EU Commission gives "Green Light" for Lufthansa Group’s participation in ITA Airways
Carsten Spohr, Chief Executive Officer of Deutsche Lufthansa AG, says: "The approval from Brussels is excellent news for ITA Airways and Lufthansa and especially for all passengers flying to and from Italy. We look forward to welcoming ITA Airways and its outstanding employees as a new member of our airline family very soon. The decision is also a clear signal for strong air traffic in Europe, which can successfully assert itself in global competition." Lufthansa Group, the Italian Ministry of Economy and Finance (MEF) and ITA Airways have expressly welcomed the EU Commission's approval under competition law. With this clearance of the competition authority, the way is now clear for the acquisition of a minority stake of 41 percent in ITA Airways (Italia Trasporto Aereo S.p.A.) and the subsequent acquisition of the remaining shares by Deutsche Lufthansa AG for a capital contribution of 325 million euros, which was already agreed in May 2023. The investment will be completed through a capital increase. The transaction is expected to close in the fourth quarter of 2024. This requires both the prior implementation of the remedies negotiated with the EU Commission and the approval of other competition authorities outside the EU. Options for the acquisition of the remaining shares in ITA Airways have been agreed between Lufthansa Group and MEF and can be exercised from 2025 at the earliest. Following the closing, ITA Airways is to become the fifth network airline to be closely integrated with Lufthansa Group while keeping its brand name ITA Airways. As part of the multi-hub, multi-airline and multi-brand system successfully established by the Lufthansa Group, the Italian airline will utilize numerous synergies, for example in world-wide sales, the loyalty program Miles & More or also in aircraft and fuel purchasing. This will strengthen and further develop the economic situation of ITA Airways. Italy will become the Lufthansa Group's fifth "home market". It will then be the Lufthansa Group's second largest market in terms of revenue after Germany and the USA. Italy is already the second most important market for the company outside its home markets after the USA. In terms of gross domestic product, Italy is the third largest economy in Europe with a strongly export-oriented economy and one of the most popular vacation destinations worldwide. Lufthansa Group and ITA Airways are jointly planning a swift integration ITA Airways with its almost 5,000 employees will make the corporate culture of the Lufthansa Group even more international and diverse. Rome-Fiumicino will become the Lufthansa Group's sixth and geographically southernmost hub. Last year, the airport was awarded with five Skytrax stars. Immediately after the closing, the route networks are to be linked with each other through code sharing so that customers can combine the airlines' offers. This will create over 1,000 new transfer options, creating many more options to destinations in South America, North Africa and the Middle East in particular. ITA Airways will also strengthen competition in Italy, which is currently characterized by a superior position of low-cost airlines. ITA Airways already focuses on quality and a premium approach with an Italian service culture. Members of its existing loyalty program "Volare" will also be able to collect or use their miles with Miles & More from the first day after the closing. In addition, the respective lounges will be mutually accessible. ITA Airways is aiming to join the Star Alliance in the near future. Commercial processes, IT systems and purchasing processes will be harmonized as quickly as possible in order to exploit the numerous synergy effects. Carsten Spohr says: "The acquisition of ITA Airways strengthens the internationalization of the Lufthansa Group. We offer our guests a significantly greater choice of connections and destinations, and with the 5-star hub in Rome we are also extending our premium offering and better connecting strategic future markets south of the equator to our network. Despite the comprehensive and far-reaching concessions, the investment in ITA Airways strengthens the Lufthansa Group's position in global competition. We will make ITA Airways a strong and successful part of our company and thus secure its future as an international airline and strong brand. ITA Airways will support us in further expanding our position as Number One in Europe." The approval of the authorities enables the cooperation between ITA Airways and Lufthansa Group on a commercial and operational level from the date of closing of the transaction. Until then, both companies will continue to act in competition. The integration of ITA Airways into the airline network of the Lufthansa Group is to start with the closing. The approval of the authorities enables the cooperation between ITA Airways and Lufthansa Group on a commercial and operational level from the date of closing of the transaction. Until then, both companies will continue to act in competition. Following intensive negotiations with the European Commission, the parties have agreed on a package of concessions. This essentially includes the transfer of slots at Milan-Linate Airport to a competitor in short-haul traffic. In the "neighboring traffic" between Italy and the Lufthansa Group's existing home markets, this competitor will take over single routes on which Lufthansa Group Airlines and ITA Airways still operate today as competitors. Additional feeder flights from Rome to hubs of European competitors will also ensure improved competition on long-haul routes from Rome to North America. ITA Airways was founded in November 2020, started its operations on 15 October 2021 and currently has around 4,860 employees. Based in Rome, the airline carried almost 15 million passengers last year and has a modern fleet of 96 Airbus aircraft, including 23 long-haul and 73 short-haul aircraft. The hub in Rome offers ideal conditions for expanding the joint route network towards Africa and Latin America, thus providing customers with improved connections to the southern hemisphere. ITA Airways currently serves a total of 69 destinations.
