American Express has teamed up with all-female racing series F1 ACADEMY in a new global partnership, which will kick off during Miami Race Week. As part of the partnership, American Express will support local communities and shed a spotlight on small business in cities that host F1 ACADEMY races throughout the season, beginning with local Miami restaurant Caja Caliente. 

Caja Caliente’s business logo will appear on a custom livery, driven by British F1 ACADEMY driver Jessica Edgar. It is the first small business that will be featured on the Amex livery and a new local business will be spotlighted during each of the remaining five races in the 2024 season. 

As announced by F1 ACADEMY in March, the 2024 season will be broadcasted in over 160 territories and will be streamed live globally, giving these small businesses a platform that helps expand their reach and exposure. 

Located in Coral Gables, Florida, Caja Caliente opened in 2019 as a way for Owner and Chef Monica “Mika” Leon to share dishes inspired by her travels through the Mediterranean and family recipes passed down for generations. Mika has spent the better part of the decade working in kitchens across South Florida, with her journey beginning humbly with Mika Bites, a wholesale desserts company she launched out of her mother’s garage just after college. Read more about the business and how this opportunity will help Caja Caliente and Chef Mika Leon. 

As a local small business, how do events like the F1 ACADEMY race help the community? 

ML: These events help the community in so many ways. It brings a lot of new people to our city that in my case now get the opportunity to come to my restaurant. It promotes growth in our city and helps build and add to our community. 

What does it mean to you as a women-owned small business to see the female talent representing your business? 

ML: This means a lot to me. Especially given the fact that I own a restaurant and small business in a male-dominated industry. It is important for me to be a role model and inspire younger women that want to get into the restaurant world or be a chef. To see my business represented by fellow female talent makes me very proud. 

What do you hope the community at the F1 ACADEMY race will remember about Caja Caliente? 

ML: I hope they remember many things, but the most important thing is that you can do anything you set your mind to. I started this business at a young age, and everyone told me how tough it is and the failure rate of restaurants. I went against the odds and did it anyways and because of that Caja Caliente is what it is today. 

How has your passion for food and entrepreneurship led you to this moment? 

ML: I believe that all those tough years getting my business started and going were crucial to getting me here today – and to a place where I run a successful business being represented by fellow female talent. I hope my business helps others to start their own journey and pursue whatever it is they want to do. It is my passion that drove me to keep pushing, and still does today. 

Open for five years now, what has been the restaurant’s secret to success? 

ML: The secret to Caja Caliente’s success is community and hard work. Since day one it has been about the community and growing with them. The ever-growing community here in Miami inspires me to constantly evolve as an entrepreneur and chef. Along with that comes a lot of hard work and dedication. Being a business owner takes a lot of sleepless nights and long days, but in the end, it always pays off. 

This global partnership with F1 ACADEMY builds on the multi-year partnership that Amex and Formula 1® announced in October 2023, declaring American Express as the Official Payments Partner of F1® in the Americas. 

Source: American Express

The post American Express and F1 ACADEMY Support Caja Caliente During Miami Race Week appeared first on ICE Global News.

Samsung Electronics and O2 Telefónica has announced that the companies have launched their first virtualized RAN (vRAN) and Open RAN commercial site in Germany. It is the first time that Samsung’s 5G vRAN solution is being used in a commercial network in Germany. The site is now operating in Landsberg am Lech, Bavaria, providing high-performance and reliable 4G and 5G services to customers. In the coming months, the companies will expand the vRAN and Open RAN network to seven additional sites in the region, aiming to further extend the Open RAN footprint.

This milestone builds on the companies’ joint initiative, announced in October 2023, where they agreed to develop a roadmap for several tests of vRAN and Open RAN technologies. Following the extensive trials, O2 Telefónica and Samsung are now progressing from lab to field with the launch of this first commercial site. 

“We are taking another big step in our Open RAN journey. Together with Samsung, we are utilizing the latest Open RAN technologies in our mobile network. On the way to the network of the future, we are integrating new network solutions to provide our customers with outstanding connectivity. Open RAN is a building block that can help us to automate our network, deploy new updates faster and use network components more flexibly,” said Mallik Rao, Chief Technology & Information Officer of O2 Telefónica. 

“Samsung is setting new standards for excellence in the telecommunications industry with our innovative vRAN and Open RAN capabilities. Celebrating Telefónica’s 100th anniversary, we are proud to be the key partner for O2 Telefónica on their trailblazing journey to usher in a new era of connectivity in Germany,” said Junehee Lee, Executive Vice President, Head of Global Sales & Marketing, Networks Business at Samsung Electronics. 

Open RAN and vRAN: Bringing Greater Flexibility and Automation 

O2 Telefónica is building an even more efficient and future-proof network leveraging modern and advanced RAN technologies, open interfaces and automation capabilities. Open RAN enables greater flexibility in the mobile network. Based on open interfaces, operators can combine network components from different providers and integrate them into their network.

