After more than 20 years Japan’s most legendary whisky distillery is back

The world-renowned Karuizawa distillery closed its doors in 2000 but thanks to a recent investment, and exclusive global partnership with dekantã, the legend lives on. The Karuizawa distillery was established in 1955 at the foothills of an active volcano, Mount Asama. The location was notable for being the highest distillery in Japan at 850m above sea level. Despite being the country’s smallest whisky producer, Karuizawa had a global reputation for producing first-class malt whiskies. Karuizawa stopped producing whisky in 2000 and has since been known as a ‘silent’ distillery. As global interest in Japanese whisky has grown in recent years, demand for stock from the closed Karuizawa distillery has increased dramatically, with bottles selling for record prices at auction houses around the world. In 2020 a bottle of Karuizawa 52-year-old became the most valuable bottle of Japanese whisky ever sold, achieving £363,000 / $435,273 through Sotheby’s in London. Now, some 24 years after the initial closure, Karuizawa Whisky is back, along with members of the original distilling team. The new Karuizawa Whisky was built by Shigeru Totsuka, who hired the former Karuizawa Master Distiller, Osami Uchibori, as an advisor, who has sadly since passed away, and his apprentice, distiller Yoshiyuki Nakazato, as Master Distiller. Unlike the old Karuizawa distillery, which was situated in the neighbouring town of Miyota, the new distillery is situated in the town of Karuizawa itself, known for its stunning year-round vistas that range from vibrant green and yellow forests in the summer months to gleaming snow- covered peaks that attract skiers from around the globe in the winter. “I strive to produce a liquid that both respects and surpasses the old Karuizawa whisky” - Yoshiyuki Nakazato, Master Distiller, Karuizawa Whisky The new distillery, built in 2022, located at the base of Mount Asama, sees water flow through volcanic lava rock that surrounds the distillery giving it a unique quality. Totsuka and his team are more than aware of the rich legacy that comes with the distillery’s name, and they are keen to protect this with everything they have. It is for this reason that they have chosen to use only top-quality sherry casks and each of these has a minimum ageing requirement of 10 years, ensuring that when bottles of Karuizawa single malt finally hit the market, they will be of the highest standard. In keeping with the tradition of the old distillery, the smallest in Japan, Karuizawa Whisky are only filling a very limited number of casks, with a clear emphasis on quality over quantity. dekantã, the world’s leading online retailer of fine and rare Japanese whisky, has fostered a close working relationship with the new Karuizawa Whisky to bring both the joys of their liquid and their epic story to Japanese whisky lovers across the world. Through a global partnership dekantã have the exclusive rights to sell a limited number of single malt sherry casks from Karuizawa Whisky which are available for their loyal customers to buy, allowing them to live the dream of owning a full cask of whisky from a legendary Japanese distillery. Cask purchases come with opportunities to sample the liquid, visit the distillery, and create one’s very own independent bottling of Karuizawa single malt whisky, once the 10-year minimum ageing requirement has been met. “It is nothing short of an honour to be entrusted with Karuizawa’s legacy and liquid.” - Makiyo Masa, Founder, dekantã What’s more, when the time finally comes, limited edition official bottle releases will be available via dekantã, while working on their very own independent bottlings of this exceptional whisky. Until then, dekantã will be keeping their customers and cask owners up to date with regular news, content, offers and updates from Karuizawa Whisky. “Nakazato is the fundamental route for a successful Karuizawa whisky style. When I look at what they are doing here, I think they will make some very very good liquid for the new, reborn, Karuizawa.” - Daniel Lam, Global Head of Wine & Whisky, Spink & Son Karuizawa Whisky casks are available exclusively through www.dekanta.com

