Pacific Prime Expands Their Global Operation to Australia
SYDNEY--(BUSINESS WIRE)--Pacific Prime, a leading global health insurance brokerage and employee benefits specialist, has expanded their operation to Australia. This strategic move marks a significant milestone in the company’s journey to further improve healthcare access and offer exceptional employee benefits solutions to clients in the Asia Pacific region. “Joining Pacific Prime and spearheading our expansion in Australia is truly a momentous opportunity,” Michael Atta, Pacific Prime Australia’s Head of Employee Benefits, expressed his enthusiasm about the company entering the Australian market. With over 40 years of experience in the insurance and financial sectors, Atta and his team are dedicated to delivering outstanding solutions that cater to the unique needs of our clients and broker partners under the Regional and Global Pacific Prime proposition. Deputy CEO Pierre de Mirman emphasized that this momentous expansion is in line with the company’s objective. “This pivotal moment aligns seamlessly with our vision for excellence in the industry. We are committed to providing top-notch advice and service in the Asia Pacific region, and now with Australia, we take a logical and exciting step forward.” Pacific Prime’s expansion into Australia assures that more people in the Asia Pacific region are provided with insurance policies tailored to their specific needs. The company remains steadfast in its commitment to delivering unparalleled advice and services to everyone in this ever-changing world. About Pacific Prime Established in 2000, Pacific Prime is an award-winning global insurance brokerage and employee benefits specialist that offers solutions to individuals and corporations. With USD $750 million premium under management, Pacific Prime is now the third largest employee benefits broker in the Asia Pacific region after acquiring CXA Group’s brokerage arms in 2021. The brokerage has over 1,000 employees and 15 offices worldwide including Hong Kong, Singapore, China, Thailand, Malaysia, UAE, the UK, the US, Mexico, and the Philippines. To learn more about Pacific Prime, please visit https://www.pacificprime.com/corporate Contacts Stephen Ho Chief Marketing Officer Pacific Prime +852 3589 0508
General Motors Unveils Plans to Forge Ahead in Korea in 2024 Through an Unprecedented Focus on Customer Experience
On February 2, General Motors hosted its New Year Press Conference at The House of GM, its integrated brand space in Seoul. The automaker highlighted its notable accomplishments in 2023 and outlined its strategic plans for 2024, with a focus on enhancing the customer experience by expanding its brand and product, sales and service, and electric vehicle offerings. This year, GM will introduce two electric vehicles built on the Ultium platform. It will also carry out the strategic positioning of the Chevrolet, Cadillac and GMC brands, launch OnStar safety and connected vehicle service, open the Seoul Service Center and expand ACDelco aftersales parts sales service. GM is dedicated to creating a distinct presence and enhancing its influence in the domestic market, emphasizing the unique and varied experiences that only GM can deliver to customers in all aspects of the business. New Year Press Conference attendees from GM's Korean Operations included President Hector Villarreal and Vehicle Sales, Service and Marketing Vice President Gustavo Colossi. The program began with a video message from Shilpan Amin, GM senior vice president and president of GM International. "Our priority remains to deliver the very best vehicles to our customers,” said Amin. “We believe we have the unique flexibility to meet customer demand and keep pace with the market for both traditional vehicles powered by internal combustion engines and electric vehicles. Last year, the sales of Trax and Trailblazer grew 311% and 82% respectively year over year in the U.S market. This is a testament to the unwavering dedication, exceptional productivity and steadfast commitment to quality competitiveness by our talented team in Korea." He added, "2024 promises to be a year in which GM reaffirms our commitment to the Korean market. We are excited to be introducing new models, showing our ongoing dedication to this crucial part of our global operations." In 2024, GM will bolster its presence in Korea by focusing its foundational strategy on offering a distinct customer experience with three elements: products and brands, sales and service, and electric vehicles. ① Brand and Product Experience Introduce four new vehicles – the Cadillac LYRIQ, Chevrolet Equinox EV, Cadillac XT4 and Chevrolet Colorado – to offer a unique and diverse product experience Extend customer engagement through integrated brand spaces including The House of GM and The Village of GM ② Sales and Service Experience Hold the grand opening of the Seoul Service Center in July Introduce OnStar global connectivity service in H1 Broaden the scope of ACDelco with an expanded range of aftermarket parts sales service ③ Electric Vehicle Experience Launch two electric vehicles – the Cadillac