Software-centric vRAN helps the adoption of cloud-native architecture, allowing network operators to better automate functions, introduce new technologies and services to their networks quickly and efficiently. This is important for accelerating network buildouts and adopting new 5G applications, including use cases that require low response speeds, such as virtual and augmented reality (VR/AR) or latency-critical applications for enterprises. 

Samsung’s Advanced and Proven Network Solutions 

The companies have successfully switched on this first commercial site just three months after the initial shipment of 4G and 5G solutions, leveraging Samsung’s expertise and pre-validated ecosystem proven from large-scale commercial vRAN and Open RAN deployments across the globe. 

For the initial deployments, Samsung’s offering includes its market-leading 4G and 5G vRAN 3.0 solution and O-RAN compliant radios supporting low- and mid-bands (700MHz, 800MHz, 1.8GHz 2.1GHz, 2.6GHz and 3.6GHz), including 64T64R Massive MIMO radios. Samsung’s advanced vRAN 3.0 features enhanced capabilities for improved energy efficiency, optimized performance and intelligent automation.

As the next step, the companies will introduce Samsung’s intelligent network automation solutions to control life cycle management — from deployment and operation to maintenance. This O-RAN compliant automation solution offers the ability to accelerate innovative software-based network rollouts by enabling automated deployment of thousands of network sites simultaneously. 

About O2 Telefónica 

O2 Telefónica is a leading full-service provider of telecommunications services for consumers and business customers. The portfolio of the core brand O2 and various secondary and partner brands includes not only traditional telephony and Internet connections but also innovative digital services in the area of the Internet of Things and data analysis. In mobile communications, O2 Telefónica serves more than 45 million mobile lines (incl. M2M – as of December 31, 2023). No other network operator connects more people in this country. The company’s high-performance, award-winning mobile network reaches over 99% of the population. In the fixed network, O2 Telefónica offers its customers the greatest technological diversity and geographical availability of any provider in Germany. In fiscal year 2023, the company generated revenues of EUR 8.6 billion with around 7,500 employees. The company is majority-owned by the Madrid-based Spanish telecommunications group Telefónica S.A., one of the largest telecommunications groups in the world. 

Source: Samsung Electronics

The post Samsung and O2 Telefónica Launch vRAN and Open RAN Network in Germany appeared first on ICE Global News.

Hyatt Hotels Corporation has announced the opening of Yada Xishan Hotel Yixing, the first Hyatt-branded hotel in the charming city of Yixing and the latest addition to The Unbound Collection by Hyatt portfolio. Located in the heart of the Yangxian Ecotourism Resort in Yixing, this enchanting sanctuary marks a significant milestone in The Unbound Collection by Hyatt’s brand expansion, as the eighth property to open in Greater China. Designed for those who are seeking an escape from the fast-paced urban life, this 102-room hotel is a one-of-a-kind luxurious retreat, offering guests a unique blend of natural wonders and cultural richness nestled where the majestic Taihu Lake begins. 

Yixing is located in the south of the Yangtze River, where the provinces of Jiangsu, Zhejiang, and Anhui meet. In addition to its extraordinary natural landscapes and scenery, Yixing is known for its unique geographical location and long-standing heritage that has been present for over a thousand years. Renowned for its purple sand ceramics, it is known within the region as the “pottery capital,” as well as the birthplace of calligraphy, painting and academics.” Situated within the Yangxian Ecotourism Resort, which is built on a slope among 185,000 acres of bamboo forest and 43,000 acres of tea plantations, the hotel is surrounded by several historical landmarks such as the Bamboo Sea View Area, Zhanggong Cave, and the Taozu Holy Land, creating a tranquil destination to recharge and revitalize. 

The architectural and interior design of Yada Xishan Hotel Yixing is a tribute to the serene elegance of the Jiangnan area’s traditional aesthetics, seamlessly integrated with modern design philosophies. The hotel’s design ethos respects the local heritage while embracing contemporary comfort, offering guests a sanctuary where the past and present coexist in harmony. Every element, from the minimalist grace of the public spaces to the tranquil retreats of the guestrooms and suites, is designed to enhance the interaction between guests and the serene Jiangnan landscape, providing a multi-sensory experience that is both rejuvenating and inspiring. 

Guestrooms 

Yada Xishan Hotel Yixing features 102 comfortable and modern Chinese-style rooms, including 17 suites, which combine elegant and simple design concepts in the traditional Jiangnan design and architecture. Each guestroom offers a dedicated north and south double courtyard or private balcony, allowing guests to lose themselves in the tranquil beauty of Jiangnan landscapes. French casements are specially designed in each room to give full exposure to the aesthetic application of light and shadow, creating a pleasant atmosphere. All rooms are equipped with luxurious bedding, modern amenities, and separate rain showers and bathtubs, allowing guests to have a luxuriously comfortable stay.