New culinary highlights in Lufthansa Business Class

Board, take off, relax: Lufthansa is constantly developing its product range in all classes in order to provide passengers with a pleasant journey. In Business Class on long-haul flights, new highlights are now being added to the culinary offering. Heiko Reitz, Chief Commercial Officer Lufthansa Airlines, explains: "The entire Lufthansa team is proud to present our new Business Class experience. Our culinary highlights, the celebration of German bread culture and the collaboration with traditional brands such as Ziegler for the new Lufthansa Aperitif Avionic underline the timeless elegance of our brand. The other new products that we will soon be introducing in various travel classes are further steps towards our goal of creating a whole new level of excitement for our guests." Bread is one of the Germans' favorite foods. There are more than 3,000 different types of bread in Germany, and bread culture has been part of the German UNESCO Intangible Cultural Heritage for ten years. Lufthansa guests in Business Class on long-haul flights from Germany can now enjoy special bread developed exclusively for Lufthansa by baker-sommelier and World Baker of the Year 2022 Axel Schmitt. The handmade breads, which are only available on board Lufthansa flights from Germany, are baked fresh daily from natural ingredients, do not contain any additives and are served with handmade butter and high-quality olive oil as an appetizer. In each new quarter, there will be a different type of bread specially created for Lufthansa. Lufthansa guests can also look forward to further innovations in in-flight service in Business Class on long-haul routes. In future, the new signature drink Avionic, as an alternative to water and sparkling wine, will be served with nuts as a welcome drink on board before take-off. The Avionic Apéritif is a special creation by the Ziegler distillery, developed with Sven Riebel, Frankfurt bar icon and "Host of the Year". The drink, which is based on peach notes and wild meadow herbs, is mixed on ice with tonic. For the first time ever, Business Class guests will be served a vegetarian amuse-bouche, from antipasti to sushi, as a prelude to the first service on board. Fresh fruit will also be added to the dessert menu. There is a new, modular snack offer for the small appetite in between, which varies depending on the length of the route and time of day. This includes snacks, fresh fruit and, on longer flights, fresh salty and sweet treats such as tomato and mozzarella skewers or wraps with pastrami. From June, every passenger will be given a small box of Lindt chocolates in an exclusive Lufthansa design as a farewell gift. Lufthansa Business Class guests will thus be offered an all-round appealing service, from the welcome moment to the farewell gesture.

Vitesco Technologies and DHL enter into strategic partnership

Vitesco Technologies focuses on maximum sustainability, resilience and efficiency in logistics. Key to this is a new strategic partnership with DHL Supply Chain as a Lead Logistics Partner (LLP). As of March 2024, the logistics flows of Vitesco Technologies’ twelve European locations will be centrally managed by DHL through the LLP Center of Excellence in Warsaw, Poland. This corresponds to around 100,000 transport movements within the supply chain to the plants as well as from the plants to the customers – and thus accounts for about a third of Vitesco Technologies’ total freight volume. “The main driver of our business is the development and production of sustainable technologies for the mobility of tomorrow. We want to run this business in a CO2-neutral way by 2040. Sustainable logistics solutions are an important step along this path, which we will be taking together with DHL Supply Chain in the future,” says Thomas Kirchermeier, Head of Supply Chain Management at Vitesco Technologies. The big advantage of the new logistics concept is that, as a lead logistics partner, DHL Supply Chain bundles the freight volumes of numerous large companies in order to generate synergy effects and thus achieves new potentials for optimization. The logistics experts make use of the entire market of freight carriers and forwarding agents and can provide the fastest, safest, most environmentally friendly and most cost-effective transport solutions. This benefits Vitesco Technologies and all customers: supply chains become more robust and more reliable. Intelligent logistics helps to reduce Greenhouse Gas Emissions Central freight management by a leading global logistics provider such as DHL also enables the maximum transparency of transport routes – which not only benefits efficiency, but also reduces greenhouse gas emissions. This is achieved by combining deliveries that were previously handled separately or by increasingly relying on low and zero carbon emissions transportation. This is where Vitesco Technologies’ expertise in the field of electromobility meets DHL’s practical experience, as the company operates the largest fleet of electric vehicles within the logistics sector. “The first joint pilot projects have already shown that we can leverage considerable synergies through a seamlessly integrated supply chain. The cost savings and efficiencies that we have already been able to realize together with Vitesco Technologies are now paving the way for further global growth. With our focus on a consistent standardization and orchestration of logistics processes, we want to further minimize greenhouse gas emissions, maximize the efficiency of supply chains and improve their resilience in the coming years,” says Hendrik Venter, CEO DHL Supply Chain Europe, Middle East & Africa.

