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HoneyNaps Accelerates Clinical Trial Pipelines with FDA-Cleared AI “SOMNUM”

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Advertorial Desk
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  • Enhancing Clinical Efficiency with AI Sleep Analysis: Cutting Both Cost and Time
  • Joint Clinical Studies with CROs: SOMNUM™ AI Sleep Scoring Drives Higher Efficiency
  • FDA-cleared AI solution shortens clinical trial timelines while ensuring data reliability
  • Expanded global partnerships with CROs enable a large-scale clinical data analysis platform

BOSTON, Nov. 24, 2025 /PRNewswire/ — HoneyNaps, an AI-driven sleep-medicine technology company, announced that its AI-based sleep disorder diagnostic support software, SOMNUM™, which recently received clearance from the U.S. Food and Drug Administration (FDA), is significantly reducing clinical trial timelines and costs for pharmaceutical and medical device companies through enhanced data-analysis efficiency.

HoneyNaps Accelerates Clinical Trial Pipelines with FDA-Cleared AI “SOMNUM”
HoneyNaps Accelerates Clinical Trial Pipelines with FDA-Cleared AI “SOMNUM”

SOMNUM™ is a medical AI software solution designed to automatically analyze polysomnography (PSG) data. The system identifies sleep stages and key events—including apnea, hypopnea, and arousals—using advanced artificial intelligence–based PSG scoring.

Following its FDA 510(k) clearance last year, SOMNUM™ has been formally recognized as a validated analytical tool for sleep-related clinical trials and medical device evaluations. This clearance underscores the safety and reliability of AI-based sleep-analysis technology as acknowledged by global regulatory authorities.

Traditionally, PSG scoring required specialists to manually review and classify data for more than three to four hours per case, resulting in high labor and time costs. SOMNUM™ automates this process, shortening scoring time to just minutes, while clinicians review and verify the results to maintain diagnostic quality.

By integrating SOMNUM™, pharmaceutical companies and medical device manufacturers have been able to accelerate clinical trial pipelines, increase data-processing speed by more than 70%, and reduce overall study timelines by approximately 50%. Scoring labor costs and quality-control (QC) expenses have also dropped by 80–90%.

HoneyNaps is expanding its global clinical-market presence with SOMNUM™ at the core of its business strategy. The company is currently in discussions with U.S. pharmaceutical firms regarding the application of SOMNUM™ in sleep-related clinical studies and has established strategic partnerships with multiple CROs. Through these collaborations, HoneyNaps provides a large-scale biosignal-analysis platform essential for sleep-medicine and neurological clinical trials—delivering both accelerated pipelines and enhanced data accuracy.

The company is also offering an AI-based re-scoring (verification scoring) service for already-scored PSG datasets. This new business model provides an objective check on the accuracy of existing scoring results. CROs leverage this re-scoring solution to secure data quality while shortening trial timelines and strengthening the reliability of data submitted to regulatory bodies. Beyond simple verification, the service supports clients in advancing future projects, proprietary algorithms, and technology development—ultimately enhancing R&D competitiveness.

SOMNUM™ goes beyond conventional AI analysis by incorporating explainable AI (XAI) technology, enabling clinicians to review the rationale behind the AI’s scoring decisions. This ensures transparency and verifiability of trial data, meeting the stringent quality standards required by global regulatory agencies.

HoneyNaps is currently collaborating with major tertiary hospitals and sleep centers in Korea, as well as university hospitals and clinical institutions across the United States and Europe, to expand its SOMNUM™-based AI analysis platform. The technology is being used not only in clinical trials for sleep and wake-promoting therapeutics, but also in evaluating the effectiveness of CPAP devices, sleep sensors, wearable devices, and a range of sleep-technology products.

Taekyoung (Sean) Ha, PhD, President of HoneyNaps USA, stated, “SOMNUM’s PSG AI scoring technology is fundamentally transforming the traditionally time-consuming manual scoring process that has long been a bottleneck in sleep-related clinical trials. Backed by FDA clearance, SOMNUM™ is now delivering tangible improvements in research efficiency and cost reduction for global pharmaceutical and medical device companies.”