Culinary experiences 

Yada Xishan Hotel Yixing not only provides guests a place to commune with nature, but also invites them to enjoy the art of Jiangnan cuisine among the mountains and rivers. JUNIAN, an all-day Chinese restaurant, exquisitely blends local seasonal ingredients with modern culinary styles. The elegant dining environment echoes classic Jiangnan culture from the cutlery to the furniture. Located on the ground floor of the hotel, the Lobby Lounge offers a relaxing atmosphere and a variety of dining options, while a specially designed afternoon tea service brings guests a wide selection of local varieties. Guests can enjoy a cup of coffee or tea at any time of day or opt for a delicious dish from the à la carte menu, making the lounge an ideal place to wind down. With its open-concept design and relaxed atmosphere, The Brook bar offers a wide range of beverages and Chinese and Western style snacks, enjoyed either indoors against a relaxing soundtrack, or outdoors among the hotel’s surrounding natural beauty.

Meetings and Events 

With a commitment to excellence and innovation, Yada Xishan Hotel Yixing provides a diverse range of event spaces that embody the story-worthy sophistication of Jiangnan. From the expansive elegance of the 6,458-square-foot (600-square-meter) pillarless ballroom to the intimate charm of three salon-style meeting rooms and two chamber meeting rooms, each space is equipped with cutting-edge technology and backed by a professional events team to ensure that every meeting, celebration, or gathering is an unforgettable experience. The outdoor terrace and lawns offer a canvas for creativity, allowing guests to craft events that blend the beauty of Jiangnan’s natural landscape with the unparalleled service for which The Unbound Collection by Hyatt brand is known.

Wellbeing and Recreation 

Recognizing the importance of wellness experiences in today’s world, Yada Xishan Hotel Yixing offers an array of facilities designed to nurture the mind, body and soul. The 24-hour state-of-the-art fitness center, the serene indoor heated swimming pool, and dedicated Camp Hyatt kids club offers guests and their families opportunities for rejuvenation and discovery, ensuring each stay is as restorative as it is memorable.

“We are thrilled to welcome guests to Yada Xishan Hotel Yixing, where they can experience a tranquil space to return to nature. The combination of traditional and modern aesthetics, as well as natural and man-made elements allows guests to discover the profound cultural heritage and natural beauty of Jiangnan while enjoying modern and comfortable amenities,” said Meg Zhang, general manager, Yada Xishan Hotel Yixing. “We look forward to the arrival of every guest and hope they’ll find peace away from the hustle and bustle, feel the essence of Jiangnan’s nature, and enjoy the Jiangnan lifestyle.” 

World of Hyatt Gives Members More Reasons to Stay Somewhere New 

In celebration of The Unbound Collection by Hyatt brand’s continued growth in Asia, World of Hyatt is providing members with even more ways to be rewarded by offering members the opportunity to earn 500 Bonus Points for qualifying nights at Yada Xishan Hotel Yixing from May 1 to July  31, 2024, part of World of Hyatt’s new hotel member offer.

Guided by its purpose of care, Hyatt’s multi-layered Global Care & Cleanliness Commitment further enhances its operational guidance and resources around colleague and guest safety and peace of mind. More information on Hyatt’s commitment can be found here: hyatt.com/care-and-cleanliness. 

Source: Hyatt Hotels Corporation

The post Yada Xishan Hotel Yixing: The Unbound Collection by Hyatt Brand appeared first on ICE Global News.

Rakuten Group, Inc. has announced the launch of an anime series starring the company’s official mascot, Okaimono Panda, set to premiere in the fall of 2024. Content production for the series will be led by Rakuten Content Central, a company specializing in intellectual property and media franchising. 

Okaimono Panda – literally “shopping panda” – celebrates its 11th anniversary as Rakuten’s official mascot this year on May 7. Entitled Rakuten Panda!, this televised anime series will be the first to feature the mascot character and is slated to hit Japanese small screens in fall 2024. 

Rakuten’s beloved Panda will be voiced by veteran voice actor Ikue Otani, known for her iconic character voices including Pikachu in the Pokémon series and Tony Tony Chopper from ONE PIECE, as well as for voicing Okaimono Panda in TV commercials. To bring the original storyline to life, Rakuten has gathered a production team comprised of top talent behind many of Japan’s most popular anime, including Sazae-san, Doraemon, Crayon Shin-chan and Gintama. Shinji Takamatsu will direct the new anime, with series composition overseen by Higashi Shimizu. Character design will be led by Yasue Sosogi and Shin-Ei Animation will lead on anime production. 

The teaser video for Rakuten Panda! is now available on the official site, with details on the anime release date and available channels to be announced soon. 

In a special promotion initiative, the Okaimono Panda anime will feature at one of Japan’s largest fashion and music events Rakuten GirlsAward 2024 SPRING / SUMMER held on May 3, 2024 at Yoyogi National Stadium First Gymnasium. Guest attendees will join the Okaimono Panda stage to showcase the anime series. At the Okaimono Panda booth, a screening of the teaser video will be available in addition to a photo booth where fans can greet and meet Okaimono Panda. The event will be live-streamed on the official TikTok channel of GirlsAward. 

Rakuten will continue developing a variety of entertainment experiences featuring Okaimono Panda and rolling out original content IP for customers in Japan and overseas through Rakuten Content Central. 

