
Spanning 4 continents from Türkiye, Kordsa celebrates its 50th year of global leadership
Kordsa, a global player in tire, construction reinforcement and composite technologies, has clocked half a century on its reinforcement journey that started in 1973. Operating in 7 countries - Türkiye, Brazil, Indonesia, Thailand, the USA, Germany, and Italy, with a total of 13 manufacturing facilities and providing employment for over 4,000 people across 4 continents, Kordsa continues to expand its global footprint in the fields of construction reinforcement and composite technologies while maintaining its global leadership in the tire reinforcement sector. The 50th anniversary of Kordsa, a Sabancı Holding subsidiary, was celebrated with a special event held at the Sakıp Sabancı Museum with the participation of Güler Sabancı, Chair of Sabancı Holding, Sabancı Holding Board Members, Sabancı Holding CEO Cenk Alper and senior executives from Sabancı Group. Employees and business partners from diverse geographical locations attended the event and were press event and the opportunity to witness company's 50-year success story. KORDSA TO KEEP REINFORCING LIFE IN DIFFERENT GEOGRAPHIES AND EVEN IN SPACE Speaking at the event, Güler Sabancı, Chair of Sabancı Holding, emphasized that Kordsa has always stood by its customers, regardless of time or place, over the course of its 50-year journey and stated: "Today, if Kordsa, has become one of the world's leading companies in advanced material technologies, the primary factor is the presence of our customers. What defines Kordsa are our incredibly strong, meticulous, excellence-driven, and technology-focused customers. It is this passion for excellence that has propelled Kordsa to its current success. As a result, Kordsa has transformed into a company that reinforces two out of every three aircraft tires and one out of every three car tires globally." Highlighting the rapid pace of change in the world, Güler Sabancı remarked: "One thing, however, remains consistent for Kordsa: Our purpose of existence that keeps us together, the importance we place on teamwork and collective wisdom, our unwavering commitment to high quality and our customer-centric approach. This mindset unites hundreds of employees from Indonesia, Thailand, the United States, Brazil, and Italy into one team. Just as globalization cannot be explained solely through commercial relationships, being 'global' is not just about exporting. It's about keeping a team together through all the time zone differences and cultural diversities, walking towards the same goal despite all the challenges. Kordsa is a global company because it has succeeded in doing just that." “KORDSA'S VISION IS TO BECOME A 'GLOBAL ADVANCED MATERIALS TECHNOLOGY COMPANY'” Emphasizing that lasting success is more attainable through teamwork than individual efforts, Güler Sabancı remarked: "Kordsa has always been a leader in human capital and employee development. Even in our early days, we found ways to send our colleagues to prestigious international universities. Our colleagues continue this same approach today, notably through Sabancı University. To date, nearly 100 Kordsa employees have graduated from Sabancı University's development programs, and we continue to augment this number. Our perspective on development is not limited to university programs alone. Our Composite Technologies Excellence Center (CTCE), established in 2016 as the first university-industry collaboration of its kind in Europe, has become a symbol of our mission to lead in innovation. Today, over 100 faculty members, visiting researchers, doctorate, and master's students at this center are researching the advanced material technologies of the future, offering them to the world, to humanity and to our country." Adding that Kordsa will continue to embrace the same values in its future achievements, Güler Sabancı concluded her speech as follows: “Kordsa's vision is to become a 'global advanced materials technology company.' To set a technology-focused vision is, in fact, a commitment to continuous development. It's about keeping pace with the spirit of the times, and even going beyond it. It's about involving your customers and stakeholders in this journey. The materials of the future will be a revolution, and Kordsa will surely be at the forefront of this revolution. The Company will extend its 50 years of experience and knowledge in tire reinforcement to composite technologies, construction reinforcement and new business areas. Kordsa will continue to reinforce life in different geographies and even in space. Just as stated in Sabancı Group Purpose; ‘We will unite Türkiye and the world’." KORDSA TO CONTINUE RUNNING ITS 'INNOVATION ENGINE' AT HIGH SPEED Kordsa CEO İbrahim Özgür Yıldırım stated: “The materials of the future signify new horizons. As an industry leader, we are aware of our responsibility. At Kordsa, the 'innovation engine' will continue to operate at higher speeds. A corporation is as strong as its values. With our global footprint, innovation, and sustainability leadership, we will continue to create value for our customers." Emphasizing Kordsa's role in advancing technology for the entire world through its tire, construction reinforcement and composite technologies, İbrahim Özgür Yıldırım continued: “As of the end of 2022, we hold over 900 patents. We will continue our technology leadership guided by the light of knowledge and science. From the tires of cars on the ground to the wings of planes in the sky and parachutes of spacecraft, just as we are present everywhere, we will also create the future by strengthening and reinforcing it with the materials of the future. 2023 marks the 50th anniversary of Kordsa and the 100th anniversary of our Republic... To ensure this journey continues with determination and strength, we will move forward with new visionary perspectives, new strategies, and new paths, but with the same determination to grow. To make life safer, more efficient, and easier, we will continue to reinforce." WORLD-RENOWNED EXPERTS DISCUSSED 'MATERIALS OF THE FUTURE' Additionally, during the first part of the event, keynote speaker and renowned expert in innovation, Professor of Technology Management and Professor of Asian Business and Comparative Management at INSEAD, Ben. M. Bensaou, shared comprehensive insights on the necessary thinking and approaches for organizations to spread innovation across the entire entity. Following Prof. Ben. M. Bensaou's speech, a panel discussion titled "Materials of the Future" was held, featuring globally recognized figures in their respective fields. The panel included Rainer Egner, Global Sourcing Director of Sustainability and Reinforcement Materials at Goodyear, Dr. Mükerrem Çakmak, Reilly Professor of Materials and Mechanical Engineering at Purdue University, Dr. Taylor Sparks, Associate Professor of Materials Science and Engineering at the University of Utah and Adrian Williams, Founder and Managing Director of Future Materials Group. The panel addressed the new trends and roadmaps in material technologies, considered a revolutionary force in the world economy. The event concluded with the Kordsa 50th Anniversary Cocktail.