For further information, please contact:
HoneyNaps USA, Inc.
Christine Kwon / Managing Director
Email: sleep@honeynaps.com
Address: #517, SPACES, 361 Newbury Street, Boston, MA, 02115

 

Bay Aesthetics Clinic and Medical Spa Unveils Key Expansion, Additional Services, and Extended Hours to Meet Rising Demand

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Advertorial Desk
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SINGAPORE – Media OutReach Newswire – 24 November 2025 – Bay Aesthetics Clinic and Medical Spa, a doctor-led aesthetic and laser clinic known for its client-first approach and evidence-based treatments, is proud to announce a significant expansion and renovation in celebration of its 3rd anniversary.

Clinic Expansion & Renovation

Founded in 2022, Bay Aesthetics Clinic and Medical Spa was established with a vision to deliver personalised, medically guided rejuvenation within a tranquil and restorative environment. Helmed by Medical Director Dr Hoe Ying Min, the clinic has now expanded into two adjacent retail units, unveiling a freshly renovated 3,000 square-foot medical aesthetic and laser clinic in the heart of Marina Bay Financial Centre.

The expanded space features 12 private treatment rooms, a VIP relaxation lounge, and in-room massage chairs, intentionally designed to offer calm and comfort amidst the CBD’s fast-paced energy.

“Many of our patients are busy professionals who visit during lunch breaks or between meetings,” says Dr Hoe. “Comfortable private rooms allow them to rest, take a power nap, or even join a quick work call while waiting for treatment.”

Partnership, not Packages

Dr Hoe Ying Min lists down three factors driving the clinic’s growth: “Firstly, we treat every client as a friend and genuinely want the best for them. There is zero culture of hard selling or pressure sales tactics. People can sense your authenticity. Secondly, we strive to build long-term relationships with our clients and walk together with them as partners through their lives, helping them look and feel good. Last but not least, we deliver results that speak for themselves. The best advertisement is a happy and beautiful client!”

Strengthened Medical Team & Extended Operating Hours

To better serve its growing clientele—now exceeding 3,000 patients, driven prominently by referrals—the clinic has strengthened its team, comprising three doctors and seven clinical staff dedicated to professional, sincere, and long-term patient care.

To ensure shorter waiting times and greater flexibility, Bay Aesthetics Clinic will now operate on Sundays and Public Holidays, reflecting its commitment to accessibility and timely service.

“We are grateful for the trust our clients place in us,” shares Dr Hoe. “Our team strives to foster genuine relationships built on mutual respect, professionalism, and personalised care.”

Hashtag: #BayAestheticsClinic

The issuer is solely responsible for the content of this announcement.

About Bay Aesthetics Clinic and Medical Spa

Located within the bustling Marina Bay Financial Centre, Bay Aesthetics Clinic and Medical Spa is a doctor-led aesthetics and laser clinic offering scientifically backed treatments in a restorative environment. Its signature services include: PicoSure Laser, MOXI Laser, Sciton BBL HERO, Hydrafacial Syndeo, Botulinum Toxin Injections, Dermal Fillers, Ultherapy Prime, and Oligio X.

For more information or appointments:
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Five Vientiane BRT Accidents in November Trigger Social Media Backlash

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Laotian Times
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An accident at BRT station

Vientiane recorded five traffic accidents on the newly designated Bus Rapid Transit lanes in November, just weeks after the city launched a two-month free trial of the system. The incidents have fueled public concern about safety and weak enforcement.

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Ping An Unveils “Ancient Tree Guardian Action” at UN Climate Change Conference (COP30)

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Advertorial Desk
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Leveraging an Innovative “Insurance + Technology” Approach to Safeguard 55,000 Ancient Trees and Promote Biodiversity Conservation

HONG KONG and SHANGHAI, Nov. 24, 2025 /PRNewswire/ — Ping An Insurance (Group) Company of China, Ltd. (“Ping An” or “the Group”, HKEX: 2318/82318; SSE: 601318) presented its biodiversity protection project, “Ancient Tree Guardian Action”, at the 30th session of the Conference of the Parties (COP 30) to the United Nations Framework Convention on Climate Change (UNFCCC), held in Belém, Brazil. This initiative deeply integrates insurance coverage, technology, and social welfare to establish a sustainable protection system for ancient and notable trees in China, demonstrating the innovative efforts of a Chinese enterprise in tackling climate change and preserving biodiversity.