Comment from Voice Actor Ikue Otani 

“I’ve been voicing Okaimono Panda for Rakuten’s commercials for many years. And when I heard it’s becoming an anime, I almost couldn’t believe it! 

I’m sure Okaimono Panda will have a lot to say as always. Up until now, most of the time I’ve expressed the character through singing, so I’m really looking forward to voicing them in even more dialogue scenes and exploring new dimensions of the character. I’m excited to see Okaimono Panda’s everyday adventures come to life in the series, and I hope you are as excited as I am to see the story unfold.” 

Comment from Director Shinji Takamatsu  

“I’ve been a fan of these characters for a long time, and even use their LINE stickers. You can imagine my surprise when I heard they were getting their own anime! Shopping (“Okaimono” in Japanese), of course, had to play a key part in the story. I thought it would be fun to create an anime where Okaimono Panda, a shopaholic, and their best friend Little Panda, go on wild shopping sprees, causing chaos along the way. I hope you enjoy jumping into their world and experiencing their adventures too.” 

Overview of Rakuten Panda!  Anime 

Title: Rakuten Panda! 

Release date: Fall 2024 

Character information: Okaimono Panda has a big heart and always gives 110% no matter what. They are also a bit of a shopaholic, which sometimes gets them into a spot of trouble… 

Cast and crew: 

・Okaimono Panda: Ikue Otani (Pikachu in Pokémon, Tony Tony Chopper in ONE PIECE, Mitsuhiko Tsuburaya in Detective Conan, Zatch Bell in Zatch Bell!, Himeko Nonohara in Himechan No Ribon) 

・Director: Shinji Takamatsu (Gintama, KochiKame: Tokyo Beat Cops, Haven’t You Heard? I’m Sakamoto) 

・Series composition: Higashi Shimizu (Sazae-san, Doraemon, Crayon Shin-chan, Pretty Cure) 

・Character design: Yasue Sosogi (Doraemon: Nobita’s Sky Utopia, The Electric Town’s Bookstore) 

・Animation production: Shin-Ei Animation (Doraemon, Crayon Shin-chan, Teasing Master Takagi-san) 

Overview of Rakuten’s Official Mascot, Okaimono Panda 

Okaimono Panda is the official mascot of Rakuten, whose adorable look and emotional expression has won the hearts of fans around the world. Since appearing as an original LINE sticker for Rakuten Ichiba in May 2013, the mascot has made over 56 million friends on Rakuten Ichiba’s official LINE account, as of March 2024. 

Overview of Rakuten Content Central 

Established in September 2022, Rakuten Content Central is a content production that handles everything from IP development to comprehensive content production. The label connects Rakuten’s more than 70 services and 100 million members in Japan to provide users with a variety of entertainment experiences, through planning, production, distribution and sales of intellectual property in manga, movies, dramas and sports. 

Source: Rakuten

The post Meet Okaimono Panda: Rakuten’s New Anime Series appeared first on ICE Global News.

In a paper titled, “Multimodal MRI reveals brainstem connections that sustain wakefulness in human consciousness,” published in Science Translational Medicine, a group of researchers at Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, and Boston Children’s Hospital, created a connectivity map of a brain network that they propose is critical to human consciousness.

The study involved high-resolution scans that enabled the researchers to visualize brain connections at submillimeter spatial resolution.  This technical advance allowed them to identify previously unseen pathways connecting the brainstem, thalamus, hypothalamus, basal forebrain, and cerebral cortex.  

Together, these pathways form a “default ascending arousal network” that sustains wakefulness in the resting, conscious human brain.  The concept of a “default” network is based on the idea that specific networks within the brain are most functionally active when the brain is in a resting state of consciousness. In contrast, other networks are more active when the brain is performing goal-directed tasks.  

To investigate the functional properties of this default brain network, the researchers analyzed 7 Tesla resting-state functional MRI data from the Human Connectome Project.  These analyses revealed functional connections between the subcortical default ascending arousal network and the cortical default mode network, contributing to self-awareness in the resting, conscious brain. 

The complementary structural and functional connectivity maps provide a neuroanatomic basis for integrating arousal and awareness in human consciousness. The researchers released the MRI data, brain mapping methods, and a new Harvard Ascending Arousal Network Atlas to support future efforts to map the connectivity of human consciousness.

“Our goal was to map a human brain network that is critical to consciousness and to provide clinicians with better tools to detect, predict, and promote recovery of consciousness in patients with severe brain injuries,” explains lead-author Brian Edlow, MD, co-director of Mass General Neuroscience, associate director of the Center for Neurotechnology and Neurorecovery (CNTR) at Mass General, an associate professor of Neurology at Harvard Medical School and a Chen Institute MGH Research Scholar 2023-2028.

From the standpoint of future treatments in patients with severe brain injuries, the researchers showed that a dopamine-producing region in the brainstem, the ventral tegmental area, is a connectivity hub that links the subcortical default ascending arousal network to the cortical default mode network. 