Gulf Capital Leads Consortium that Sells Majority Stake in Metito to Alpha Dhabi Holding
In a landmark transaction, Gulf Capital announced today that it has exited from its investment in Metito Holdings Ltd. (“Metito”) after a strategic and fruitful 17-year partnership by leading the consortium that sold a majority stake in Metito to Alpha Dhabi Holding (ADX: ALPHADHABI), one of the United Arab Emirates’ (UAE) fastest-growing investment holding companies. Gulf Capital has been instrumental in Metito's substantial growth, enabling and financing the company’s expansion into over 50 countries, the establishment of 20 offices globally, and the hiring of a committed workforce of 4,500 employees. Alpha Dhabi Holding is acquiring a majority stake in Metito, heralding its significant entry into the strategic water and wastewater sector. Alpha Dhabi Holding, with its diversified portfolio, pledges a deep commitment to the MENA region's water and wastewater imperatives by aligning with industry powerhouses like Metito. This move coincides with the UAE's hosting of COP28, emphasising the UAE's dedication to sustainable advancement, access to clean water, and transformative progress for a climate-safe world. Gulf Capital has been an early investor in clean water and sustainability since 2006 and has assembled a dedicated team focused on sustainable investments. Gulf Capital is also supporting COP28, the global climate change conference which is organised under the presidency of the UAE from November 30th to December 12th. The Firm is a signatory of the United Nations Principles for Responsible Investment (UNPRI) and of the Sustainable Markets Initiative (SMI), which was launched by His Majesty King Charles III and which provides a roadmap for businesses to move towards a sustainable future by 2030. Gulf Capital is actively focused on sustainable investments, and no investment illustrates the growth and return potential of this sector more than its early investment in Metito. Dr. Karim El Solh, Co-Founder and CEO of Gulf Capital, said: “Our journey with Metito started in 2006 with the founding Ghandour family and with the International Finance Corporation (IFC) and, in 2014, with our valued Japanese partners, Mitsubishi Corporation and Mitsubishi Heavy Industries. Our vision was to build a global leader in sustainable water solutions and, after 17 years together, Metito has become the uncontested global water leader operating in over 50 countries. This investment reinforces Gulf Capital’s track record of building global leaders from the Gulf region and of closing successful strategic sales. Gulf Capital has been an early investor in water and sustainability since 2006, and this landmark exit illustrates our ability to identify, secure, grow, and exit profitable investments in the sustainability sector. We are confident that Metito will prosper and reach new heights under Alpha Dhabi Holding’s ownership and we would like to wish the founding shareholders and the management team all the best on their next chapter of growth. "

Epishine Welcomes New CEO, Anders Kottenauer, in a Strategic Leadership Transition
Epishine, a Swedish energy impact company renowned for their market-leading printed solar cells, is proud to announce a strengthening of their executive leadership team. Anders Kottenauer, a seasoned industry leader with an exceptional track record in commercial scaling, will assume the role of Epishine's new Chief Executive Officer starting in October. With extensive expertise within the electronics industry and original equipment manufacturer (OEM) relationships, Anders is ideally positioned to navigate Epishine through its next growth phase. His leadership is particularly valuable at this juncture, as the company is gaining heightened interest from major tech giants. Epishine's provides a smarter way to power electronics, by capturing indoor light, making cables, disposable batteries, and the associated maintenance a thing of the past. With their market-leading printed solar cells, Epishine's solutions embody the future of energy efficiency and sustainability. Following her successful tenure as Epishine’s CEO, Anna Björklou will step into the role of Chief Operating Officer (COO), as part of a strategic move designed to sustain the company’s ongoing growth and innovation, while placing a greater emphasis on developing and scaling manufacturing. "We wholeheartedly welcome Anders as the new CEO of Epishine. With his long-standing expertise in business expansion within our industry sector, we are confident that he is the right leader to guide our company into the future," said Anna Björklou, outgoing CEO and newly appointed COO. "I am excited to continue my journey with Epishine in this new role, with a dedicated focus on operational excellence." Anders expressed his enthusiasm about joining Epishine, stating, "Epishine's mission to disrupt the electronics industry aligns perfectly with my own passion for sustainability. I am honored to lead such an innovative and forward-thinking company and look forward to working alongside the talented team at Epishine to drive meaningful impact." "The board of directors is excited about the new era that Anders will lead at Epishine. His vision and expertise will undoubtedly elevate our company to new heights in our aim at sustainable energy solutions," added Ola Johansson, Chairman of the Board at Epishine. Epishine remains committed to supporting their customers and the electronics ecosystem with a transition to a sustainable and maintenance-free power source. Aiming for a world where energy is not a problem.