Innovative Approaches to Overcome Challenges in Ancient Tree Conservation

China harbors a rich heritage of ancient trees, with around 5.08 million specimens recognized for their ecological, historical, and scientific significance. These venerable trees, however, face serious threats from climate change, pest infestations, and insufficient maintenance funding. Since ancient trees are widely scattered and their value is difficult to quantify, insurance companies must dedicate extensive resources to individual inspections and ongoing monitoring. This demand places a heavy burden on underwriting capabilities, making it hard for traditional commercial insurance models to offer comprehensive protection.

To tackle this challenge, Ping An introduced an innovative “Insurance + Technology” model, integrating cutting-edge technologies such as big data, artificial intelligence, and the Internet of Things (IoT). This model combines assessments of ancient tree growth, geographical location, and historical risk data to enable multidimensional evaluation. Building on this, Ping An launched Guangdong’s first ancient-tree insurance in 2023, creating a full-chain model “pre-disaster prevention, in-disaster emergency response, and post-disaster compensation” mechanism. As of October 2025, the project has provided over RMB 700 million (approximately USD 98 million) in risk protection for more than 55,000 ancient and notable trees nationwide.

Shifting From Post-Disaster Compensation to Pre-Disaster Prevention through Technology-Enabled Protection

The application of technology is a key characteristic of Ping An’s ancient tree protection program. Ping An uses IoT, environmental sensors, and wireless communications to monitor crucial indicators such as soil moisture, air quality, and tree health, 24/7. All data is uploaded to the cloud in real time, where an intelligent management system enables visualization and dynamic alerts, providing caretakers with precise, science-based guidance for tree maintenance.

Ping An has also developed its proprietary “EagleX” system, which integrates remote sensing, meteorological monitoring, big data, and AI analytics to track extreme weather, floods, typhoons, and other natural hazards in real time. The system issues timely alerts when major risks are detected, extending insurance services from post-disaster compensation to pre-disaster prevention and significantly reducing the likelihood of damage to ancient trees.

Empowering Communities and Fostering Green Economic Growth Through Public Initiatives

Beyond providing financial security, Ping An actively engages in a range of public welfare activities, including educational programs on ancient trees and photography exhibitions, to raise public awareness of biodiversity conservation. In 2025, Ping An launched an eco-tourism campaign titled “Travel with Ancient Trees,” creating distinctive tourism routes centered on ancient trees. This initiative was promoted to 250 million registered users through Ping An’s “Auto Owner” app. While spreading ecological knowledge, the campaign also stimulates the growth of local green economies.

Promoting Biodiversity Conservation Through Green Finance

Ping An’s “Ancient Tree Guardian Action” forms a vital part of its green finance strategy. In addition to safeguarding ancient trees, Ping An provides insurance coverage for carbon-sequestering ecosystems, including forests, grasslands, wetlands, and marine environments. By the end of 2024, Ping An’s Carbon Sink Insurance had expanded to cover 18 provinces and municipalities nationwide, providing robust financial backing for ecological preservation.

In recent years, the Group has expanded both the depth and breadth of its green finance initiatives, advancing coordinated efforts across green insurance, banking, and investment. As of June 30, 2025, Ping An’s green investments totaled RMB 144.482 billion (approximately USD 20 billion), green loan balances reached RMB 251.746 billion (around USD 35.3 billion), and premium income from green insurance for the first three quarters amounted to RMB 55.279 billion (about USD 7.7 billion).

Looking ahead, Chen Yao, General Manager of the Brand Department at Ping An Group, stated: “Ping An will persist in promoting innovation within green finance. The Group aims to create a wider range of green insurance and investment products, collaborating with international partners to support sustainable development and the preservation of our environment.”

–    End –

About Ping An Insurance (Group) Company of China, Ltd.