Dr. Edlow explains, “Our connectivity results suggest that stimulation of the ventral tegmental area’s dopaminergic pathways has the potential to help patients recover from coma because this hub node is connected to so many regions of the brain that are critical to consciousness.” 

Senior author Hannah Kinney, MD, Professor Emerita at Boston Children’s Hospital and Harvard Medical School, adds that “the human brain connections that we identified can be used as a roadmap to better understand a broad range of neurological disorders associated with altered consciousness, from coma, to seizures, to sudden infant death syndrome (SIDS).” 

The authors are currently conducting clinical trials to stimulate the default ascending arousal network in patients with coma after traumatic brain injury, with the goal of reactivating the network and restoring consciousness. 

Funding: This study was funded in part by the James S. McDonnell Foundation, the National Institutes of Health, the American SIDS Institute, and Chen Institute MGH Research Scholar Award. 

About Massachusetts General Hospital 

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. MGH is a founding member of the Mass General Brigham healthcare system. 

Source: Massachusetts General Hospital

The post Brain Imaging Study Reveals Connections to Human Consciousness appeared first on ICE Global News.

Merck, known as MSD outside of the United States and Canada, has announced results from STRIDE-10, a Phase 3 trial evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Barcelona, Spain. The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine. 

Key results from the study include: 

• V116 elicited immune responses that were noninferior compared to PPSV23 for the 12 serotypes (or strains) common to both vaccines, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. 
• Immune responses elicited by V116 were superior for the nine serotypes included in V116 but not PPSV23, as measured by OPA GMT ratios at Day 30, and superior for eight of nine serotypes unique to V116 compared to PPSV23, as measured by the proportions of participants with ≥4-fold rise in immune responses. 
• V116 had a safety profile comparable to PPSV23. 

These data build upon Phase 3 trial results that were presented at this year’s Meeting of the International Society of Pneumonia and Pneumococcal Diseases and the 2023 World Vaccine Congress West Coast.

“Invasive pneumococcal disease and pneumococcal pneumonia represent significant public health challenges, particularly among older adult populations and those with risk conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee. “These positive results show that V116 has the potential to help prevent invasive pneumococcal disease among adult populations.” 

“Even with the availability of current pneumococcal conjugate vaccines for adults, gaps in serotype coverage for invasive pneumococcal disease persist,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These data add to the evidence supporting the potential for V116 to become an important new preventative option for adults, with results showing V116 elicited immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.” 

In addition to the clinical data on V116, Merck also presented findings that suggest V116 may help to reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in France, Sweden, Spain, and the Netherlands. 

V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.

Summary of Findings from Select Studies Presented at ESCMID 

Data from STRIDE-10 (Abstract #353) 

STRIDE-10 (NCT05569954) is a Phase 3, randomized, double-blind, active comparator-controlled study evaluating the immunogenicity, tolerability and safety of V116 compared to PPSV23 in adults 50 years of age and older who had not previously received pneumococcal vaccine (n=1,484). Participants were randomized to receive a single dose of either V116 or PPSV23. 

The primary objectives included serotype-specific OPA GMTs 30 days post-vaccination and percentage of participants with greater than or equal to four-fold rise from baseline in serotype-specific OPAs. Serotype-specific OPA responses were measured at baseline and 30 days post-vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). Results demonstrated that: 

• V116 elicited noninferior immune responses for the 12 serotypes (or strains) shared with PPSV23 (3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F), as measured by serotype-specific OPA GMTs 30 days post-vaccination; 
• V116 elicited superior immune responses for the nine serotypes only covered by V116 and not PPSV23 (6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMT ratios 30 days post-vaccination; 
• The proportion of patients with ≥4-fold rise in OPA GMT ratios from Day 1 to Day 30 for serotype-specific OPA for V116 was superior to PPSV23 for eight out of nine serotypes unique to V116 compared to PPSV23; 
• V116 had a comparable safety profile to PPSV23. 

Data from Health and Economic Burden of Disease Studies

Four studies were conducted to quantify the health and economic burden of invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia attributable to V116 and PCV20 (pneumococcal 20-valent conjugate vaccine) serotypes among adults in France, Sweden, Spain, and the Netherlands. Across the studies, results showed that when compared with PCV20, V116 serotypes were associated with considerably higher health and economic burden in France, Sweden, Spain, and the Netherlands––the difference is driven largely by the eight unique V116 serotypes not in any currently approved pneumococcal vaccine, suggesting V116 may help reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in these countries. 

About V116 

V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. V116 is specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes not in any currently approved pneumococcal vaccine (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) which account for approximately 30% of adult invasive pneumococcal disease, according to CDC data from 2018-2021. The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data. V116 is designed to be administered as a single dose to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. 

The V116 Phase 3 program includes multiple studies, including STRIDE-3 (NCT05425732), STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954). 

Indication for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) 

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F). 

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. 

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. 

Select Safety Information for PNEUMOVAX 23 

PNEUMOVAX 23 is contraindicated in individuals with a history of a hypersensitivity reaction to any component of PNEUMOVAX 23. 