LYRIQ and Chevrolet Equinox EV – based on Ultium, GM's dedicated electric vehicle platform Continue expanding the release of Ultium-based electric vehicles, catering to various segments, purposes and price points in the future "We aim to deliver a distinct and varied product experience exclusive to GM through our Chevrolet, Cadillac and GMC brands, putting the customer at the center of everything we do," said Villarreal. "We plan to strengthen GM’s presence in the fiercely competitive domestic market and meet the needs of those seeking the unique American product experience and new lifestyle that only GM can provide by expanding our comprehensive range of products." "We take pride in offering a diverse range of vehicles that cater to a broad spectrum of preferences backed by excellent safety and outstanding performance," said Colossi. "Whether it's the sleek design and versatility of a Chevrolet, the reliability and robustness of a GMC, or the luxury and innovation of a Cadillac, our vehicle portfolio is meticulously curated to meet the unique preferences of Korean drivers." In 2024, GM will broaden its distinct product and service offerings for Korean consumers through strategic positioning, the introduction of new vehicles, and the provision of new services across the GM, Chevrolet, Cadillac and GMC brands. ① Seoul Service Center, a flagship facility delivering an upscale service experience Open at Yangpyeong-dong, Seoul, in July with a floor area of 23,556 square meters, four underground floors and eight floors above ground Offer comprehensive, one-stop service ranging from vehicle maintenance to product experience and purchase Serve as a hub for premium service with cutting-edge technology, drive-through service, valet assistance and private vehicle delivery Complement the East Seoul Service Center, which is being upgraded ② OnStar service for an extended digital customer experience Introducing in H1, with Chevrolet Trax Crossover as the first model to be applied To be applied to all brands & models that will be launched in the Korean market from H1 in order. Offer an expanded digital experience, beginning with vehicle diagnostics, remote control services, and wireless over-the-air through the Mobile App ③ ACDelco for an innovative maintenance service experience Extend parts sales service offerings to include domestic brands, on top of supporting current 13 imported premium vehicle brands Rapidly expanded the nationwide network of approx. 160 service points since its launch in 2023 Enhance customer access and service by broadening sales channels through e-commerce platforms GM’s Korean Operations achieved a remarkable 76.6% surge in demand in 2023, selling 468,059 complete vehicles. This was driven by a strategic emphasis on popular models such as the Chevrolet Trax Crossover and Trailblazer, which secured the top two spots in Korean domestic passenger car exports for 2023. This year, GM intends to fully utilize its annual production capacity of 500,000 units. Its primary focus will remain sustaining the success of the Trax Crossover and Trailblazer and fostering the sustainable business environment of its facilities.
The new Taycan impresses with a real-world range of up to 587 kilometres
Porsche launches the extensively updated Taycan. The new model variants offer more range as well as shorter and more robust charging processes. During an initial range test from Los Angeles to San Diego and back, pre-series models demonstrated their further improved efficiency. The all-electric sports cars covered up to 587 kilometres on one battery charge on public roads. "For the particularly efficient Taycan sports saloon with the large battery, this practical, final test resulted in a total range of up to 587 kilometres," says the Vice President for the model line Kevin Giek. "A great result. The range test in Southern California impressively demonstrated how efficient the reworked Taycan is. We are continuing to focus on our 'fast travel' strategy for electric mobility: short charging stops paired with high real-world ranges thanks to efficient drives." The range test was carried out under everyday conditions. Twelve international media representatives drove four vehicles on three days on Interstate Highway 405 and 5 between the Southern Californian metropolises of Los Angeles and San Diego. The teams drove at the maximum speed of 75 mph permitted on interstates. This corresponds to around 120 km/h. All four test cars were equipped with the larger Performance Battery Plus. The cars were charged at the Electrify America Charger in Torrance/Los Angeles. Here, the Taycan demonstrated over 300 kW charging power for many minutes and was able to charge from 10 to 80 per cent state of charge several times in well under 20 minutes. The charging performance, charging time and the time it takes to start charging were also greatly improved in this test. Porsche has built almost 150,000 examples of the Taycan since the start of production. The main individual markets for the model are currently the US, the UK, Germany and China. The extensively revised Taycan will be presented in a few days.
