocytes of B-cell (85%) or T-cell (15%) lineages (3) in the blood, bone marrow, and other lymphoid organs.
Although it is one of the most common cancers in children, accounting for approximately 25% of all childhood cancer diagnoses among children under 15 years of age (4), adults can also develop ALL. About 40% cases of ALL diagnosed are in adults and among them about 50% present refractory disease or undergo relapse under current conventional therapies (4).

The American Cancer Society estimates that almost 6,660 new cases of ALL will be diagnosed in the United States in 2022(5). In Europe, 7,000 cases of ALL are diagnosed each year (6). The number of patients in Japan was reported to be about 5,000 in a survey by the Japanese MHLW in 2017. The number of diagnosed incident cases of acute lymphocytic leukemia (ALL) in Europe, US, Japan and China is estimated to achieve 26,482 cases in 2029(7).

(1) ASH Publication – Blood (2022) 140 (Supplement 1): 1045 – 1047
(2) Lennart Lenk, PhD, Irène Baccelli, PhD, Dorothee Winterberg, PhD, Anna Dietterle, Frédérique Corallo, MD, Julien Taurelle, Emma Narbeburu*, Anna Laqua, PhD, Beat Bornhauser, PhD, Jean-Pierre Bourquin, MD, PhD, Fotini Vogiatzi, PhD, Martin Schrappe, MD, Gunnar Cario, Monika Brüggemann, MD, Nicolas Poirier, PhD and Denis Martin Schewe, MD
(3) DeVita, Jr. VT, Hellman S, Rosenberg SA, eds.; Cancer: Principles and Practice of Oncology, 10th ed.; Lippincott-Raven, Philadelphia, PA; 2014.
(4) Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version, accessed October 2022
(5) American Cancer Society. Key 2022 Statistics for Acute Lymphocytic Leukemia (ALL). Available at: https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html#references., accessed October 2022
(6) Gatta G, van der Zwan JM, Casali P, et al. Rare cancers are not so rare: The rare cancer burden in Europe. Eur. J. Cancer. 2011; 47: 2493-2511.
(7) Global Data

LIfT BioSciences Appoints Antonin (Tony) de Fougerolles as Chairman of its Board of Directors

LIfT BioSciences, (‘LIfT’ or ‘the Company’), a rapidly emerging biotech company preparing to start clinical trials for its first-in-class allogeneic innate cell therapy, today announces the appointment of Antonin (Tony) de Fougerolles, PhD as Chairman of its Board.

Tony brings over 25 years of biotech R&D experience in building out drug pipelines and bringing new-to-world therapeutic modalities to patients. He has most recently served as CEO of Evox Therapeutics and previously, served as CSO of Ablynx, where he led the company’s non-clinical R&D operations and played a key role in the approval of the first single domain antibody drug, caplacizumab and in building out a portfolio of immuno-oncology and immunology products. Prior to this, Tony held several leadership positions, including founding CSO at Moderna Therapeutics where he developed and invented much of the foundational science behind their revolutionary mRNA platform, CSO at Tolerx, Inc and VP of Research at Alnylam. He currently serves on the boards of etherna and Chimeron Bio and is also an advisor to MiNA Therapeutics. Tony holds a PhD in Immunology from Harvard University and a BSc in Microbiology & Immunology from McGill University.

Alex Blyth, Chief Executive Officer of LIfT BioSciences commented: “On behalf of LIfT’s Board of Directors, I am pleased to welcome Tony to the Company as Chairman. Tony has extremely relevant experience, having played a key role in successfully bringing three new drug modalities to the market, extensive experience in immuno-oncology, and has helped build several multi-billion-dollar companies from start-up stage. This wealth of experience will prove invaluable to LIfT as we prepare to move into clinical trials for our allogeneic first-in-class neutrophil-based immuno-cell therapy and other exciting pipeline developments.”

Antonin (Tony) De Fougerolles, Chairman of the Board commented: “I’m delighted to join LIfT at such a crucial stage in its journey. The team at LIfT have been leading the field in characterising and developing an immuno-oncology therapeutics platform around a newly described subset of neutrophils called Immuno-Modulatory Alpha Neutrophils (IMANs). These IMANs dramatically outperform traditional neutrophils in their tumour killing abilities by rapidly infiltrating tumours and recruiting additional immune cells. As an immunologist, it is not a surprise that neutrophils like other immune cell types are also comprised of subsets of cells with different functions. I look forward to using my varied experience to support Alex and the team to advance LIfT’s IMANs through the clinic towards the market as a new transformational therapy for solid tumours.”

Study: Private Equity Acquisitions in Cardiology on the Rise

Over the past decade, 342 cardiology clinics have been acquired by private equity firms, with over 94% of those occurring between 2021 and 2023, according to a study published today in JACC, the flagship journal of the American College of Cardiology, and presented at the AcademyHealth 2024 Annual Research Meeting in Baltimore. As this practice grows, the study highlights the critical need to monitor the effects of private equity acquisitions on quality of care and outcomes for patients with cardiovascular disease, as well as procedural utilization.

Private equity in health care is when a medical practice and their sites of service are acquired through pooled investment from multiple sources, including individual and institutional investors, pension funds, endowments, etc., with the intention of improving operations, financially supporting innovation and technology, increasing growth through additional acquisitions and ultimately, increasing profitability.