GM Korea Reopens its Owned Seoul Service Center in a State-of-the-Art Facility, Providing the Highest Level of Integrated Customer Service
SEOUL – The Chevrolet-owned Seoul Service Center of GM’s Korean Operations has relocated to a new state-of-the-art facility. It will serve as an integrated service hub for all GM brands, including Chevrolet, Cadillac and GMC. Construction began in November 2021 and was completed last month, with operations starting on July 1. The new building is highly accessible, positioned at the southern end of Yanghwa Bridge in Seoul, near the former GM Seoul Service Center. It spans a land area of 3,970.60㎡ (1,201 pyeong) with a total floor space of 26,252.23㎡ (7,941 pyeong), from three underground floors to eight above-ground levels, making it the largest service center in the country. The facility is equipped to diagnose and repair approximately 100 vehicles daily. The service center, previously limited to maintenance services, will expand to include sales services in the same location. It boasts an expanded parking capacity of up to 180 vehicles across three underground levels. The ground floor consists of a vehicle showroom and a consultation area, with repair areas on the second through fourth floors, sheet metal painting areas on the fifth and sixth floors, and office space on the seventh and eighth floors. The Seoul Service Center has been significantly enhanced with the latest equipment, and has luxurious lounge areas for customer convenience, alongside an efficient one-stop reception and reservation system. A new KakaoTalk channel has been created to provide customers with up-to-date information, and English services have been strengthened for customers from overseas. GM continues to provide exceptional and efficient vehicle solutions through its extensive national network of approximately 400 service centers. Notably, it has been offering specialized premium services, including pick-up and delivery, and express services for Cadillac and GMC vehicle owners, as well as for premium imports such as the Chevrolet Colorado, Traverse, and Tahoe, all of which are available at the Seoul Service Center as well. "Opening the Seoul Service Center is a significant milestone for offering customers all-in-one premium experience – from exploring products to purchasing and receiving service – thereby enhancing GM's customer service quality," said William Henrie, Director of GM International Operations' Aftersales Service Division. "We aim to offer a more efficient and unique service experience, and with a showroom set to open soon, it will become a space where customers can fully engage with GM's premium brands." To celebrate the new facility’s opening, the Seoul Service Center is offering special promotions. Throughout July, customers requesting service will receive complimentary windshield washer fluid, and the first 2,000 customers will receive a vehicle safety kit. Additionally, 300 customers who join the Seoul Service Center’s new KakaoTalk channel and participate in a comment event in July will be entered into a lucky draw for Starbucks and McDonald's coupons. The Seoul Service Center’s new address is 234 Seonyu-ro, Yeongdeungpo-gu, Seoul. Reservations can be made via the call center at 1600-0992 or the website, with quick updates available through the KakaoTalk channel. Earlier this year, GM's Korean Operations announced plans to enhance the company’s domestic market presence by delivering unique customer experiences in sales and service. This initiative includes the renovation of the East Seoul Service Center in Seongsu-dong into a large-scale, multipurpose service center with eight above-ground and four underground floors. Moreover, GM’s Korean Operations introduced the OnStar global connectivity service to the domestic market this year and expanded ACDelco parts sales service to include domestic brands. This strategy aims to deliver a genuine American product experience and a new lifestyle, upholding GM's customer-first value by providing unique experiences exclusive to GM customers.
Jens Fehlinger to become CEO of Swiss International Air Lines
Jens Fehlinger will be the new CEO of Swiss International Air Lines (SWISS). He will assume his new role on 1 October 2024 and succeed Dieter Vranckx who will become a member of the Lufthansa Group Executive Board as of 1 July 2024. Jens Fehlinger (43) started his professional career at the Lufthansa Group in 2006, where he held various management positions. Among other things, he was in charge of strategy and business development at Lufthansa Airlines and the operational performance management for Lufthansa Group. During the Covid pandemic, he was responsible for the Group's crisis management office and subsequently headed the ReNew restructuring project. In recent years, Jens Fehlinger has been Co-Managing Director of Lufthansa Cityline and at the same time established as managing Director the new airline Lufthansa City Airlines. Jens Fehlinger holds a commercial pilot's license for the Airbus A320 and is currently an active pilot for Lufthansa Cityline. Fehlinger holds a graduate degree (Dipl.-Ing.) in Aviation Systems Engineering and Management from the University of Bremen, Germany, and a master’s degree (M.Sc.) in Traffic and Transport from the Technical University of Darmstadt, Germany. He also received an Executive MBA from the IE Business School in Madrid, Spain. Jens Fehlinger is married and father of two children. Heike Birlenbach, Chief Commercial Officer SWISS, will act as interim CEO until Jens Fehlinger takes over.