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Metal and Monsters New Episode Features Rex Brown of Pantera, Dug Pinnick of King's X, and Legendary Filmmaker Roger Corman
Gibson TV, the iconic American instrument brand’s award-winning, worldwide online network--features original series about music and culture from the world’s best storytellers. Gibson TV has premiered the third episode of the original series titled “Metal and Monsters”--the network’s first show dedicated to heavy metal and monster culture. Throughout “Metal And Monsters,” viewers are treated to different segments that explore the worlds of music, film, and tales from the dark side. All Gibson TV original shows are streamed for free on Gibson.com HERE; subscribe to Gibson TV on YouTube and be notified when new episodes become available HERE. Gibson TV’s “Metal and Monsters” returns with host Count D for this “Texas Sized” new episode featuring iconic bass players and longtime friends Rex Brown (Pantera) and Dug Pinnick (Kings X) as they reunite for an evening of stories surrounding friendship, music, and their Texas roots. Legendary filmmaker, director, producer, and actor Roger Corman is featured in special segment with an intimate interview reflecting on his early career. “It was great reuniting with my old friend Dug Pinnick for this episode of ‘Metal and Monsters’,” says Rex Brown of Pantera. “We sat and talked for hours that day, and you could really feel the love in that old theater! It's so special to my heart that we did this off-cuff. Just two friends sitting and reminiscing about life and music. What a wonderful night!” In the segment “Tunes From The Crypt,” “Metal and Monsters” host Count D details the history of the landmark album “Leprosy” from Florida death metal legends Death. Viewers also have the chance to win several different Death prizes including CDs, vinyl, t-shirts, Halloween masks and two exclusive Death skateboards from our friends at Check Your Head Skateboards. In the segment “Terror Trek,” the monster squad heads to Las Vegas to visit KISS WORLD at the Rio Hotel to explore Gene Simmons iconic personal collection of KISS memorabilia. Viewers are also treated to guest appearances from Brent Fitz (drums), and Todd “Dammit” Kerns (bass) from Slash featuring Myles Kennedy and The Conspirators, and KISS drummer Eric Singer. Known as “The King of Cult” and “The Pope of Pop Cinema,” famed director and producer Roger Corman is featured in the historical segment “Exhumed From The Tomb.” Not only is Roger responsible for films including The Raven, Little Shop of Horrors, The Fast & The Furious and Death Race 2000, but he is also credited for launching the careers of film legends Jack Nicholson, Ron Howard, Sylvester Stallone, Martin Scorsese, and Francis Ford Coppola.