Ping An Insurance (Group) Company of China, Ltd. (HKEX:2318 / 82318; SSE:601318) is one of the largest financial services companies in the world. It strives to become a world-leading provider of integrated finance, health and senior care services. Under the technology-enabled “integrated finance + health and senior care” dual-pronged strategy, the Group provides professional “financial advisory, family doctor, and senior care concierge” services to its nearly 250 million retail customers. Ping An advances intelligent digital transformation and employs technologies to improve financial businesses’ quality and efficiency and enhance risk management. The Group is listed on the stock exchanges in Hong Kong and Shanghai. As of the end of December 2024, Ping An had more than RMB12 trillion in total assets. The Group ranked 27th in the Forbes Global 2000 list in 2025, 47th in the Fortune Global 500 list in 2025, and ranked AAA in MSCI ESG Ratings in 2025.

For more information, please visit the www.group.pingan.com and follow our LinkedIn page – PING AN.

The Bicester Collection announces the Winners of the Unlock Her Future Prize 2025 – South Asia Edition

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Advertorial Desk
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Representing Bangladesh, India, Nepal, Pakistan and Bhutan, six bold innovators are advancing inclusive solutions that deliver transformative social impact in support of the United Nations Sustainable Development Goals.

LONDON, Nov. 24, 2025 /PRNewswire/ — The Bicester Collection is proud to announce the of the winners of the Unlock Her Future™ Prize 2025 – South Asia Edition, the flagship initiative of its philanthropic programme, DO GOOD.

LONDON, ENGLAND - NOVEMBER 19: (L to R) Chantal Khoueiry, Desiree Bollier and Paroma Chatterjee attend The Bicester Collection's Unlock Her Future Prize 2025 at Battersea Arts Centre on November 19, 2025 in London, England. (Photo by Sam Simpson/Dave Benett/Getty Images for The Bicester Collection)
LONDON, ENGLAND – NOVEMBER 19: (L to R) Chantal Khoueiry, Desiree Bollier and Paroma Chatterjee attend The Bicester Collection’s Unlock Her Future Prize 2025 at Battersea Arts Centre on November 19, 2025 in London, England. (Photo by Sam Simpson/Dave Benett/Getty Images for The Bicester Collection)

The Unlock Her Future Prize is a global start-up competition that empowers women social entrepreneurs with innovative ideas to create positive social and environmental change in support of the United Nations Sustainable Development Goals. Open to women of all ages, with ventures in any sector at either idea stage or early-growth stage (up to three years), the Prize was created to close a clear gap: while women around the world have the ideas and ambition to drive meaningful change, too often they lack the recognition, resources and support to do so.

By combining the power of the private sector with philanthropic purpose, the Prize creates a platform for women-led ventures to take root and scale from the ground up.

Launched in the MENA region in 2023, expanded to Latin America in 2024, and now in its third edition shining a light on the extraordinary women of South Asia, the Prize has quickly become a global platform championing women who are creating lasting, positive change. Supported by Ashoka and endorsed by UN Women, it has reached women across 39 countries, contributed solutions to 16 UN Sustainable Development Goals, and allocated more than US$600,000 in philanthropic funding to women-led ventures.

For the 2025 South Asia Edition, judges Desirée Bollier, Chair and Global Chief Merchant, The Bicester Collection, Dr Rubana Huq, Vice Chancellor, Asian University for Women, Priya Sigdel, Social Entrepreneur & Media Personality, Rishini Weeraratne, Editor, The Sun (Daily Mirror) and Head of Social Media, Wijeya Newspapers and Paroma Chatterjee, CEO Revolut India, agreed to award the prize fund across six winners:

  • Amritha Krishnamoorthy (India), Stepping Stones Centre, SDG 4 (Quality Education): Transforming education and therapy for children with autism and developmental disabilities, so no child is left behind.
  • Jhillika Trisal (India) Cognitii, SDG 4 (Quality Education): Democratizing access to quality education for children with special educational needs by combining AI with human special educators.
  • Sophiya Tamang (Nepal) Idea to Impact, SDG 2 (No Hunger): Turning surplus produce into fruit purees that nourish children, cut food waste, empower women farmers, and promote sustainable agriculture.
  • Nida Yousaf Sheikh (Pakistan) H2O Technologies, SDG 6 (Clean Water & Sanitation): Turning air humidity into safe drinking water to fight Pakistan’s water scarcity crisis, eliminate waste, and empower communities.
  • Nishat Anjum Palka (Bangladesh) Mommykidz, SDG 3 (Good Health & Wellbeing): A safe, affordable community where women and parents can access health information, care, and essential products without stigma.
  • Yangchen Dolkar Dorji (Bhutan) LEAD+, SDG 10 (Reduced Inequalities): Empowering grassroots, women-led, and marginalized businesses with funding, mentorship, and market access—while fostering self-reliance and community resilience.