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Kuhmo Chamber Music never ceases to surprise us! Next year, we bring you a Scandinavian Utopia
After fourteen days featuring almost 60 concerts and over 20 free events, the 54th Kuhmo Chamber Music festival reached its glorious conclusion on Saturday 27th July with a performance of Vivaldi’s La Folia, incorporating Armenian folk music and improvisations from many other musical cultures. This concert was a great example of the way the festival’s artistic directors Minna Pensola and Antti Tikkanen planned the entire festival programme. Each concert contained something old, something new and something outside the box. The theme of Borderlines was examined from many different angles – geographical, linguistic, cultural, social, spiritual and physical, to name but a few. The highlights of this year’s festival included the premiere performances of festival commissions by featured composers Sebastian Fagerlund and Lotta Wennäkoski, the Tangomania concert, which sold out earlier in the spring, and a programme of songs composed in the Theresienstadt concentration camp. This year’s festival featured a total of 114 international artists. Alongside the many familiar faces, performances by the Ostrobothnian Chamber Orchestra, the Storioni String Trio, the soprano Anu Komsi and the violinist Sini Simonen were particularly well received. Among those appearing at Kuhmo Chamber Music for the very first time, it is safe to say that the Cuarteto Quiroga, the Paddington Trio, the accordionist Janne Valkeajoki and the kantele player Eija Kankaanranta are set to become new festival favourites. This year’s Kuhmo Chamber Music Summer School attracted 85 students in total. The chamber-music masterclasses proved particularly popular. This year, students travelled to Kuhmo from as far afield as Australia and the USA. “We are really thrilled at this year’s programme and at all the performers who helped bring it to life. We’ve had a lot of positive feedback, from colleagues and audiences alike, so we’re in a good place to start planning the 55th festival for next year,” say a thrilled Pensola and Tikkanen. At this year’s festival we managed to get over 21,000 concert visits. In 2021 and 2022, the figure was between 21,000 and 24,000. “It seems that breaking the 21,000 mark is the new normal, which we’ve reached since Covid-19. Before the pandemic, we used to have 5-6 concerts per day; now there are four”, explains festival CEO Sari Rusanen. “Our goal was to sell tickets to a total value of 500,000€, but this year we didn’t quite get there. We sold around 476,000€, which is still an excellent result. We’ll be able to balance the books by cutting back on some expenses”, Rusanen explains. “And while the line-up of festival artists has seen some changes, so has the organisational side of things too. Among our 240 staff members, there were lots of first timers. At Kuhmo Chamber Music, we are constantly aware that we need to keep training up the next generation of organisational staff, and in that we have certainly succeeded,” she says. Scandinavian Utopia The 55th Kuhmo Chamber Music will take place from 13th to 26th July 2025. Next year’s theme will be a “Scandinavian Utopia”. We will have the opportunity to hear lots of music from the Nordic countries, not forgetting central Europe, of course, and our line-up of performers will focus on artists from across the Nordic region. The programme will also feature a variety of thought-provoking perspectives on environmental concerns. The full programme and list of performers will be published in January 2025. Thank you to all our supporters! Kuhmo Chamber Music 2024 has received generous support from the Ministry of Education and Culture, the City of Kuhmo, and the Jenny and Antti Wihuri Foundation. Our corporate sponsors include OP Kuhmo, OP Kainuu, OP Ylä-Kainuu, OP Paltamo, F-Musiikki Oy, Kainuun Sanomat, Kouta Media, Kuhmo Oy, No-Pan Auto Oy, and Osuuskauppa Maakunta.
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Gibson Gives' Second Annual Music Scholarship in Honor of the Music Icon Awarded in Partnership With the Arkansas Arts Academy
Gibson, the iconic, leading American instrument brand headquartered in Nashville, TN, is thrilled to announce its second annual Gibson Gives Sister Rosetta Tharpe music scholarship--administered by the Arkansas Art Academy--has been awarded to music student Luis Melchor. The music scholarship created in honor of the incomparable, Sister Rosetta Tharpe, with the Gibson Gives Sister Rosetta Tharpe Scholarship, Gibson--through its philanthropic division Gibson Gives--awards a music scholarship directly every year to a high school senior as they prepare to navigate their post graduate education and future career in the music industry. The scholarship is comprised of cash grants as well instruments and gear, with each recipient receiving one acoustic or electric guitar, as well as a $5,000 cash grant to assist in their education. The annual Gibson Gives Sister Rosetta Tharpe music scholarship honoring the iconic Godmother of Rock ‘n’ Roll, Sister Rosetta Tharpe, brings her massive musical influence back to her birth state of Arkansas. “Luis is a great kid and has grown so much as a musician,” says Patrick, Music Instructor, Arkansas Art Academy. “He has an insatiable passion for music - particularly vocally, and as a guitarist. If he continues to put the time and effort into his playing, he will have a great future in music.” “Gibson Gives believes in nurturing young talent who will shape the soundscape of tomorrow,” adds Erica Krusen, Global Executive Director of Gibson Gives. “Supporting a music education scholarship with the Arkansas Arts Academy means investing in the future harmony of our world.” An audacious performer from Cotton Plant, Arkansas who became