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Porsche Korea Presents the Global Artwork 'Dream Big' as Public Art Exhibition at Lotte World Tower World Park
Seoul - Porsche Korea (CEO Holger Gerrmann) announced the opening of the ‘911 Dream Park’ at Lotte World Tower World Park in Songpagu, Seoul, to celebrate the 60th anniversary of the brand's iconic model 911 with the large-scale global artwork sculpture ‘Dream Big’. The exhibition is part of a public art project that brings art closer to the citizen's daily life, featuring graphic artist Chris Labrooy's ‘Dream Big’ which is inspired by Porsche’s ‘911’ and a childhood ‘Dream’. After its worldwide exhibition in Miami, Singapore, the United Kingdom, France and China, the ‘Dream Big’ exhibition will have its highlight finale in Korea, held until September 3rd. Paying homage to the artist’s childhood dream, ‘Dream Big’ depicts a larger-than-life figure in a racing driver's helmet playing with a ‘Porsche 911 Carrera 4 Coupé’, comparatively the size of a toy figure. Along with Porsche 911 which has become a timeless icon over the past 60 years, Porsche will share its inspiration with a wider audience as a brand that strives to make dreams come true. Alongside the 'Dream Big' exhibition, Porsche Korea offers various programs at the '911 Dream Park'. The ‘Dream Racing Zone’ allows visitors to enjoy the fun of driving in Go-karts and receive a Porsche Dream Racing license. Additionally, the 'Dream Station' has been set up to show visitors the history of the past eight generations of the Porsche 911 since its introduction in 1963 and experience the brand lifestyle. Porsche Korea CEO Holger Gerrmann stated, "This public art exhibition carries even deeper meaning since it delivers the values of ‘dream’ and its ‘realization’ in the 60th anniversary of the 911 and shares it with the Seoul citizens in this unique setting defying size and perception." He also added, “We hope the “Dream Big” Sculpture sparks the interest of many and inspires to dream." On the evening of the first day of the exhibition, the 25th, a special event will be held to commemorate the opening of the '911 Dream Park'. The students from 'Porsche Dream Up', a social contribution program for talented children in sports and arts that marks its sixth year, will attend and perform a celebratory recital with clarinet and cello, as part of their journey of realizing their dream. Souvenirs will be given to a total of 100 people, including invitees from Porsche Korea's official Instagram and on-site first-come-first-serve viewers. As a brand for those who dream, Porsche has persistently launched a global art series to engage and inspire fans in new ways. With the start of ‘Porsche Dreamers. On.’ in 2021, Porsche Korea has been supporting the dreams and talents of emerging artists as well as expanding opportunities for citizens to enjoy public art. In addition, Porsche Korea plans to support more dreams through ongoing social contribution campaigns. Meanwhile, Chris Labrooy, a 3D graphic artist from Scotland, presents works that combine objects from the real world with surrealism. Labrooy, an actual Porsche fan and owner, has created iconic works such as 'Palm Springs Porsche 911', which features 12 Porsches floating in a swimming pool, and '996 Swan', which commemorates the 20th anniversary of Porsche China, in addition to 'Dream Big'.
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Porsche Korea Officially Launches the New Cayenne, More Luxurious and More Powerful than Ever
Porsche Korea (CEO Holger Gerrmann) officially launched the new Cayenne (facelift of the 3rd generation) in Korea on the 17th. Three trims, the Cayenne, Cayenne Coupé, and Cayenne Turbo GT will be available, with customer delivery starting in September. The new Cayenne is positioned as the sportiest model in the SUV segment with its powerful engine and brand-new design, highly digitized display and control concepts, new chassis technology and innovative high-tech features. Porsche Korea CEO Holger Gerrmann stated, "The Porsche Cayenne is a style icon of the luxury SUV segment as well as a symbol of Porsche's continuous innovation.” He also added, "We look forward to the positive reactions of our fans and customers for the new Cayenne, which, despite being a facelift model, has undergone a complete makeover with the highest investment ever." Powered by a three-litre V6 turbo engine, the new Cayenne entry model has a maximum output of 360 PS and a torque of 51 kg·m. The Cayenne accelerates from 0 to 100km/h in 6 seconds and the Cayenne Coupé in 5.7 seconds, with a top speed of 248km/h for both models. The Cayenne Turbo GT, the flagship model of the portfolio, has maximized its on-road performance even further. Available in the dynamic Coupé design, it includes all the innovative and optimized features of the Cayenne. Powered by a four-litre V8 biturbo engine, its output marks 673 PS, and can accelerate from 0 to 100 km/h in breath-taking 3.3 seconds with 305 km/h top speed. Porsche has integrated a completely revised display and control concept into the new Cayenne. The Porsche Driver Experience, which was first introduced in the Porsche Taycan, offers a perfect balance between digital and analogue elements for optimized, driver focused operation. Frequently used functions have been placed around the steering wheel, and additional functions for operating the driver assistance systems are added to the left lever behind the steering wheel. The automatic transmission selector lever is located on the dashboard, providing an elegant black panel design for the air conditioning controller and a larger centre console space for storage compartments. Especially, in the new Cayenne, both the driver and the passenger can experience a fully redesigned cockpit. New interactive elements are combined to provide a brand-new driving experience. For the first time, the redesigned cockpit of the Cayenne includes a fully digital 12.6-inch instrument cluster with a so-called curved and free-standing design and variable display options. An optimised head-up display is available as an option. The standard 12.3-inch central Porsche Communication Management (PCM) display integrates harmoniously into the new dashboard and provides access to all the relevant vehicle functions. Native apps such as Spotify® and Apple