Sands China Receive Five-Star Rating from Forbes Travel Guide 2024 for Five of its Luxury Properties
Sands China Ltd. is honoured to announce a new addition to its Forbes Travel Guide Five-Star rated portfolio, Paiza Lofts at The Parisian Macao, receiving the prestigious award in its first rating year. Other Five-Star recipients in Forbes Travel Guide’s 2024 Star Awards include The Londoner® Macao’s The Londoner Hotel and Londoner Court, Four Seasons Hotel Macao and The Grand Suites at Four Seasons. Grant Chum, CEO and President of Sands China Ltd. said, “We are thrilled that Paiza Lofts at The Parisian Macao has been recognized as a Five-Star property for the first time, and that The Londoner Hotel, Londoner Court, Four Seasons Hotel Macao and The Grand Suites at Four Seasons have again achieved this truly remarkable accolade. As the integrated resort operator with the most Five-Star hotels in Macao, this result further amplifies our reputation as a leader in world-class hospitality.” Kris Kaminsky, Senior Vice President of Hotel Operations, Sands China Ltd. added, “We are honoured to have received Five-Star ratings for five of our luxury hotels from the prestigious Forbes Travel Guide, the gold standard for global luxury hospitality. This recognition is a true testament to the dedication of our team and the excellence they deliver. Our devoted and passionate team members, of whom we are extremely proud, will continue to provide the highest levels of service, elevate guest engagement and create one-of-a-kind Sands Lifestyle experiences.” - Paiza Lofts: Contemporary French Elegance Located within The Parisian Macao, the elegantly appointed all-suite Paiza Lofts is a haven for the discerning traveller seeking a bespoke experience. The 208 light-filled, apartment-style suites have a contemporary residential ambience and are equipped with exemplary features and amenities. The largest is the palatial three-bedroom Versailles Suite (4,300 square feet), which has a host of opulent lifestyle rooms including media, massage and gym. One of Paiza Lofts’ defining success factors is the indulgent 24-hour personalised concierge service provided to its guests. The dedicated team proactively and intuitively meet any guest needs or special requests, ensuring a curated experience that is seamless and unrivalled, before and during the stay. - The Londoner Hotel: A Quintessential Classic The Londoner Hotel is a refined all-suite hotel with approximately 600 suites that feature a modern interpretation of quintessential British design. Guests enjoy the suite’s lavish styling and facilities as well as the exuberant artistic touches. One of their favoured locations outside of their suite is the exclusive British-style club The Residence. A place for guests to feel immersed in a glamourous London lifestyle, including a gourmet breakfast and elegant evening cocktails. The luxurious hotel is also home to the sophisticated and invite-only Suites by David Beckham. The first celebrity-designed suites in Macao, they reflect the discriminating style of David Beckham, Sands global ambassador. Through the ‘Be My Guest’ programme, VIP guests step into the legendary footballer and style icon’s lifestyle as they partake in Beckham’s favourite dishes, whiskeys and cocktails at an array of signature restaurants. - Londoner Court: Distinctive British Hospitality Londoner Court is a 368-suite hotel offering a unique expression of British sophistication and hospitality at The Londoner Macao. Guests are pampered 24-7 by the Londoner Court Butler service, which is headed by Paul Vincent Benedict Brown, who has worked with numerous high-profile VIPs, world-famous celebrities and the British Royal Family. Brown and his professional team ensure that all guests who stay at this prestigious hotel have all needs met, allowing them to feel at home in complete comfort combined with indulgent opulence. Other Sands China Five-Star recipients include Four Seasons Hotel Macao, The Grand Suites at Four Seasons, The Spa at Four Seasons Hotel Macao and renowned Cantonese restaurant Zi Yat Heen. Forbes Travel Guide is the only independent global rating system for luxury hotels, restaurants, and spas, which are judged across 900 objective criteria. A Five-Star rating is the pinnacle to which all hotels aspire and is described by Forbes Travel Guide as delivering an outstanding experience and consistently offering a highly customisable level of service.
Jumbo Offshore awarded scope expansion contract for the Yunlin Offshore Wind Farm
Jumbo Offshore has recently been awarded a contract by Yunnneg Wind Power Co., Ltd. (YWPC) for the removal of monopiles at the Yunlin Offshore Wind Farm. The contract award represents an expansion of the company’s existing scope, which has involved transport and installation of the project’s transition pieces. Under the amendment, some monopiles, which were installed during an earlier project phase, are to be removed approximately 3m below mean seabed level. To undertake this scope, Jumbo Offshore will mobilise the DP2 Heavy Lift Crane Vessel Fairplayer. The vessel will be outfitted with an underwater abrasive cutting and lifting tool as well as an ROV. With these, the Fairplayer will remove the monopiles in several sections. These will then be lifted into the vessel’s 1,400m2 cargo hold for transportation to a local Taiwanese port, where the vessel will offload the monopile sections to the quayside. Milad Sheikhi, Head of Sales and Business Development at Jumbo Offshore said, “We have been active on the Yunlin OWF project since 2021, carrying out transport and installation of transition pieces and will continue to perform this role in 2024. Being awarded this additional scope shows trust in our performance, project management, engineering and installation capabilities, for which are very grateful to our client.” Brian Boutkan, Manager Commerce at Jumbo Offshore, added, “We are very proud to have been awarded this additional scope of work on the Yunlin OWF project. We see this as a confirmation that Jumbo’s values bring real benefit to our clients. With our client-centric approach, we aim to cooperate with our customers as a partner in all that we do, in order to offer a reliable service that inspires confidence.” The Yunlin Offshore Wind Farm is developed by Yunneng Wind Power Co., Ltd., a joint project company involving Skybporn Renewables, TotalEnergies, Electricity Generating Public Company (EGCO) and Sojitz Corporation. Located in the Taiwan Strait between 8 to 17km off Taiwan’s west coast, the 82km2 offshore wind farm will comprise 80 wind turbine generators installed at water depths of between 8 and 35m. Once completed, the 640 MW project will be one of the largest offshore wind farms in Taiwan, producing enough clean energy to serve the energy needs of more than 600,000 Taiwanese households.
ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Equity LifeStyle Properties, Inc. Investors to Inquire About Securities Class Action Investigation – ELS
NEW YORK--(BUSINESS WIRE)--WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Equity LifeStyle Properties, Inc. (NYSE: ELS) resulting from allegations that Equity LifeStyle Properties may have issued materially misleading business information to the investing public. SO WHAT: If you purchased Equity LifeStyle Properties securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. The Rosen Law Firm is preparing a class action seeking recovery of investor losses. WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=22421 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email email@example.com or firstname.lastname@example.org for information on the class action. WHAT IS THIS ABOUT: On January 22, 2024, after market hours, Equity LifeStyle Properties filed with the SEC a current report on Form 8-K in which it announced that it had “determined that the Prior Period Financial Statements”, which included its 2022 annual report and quarterly report for quarter ended March 31, 2023, “as well as, any reports, related earnings releases, investor presentations or similar communications of the Company’s Prior Period Financial Statements, should no longer be relied upon.” On this news, the price of Equity LifeStyle Properties stock fell $1.96 per share, or 2.84%, to close at $67 per share on January 23, 2024. The next day, it fell another $1.45, or 2.16%, to close at $65.55 per share. WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers. Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/. Attorney Advertising. Prior results do not guarantee a similar outcome. Contacts Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 email@example.com@firstname.lastname@example.org
James Cook University Singapore Selects Juniper Networks to Enable Transformative Blended Learning Experiences Powered by an AI-Driven Network
Juniper's AI-driven solutions provide a predictable, reliable and measurable network, enhancing campus experiences for students, staff and guestsSINGAPORE--(BUSINESS WIRE)--#AIdriven--Juniper Networks® (NYSE:JNPR), a leader in secure, AI-driven networks, today announced that James Cook University Singapore (JCU Singapore), the first international campus of James Cook University Australia (JCU Australia), deployed Juniper’s cloud-delivered wireless access solutions driven by Mist AI™ for upgrades to its campus network. With the Juniper Access Points, JCU Singapore has built an AI-driven wireless network that supports its drive towards creating a technology-enhanced education program, delivering seamless blended learning experiences for its students. Fully owned by JCU Australia and ranked in the top 2% of universities in the world, the Singapore campus was established in 2003 as part of its commitment to internationalize its operations. In addition to its research programs, the university offers a range of university-level programs spanning various disciplines, including Business, Tourism & Hospitality, Information Technology, Education and Psychology. Over the years, the university has invested in technology infrastructure to facilitate effective communication, virtual learning, collaboration, and campus facility enhancements. During the pandemic, the university conducted over 60,000 online learning and teaching sessions before resuming full campus operations in 2022. In response to students’ feedback for JCU Singapore to continue providing a flexible learning environment, the university embarked on an ambitious project to offer most courses through a blended learning approach. Additionally, as the student population grew (surpassing the 2022 target by 6%), the university recognized the need for a more robust network to support their evolving mobility requirements. Building on a long-term relationship that spans across its campuses in Australia and Singapore, JCU Singapore teamed up with Juniper to overhaul its campus wireless network. The university deployed the Juniper AP43 and AP63 Wireless Access Points across its facilities – including its lecture and seminar rooms, libraries, labs, aquaculture research centers and sports facilities – ensuring comprehensive high-speed wireless coverage across the entire campus. Using Juniper's Mist AI and Cloud, the university's IT team effortlessly deployed the APs campus-wide, establishing the wireless network before the school term and achieving comprehensive network visibility through a unified management interface. The APs work in conjunction with Juniper Mist™ Wi-Fi Assurance, enabling the IT team to swiftly resolve Wi-Fi issues by pinpointing their source, ensuring the best possible experience for students. Since implementing an AI-driven network, students and faculty have enjoyed improved wireless experiences. With the upgraded network from Juniper, JCU Singapore now has access to automated troubleshooting, analytics, and optimization. In addition, cloud-based management also allows for centralized control, rapid deployment, and easy scalability. Looking