a gospel superstar, Sister Rosetta Tharpe is an artist that rarely comes up in debates about the true founding father of rock ‘n’ roll. She fronted her own band, she was one of the first artists of note to play the iconic ‘61 Les Paul SG Custom electric guitar, she was a headlining, black female artist who toured through the segregated Jim Crow South, and she has been largely overlooked as a seminal figure in the creation of rock music. As it turns out, the founding father of rock ‘n’ roll wasn’t a father at all – that distinction belongs to Sister Rosetta. A gospel-trained force of nature that broke barriers, stereotypes, and norms with astonishing regularity, her electrifying music predates the work of like-minded guitar legends including Chuck Berry, Muddy Waters, and Elvis. Sister Rosetta Tharpe unequivocally remains the textbook definition of an iconoclast – The Godmother of Rock ‘n’ Roll. Watch and share "Shout, Sister, Shout! Sister Rosetta Tharpe,” Gibson TV’s tribute to Sister Rosetta Tharpe, featuring Celisse--who also served as creative director of the Sister Rosetta Tharpe Collection--and Amythyst Kiah, which takes viewers on a journey of Sister Rosetta’s monumental impact on music. One of the first artists of note to play the iconic 1961 Les Paul Gibson SG Custom electric guitar, Gibson proudly partners with the Sister Rosetta Tharpe estate to celebrate her music and cultural influence with a lifestyle and accessories collection, which aligned with the 61st anniversary of her well-known, No. 1 instrument, the 1961 Les Paul SG, available as both a Gibson HERE, and an Epiphone, HERE. View all similar Gibson SG's https://www.gibson.com/en-US/Search?q=white+SG Sister Rosetta Tharpe--her music, and her beloved ’61 Les Paul SG, are as iconic and relevant today as 63 years ago, evidenced by the artists who to this day honor Sister Rosetta as the original force of nature that ignited the invention of rock music. Explore the entire Sister Rosetta Tharpe Collection on Gibson.com The leading global guitar brand, Gibson continues to shape the sounds of generations of musicians across the globe. Gibson supports the global music community through its philanthropic arm, Gibson Gives. The mission of Gibson Gives is to support non-profit organizations worldwide in their efforts to advance musicians, youth-focused education, music, and health and wellness initiatives. 100% of donations to Gibson Gives go towards giving the gift of music.
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SLASH’s S.E.R.P.E.N.T. Blues Festival Kicks Off Nationwide
“The inaugural S.E.R.P.E.N.T. Festival show featured supercharged Blues turned up to 11 as Slash’s guitar captivated the crowd, the evening closed with Warren Haynes returning to the stage for an encore performance of ‘Shake Your Money Maker’ with Slash. It was an unforgettable night featuring four and a half hours of live music. - BLUES ROCK REVIEW SLASH the iconic, GRAMMY® Award-winning guitarist and songwriter has kicked off his first-ever nationwide S.E.R.P.E.N.T. Festival Blues tour. On the S.E.R.P.E.N.T. trek, SLASH handpicked an all-star Blues lineup with Warren Haynes Band, Keb’ ‘Mo, Christone “Kingfish” Ingram, Robert Randolph, Samantha Fish, Eric Gales, ZZ Ward, Jackie Venson, and Larkin Poe. SLASH and his Blues Ball Band--Johnny Griparic (bass), Teddy ‘ZigZag’ Andreadis (keys/vocals), Michael Jerome (drums), and Tash Neal (vocals/guitars)--also perform on all S.E.R.P.E.N.T. Blues Festival dates, among other special guest vocalists; for S.E.R.P.E.N.T. tickets, visit: SerpentFestival.com. SLASH’s S.E.R.P.E.N.T. festival is celebrating the release of his acclaimed sixth solo album titled Orgy of the Damned, available worldwide now via Gibson Records HERE. https://gibsonrecords.lnk.to/ootd A first for SLASH, Orgy of the Damned has now spent six weeks at #1 on the Blues Album Chart in the U.S. The new album also debuted as the #1 Blues Album in the U.S and the U.K., and #2 on the U.S. Rock Albums Chart, as well as achieving Top 10 Chart positions in 7 countries around the world. SLASH and his Blues Ball Band stopped by the Gibson Garage Nashville for a pre festival gig. Watch/share as the group performs “Papa Was A Rolling Stone” live from the Gibson Garage Nashville HERE. The S.E.R.P.E.N.T. Festival, which stands for Solidarity, Engagement, Restore, Peace, Equality N’ Tolerance is designed by SLASH with maximum social impact in mind. SLASH has chosen five nonprofit organizations to benefit from touring proceeds that will lift marginalized communities and support mental health initiatives that share his restorative focus of elevating lives for the benefit of all. Through PLUS1.ORG, the S.E.R.P.E.N.T Festival will donate a portion of the proceeds from every VIP package, as well as every ticket sold, directly to NAMI the National Alliance on Mental Illness, The Equal Justice Initiative, Know Your Rights Camp, The Greenlining Institute, and War Child. The goal of the SLASH’s S.E.R.P.E.N.T. festival is to bring music fans together in these divisive times to celebrate the spirit of the Blues, and for SLASH and his band to collaborate and perform with other Blues artists he admires who share his love of the genre. For details on all S.E.R.P.E.N.T Festival VIP packages, visit serpentfestival.com/vip. A vibrant homage to the blues, SLASH’s star-studded blues album--and the sixth solo album of his career overall--Orgy of the Damned is a collection of 12 songs that revitalize the blues. SLASH handpicked the album’s diverse guest vocalists, which include Brian Johnson (AC/DC), Chris Stapleton, Iggy Pop, Gary Clark Jr., Billy F. Gibbons (ZZ Top), Chris Robinson (The Black Crowes), Dorothy, Paul Rodgers, Demi Lovato, Tash Neal, and Beth Hart. The legendary guitarist reteamed with producer Mike Clink, and Johnny Griparic (bass), Teddy ‘ZigZag’ Andreadis (keys/vocals), Michael Jerome (drums), and Tash Neal (vocals/guitar) formed SLASH’s Blues Ball Band in the studio and on the road. Acclaim from the press continues to roll in for SLASH’s Orgy of the Damned, with current cover stories out now in Premier Guitar, Guitar World, and the Los Angeles Times, among many others. While recording Orgy of the Damned, everything was played live in the room, with an emphasis on improvisation which resulted in a striking collection of energized songs that are vital and raw. Highlights include “Oh Well” with outlaw country star Chris Stapleton’s gritty vocals on the beloved early Peter Green/Fleetwood Mac tune, listen HERE and the Howlin’ Wolf-penned first single “Killing Floor” an electrifying collaboration with Brian Johnson of AC/DC on vocals, and Steven Tyler of Aerosmith on harmonica, listen HERE. “Hoochie Coochie Man,”--written by Willie Dixon and made famous by Muddy Waters--showcases the album’s powerful in-the-moment nature with Z.Z. Top’s Billy F. Gibbons stepping in on vocals and guitar. Gary Clark Jr. joins in for a rowdy take on Robert Johnson’s “Crossroads,” while Beth Hart stuns on the twanging and soulful rendition of T. Bone Walker’s “Stormy Monday,” and Iggy Pop’s vocals soothe the soul on a unique version of “Awful Dream” by Lightnin’ Hopkins. Some of the songs, like Steppenwolf’s “The Pusher,” Charlie Segar’s “Key to the Highway,” and Albert King’s “Born Under a Bad Sign,” had been performed by Slash’s Blues Ball, while others, including like Stevie Wonder’s “Living for the City” with powerful vocals from Tash Neal, were long-time favorites for SLASH. Read SLASH’s full breakdown of every song and artist collaborations on Orgy of the Damned. For a deep dive into the making of the new album, watch Gibson TV’s new music documentary “The Making of Slash’s Orgy of the Damned,’” Episodes 1, 2, 3 and 4, are all streaming now.
Review
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[CES 2021] LG Emphasized "Needs to Innovate Beyond Boundaries Between Fields in the New Normal Era" Through Future Talk
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[CES 2021] Sony Unveiled Its Latest Initiatives Surpassing “Limits of Creativity” at CES 2021
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Hyperconnect, Key to social platform success: reflecting the ‘user voice’
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Hyperconnect : real-time video AI monitoring system can now auto-block live video content within 0.006 seconds
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India Credit Card Market Competition, Forecasts & Opportunities, 2028F - A Shift from Debit-based to Credit-based Economy and Emergence of Co-branded
DUBLIN--(BUSINESS WIRE)--The "India Credit Card Market Competition Forecast & Opportunities, 2028" report has been added to ResearchAndMarkets.com's offering. The Indian credit card market is poised to exhibit robust growth to 2028 The increasing adoption of cashless transactions, coupled with enticing credit card offers, rising acceptance of credit cards, a shift from debit-based to credit-based economy, and the emergence of co-branded card offerings are driving this growth. India's credit card market has undergone significant expansion, characterized by rapid technological advancements. Noteworthy developments, including streamlined onboarding processes, unique card products, personalized offers and rewards, and enhanced mobile apps, have proven advantageous to existing customers while attracting new ones. Credit card issuers are diligently working to raise awareness and foster innovation in this market, and the notable growth of the credit card market in India attests to these efforts. As of July 2022, there were 78 million active credit cards in circulation. Moreover, credit card spending reached a record high of USD 15.16 billion (INR 1.13 lakh crore) in May 2022. The growth trajectory, however, experienced a minor dip during FY 2020-21 due to the COVID-19 pandemic, resulting in a modest 9% increase in credit card spending. This occurred despite the overall uptick in credit card usage. Notably, the Reserve Bank of India (RBI) intervened to curb some of the major credit card issuers from issuing new cards in India during this period. Following the wave of demonetization and government initiatives to promote a cashless economy, credit card acceptance has witnessed a surge in India. Point-of-sale (POS) terminals across the country have adapted to accepting credit cards for a diverse range of goods and services. For instance, as of November 2022, India boasts 131,998,684 POS terminals, affirming the widespread adoption of credit cards. The rise of digital payments, particularly Unified Payments Interface (UPI) transactions, has significantly impacted the credit card industry. Factors such as smartphone proliferation, affordable internet access, and widespread merchant acceptance have propelled UPI transactions. Fintech companies are collaborating with traditional banks to offer credit cards and various digital lending services, including buy now, pay later (BNPL) and equated monthly installment (EMI) options. For example, RuPay credit cards, primarily issued by public sector banks, can now be linked to UPI apps, enabling QR-based credit payments at physical stores and streamlining payment processes for consumers. Market Growth Hindered by Limited Credit Card Penetration Comparatively, the United States boasts 1.5 billion active credit cards, constituting 67% of all active cards in the country. The widespread use of credit cards for purchases is prominent in the US due to convenience and straightforward usage, minimizing concerns about account-related fraud. In India, psychological factors continue to impact penetration. The conservative middle class exhibits reservations