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine. 

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness. 

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk. 

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. 

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out. 

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23. 

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures or neurosurgical procedures. 

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia. 

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination. 

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection. 

About Pneumococcal Disease 

Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are more than 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Certain serotypes threaten to put more people at risk for invasive pneumococcal illnesses, such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs). 

While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults and those with certain chronic or immunocompromising health conditions (including diabetes, HIV, or heart, lung and liver diseases). Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older. 

Merck’s Commitment to Pneumococcal Disease Protection 

Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck’s ongoing pneumococcal vaccine development program is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups. This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population.

About Merck 

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. 

Source: Merck

The post Merck Announces Positive Data for V116 Specifically Designed for Adults appeared first on ICE Global News.

Zoetis Inc. and Phibro Animal Health Corporation has announced that they have entered into a definitive agreement where Phibro Animal Health will acquire Zoetis’ medicated feed additive (MFA) product portfolio, certain water soluble products and related assets for $350 million, subject to customary closing adjustments. This transaction is expected to be complete in the second half of calendar year 2024. 

Both Zoetis and Phibro Animal Health have a longstanding commitment to the production animal health sector. The acquired medicated feed additive product portfolio, which generated approximately $400 million in revenue in 2023, is comprised of more than 37 product lines that are sold in approximately 80 countries. Also included in the agreement are six manufacturing sites, four in the U.S., one in Italy and one in China. More than 300 Zoetis colleagues who support manufacturing, distribution and commercial activities are expected to transition to Phibro Animal Health. 

This transaction demonstrates Zoetis’ disciplined capital allocation strategy to focus its investments on solutions for animal health, productivity and sustainability. With this divestiture, Zoetis can focus its livestock investments in other solutions, including vaccine, biologic and genetic programs. 

“We remain committed to providing innovative solutions to our livestock customers,” said Kristin Peck, Chief Executive Officer of Zoetis. “We believe that the long-term value of the transferred medicated feed additive product portfolio will be fully realized with Phibro Animal Health which will continue to expand its reach given their strong relationships with customers worldwide.” 

Zoetis’ strong portfolio of MFA and water soluble products across cattle, swine and poultry will complement and expand Phibro Animal Health’s species and product portfolios, helping customers meet the highest standards of animal care, prevent disease, and enhance nutrition. On a combined basis for the acquisition, Phibro Animal Health sales in the last twelve months would have been approximately $1.4B. The portfolio is expected to boost Phibro Animal Health’s profitability and EBITDA margin and be accretive to its Adjusted Earnings Per Share. The acquisition is expected to be funded primarily with debt, and Phibro Animal Health has received financing commitments from a number of key relationship banks. Phibro Animal Health expects to have net leverage of 3.5-4.0x Debt / Adjusted EBITDA at close and will target net leverage of below 3.0x by its fiscal year end June 30, 2027.

“Over a long period of time, Zoetis has built a valuable, high-quality and reliable source of medicated feed additives around the globe,” said Jack C. Bendheim, Chairman, President and Chief Executive Officer of Phibro Animal Health. “This investment will enhance, diversify and broaden our portfolio globally and help us continue to deliver value to our customers and to our shareholders. We believe our cash generation will allow for continued investment into our higher growth businesses of Nutritional Specialties, Companion Animal, and Vaccines. I am confident we have the right capabilities to integrate and strengthen this business. I look forward to collaborating with the Zoetis team and welcoming new colleagues to Phibro Animal Health to support this portfolio.” 

Zoetis and Phibro Animal Health will work closely with their colleagues and customers to ensure a smooth transition and continued supply of these important products. 

Guggenheim Securities, LLC is acting as exclusive financial advisor to Zoetis and Wachtell, Lipton, Rosen & Katz is acting as legal advisor. Citi is acting as exclusive financial advisor to Phibro and Kirkland & Ellis LLP is acting as legal advisor.

Phibro Animal Health will be hosting an investor call on April 29 at 8:30 am. Interested parties are invited to listen to the conference call and view the presentation slides. 

About Zoetis 

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock farmers and ranchers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $8.5 billion in 2023 with approximately 14,100 employees. 

About Phibro Animal Health 

Phibro Animal Health Corporation is a leading global diversified animal health and nutrition company. We strive to be a trusted partner with livestock producers, farmers, veterinarians and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. 

Source: Zoetis

The post Zoetis to Sell Medicated Feed Additive Portfolio to Phibro Animal Health appeared first on ICE Global News.

More than 20,000 artefacts unearthed in a detailed archaeological survey carried out on the site of the proposed extension to the Home of Rolls-Royce at Goodwood. Children from Years 3, 4 and 5 at The March CE Primary School, which adjoins the Home of Rolls‑Royce, were invited onto the site to see the work at first hand. 