Winners will each receive a grant of $50,000 ; mentoring and leadership training with global experts; access to The Bicester Collection’s global network of partners, affiliates and industry leaders; dedicated media training and exposure; and academic support from Oxford University Saïd Business School, which will provide world-class learning, mentoring and access to its global entrepreneurial network as part of the programme.

The 2025 South Asia Edition reflects The Bicester Collection’s long-standing ties with South Asian communities in the UK and the millions of guests from the region who visit its Villages in Europe, China and the USA each year. Its return to the UK — and to Bicester Village — coincides with the Collection’s 30th anniversary, marking three decades of reimagining shopping as a force for good.

“From 2,400 applicants to 11 exceptional finalists — and now our winners — each reminds us that behind every number is a story of courage, creativity and the determination to build a better world. The 2025 winners embody the diversity and ingenuity of South Asia, proving why investing in women matters. As The Bicester Collection marks 30 years of reimagining shopping as a force for good, this edition reinforces a purpose that defines us: progress is meaningful only when it unlocks opportunity for others. This is the spirit of Unlock Her Future.” Chantal Khoueiry, Chief Culture Officer-The Bicester Collection

In 2026, the Prize will expand its footprint across East and South-East Asia, opening to fifteen countries: Brunei, Cambodia, China, Indonesia, Japan, Laos, Malaysia, Mongolia, Myanmar, the Philippines, Singapore, South Korea, Thailand, Timor-Leste and Vietnam.

For more information: www.unlockherfutureprize.com, @dogood_thebicestercollection

About The Bicester Collection

Created in 1995, The Bicester Collection has reimagined the boundaries around the worlds of luxury retail, hospitality, live music and sports entertainment, curating extraordinary experiences for the world’s most discerning guests. Located in Europe, China and North America, The Bicester Collection’s 12 Villages are world-renowned as iconic, open-air shopping destinations. Each offers the world’s best brands at incredible value, as well as celebrated restaurants and peerless services. For more than a quarter of a century since its founding, The Bicester Collection Villages’ mission has been to make the lives of others better – from the communities it serves to its guests, brand partners and its people. Through its DO GOOD programme, The Bicester Collection aims to drive sustainable social change in support of the United Nations’ Sustainable Development Goals, with a focus on unlocking futures for women and children, locally and globally. 

The Bicester Collection brings together extraordinary live music and sports experiences at the first third-generation UBS Arena serving the New York metro area (home to the New York Islanders ice hockey team), a pioneering concert venue featuring the Isles Lab Team concept store. The Collection’s award-winning hotel destinations, Mission Pacific Beach Resort and The Seabird Ocean Resort & Spa (with its Michelin-starred restaurant, Valle; celebrated Sunny’s Spa & Beauty Lounge; and locally curated boutique The Ozone), are vibrant destinations in Southern California’s hidden gem, Oceanside.

The Bicester Collection exists to be experienced in the real world. To be actual, not virtual. To be lived. Discover more at TheBicesterCollection.com.

LONDON, ENGLAND - NOVEMBER 19: (L to R) Nida Yousaf Sheikh, Rubina Raut, Prapti Mittal, Amritha Krishnamoorthy, Jhillika Trisal, Sophiya Tamang, Shenali Nimanthini Wijesinghe, Tangchen Dolkar Dorji, Nishat Anjum Palka and Khushbakht Shah Jilani attend The Bicester Collection's Unlock Her Future Prize 2025 at Battersea Arts Centre on November 19, 2025 in London, England. (Photo by Sam Simpson/Dave Benett/Getty Images for The Bicester Collection)
LONDON, ENGLAND – NOVEMBER 19: (L to R) Nida Yousaf Sheikh, Rubina Raut, Prapti Mittal, Amritha Krishnamoorthy, Jhillika Trisal, Sophiya Tamang, Shenali Nimanthini Wijesinghe, Tangchen Dolkar Dorji, Nishat Anjum Palka and Khushbakht Shah Jilani attend The Bicester Collection’s Unlock Her Future Prize 2025 at Battersea Arts Centre on November 19, 2025 in London, England. (Photo by Sam Simpson/Dave Benett/Getty Images for The Bicester Collection)