about using credit cards and credit in general. Perceived high interest rates and uncertainty about credit card benefits are obstacles to credit card market expansion. Nonetheless, credit card companies have countered these challenges by offering extra perks such as discounts, travel points, and other incentives to attract customers. Diverse Offers with Credit Cards Credit card usage offers users a myriad of advantages when making online payments for various services. These benefits include rewards, vouchers, cashback offers, and more, enhancing the value proposition of credit card payments for activities such as hotel bookings, mobile recharges, movie tickets, and shopping. Notable credit cards like HDFC Bank Regalia Credit Card and SBI Card Elite offer cardholders lounge access, golf privileges, dining and retail discounts, reward points, and travel insurance, amplifying the attractiveness of credit card usage. Entry of NBFCs Fueling Market Competition The credit card market is highly concentrated, with the top six issuers accounting for 81% of the market. However, with an estimated 350 million people anticipated to access online shopping in the next five years, more players are needed. The RBI's more permissive approach toward allowing Non-Banking Financial Companies (NBFCs) to launch credit businesses, provided they meet specific net worth criteria, will foster competition and encourage new entrants into the credit card market. Competitive Landscape Company Profiles: Detailed analysis of the major companies present in India Credit Card market. HDFC Bank Limited SBI Cards and Payment Services Limited ICICI Bank Limited Axis Bank Limited Citibank India Bank of Baroda RBL Bank Ltd. Kotak Mahindra Bank Limited Punjab National Bank IndusInd Bank Market Dynamics Drivers Increasing Adoption of Cashless Transactions Attractive Offers on Usage of Credit Cards Rising Acceptance of Credit Cards Market Trends & Developments Increasing Penetration of Co-Branded Cards Increasing Security Adoption of 5G Digital India Initiative Rising Contactless Payments Challenges Credit Card Payment Defaults High Interest and Charges Voice of Customer Analysis (B2C Model Analysis) Sample Size Determination Respondent Demographics By Gender By Age By Occupation Most Important Factors Determining Usage for Credit Card Users Factors Influencing Credit Card Adoption in India Leading Credit Card Companies in Terms of Customer Service Frequency of Review of Credit Score by Credit Card Users Purpose of Using Credit Card Readiness to Increase Credit Limit Report Scope India Credit Card Market, by Type: General Purpose Private Label India Credit Card Market, Service Providing Company: Visa Mastercard RuPay Others India Credit Card Market, Credit Limit: Up to 25 K 25-50K 51k-2L 2-5L India Credit Card Market, Card Type: Base Signature Platinum India Credit Card Market, Benefits: Cashback Voucher India Credit Card Market, by Region: North West South East For more information about this report visit https://www.researchandmarkets.com/r/cjsdmb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Contacts ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
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The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease
BALTIMORE--(BUSINESS WIRE)--ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center. The HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D) Study, is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. The HYDRAFIL-D Study will enroll approximately 225 patients in up to fifteen centers across North America and is expected to start in early 2024 after the company completes its next round of financing. “I have been advising ReGelTec on their injectable hydrogel for chronic low back pain for more than four years and was able to treat a number of patients with the device during the initial studies performed outside the United States. The early results are excellenti and I can’t wait to begin the HYDRAFIL-D Study here in Oklahoma City,” said Dr. Douglas Beall, Chief of Interventional Spine Services, Comprehensive Specialty Care, Edmond, Oklahoma, who is an advisor to ReGelTec and one of two national principal investigators for the trial. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. in Walnut Creek, CA and the other national principal investigator said, “the HYDRAFIL System is designed for a segment of the chronic low back pain population who are not very good candidates for conventional spine surgery. When conservative care fails, these patients have limited treatment options. HYDRAFIL appears to be a great option for these patients, and we are excited to demonstrate the value of the technology in this randomized, controlled trial.” “Obtaining IDE Approval for the HYDRAFIL-D Study from the FDA is a major milestone for ReGelTec,” said Bill Niland, the company’s co-founder and CEO who has successfully founded and exited multiple healthcare companies including Harpoon Medical, Inc., Vapotherm (NYSE:VAPO), and National Sleep Technologies. The company has treated more than 70 patients with 1-year follow-up on the first sixty patients showing a 69% reduction in pain scores and an 81% improvement in Oswestry Disability Index, a measurement of how low back pain is impacting a person’s daily living.ii Mr. Niland said that “once we were able to share the 1-year follow-up data on our first sixty patients with the FDA, the team was able to work with the agency to obtain IDE approval, and now we are fundraising to secure the capital needed to fund the study and attain FDA approval.” ABOUT REGELTEC, INC: ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL®, a percutaneous treatment for chronic low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals with multiple successful exits. The HYDRAFIL System contains a hydrogel that can be injected into a degenerated disc via a needle. Once approved, HYDRAFIL will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. The HYDRAFIL System is an investigational device, limited by United States law to investigational use. i https://www.jvir.org/article/S1051-0443(23)00694-2/pdfii Internal data on file Contacts Peter Boyd (443) 451-3915 pboyd@regeltec.com