• Rolls-Royce Motor Cars undertakes detailed archaeological survey on the site of its proposed extension 
• Conducted by experts from Oxford Archaeology, one of Europe’s largest and longest-established independent archaeology and heritage practices 
• Children from Years 3, 4 and 5 at neighbouring March CE Primary School invited to become ‘junior archaeologists’ for a day 
• Artefacts found during the survey will be shared with Rolls-Royce Motor Cars’ neighbours later this year   

“As Rolls-Royce Motor Cars celebrates 120 years of the marque in 2024, we look back to the distant past, of the place we call home, and reflect on how we are a small part of the long history of Westhampnett. This archaeological survey, conducted as part of the due diligence for our recent planning application, is providing new insights into the fascinating story of the area surrounding us. It was a particular pleasure to welcome children from The March CE Primary School; as well as discovering more about the hidden world around them, they were greatly inspired by the Oxford Archaeology team’s amazing work, with a number telling us they’re now considering it as a future career! We look forward to sharing these artefacts with our neighbours later this year.” – Andrew Ball, Head of Corporate Relations and Heritage, Rolls-Royce Motor Cars.

Roman roof tiles, traces of human fingerprints, animal paw prints, pigs’ teeth and pottery shards (or ‘potsherds’) over 2,000 years old are among more than 20,000 artefacts unearthed in a detailed archaeological survey carried out on the site of the proposed extension to the Home of Rolls-Royce at Goodwood. 

Rolls-Royce Motor Cars is keenly aware of the richness and importance of the local area’s history. The survey, which began in November 2023, was conducted by experts from Oxford Archaeology, one of Europe’s largest and longest-established independent archaeology and heritage practices. As a charitable organisation, it also provides educational activities as part of its services. Children from Years 3, 4 and 5 at The March CE Primary School, which adjoins the Home of Rolls‑Royce, were invited onto the site to see the work at first hand. The team explained what archaeology is, its significance and methodologies, and the role archaeologists play in uncovering and interpreting the past.

Working in small groups, the children were tasked to think like archaeologists, piecing together potsherds, some dating back to 200 BC, and examining a range of other discoveries. Out on-site, the archaeologists showed them evidence of earlier settlements in what is now Westhampnett, including roads and houses. This helps the children connect with their home area’s long history – inspiring future career aspirations in some cases. 

The artefacts are currently undergoing further study and cataloguing, to develop a more detailed picture of life in the area over the past two millennia. One early hypothesis is that the site was once used for metal-working activities. If confirmed, this would mean Rolls-Royce is actually continuing a long but often overlooked industrial tradition in this part of southern England.

Throughout the process of preparing its planning application, Rolls-Royce has been committed to transparency and positive engagement with the local community. In this spirit, the artefacts will be placed on display in a local venue later this year, allowing residents to gain new and fascinating insights into the place they and Rolls-Royce call home. 

West Sussex has been inhabited since the early Old Stone Age, or Lower Palaeolithic period, around 500,000 years ago. Nearby Chichester was founded by the Romans, and Fishbourne Roman Palace, to the west of the city, is the largest Roman residence north of the Alps. Chichester was rebuilt and fortified by King Alfred the Great in the 9th Century: its magnificent Cathedral dates from Norman times. The Home of Rolls-Royce itself stands on a corner of the Goodwood Estate, family seat of the Dukes of Richmond for over 300 years. 

Source: Rolls-Royce

The post ROLLS-ROYCE MOTOR CARS WELCOMES YOUNG ARCHAEOLOGISTS appeared first on ICE Global News.

Petrobras’ oil, NGL and natural gas production in the 1st quarter of 2024 (1Q24) reached 2,776 million barrels of oil equivalent per day (boed), an increase of 3.7% compared to production in the same period of previous year (1Q23). Among the main factors for this variation, we can highlight the evolution of production (ramp-ups) of the FPSOs Almirante Barroso, P-71, Anna Nery, Anita Garibaldi and Sepetiba, in addition to the entry into production of 19 new wells from complementary projects in the Basins de Campos (11) and Santos (8).

In comparison with 4Q23, natural gas production was lower by 5.4%, mainly due to the greater volume of losses due to stoppages and maintenance, within the provisions of the Strategic Plan 2024-28 (PE 2024-28), and the natural decline of mature fields. These effects were partially offset by the greater contribution of FPSOs Almirante Barroso (Búzios field) and P-71 (Itapu field), after reaching peak production during 4Q23, and by the ramp-up of FPSOs Sepetiba (Mero field) and Anita Garibaldi (Marlim, Voador and Espadim fields).

Petrobras began, on March 7, the flow of gas through P-68, located in the Berbigão and Sururu fields, contributing to increasing the reliability of gas delivery through the integrated network of the Santos Basin. On February 24, the FPSO Marechal Duque de Caxias left the shipyard in Yantai, China, heading to the Mero field, in the pre-salt of the Santos Basin. The platform, which will be the field’s third definitive production system, is scheduled to come into operation in the second half of this year and has the capacity to produce up to 180 Mbpd of oil and 12 MMm³/d of natural gas. In March 2024, the shared Búzios deposit reached the mark of 1 billion barrels of oil produced. Currently, the field operates with five platforms: P-74, P-75, P-76, P-77 and Almirante Barroso. The horizon of Petrobras’ PE 2024-28 foresees the installation of six more units in the field by 2027.