Music® are provided to optimise connectivity in the new Cayenne. A 10.9-inch display is now available as an option for the first time for the passenger side. This enriches the front passenger’s driving experience by displaying performance data, providing separate access to the infotainment system controls and, depending on the market, the option of streaming video content on the road. A special foil ensures that the driver cannot see this display. The new Cayenne has a particularly expressive appearance. A new front end combined with more strongly arched wings, a new bonnet and technically appealing headlights emphasises the vehicle’s width. Three-dimensionally designed taillights, uncluttered surfaces beneath and a new rear apron with integrated number plate holder characterise the rear end design of the new Cayenne. An expanded colour palette with three new colours, lightweight sports packages saving up to 33 kilograms for the Cayenne Coupé, and a new extensive range of 20, 21, and 22-inch wheels make it possible to individually and dynamically configure the new Cayenne. The new Cayenne is equipped with a steel spring suspension including Porsche Active Suspension Management (PASM). New shock absorbers with 2-valve technology with separate rebound and compression stages allow optimised performance in all driving situations. In particular, comfort at low speeds, handling during dynamic cornering, and pitch and roll supports have also been significantly improved. The new adaptive air suspension with 2-chamber, 2-valve technology further enhances the driving experience. Compared to the predecessor models, the softer suspension characteristic stabilises the vehicle and simplifies on-road and off-road handling. The adaptive air suspension improves driving precision and performance and reduces body movement in dynamic driving situations. The suspension also offers an even sharper differentiation between Normal, Sport and Sport Plus driving modes. Matrix LED Headlights are now standard in the new Cayenne. Innovative HD Matrix LED Headlights are a new optional feature. With two high-definition modules and more than 32,000 pixels per headlamp, their technology picks out other users and blocks out the light of the high beam to them with pixel accuracy so as not to dazzle them. Porsche has also introduced an air quality system in the new Cayenne. As standard, the vehicle uses predictive navigation data to detect approaching tunnel entrances and automatically activates air recirculation. In addition, customers can use a comprehensive range of new and optimised assistance systems. These include the active speed limiter and the swerve assist, the cornering assist, and the improved Porsche InnoDrive as part of the adaptive cruise control. Porsche Korea is offering the new Cayenne, Cayenne Coupé, and Cayenne Turbo GT at 133.1 million, 137.8 million, and 261.9 million KRW respectively, including VAT. Since its introduction in 2002, the Porsche Cayenne became the brand’s best-selling model with over a million units sold. The cumulative sales record in Korea until July 2023 marks more than 25,000 units, establishing its worth in the Korean market. In addition, Porsche Korea is hosting a pop-up exhibition to celebrate the launch of the new Cayenne at L’espace Etnah Cheongdam in Gangnamgu, Seoul until August 27th. Under the theme "The Art of Living," the exhibition will feature various lifestyle experiences inspired by the refined luxury design and powerful performance of the new Cayenne. The new Cayenne models will be showcased in this special exhibition, adorned with a luxurious salon and garden to emphasize its villa concept. The exhibition is open to anyone via the Naver reservation system. In addition to the new Cayenne, a participatory program for visitors, including creating their own Cayenne whiskey glass and hashtag events are prepared. Porsche Rimowa carrier (1 person) will be provided through a lucky draw among hashtag event participants.
Review
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[CES 2021] LG Emphasized "Needs to Innovate Beyond Boundaries Between Fields in the New Normal Era" Through Future Talk
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[CES 2021] Sony Unveiled Its Latest Initiatives Surpassing “Limits of Creativity” at CES 2021
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Hyperconnect, Key to social platform success: reflecting the ‘user voice’
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Hyperconnect : real-time video AI monitoring system can now auto-block live video content within 0.006 seconds
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India Credit Card Market Competition, Forecasts & Opportunities, 2028F - A Shift from Debit-based to Credit-based Economy and Emergence of Co-branded
DUBLIN--(BUSINESS WIRE)--The "India Credit Card Market Competition Forecast & Opportunities, 2028" report has been added to ResearchAndMarkets.com's offering. The Indian credit card market is poised to exhibit robust growth to 2028 The increasing adoption of cashless transactions, coupled with enticing credit card offers, rising acceptance of credit cards, a shift from debit-based to credit-based economy, and the emergence of co-branded card offerings are driving this growth. India's credit card market has undergone significant expansion, characterized by rapid technological advancements. Noteworthy developments, including streamlined onboarding processes, unique card products, personalized offers and rewards, and enhanced mobile apps, have proven advantageous to existing customers while attracting new ones. Credit card issuers are diligently working to raise awareness and foster innovation in this market, and the notable growth of the credit card market in India attests to these efforts. As of July 2022, there were 78 million active credit cards in circulation. Moreover, credit card spending reached a record high of USD 15.16 billion (INR 1.13 lakh crore) in May 2022. The growth trajectory, however, experienced a minor dip during FY 2020-21 due to the COVID-19 pandemic, resulting in a modest 9% increase in credit card spending. This occurred despite the overall uptick in credit card usage. Notably, the Reserve Bank of India (RBI) intervened to curb some of the major credit card issuers from issuing new cards in India during this period. Following