 

LONDON, ENGLAND - NOVEMBER 19: (L to R) Nida Yousaf Sheikh, Amritha Krishnamoorthy, Sophiya Tamang, Jhillika Trisal, Nishat Anjum Palka and Tangchen Dolkar Dorji attend The Bicester Collection's Unlock Her Future Prize 2025 at Battersea Arts Centre on November 19, 2025 in London, England. (Photo by Sam Simpson/Dave Benett/Getty Images for The Bicester Collection)
LONDON, ENGLAND – NOVEMBER 19: (L to R) Nida Yousaf Sheikh, Amritha Krishnamoorthy, Sophiya Tamang, Jhillika Trisal, Nishat Anjum Palka and Tangchen Dolkar Dorji attend The Bicester Collection’s Unlock Her Future Prize 2025 at Battersea Arts Centre on November 19, 2025 in London, England. (Photo by Sam Simpson/Dave Benett/Getty Images for The Bicester Collection)

Xposure Marks 10 Years of Visual Storytelling with Stellar Global Artists

By
Advertorial Desk
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SHARJAH, UAE, Nov. 24, 2025 /PRNewswire/ — Xposure’s International Photography and Film Festival unites 420 artists from around the world under the theme “A Decade of Visual Storytelling.” From January 29 to February 4, 2026, the 49,000-square-metre Aljada site will become a global hub for photography and film, hosting 570 events, including 95 exhibitions featuring 3,200 works.

Over the past decade, Xposure has established Sharjah as a global destination for visual storytelling. Organized by the Sharjah Government Media Bureau (SGMB), the 2026 edition will feature 126 talks, 72 workshops, and portfolio reviews. Tariq Saeed Allay, SGMB Director-General, said: Xposure has become a global space for human connection, shaped by the stories photographers tell and the perspectives they capture.

Since its launch, the festival has grown into a meeting point for visual artists worldwide. The Xposure Photography and Film Awards 2026 received more than 29,000 entries and 634 films from over 60 countries, reflecting its international reach.

Award-winning environmental photographer Sebastian Copeland highlights Xposure as a platform that showcases photography not only as art but also as a tool for environmental awareness: “When nature speaks and we do not listen, photography can make us hear with our eyes.” Acclaimed American photographer George Steinmetz offers a contrasting perspective with “Feeding the Planet,” a long-term project documenta global food systems and their environmental impact. For the first time, Xposure will feature a Guest of Honour: Athens, presented through a curated programme highlighting the city’s heritage and contemporary creativity. Mayor Haris Doukas described the selection as a significant distinction: “Our legacy is not only inherited but alive — and shaping the future.”

More information: Here

– Picture is available at AP –

Media Contact:

Hussain Al Mulla – Sharjah Government Media Bureau
+971 56 398 0067 | Hussain.almulla@sgmb.ae 

Xposure Marks 10 Years of Visual Storytelling with Stellar Global Artists

By
Advertorial Desk
-

SHARJAH, UAE, Nov. 24, 2025 /PRNewswire/ — Xposure’s International Photography and Film Festival unites 420 artists from around the world under the theme “A Decade of Visual Storytelling.” From January 29 to February 4, 2026, the 49,000-square-metre Aljada site will become a global hub for photography and film, hosting 570 events, including 95 exhibitions featuring 3,200 works.

Over the past decade, Xposure has established Sharjah as a global destination for visual storytelling. Organized by the Sharjah Government Media Bureau (SGMB), the 2026 edition will feature 126 talks, 72 workshops, and portfolio reviews. Tariq Saeed Allay, SGMB Director-General, said: Xposure has become a global space for human connection, shaped by the stories photographers tell and the perspectives they capture.

Since its launch, the festival has grown into a meeting point for visual artists worldwide. The Xposure Photography and Film Awards 2026 received more than 29,000 entries and 634 films from over 60 countries, reflecting its international reach.