“Policymakers and clinicians have raised concern about the growing presence of private equity in other medical specialties. Although cardiology is an attractive target for private equity firms, little is known about the number and types of practices that are being acquired,” said Senior Author Rishi K. Wadhera, MD, MPP, MPhil, a cardiologist at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School in Boston. “Private equity acquisitions in other specialties have been shown to decrease quality and increase costs, so it is critical to understand the impact on cardiology.”

Researchers found that Between January 2013 and September 2023, private equity firms acquired 41 outpatient cardiology practices, corresponding to 342 clinic sites. The number of clinic sites acquired per year increased from zero in 2013 to 215 in 2023, with 324 of those happening from 2021-2023, and 64 of these clinics were acquired more than once. Acquisitions happened in 20 states; Florida had the most, followed by Texas and Arizona. The study also found that acquisitions tended to be highly concentrated in the same areas, and that the highest poverty communities were less likely to be acquired compared to the wealthiest communities.

In an accompanying editorial comment, ACC Past President Edward Fry, MD, MACC, said it is equally important to understand what is enticing cardiologists to be acquired by these ventures.

“Is it just about the money or is the move to private equity a symptom of more foundational problems with the current practice of medicine and cardiology?” he said. “Clinicians, health system administrators, policymakers, and the public need to define the elements of clinical practice that encourage a growing number of cardiologists to seek out alternative employment models. Addressing them will be necessary to truly transform care and promote equity and value.”

Wondering How to Prevent Running Injuries? Here’s What You Need to Know

Prevent Running Injuries

Running is an excellent way to stay fit, manage stress, and enjoy the outdoors. However, without proper precautions, it can also lead to injuries that can sideline you from your favorite activity. To prevent running injuries effectively, it’s crucial to understand the common causes and the preventative measures that can help keep you running safely and effectively.

Here’s what you need to know about preventing running injuries.

Understanding Your Running Gait

Understanding your running gait is crucial in preventing injuries. Analyze how your foot impacts the ground, the length of your stride, and your overall posture during a run to significantly influence your efficiency and risk of injury. Recognizing abnormalities in these areas can guide you to make necessary adjustments, helping to enhance your running performance and minimize the likelihood of getting hurt.

For detailed guidance on assessing your running mechanics, tips on how to check running gait provide an excellent resource. You can make adjustments to avoid potential injuries by identifying any irregularities in your gait.

Proper Footwear: Choosing the Right Shoes

Choosing the right running shoes is paramount in the quest to prevent injuries. Shoes that do not fit properly or fail to provide adequate support can lead to various issues, such as plantar fasciitis, shin splints, and knee pain. When selecting running shoes, consider factors such as arch support, cushioning, and the specific needs of your running gait. It is often advisable to visit a specialized running store where you can receive expert advice and even have your gait analyzed professionally.

Gradual Progression and Training Variation

To minimize the risk of injury, gradually increase the intensity and duration of your runs. This approach, known as progressive overload, allows your body to adapt to new stress levels without overstraining. Additionally, incorporating various training methods, such as interval training, long slow runs, and strength training, can help build a stronger, more resilient body. This variation can help prevent the monotony of running and reduce the risk of overuse injuries.

Strength Training and Flexibility

Strength training is integral to injury prevention for runners, focusing on enhancing muscle strength and stabilizing joints. Target critical areas like the core, hips, and legs with exercises such as squats, lunges, and planks to support your running mechanics. Equally critical is improving flexibility. Engage in regular stretching and mobility exercises to increase muscle elasticity and joint movement, which is crucial in decreasing the risk of muscle tears and strains. This combination can help create a more resilient and flexible runner capable of handling the demands of regular training.

Importance of Rest and Recovery

Rest and recovery are fundamental elements of a successful running program, just as important as the training. Overtraining can quickly lead to injuries, making integrating scheduled rest days into your regimen crucial. These breaks allow your body to repair and strengthen. Quality sleep and proper nutrition are also vital, providing the necessary resources for your body to heal and maintain high performance. Prioritize rest and recovery to ensure you can train more effectively and sustainably.

Listen to Your Body: Recognizing Warning Signs

Being attuned to your body’s signals is vital in preventing running injuries. Pay close attention to any signs of fatigue, discomfort, or pain, as these are early warnings from your body requesting a break. Disregarding these symptoms can escalate to more severe injuries.

Should you notice persistent pain or discomfort, it is crucial to consult a healthcare professional before continuing with your running activities. Understand and respond to your body’s signals to prevent injuries and enhance your overall running experience by maintaining health and well-being.

Hydration and Nutrition

Proper hydration and nutrition play vital roles in performance and injury prevention. Dehydration can lead to decreased performance, fatigue, and an increased risk of injuries. Ensure you drink adequate fluids before, during, and after your runs. Moreover, a balanced diet rich in vitamins, minerals, and antioxidants can help strengthen your body’s tissues, making them more injury-resistant.

Regular Health Checks

Regular consultations with a sports medicine professional or physical therapist are essential for maintaining optimal running health. These specialists offer crucial insights into your running form, helping pinpoint and correct biomechanical imbalances or weaknesses that may predispose you to injuries. They can also recommend specific exercises tailored to your needs, which enhances strength and flexibility where necessary.

Additionally, they are equipped to develop personalized training plans that align with your unique physical conditions and goals, ensuring you train effectively while minimizing the risk of injury.

Conclusion

Preventing running injuries is about being proactive—understanding your body, choosing the right equipment, and adjusting your training program. By following these guidelines and paying attention to the signs your body gives you, you can enjoy a healthy and fulfilling running experience. Remember, the goal is not just to run faster or longer but to run smarter and with longevity in mind.

 

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