the wave of demonetization and government initiatives to promote a cashless economy, credit card acceptance has witnessed a surge in India. Point-of-sale (POS) terminals across the country have adapted to accepting credit cards for a diverse range of goods and services. For instance, as of November 2022, India boasts 131,998,684 POS terminals, affirming the widespread adoption of credit cards. The rise of digital payments, particularly Unified Payments Interface (UPI) transactions, has significantly impacted the credit card industry. Factors such as smartphone proliferation, affordable internet access, and widespread merchant acceptance have propelled UPI transactions. Fintech companies are collaborating with traditional banks to offer credit cards and various digital lending services, including buy now, pay later (BNPL) and equated monthly installment (EMI) options. For example, RuPay credit cards, primarily issued by public sector banks, can now be linked to UPI apps, enabling QR-based credit payments at physical stores and streamlining payment processes for consumers. Market Growth Hindered by Limited Credit Card Penetration Comparatively, the United States boasts 1.5 billion active credit cards, constituting 67% of all active cards in the country. The widespread use of credit cards for purchases is prominent in the US due to convenience and straightforward usage, minimizing concerns about account-related fraud. In India, psychological factors continue to impact penetration. The conservative middle class exhibits reservations about using credit cards and credit in general. Perceived high interest rates and uncertainty about credit card benefits are obstacles to credit card market expansion. Nonetheless, credit card companies have countered these challenges by offering extra perks such as discounts, travel points, and other incentives to attract customers. Diverse Offers with Credit Cards Credit card usage offers users a myriad of advantages when making online payments for various services. These benefits include rewards, vouchers, cashback offers, and more, enhancing the value proposition of credit card payments for activities such as hotel bookings, mobile recharges, movie tickets, and shopping. Notable credit cards like HDFC Bank Regalia Credit Card and SBI Card Elite offer cardholders lounge access, golf privileges, dining and retail discounts, reward points, and travel insurance, amplifying the attractiveness of credit card usage. Entry of NBFCs Fueling Market Competition The credit card market is highly concentrated, with the top six issuers accounting for 81% of the market. However, with an estimated 350 million people anticipated to access online shopping in the next five years, more players are needed. The RBI's more permissive approach toward allowing Non-Banking Financial Companies (NBFCs) to launch credit businesses, provided they meet specific net worth criteria, will foster competition and encourage new entrants into the credit card market. Competitive Landscape Company Profiles: Detailed analysis of the major companies present in India Credit Card market. HDFC Bank Limited SBI Cards and Payment Services Limited ICICI Bank Limited Axis Bank Limited Citibank India Bank of Baroda RBL Bank Ltd. Kotak Mahindra Bank Limited Punjab National Bank IndusInd Bank Market Dynamics Drivers Increasing Adoption of Cashless Transactions Attractive Offers on Usage of Credit Cards Rising Acceptance of Credit Cards Market Trends & Developments Increasing Penetration of Co-Branded Cards Increasing Security Adoption of 5G Digital India Initiative Rising Contactless Payments Challenges Credit Card Payment Defaults High Interest and Charges Voice of Customer Analysis (B2C Model Analysis) Sample Size Determination Respondent Demographics By Gender By Age By Occupation Most Important Factors Determining Usage for Credit Card Users Factors Influencing Credit Card Adoption in India Leading Credit Card Companies in Terms of Customer Service Frequency of Review of Credit Score by Credit Card Users Purpose of Using Credit Card Readiness to Increase Credit Limit Report Scope India Credit Card Market, by Type: General Purpose Private Label India Credit Card Market, Service Providing Company: Visa Mastercard RuPay Others India Credit Card Market, Credit Limit: Up to 25 K 25-50K 51k-2L 2-5L India Credit Card Market, Card Type: Base Signature Platinum India Credit Card Market, Benefits: Cashback Voucher India Credit Card Market, by Region: North West South East For more information about this report visit https://www.researchandmarkets.com/r/cjsdmb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Contacts ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
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The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease
BALTIMORE--(BUSINESS WIRE)--ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center. The HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D) Study, is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. The HYDRAFIL-D Study will enroll approximately 225 patients in up to fifteen centers across North America and is expected to start in early 2024 after the company completes its next round of financing. “I have been advising ReGelTec on their injectable hydrogel for chronic low back pain for more than four years and was able to treat a number of patients with the device during the initial studies performed outside the United States. The early results are excellenti and I can’t wait to begin the HYDRAFIL-D Study here in Oklahoma City,” said Dr. Douglas Beall, Chief of Interventional Spine Services, Comprehensive Specialty Care, Edmond, Oklahoma, who is an advisor to ReGelTec and one of two national principal investigators for the trial. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. in Walnut Creek, CA and the other national principal investigator said, “the HYDRAFIL System is designed for a segment of the chronic low back pain population who are not very good candidates for conventional spine surgery. When conservative care fails, these patients have limited treatment options. HYDRAFIL appears to be a great option for these patients, and we are excited to demonstrate the value of the technology in this randomized, controlled trial.” “Obtaining IDE Approval for the HYDRAFIL-D Study from the FDA is a major milestone for ReGelTec,” said Bill Niland, the company’s co-founder and CEO who has successfully founded and exited multiple healthcare companies including Harpoon Medical, Inc., Vapotherm (NYSE:VAPO), and National Sleep Technologies. The company has treated more than 70 patients with 1-year follow-up on the first sixty patients showing a 69% reduction in pain scores and an 81% improvement in Oswestry Disability Index, a measurement of how low back pain is impacting a person’s daily living.ii Mr. Niland said that “once we were able to share the 1-year follow-up data on our first sixty patients with the FDA, the team was able to work with the agency to obtain IDE approval, and now we are fundraising to secure the capital needed to fund the study and attain FDA approval.” ABOUT REGELTEC, INC: ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL®, a percutaneous treatment for chronic low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals with multiple successful exits. The HYDRAFIL System contains a hydrogel that can be injected into a degenerated disc via a needle. Once approved, HYDRAFIL will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. The HYDRAFIL System is an investigational device, limited by United States law to investigational use. i https://www.jvir.org/article/S1051-0443(23)00694-2/pdfii Internal data on file Contacts Peter Boyd (443) 451-3915 pboyd@regeltec.com
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Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastat
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone (Clinicatrials.gov identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Chicago and online. The Phase II trial was conducted through The US Oncology Network. The results of this trial were published by Joyce O’Shaughnessy et al. (Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005). The poster (Abstract #1037, poster #258), entitled, “Association of C-MYC, MYC target gene, and unfolded protein response (UPR) expression with clinical benefit from the oral aurora kinase A (AURKA) inhibitor, alisertib (A), in combination with paclitaxel (P) compared with P alone in patients (Pts) with HER2-negative metastatic breast cancer (MBC),” was presented at the Breast Cancer – Metastatic Poster Session by Sara A. Byron, Ph.D., Integrated Cancer Genomics Division, Translational Genomics Research Institute (TGen), part of City of Hope, on June 4 at 8:00 a.m. CDT. A copy of the poster is available on the Puma Biotechnology website. Archival tissue samples from patients enrolled in the clinical study were analyzed at TGen. Of the 140 patients enrolled in the trial, 45 from the alisertib plus paclitaxel arm and 51 from the paclitaxel arm had sufficient tissue available for next generation sequencing, and 31 from the alisertib plus paclitaxel arm and 35 from the paclitaxel arm had enough for RNA sequencing/gene set enrichment analysis. The most frequently mutated genes were PIK3CA (45%) and TP53 (44%). No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1. Increased MYC RNA expression was observed in tumors from patients who did not derive clinical benefit from paclitaxel alone (defined as PFS less than 6 months) compared to those with benefit from paclitaxel alone (defined as PFS greater than or equal to 6 months). Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel. Elevated expression of genes involved in MYC activation and in unfolded protein response (a pro-survival mechanism) were enriched in alisertib plus paclitaxel responders compared to paclitaxel responders and were associated with poor response to paclitaxel alone. In 12 patients with exceptional response to alisertib plus paclitaxel (defined as PFS greater than or equal to 12 months), increased expression of genes involved in MYC activation and in epithelial to mesenchymal transition (a hallmark of cancer progression and metastasis) was observed in comparison to cancers from patients whose disease progressed within 6 months of initiating alisertib + paclitaxel (n=11) or those with exceptional response to paclitaxel alone (n=4). “There continues to be a need for new drugs for the treatment of metastatic ER-positive, HER2-negative breast cancer and triple negative breast cancer,” said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. “The results of this study and the subsequent biomarker analysis demonstrate that the addition of alisertib to paclitaxel may help to identify which patients are likely to derive the most benefit from alisertib and helps to identify biomarker focused populations that can be studied in future clinical trials of alisertib.” Sara Byron, Ph.D., Research Associate Professor in the Integrated Cancer Genomics Division at TGen, added, “We are pleased to have collaborated with Dr. O’ Shaughnessy on evaluating the effect of alisertib in this breast cancer trial. The biomarkers that were associated with clinical benefit to alisertib appeared to be the ones associated with an aurora kinase A inhibitor like alisertib, and we are hopeful that this work will help identify future patient populations that may benefit from alisertib.” Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are very pleased with the results of this biomarker analysis. We are committed to and focused on the development of alisertib in biomarker defined populations who may derive the greatest benefit from treatment with alisertib. This biomarker analysis will be very helpful to the design of the future trials of alisertib that we are planning in hormone receptor positive HER2-negative breast cancer.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.comir@pumabiotechnology.com David Schull, +1 212 845 4200 david.schull@russopartnersllc.com
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Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles