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  CONTACT Elements as the ideal foundation for the digital thread

  The international management consultancy recommends CONTACT Elements as the cornerstone for a digital thread spanning the entire product lifecycle, as demonstrated by the plant manufacturer Marel with its "Digital Product Highway." Data silos cause delays, increased costs, and dissatisfied customers. Information is isolated in different departments, making analysis inefficient, collaboration challenging, and innovation potential limited. Against the backdrop of growing data volumes due to increasingly complex and smart products, companies require a digital thread that enables smooth management and analysis of information. The experts at CIMdata see the modular platform CONTACT Elements as an ideal basis for this purpose. CIMdata emphasizes that CONTACT Software’s products and the underlying low-code platform connect data and processes end-to-end. Information is available across the company — from development and production to smart service and recycling. CONTACT Elements is modular and can be flexibly adapted to individual needs and scaled gradually — on-premises and in the cloud. CONTACT Elements offers end-to-end solutions for Industry 4.0, Product Lifecycle Management, and digital services through its flexible modular system. Companies increase their productivity and operate more collaboratively with a digital thread, as all stakeholders in the value chain have access to a single source of truth. Although often perceived as linear, the digital thread works more like a network, including various departments, suppliers, and customers, spanning from concept to end of life. Previous decisions can thus be traced back transparently. A common application is linking a physical asset with its digital twin. CIMdata highlights Marel as an example of a successful implementation of the digital thread with CONTACT Elements. The full-line supplier of innovative food processing solutions benefits from a smooth interaction between systems, processes, and players along its value-creation networks. “Marel were able to use CONTACT Elements to enable a “Digital Product Highway” ensuring that everyone is looking at the correct information, in easy-to-understand formats with data consistency in a cohesive integrated approach from concept through the end of the product lifecycle," say the CIMdata experts. The detailed commentary by the consulting and market research company can be found here. The software provider showcases the entire solution portfolio of the open low-code platform CONTACT Elements at the Hannover Messe as well. Visitors can experience the capabilities for PLM, IoT, and MES at the main booth H24 in hall 17, as well as at the OWL community booth D27 in hall 07 and the Fujitsu booth H62 in hall 14.

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  Epiphone Expands the Inspired by Gibson Custom Collection

  For 150 years, Epiphone has been a leading innovator in instrument design. By leveraging its iconic past and leaning into the future, Epiphone has set the stage for the next era of sound for present and future generations. Epiphone’s game-changing Inspired by Gibson Custom Collection developed in close collaboration with the skilled luthiers at Gibson Custom continues to expand establishing a new tier of premium Epiphones--for every stage. Featuring Gibson USA pickups and premium electronics, world-renowned Gibson “open book” headstocks, solid wood construction, and one-piece necks, Epiphone’s Inspired by Gibson Custom Collection brings Custom Shop designs to the masses adding to Epiphone’s full array of instruments for all player levels. Epiphone's Inspired by Gibson Custom Collection is now available at Authorized Epiphone dealers and worldwide on www.epiphone.com “While you can still get all the same beloved Epiphone instruments at the same affordable price points, the new Epiphone Inspired by Gibson Custom line appeals to those who want the historic and premium specs that our Custom Shop fans love. I am proud to say that this new line of instruments represents a true collaboration of our USA teams and our overseas teams in every sense. Collectively, we made sure every possible upgrade was included so that these would become the new crown jewels of our Epiphone range.” - Mat Koehler, Vice President of Product at Gibson Watch/hear the new Epiphone Inspired by Gibson Custom guitars in action on the Gibson Gear Guide Channel

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  Slash Announces S.E.R.P.E.N.T.