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Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastat
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone (Clinicatrials.gov identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Chicago and online. The Phase II trial was conducted through The US Oncology Network. The results of this trial were published by Joyce O’Shaughnessy et al. (Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005). The poster (Abstract #1037, poster #258), entitled, “Association of C-MYC, MYC target gene, and unfolded protein response (UPR) expression with clinical benefit from the oral aurora kinase A (AURKA) inhibitor, alisertib (A), in combination with paclitaxel (P) compared with P alone in patients (Pts) with HER2-negative metastatic breast cancer (MBC),” was presented at the Breast Cancer – Metastatic Poster Session by Sara A. Byron, Ph.D., Integrated Cancer Genomics Division, Translational Genomics Research Institute (TGen), part of City of Hope, on June 4 at 8:00 a.m. CDT. A copy of the poster is available on the Puma Biotechnology website. Archival tissue samples from patients enrolled in the clinical study were analyzed at TGen. Of the 140 patients enrolled in the trial, 45 from the alisertib plus paclitaxel arm and 51 from the paclitaxel arm had sufficient tissue available for next generation sequencing, and 31 from the alisertib plus paclitaxel arm and 35 from the paclitaxel arm had enough for RNA sequencing/gene set enrichment analysis. The most frequently mutated genes were PIK3CA (45%) and TP53 (44%). No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1. Increased MYC RNA expression was observed in tumors from patients who did not derive clinical benefit from paclitaxel alone (defined as PFS less than 6 months) compared to those with benefit from paclitaxel alone (defined as PFS greater than or equal to 6 months). Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel. Elevated expression of genes involved in MYC activation and in unfolded protein response (a pro-survival mechanism) were enriched in alisertib plus paclitaxel responders compared to paclitaxel responders and were associated with poor response to paclitaxel alone. In 12 patients with exceptional response to alisertib plus paclitaxel (defined as PFS greater than or equal to 12 months), increased expression of genes involved in MYC activation and in epithelial to mesenchymal transition (a hallmark of cancer progression and metastasis) was observed in comparison to cancers from patients whose disease progressed within 6 months of initiating alisertib + paclitaxel (n=11) or those with exceptional response to paclitaxel alone (n=4). “There continues to be a need for new drugs for the treatment of metastatic ER-positive, HER2-negative breast cancer and triple negative breast cancer,” said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. “The results of this study and the subsequent biomarker analysis demonstrate that the addition of alisertib to paclitaxel may help to identify which patients are likely to derive the most benefit from alisertib and helps to identify biomarker focused populations that can be studied in future clinical trials of alisertib.” Sara Byron, Ph.D., Research Associate Professor in the Integrated Cancer Genomics Division at TGen, added, “We are pleased to have collaborated with Dr. O’ Shaughnessy on evaluating the effect of alisertib in this breast cancer trial. The biomarkers that were associated with clinical benefit to alisertib appeared to be the ones associated with an aurora kinase A inhibitor like alisertib, and we are hopeful that this work will help identify future patient populations that may benefit from alisertib.” Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are very pleased with the results of this biomarker analysis. We are committed to and focused on the development of alisertib in biomarker defined populations who may derive the greatest benefit from treatment with alisertib. This biomarker analysis will be very helpful to the design of the future trials of alisertib that we are planning in hormone receptor positive HER2-negative breast cancer.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.comir@pumabiotechnology.com David Schull, +1 212 845 4200 david.schull@russopartnersllc.com
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Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles
Patients treated with dual immunotherapy-based combination demonstrate sustained clinical benefits after four years vs. chemotherapy alone, with magnitude of benefit more pronounced amongst patient subgroups with high unmet needs Late-breaking data to be presented during the 2023 American Society of Clinical Oncology Annual MeetingPRINCETON, N.J.