Patients treated with dual immunotherapy-based combination demonstrate sustained clinical benefits after four years vs. chemotherapy alone, with magnitude of benefit more pronounced amongst patient subgroups with high unmet needs Late-breaking data to be presented during the 2023 American Society of Clinical Oncology Annual MeetingPRINCETON, N.J.--(BUSINESS WIRE)--$BMY #ASCO--Bristol Myers Squibb (NYSE: BMY) today announced four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer (NSCLC). With a minimum follow-up of 47.9 months, the dual immunotherapy-based combination continued to enhance overall survival (OS), the trial’s primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years (Hazard Ratio [HR] 0.74; 95% Confidence Interval [CI]: 0.63 to 0.87). With extended follow-up, the clinically meaningful efficacy benefit of Opdivo plus Yervoy with two cycles of chemotherapy was maintained across secondary endpoints and key subgroups of patients, with benefits more pronounced amongst high unmet need patients with tumor PD-L1 expression <1% and squamous histology: PD-L1 <1%: Among patients with tumor PD-L1 expression <1%, the OS rate was 23% for those treated with the dual immunotherapy-based combination vs. 13% for chemotherapy alone, representing a 34% reduction in the risk of death (HR 0.66; 95% CI: 0.50 to 0.86). Squamous histology: Among those with squamous histology, twice the number of patients treated with Opdivo plus Yervoy with chemotherapy were alive at four years compared to those who received chemotherapy alone (20% vs. 10%, respectively). In this group, the dual immunotherapy combination reduced the risk of death by 36% compared to chemotherapy alone (HR 0.64; 95% CI: 0.48 to 0.84). No new safety signals were observed with Opdivo plus Yervoy with two cycles of chemotherapy with extended follow-up in the CheckMate -9LA trial. These data will be featured in a late-breaking poster presentation (Abstract #LBA9023) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2023, from 5:30 - 7:00 p.m. EDT. “The durable results seen with nivolumab plus ipilimumab with chemotherapy over four years, especially in patients typically facing a poor prognosis, demonstrate the sustained benefits of combining dual immunotherapy with limited chemotherapy for patients with advanced or metastatic non-small cell lung cancer, which remains an incredibly challenging disease to treat,” said David P. Carbone, M.D., Ph.D., CheckMate -9LA investigator and Director of the Thoracic Oncology Center at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. “The data in patients with tumor PD-L1 expression <1% and squamous histology are particularly encouraging, as they show that the combination therapy continues to reduce the risk of death by approximately one-third compared to chemotherapy alone four years following treatment in patient groups historically facing the worst outcomes.” “Cancer treatment is never a one-size-fits-all approach given that patients with thoracic cancers like non-small cell lung cancer have diverse sets of needs. We are committed to researching solutions that work for more patients and can potentially help improve outcomes and fill areas of high unmet need,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Our data in lung cancer at ASCO 2023 add to the growing body of evidence supporting the potential of our medicines to improve long-term outcomes for patients in both advanced settings and earlier stages of disease, as well as difficult-to-treat patient groups requiring personalized approaches to treatment. The CheckMate -9LA results, which demonstrate sustained efficacy benefits over four years with an Opdivo-based combination, further reinforce our promise to deliver durable options to more patients across varying stages and types of cancer.” Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma. About CheckMate -9LA CheckMate -9LA is an open-label, global multi-center, randomized Phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the experimental arm (n=361) were treated with immunotherapy for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm (n=358) were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or unacceptable toxicity. The primary endpoint of the trial was overall survival (OS) in the intent-to-treat (ITT) population. Secondary hierarchical endpoints included progression-free survival (PFS) and overall response rate (ORR), and the study also evaluated efficacy measures according to biomarkers. About Lung Cancer Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. About Yervoy Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. INDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years of age or older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12). Immune-Mediated Colitis OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%). Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%). OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Immune-Mediated Endocrinopathies OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%). In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%). In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0. Contacts Bristol Myers Squibb Media Inquiries:media@bms.com Investors:investor.relations@bms.com Read full story here
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Nucleai and Mayo Clinic BioPharma Diagnostics Announce Strategic Collaboration to Transform Digital Pathology for Drug Development and Clinical Practi
CHICAGO--(BUSINESS WIRE)--#biomarker--Nucleai, a leading provider of artificial intelligence (AI) solutions for pathology and spatial biology, and Mayo Clinic BioPharma Diagnostics are pleased to announce a strategic collaboration to bring world-class digital pathology solutions, technologies, and services to support drug development and clinical practice. This collaboration combines Nucleai’s AI-powered spatial biology technology with Mayo’s longitudinally annotated, multi-modal data sets, world-class lab services, and clinical diagnostic footprint. "We are excited to work closely with Mayo to bring spatial biology to the hands of the biopharma industry, clinicians and researchers,” said Avi Veidman, CEO of Nucleai. "By combining Mayo Clinic's extensive multi-modal datasets, laboratories, and clinical expertise with Nucleai's advanced AI platform, we can bring scale and impact to the entire precision medicine landscape.” Through this collaboration, Nucleai and Mayo Clinic will focus on several distinct offerings to support drug development including biomarker discovery and validation, end-to-end spatial biology testing and algorithm deployment for clinical trials and diagnostic use. About Nucleai: Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. For more information, please visit www.nucleai.ai. Contacts Jonathan Daniels VP, Head of Business Development and Strategy Email: jonathan@nucleai.ai