  Following the announcement of his highly anticipated sixth solo album Orgy of the Damned, due out May 17 on Gibson Records, the iconic, GRAMMY®-winning guitarist and songwriter SLASH, has confirmed a North American tour in celebration of the Blues this summer. SLASH’s newly announced S.E.R.P.E.N.T. festival, an anagram that stands for Solidarity, Engagement, Restore, Peace, Equality N’ Tolerance will kick off on July 5 in Bonner, Montana, and travel to Los Angeles, Denver, Cincinnati, Toronto, New York City, Boston, Atlanta, and many more cities. SLASH has curated an all-star Blues lineup to join him on the inaugural S.E.R.P.E.N.T. festival this summer, including Warren Haynes Band, Keb’ ‘Mo, Christone “Kingfish” Ingram, Robert Randolph, Samantha Fish, Eric Gales, ZZ Ward, Jackie Venson, and Larkin Poe. On all dates, SLASH will perform alongside his Blues band featuring bassist Johnny Griparic, keyboardist Teddy ‘ZigZag’ Andreadis, drummer Michael Jerome, and singer/guitarist Tash Neal. SLASH formed the S.E.R.P.E.N.T. festival which stands for Solidarity, Engagement, Restore, Peace, Equality N’ Tolerance to bring fans together to celebrate the spirit of the Blues, and to perform with other Blues artists he admires who share his love of the genre. SLASH also has a strong desire to give back to charities that he has supported over the years, as well as to help lift marginalized communities that share his restorative focus of elevating lives for the benefit of all. A portion of the proceeds from each VIP package and S.E.R.P.E.N.T. festival ticket sold will directly benefit the following charities that SLASH has selected The Equal Justice Initiative, Know Your Rights Camp, The Greenlining Institute, and War Child. S.E.R.P.E.N.T Festival has partnered with PLUS1.ORG to support these charitable endeavors. “The S.E.R.P.E.N.T. tour is a celebration of blues and rock ‘n’ roll music, and a celebration of unity and togetherness in these uncertain and divisive times,” says SLASH. “S.E.R.P.E.N.T is a vehicle to help support and uplift people and communities suffering from the injustices of racism and equal rights violations, as well as to support children adversely affected by war and poverty across the world. So, we are contributing a portion of every ticket and VIP package sold from the tour to those ends. S.E.R.P.E.N.T. will also provide an environment where folks can get together for a day of great music and hang out and have a good time.” General on sale for tickets begins Friday, March 15 at 10am local time. For pre-sales, visit www.serpentfestival.com. A limited number of S.E.R.P.E.N.T. festival VIP packages are available now which include access to watch SLASH’s soundcheck before the show, hand-signed vinyl of Orgy of the Damned, and more, go to: www.serpentfestival.com. S.E.R.P.E.N.T Blues Festival 2024 North American Dates: * Warren Haynes Band, Samantha Fish, and Eric Gales ** Keb’ ‘Mo, Samantha Fish, and Jackie Venson # Keb’ ‘Mo, ZZ Ward ,and Jackie Venson $ Keb’ ‘Mo, ZZ Ward, and Robert Randolph ^ZZ Ward and Robert Randolph + Larkin Poe, ZZ Ward, and Robert Randolph ^^Christone “Kingfish” Ingram, ZZ Ward, and Robert Randolph SLASH’s Orgy of the Damned cover art. SLASH’s star-studded debut blues album, Orgy of the Damned, is a collection of 12 dynamic songs that shakes up and revitalizes blues classics with a stripped-down, instinctive approach, creating a singular expression that pays homage to the blues. Celebrating both well-known and largely undiscovered songs, SLASH offers a nostalgic nod to the past while reinvigorating the songs with his inimitable guitar playing and the spirit of collaboration. For Orgy of the Damned, the acclaimed guitarist reteamed with storied producer Mike Clink and enlisted the album’s diverse guest vocalists, which include Gary Clark Jr, Billy F. Gibbons, Chris Stapleton, Dorothy, Iggy Pop, Paul Rodgers, Demi Lovato, Brian Johnson, Tash Neal, Chris Robinson, and Beth Hart, in a similar way to his 2010 self-titled solo LP Slash. Rounding out his band in the studio and on the road, SLASH reunited with two of his bandmates from his Blues Ball outfit in the 90s, bassist Johnny Griparic and keyboardist Teddy ‘ZigZag’ Andreadis, and brought on drummer Michael Jerome and singer/guitarist Tash Neal. The first single “Killing Floor,”--which features Brian Johnson of AC/DC on vocals, and Steven Tyler of Aerosmith on harmonica--is an electrifying, raucous and gleefully unbridled take on Howlin’ Wolf’s 1964 Chicago blues standard; stream “Killing Floor,” now HERE. Watch/share the new video for “Killing Floor,” which offers a first look at SLASH and his Blues band recording the song in the studio HERE. Although he grew up in England, SLASH’s American grandmother turned him on to the blues early on, and he was immediately taken with B.B. King. At the same time, his parents raised him on a healthy diet of 60s British rock ‘n’ roll, from The Who to The Kinks. Once he moved to Laurel Canyon, SLASH found himself surrounded by rock and folk singers like Joni Mitchell, Crosby, Stills & Nash, and Neil Young—all of whom eventually inspired his playing and songwriting. It wasn’t until he began playing guitar himself that SLASH realized all of his favorite musicians had been influenced by the same B.B. King blues records he’d listened to as a young kid. Orgy of the Damned encompasses a broad range of styles within the blues genre, veering from an upbeat, rowdy take on Robert Johnson’s “Crossroads” to a plaintive, twanging rendition of T. Bone Walker’s “Stormy Monday.” 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, like Stevie Wonder’s “Living for the City,” were long-time favorites for SLASH. “Hoochie Coochie Man,” written by Willie Dixon and made famous by Muddy Waters in 1954, showcases the in-the-moment nature and unrestrained energy of Orgy of the Damned, with Z.Z. Top’s Billy F. Gibbons stepping in on guitar and vocals. The group went into a rehearsal room in North Hollywood and began hashing out soulful, rollicking takes on the classic songs. Everything was played live in the room, with an emphasis on improvisation which resulted in a collection of dynamic, energized songs that are immediate, raw, and distinctly familiar. A vibrant homage to the Blues, Orgy of the Damned is a landmark moment in SLASH’s career and a rare opportunity to bring to the forefront a rollicking musical journey through his Blues inspirations that have long been in the background of his illustrious career. SLASH’s Orgy of the Damned is available digitally, on vinyl and CD via Gibson Records for pre-order https://gibsonrecords.lnk.to/ootd Preview the album https://gibsonrecords.lnk.to/killingfloor , and for more information, go to www.slashonline.com