In the Refining, Transport and Marketing segment, total natural gas production of derivatives in 1Q24 was 1,753 mbpd, 6.1% above the production of 1Q23. The share of diesel, gasoline and QAV in relation to total production was 67% in 1Q24, in line with the same period in the previous year. The total utilization factor (FUT) of the refining park remains high, reaching 92% in 1Q24, 7 percentage points (pp) above 1Q23 and 2 pp below 4Q23, even with important scheduled stoppages at Repar and Replan, in addition to lower demand in 1Q compared to 4Q due to seasonality. 

In 1Q24, pre-salt oils represented 67% of the cargo processed in Refining, 2 percentage points above 4Q23, contributing to a more sustainable refining activity and high yield of diesel, gasoline and QAV. In the theme of Energy Efficiency and Operational Excellence in Refining, the RefTOP Program, from PE 2024-28, covers all refineries in the park. The Program’s optimization projects and initiatives contributed to Petrobras reaching 36.3 kgCO2e/CWT in Greenhouse Gas Emission Intensity in 1Q24, 1.4 kgCO2e/CWT less compared to 1Q23, and 104.8 in Intensity Energy, 1.7 points below 1Q23, following the focus on achieving the commitments made by the company for 2030. These results indicate a reduction in greenhouse gas emissions in the quarter equivalent to more than 2,200 urban buses circulating 5 days a week, 300 km/day.   

From March onwards, Petrobras expanded the offer of more sustainable products in the national market, starting in São Paulo the sale of diesel with renewable content (R5) in RPBC, which, like Repar, is already able to sell regularly the fuel capable of reducing greenhouse gas emissions. Additionally, the company established a partnership with the second largest asphalt distributor in the country to sell CAP Pro W, a product launched at the end of last year, stimulating the development of the more sustainable asphalt market. In line with the strategy of expanding access to markets in the interior of the country, the company began selling diesel and gasoline in Rio Verde (GO), the second new sales hub in the Center-West, a region whose demand for fuels has increased mainly in function of agribusiness. The first new hub was Rondonópolis (MT), opened at the beginning of last year. 

The company carried out a scheduled shutdown of the Mexilhão Platform (Route 1) for preventive maintenance, aiming to continue natural gas production, flow and supply of natural gas operations safely. During this period of restriction on national gas supply, the Company acted through its portfolio of offers made up of national and imported sources (Bolivian gas and LNG) to fulfill the commitments signed. It is worth noting that this intervention was carried out in parallel with the scheduled maintenance of the Caraguatatuba Gas Treatment Unit (UTGCA), in order to minimize the effects of restricting gas delivery. 

Ownership of the Bahia LNG Regasification Terminal (TRBA) was resumed by Petrobras, on January 1, 2024, without operational discontinuity, after the end of the lease period to third parties at the same time that we put into operation the LNG regasification vessel. LNG (FSRU) Excelerate Sequoia at TRBA. 

The company also acquired international certification I-REC ( Renewable Energy Certificate ) that neutralizes Petrobras’ scope 2 emissions in 2023, ensuring that all electrical energy acquired by Petrobras for the development of its activities was generated by renewable sources. 

Source: Petrobras

The post Petrobras’ oil and natural gas production grows 3.7% in 12 months appeared first on ICE Global News.

Biogen Receives Positive CHMP Opinion for TOFIDENCE (tocilizumab), a Biosimilar Referencing ROACTEMRA

Biogen Inc. (Nasdaq: BIIB) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. 

The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI (adalimumab) and FLIXABI (infliximab), offering an extension to the cost-effective treatment options with an additional mechanism of action.

“The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers and healthcare systems in Europe.” 

This positive CHMP opinion on TOFIDENCE was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports equivalence with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the EU and US reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic. 

Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). 

About TOFIDENCE (tocilizumab) 

TOFIDENCE (tocilizumab), an inteleukin-6 receptor antagonist, is a treatment developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. 

Indications 

Rheumatoid Arthritis (RA) 

Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to, or who were intolerant to, one or more Disease-Modifying Anti-Rheumatic Drug (DMARD) or tumor necrosis factor (TNF) antagonist. 

Adult patients with severe, active and progressive RA not previously treated with methotrexate (MTX). 

In these patients, TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. 

Polyarticular Juvenile Idiopathic Arthritis (PJIA) 

Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have responded inadequately to previous therapy with MTX. In these patients, TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with methotrexate (MTX) is inappropriate.

Systemic Juvenile Idiopathic Arthritis (SJIA) 

Patients 2 years of age and older with active systemic juvenile idiopathic arthritis who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. 

Coronavirus disease 2019 (Covid-19) 

Adult patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. 

About Biogen 

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. 

Source: Biogen

The post Biogen Receives Positive CHMP Opinion for TOFIDENCE appeared first on ICE Global News.