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.
February 26th~ “All Roads Lead to History: Italy and Korea”
On the occasion of the celebrations for the 140th anniversary of the establishment of diplomatic relations between Italy and the Republic of Korea, the Italian Embassy in Seoul realized a photographic exhibition titled 'All Roads Lead to History, Italy and Korea', in collaboration with the Italian Cultural Institute, the National Museum of Korean Contemporary History, the Yonhap News Agency and the Italian National Press Agency ANSA. The opening ceremony, which will take place on Monday 26 February, 2024, will be attended by high-level Italian and Korean representatives, in particular the Korean Minister of Culture, Yu In Chon, and the Ambassador of Italy to the Republic of Korea, Emilia Gatto, as well as numerous personalities from the cultural, scientific, and industrial sectors. The initiative will officially launch a year-long programme of events aimed at enhancing the two countries' historical fields of cooperation, as well as finding new opportunities for dialogue in other areas. The exhibition, which may be visited at the National Museum of Korean Contemporary History, allows the visitors to admire documents and photographic and video material tracing the salient stages of the 140 years of the two countries' shared history, both the most painful ones, such as the Korean War, during which Italian Red Cross volunteers provided support with the field hospital No. 68, and the more joyful ones, in which the relations were strengthened, such as the recent State Visit of the President of the Republic of Italy, Sergio Mattarella, to Korea. The words of the Italian Ambassador to the Republic of Korea, Emilia Gatto. "Photographic exhibitions, by definition, are a glance at the past, but in this case the value of the documents and photographs collected is such as to constitute a solid and articulate basis, which allows us to look to the future of our bilateral relations. Our wish is that this photographic journey will highlight the similarities of two countries that are only geographically distant, but close in sharing values and objectives." The exhibition has been supported by the Ministry of Foreign Affairs and the Ministry of Culture, Sports and Tourism of Republic of Korea and sponsored by Bulgari.
NIST CSF 2.0 Governance: SeeMetrics Launches Cybersecurity Governance Boards
SeeMetrics, the pioneering Cybersecurity Performance Management (CPM) platform reshaping how security leaders measure, track, and improve security performance, launches its latest development: Governance Boards. This product feature launch comes in anticipation of the NIST CSF 2.0 framework expansion, which introduces the new Govern function. The new NIST Govern function is aimed at monitoring organizations’ cybersecurity risk management strategy, expectations, and policy. The six categories listed under Govern correlate with SeeMetrics’ approach to Cybersecurity Performance Management (CPM), focused on granting a panoramic oversight to the CISO and CISO’s team. With these boards, which are out-of-the-box (OOTB) collections of ready-to-use metrics, security leaders will manage their policies, processes, and KPIs driven by organizational context and a clear connection between risk and business strategy. The Governance Boards will initially be comprised of three boards needed in order to govern effectively, with each board providing a different point of view on policies: (1) CISO Lay of the Land Board – The primary purpose of this board is to provide security decision-makers with a rapid and intuitive understanding of overall system performance, enabling informed and timely responses to safeguard the organization. It’s a dashboard that shows CISOs the current state of security operations at a glance, backed by a comprehensive analysis of the entire operations. It collects the relevant data and metrics from different boards representing various security programs, offering a visual representation of what really matters. Serving as a snapshot of the organization’s security landscape for the CISO to look at every morning, this board offers a high-level view, tracking and analyzing trends against key performance indicators (KPIs). (2) CISO Policy Enforcement Board – A centralized dashboard designed to oversee and enforce a cohesive set of policies that are currently most important for the CISO to track on a daily basis. This board is an assembly of key metrics from various security domains such as security awareness and endpoint protection. The CISO Policy Enforcement Board plays a crucial role in ensuring that organizational policies are consistently applied, helping to mitigate risks and enhance security posture across the entire enterprise. Coupled with SeeMetrics’ customizations capabilities, each CISO can easily adapt the board on an ongoing basis as their priorities change. (3) NIST Functions Dedicated Board – This board corresponds with all of the NIST functions, providing a systematic approach to cybersecurity management. The board serves as an organized platform where relevant information, processes, and metrics are categorized based on the corresponding NIST function. Each board is designed to streamline and guide activities related to that specific function. The NIST Functions Dedicated Board facilitates a comprehensive and structured implementation of cybersecurity measures. By breaking down the NIST functions into a dedicated board, organizations can effectively govern, as NIST CSF 2.0 suggests. "Introducing the Governance Boards underscores our strong commitment to proactive and strategic cybersecurity governance,” says Shirley Salzman, CEO and Co-Founder of SeeMetrics. “By building these dedicated boards we are providing CISOs with a new kind of automated oversight that previously took too much time and resources to achieve. We are taking on the work of identifying what needs to be measured and the long, tedious process behind it. By automating it we are freeing up the CISO’s time and resources while also giving them a new layer of knowledge.”
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.
OSE Immunotherapeutics to Host a Live Webcast to Discuss AbbVie Global Partnership
On February 28, 2024, at 6:00 p.m. CET / 12:00 a.m. ET.NANTES, France--(BUSINESS WIRE)--Regulatory News: OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), will host a live webcast on February 28, 2024, at 6:00 p.m. CET to discuss the global collaboration and license agreement with AbbVie and outline the Company’s strategic focus moving forward. The live webcast will be available at the following link: WEBCAST Link: https://channel.royalcast.com/landingpage/oseimmunotherapeutics-en/20240228_1/ A replay of the webcast following the event will be available on the Company’s website: https://ose-immuno.com/en/ ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.). BI 765063 and BI 770371 (anti-SIRPα monoclonal antibodies on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). OSE-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs. Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidate generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs. Cytokine platform focused on leveraging the Cis-Delivery of cytokine in IO and I&I. BiCKI® is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI®-IL-7v is the most advanced BiCKI® candidate targeting anti-PD1xIL-7. Ongoing additional discovery programs on Cis-Demasking technologies. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.comClick and follow us on Twitter and LinkedIn Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Contacts Sylvie Détry email@example.com Nicolas Poirier Chief Executive Officer firstname.lastname@example.org French Media: FP2COMFlorence Portejoie email@example.com+33 6 07 768 283 U.S. Media ContactRooneyPartners LLC Kate Barrette firstname.lastname@example.org+1 212 223 0561
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 email@example.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
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 firstname.lastname@example.org
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 email@example.com@pumabiotechnology.com David Schull, +1 212 845 4200 firstname.lastname@example.org
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:email@example.com Investors:firstname.lastname@example.org 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: email@example.com