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  Epiphone Partners With Dave Grohl to Release His Legendary Dave Grohl DG-335, Available Worldwide Today

  For 150 years, Epiphone has been a leading innovator in instrument design. By leveraging its iconic past and leaning into the future, Epiphone has set the stage for the next era of sound for present and future generations. Epiphone is proud to unveil its global partnership with Dave Grohl. The Dave Grohl DG-335 pays tribute to the longtime six-string mainstay of Dave’s world-spanning tours with the Foo Fighters. As part of the Epiphone Inspired by Custom Collection, the guitar continues a new era of premium features for Epiphone, including high-quality electronics and design upgrades. The Epiphone Dave Grohl DG-335 is now available at Authorized Epiphone dealers and worldwide on www.epiphone.com A longtime Gibson user, Dave’s previous Gibson signature guitars have remained extraordinarily popular and continue to command premium prices on the used market. Epiphone is proud to once again partner with Gibson Custom on the release of the Dave Grohl DG-335. It features the combination of ES-335 and the Trini Lopez model features Dave requested and that fans expect, including a semi-hollow ES™ body made of layered maple/poplar, with bound diamond-shaped sound holes, a one-piece mahogany neck with an elliptical C profile, a Trini Lopez style headstock with Grover® Mini Rotomatic® tuners, a laurel fretboard, and split diamond inlays. The pickups are Dave’s preferred Gibson USA Burstbucker™ models, with a Burstbucker 2 in the neck and a Burstbucker 3 in the bridge position. They’re wired to CTS® potentiometers, Mallory™ capacitors, and a Switchcraft® 3-way toggle switch and 1/4” output jack. The Dave Grohl DG-335 is one of the most requested models in Epiphone’s history, and Epiphone is X-Static to offer this exceptional guitar to players worldwide. An Epiphone Dave Grohl hardshell case is also included. Foo Fighters will resume their Everything or Nothing at All global stadium tour on May 1 in Dallas, TX. The tour takes its name from the chorus of “Nothing at All,” from Foo Fighters’ universally acclaimed 11th album But Here We Are. Released June 2, 2023 on Roswell Records/RCA Records, But Here We Are has garnered some of the best critical notes of the band’s storied career, while its singles “Rescued” and “Under You” have cemented the band’s tally of more #1s than any other artist on Rock and Alternative Radio. For all Foo Fighters tour dates, visit: https://foofighters.com/tour-dates/

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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