--(BUSINESS WIRE)--$BMY #ASCO--Bristol Myers Squibb (NYSE: BMY) today announced four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer (NSCLC). With a minimum follow-up of 47.9 months, the dual immunotherapy-based combination continued to enhance overall survival (OS), the trial’s primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years (Hazard Ratio [HR] 0.74; 95% Confidence Interval [CI]: 0.63 to 0.87). With extended follow-up, the clinically meaningful efficacy benefit of Opdivo plus Yervoy with two cycles of chemotherapy was maintained across secondary endpoints and key subgroups of patients, with benefits more pronounced amongst high unmet need patients with tumor PD-L1 expression <1% and squamous histology: PD-L1 <1%: Among patients with tumor PD-L1 expression <1%, the OS rate was 23% for those treated with the dual immunotherapy-based combination vs. 13% for chemotherapy alone, representing a 34% reduction in the risk of death (HR 0.66; 95% CI: 0.50 to 0.86). Squamous histology: Among those with squamous histology, twice the number of patients treated with Opdivo plus Yervoy with chemotherapy were alive at four years compared to those who received chemotherapy alone (20% vs. 10%, respectively). In this group, the dual immunotherapy combination reduced the risk of death by 36% compared to chemotherapy alone (HR 0.64; 95% CI: 0.48 to 0.84). No new safety signals were observed with Opdivo plus Yervoy with two cycles of chemotherapy with extended follow-up in the CheckMate -9LA trial. These data will be featured in a late-breaking poster presentation (Abstract #LBA9023) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2023, from 5:30 - 7:00 p.m. EDT. “The durable results seen with nivolumab plus ipilimumab with chemotherapy over four years, especially in patients typically facing a poor prognosis, demonstrate the sustained benefits of combining dual immunotherapy with limited chemotherapy for patients with advanced or metastatic non-small cell lung cancer, which remains an incredibly challenging disease to treat,” said David P. Carbone, M.D., Ph.D., CheckMate -9LA investigator and Director of the Thoracic Oncology Center at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. “The data in patients with tumor PD-L1 expression <1% and squamous histology are particularly encouraging, as they show that the combination therapy continues to reduce the risk of death by approximately one-third compared to chemotherapy alone four years following treatment in patient groups historically facing the worst outcomes.” “Cancer treatment is never a one-size-fits-all approach given that patients with thoracic cancers like non-small cell lung cancer have diverse sets of needs. We are committed to researching solutions that work for more patients and can potentially help improve outcomes and fill areas of high unmet need,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Our data in lung cancer at ASCO 2023 add to the growing body of evidence supporting the potential of our medicines to improve long-term outcomes for patients in both advanced settings and earlier stages of disease, as well as difficult-to-treat patient groups requiring personalized approaches to treatment. The CheckMate -9LA results, which demonstrate sustained efficacy benefits over four years with an Opdivo-based combination, further reinforce our promise to deliver durable options to more patients across varying stages and types of cancer.” Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma. About CheckMate -9LA CheckMate -9LA is an open-label, global multi-center, randomized Phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the experimental arm (n=361) were treated with immunotherapy for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm (n=358) were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or unacceptable toxicity. The primary endpoint of the trial was overall survival (OS) in the intent-to-treat (ITT) population. Secondary hierarchical endpoints included progression-free survival (PFS) and overall response rate (ORR), and the study also evaluated efficacy measures according to biomarkers. About Lung Cancer Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. About Yervoy Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. INDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years of age or older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12). Immune-Mediated Colitis OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%). Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%). OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Immune-Mediated Endocrinopathies OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%). In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%). In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0. Contacts Bristol Myers Squibb Media Inquiries:media@bms.com Investors:investor.relations@bms.com Read full story here
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Nucleai and Mayo Clinic BioPharma Diagnostics Announce Strategic Collaboration to Transform Digital Pathology for Drug Development and Clinical Practi
CHICAGO--(BUSINESS WIRE)--#biomarker--Nucleai, a leading provider of artificial intelligence (AI) solutions for pathology and spatial biology, and Mayo Clinic BioPharma Diagnostics are pleased to announce a strategic collaboration to bring world-class digital pathology solutions, technologies, and services to support drug development and clinical practice. This collaboration combines Nucleai’s AI-powered spatial biology technology with Mayo’s longitudinally annotated, multi-modal data sets, world-class lab services, and clinical diagnostic footprint. "We are excited to work closely with Mayo to bring spatial biology to the hands of the biopharma industry, clinicians and researchers,” said Avi Veidman, CEO of Nucleai. "By combining Mayo Clinic's extensive multi-modal datasets, laboratories, and clinical expertise with Nucleai's advanced AI platform, we can bring scale and impact to the entire precision medicine landscape.” Through this collaboration, Nucleai and Mayo Clinic will focus on several distinct offerings to support drug development including biomarker discovery and validation, end-to-end spatial biology testing and algorithm deployment for clinical trials and diagnostic use. About Nucleai: Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. For more information, please visit www.nucleai.ai. Contacts Jonathan Daniels VP, Head of Business Development and Strategy Email: jonathan@nucleai.ai