Award-winning environmental photographer Sebastian Copeland highlights Xposure as a platform that showcases photography not only as art but also as a tool for environmental awareness: “When nature speaks and we do not listen, photography can make us hear with our eyes.” Acclaimed American photographer George Steinmetz offers a contrasting perspective with “Feeding the Planet,” a long-term project documenta global food systems and their environmental impact. For the first time, Xposure will feature a Guest of Honour: Athens, presented through a curated programme highlighting the city’s heritage and contemporary creativity. Mayor Haris Doukas described the selection as a significant distinction: “Our legacy is not only inherited but alive — and shaping the future.”

More information: Here

– Picture is available at AP –

Media Contact:

Hussain Al Mulla – Sharjah Government Media Bureau
+971 56 398 0067 | Hussain.almulla@sgmb.ae 

Beyfortus® (nirsevimab) now available in Malaysia to protect all infants against RSV disease

By
Advertorial Desk
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  • Beyfortus® (nirsevimab) is an available option designed to protect all infants – whether born full-term or pre-term, healthy or with underlying conditions – against respiratory syncytial virus (RSV), with proven high and sustained efficacy, a favourable safety profile, and real-world public health impact.[1]
  • Administration can be timed during the first year of life to provide protection from birth, or as early as possible. [1]
  • In the recent HARMONIE trial findings, Beyfortus reduced RSV hospitalisations in infants by 82.7% (95% CI: 67.8 to 91.5; p<0,0001) through six months (180 days).[2]
  • Real world evidence from several national immunisation programs globally underscores the urgency for infant RSV prevention and reinforces the proven efficacy and favourable safety profile of Beyfortus against RSV disease and hospitalization in all infants.[3]
  • Beyfortus has demonstrated high real-world effectiveness consistently exceeding 80% with high acceptance rate.[3]

KUALA LUMPUR, Malaysia, Nov. 24, 2025 /PRNewswire/ — Sanofi and AstraZeneca’s Beyfortus (Nirsevimab) is now approved by the National Pharmaceutical Regulatory Agency (NPRA) and is available for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants born during or entering their first RSV season.[1]

RSV is predominantly seen in infants less than 1 year old and infected children below 2 years old had a high hospitalisation rate of 84.5%[4]. As a tropical climate country, RSV circulation in Malaysia is seen throughout the year with distinct peaks.[4], [5]

Datuk Dr Zulkifli Ismail
Technical Chairman of Immunise4Life and former president of the Malaysian Paediatric Association
“In Malaysia, RSV remains a significant but under-recognised public health burden. Hospital data consistently show that the majority of infants admitted with RSV are full-term and generally healthy, which highlights the importance of preventive solutions that extend protection to all babies across the board. Broader awareness and stronger cross-industry collaboration will be critical in easing the burden RSV places on families and our healthcare system overall.”

Zainab Sadat
Vaccines General Manager, Sanofi Southeast Asia & India
“Today, Malaysia joins other countries worldwide where an innovative immunisation solution is now available to protect all infants against RSV. The approval of Beyfortus marks a critical step towards giving parents the ability to protect their babies during their first year of life, when they are most vulnerable to severe RSV disease. We are committed to working with stakeholders across the RSV care continuum to ensure seamless implementation and broad availability of this innovative preventive solution — because every baby needs protection. Our goal is simple: to help parents protect their babies, and give them peace of mind.”

The approval was based on results from the extensive Beyfortus clinical development programme spanning across broad infant population from pre-term, heathy full-term and those with underlying comorbidities. Across all clinical endpoints, a single dose of Beyfortus demonstrated high and consistent efficacy against RSV disease sustained for at least six months. Beyfortus was well tolerated with a favourable safety profile that was consistent across all clinical trials and real world evidence. The overall rates of adverse events were comparable between Beyfortus and placebo and the majority of adverse events were mild or moderate in severity.

In temperate countries, the single administration of Beyfortus was developed to correspond with the beginning of the RSV season for babies born prior to the season or at birth for those born during the RSV season. In clinical trials, Beyfortus helped prevent RSV disease requiring medical care in all infant populations studied, including those born healthy, at term or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. RSV disease requiring medical care included physician office, urgent care, emergency room visits and hospitalisations.

For more information and references, please visit this link: https://bit.ly/SanofiRSVENG.

 

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