forward, the university is also exploring the upgrade of its existing Juniper switches, with plans to utilize Juniper’s Indoor Location Services to develop a campus navigation app. These network enhancements align with the university's commitment to redefining the campus experience to better cater to the needs and preferences of its students, staff, and guests. Supporting Quotes: “As James Cook University Singapore embraces blended learning, we recognized the need to modernize our network to deliver a stronger digital experience for our students, staff, and guests. Juniper’s AI-driven solutions were key to helping us undergo a smooth transformation, enabling our IT team to seamlessly upgrade our network and provide a dependable high-speed wireless campus experience. With an AI-driven network, we are confident in our ability to continue offering the innovative events and programs that we believe set us apart as we look to redefine the learning journey at our campus.” - Abdul Samathu, Assistant Manager, ICT, James Cook University “Technology, in particular AI, is leading the transformation of education, reshaping the way universities operate. We are honored to support James Cook University Singapore in their endeavors that seek to effectively transform the learning experience for its students. With our AI-driven solutions, we are committed to empowering the university to achieve a revitalized blended learning program for its students, all while enhancing the digital experience for everyone across its campus.” - Perry Sui, Area Vice President, ASEAN & Taiwan, Juniper Networks Additional Resources Case Study: James Cook University Singapore Powers Learning with an AI-driven Network Product & Solution Pages: Juniper Networks Wireless Access Points and Edge Juniper Mist™ Wi-Fi Assurance Follow Juniper Networks online: Facebook | X (Twitter) | LinkedIn Juniper Blogs and Community: J-Net About Juniper Networks Juniper Networks is dedicated to dramatically simplifying network operations and driving superior experiences for end users. Our solutions deliver industry-leading insight, automation, security and AI to drive real business results. We believe that powering connections will bring us closer together while empowering us all to solve the world’s greatest challenges of well-being, sustainability and equality. Additional information can be found at Juniper Networks (www.juniper.net) or connect with Juniper on X (Twitter), LinkedIn and Facebook. Juniper Networks, the Juniper Networks logo, Juniper, Junos, and other trademarks listed here are registered trademarks of Juniper Networks, Inc. and/or its affiliates in the United States and other countries. Other names may be trademarks of their respective owners. Contacts Media Relations:Kenneth Chew Juniper Networks +65 6959 0553 email@example.com
Review – All-New Range Rover Evoque (2019) D180 First Edition
In the SUV market highly popular around the world, Land Rover and Range Rover are considered the most iconic brands. Land Rover has been showing a special presence since SUV’s early concept esta...
Technical Overview of the 2nd Gen Xeon Scalable Processors
Intel hosted ‘Intel Data-Centric Press Workshop’ at Intel Jones Farm Campus in Hillsboro, Oregon, US on March 5 and 6, and introduced Intel's portfolio of solutions for the data-centric er...
Review - Encounter of Eun-hee Kim and Netflix, ‘Kingdom’ opened a new horizon
The master of drama genres, Eun-hee Kim, who had produced drama 'Sign', 'Signal', etc. unveils 'Kingdom' on Janua...
Review – [Jekyll and Hyde] Return of the King! There Is No Such Word as “Disappointment” in Seung Woo Jo, Jo-Jekyll’s Dictionary
It has been four years. It took a full four years for Seung Woo Jo to return to ‘Jekyll and Hyde’ as Jo-Jekyll. I can assure there wouldn’t have been any musical fans who did...
Review - Allm's Action Game 'CapsuleMon Fight', "A Game with Strategic confrontation of Capsule monsters" (mobile)
Allm, which has released popular games such as 'Lunia Z' and 'Kritika', is preparing various games to give new fun with mobile games, ‘CapsuleMon Fight’ will start service in early Novembe...
[CES 2021] LG Emphasized "Needs to Innovate Beyond Boundaries Between Fields in the New Normal Era" Through Future Talk
[CES 2021] Sony Unveiled Its Latest Initiatives Surpassing “Limits of Creativity” at CES 2021
Hyperconnect, Key to social platform success: reflecting the ‘user voice’
Hyperconnect : real-time video AI monitoring system can now auto-block live video content within 0.006 seconds
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 firstname.lastname@example.org 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
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 email@example.com
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 firstname.lastname@example.org@pumabiotechnology.com David Schull, +1 212 845 4200 email@example.com
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:firstname.lastname@example.org Investors:email@example.com Read full story here
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: firstname.lastname@example.org