NNPA Sponsor Pfizer’s Submission of Cancer Drug Accepted for Priority Review by FDA
The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024
By Stacy M. Brown, NNPA Newswire Senior National Correspondent@StacyBrownMedia
Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK (tisotumab vedotin-tftv) to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.
Pfizer is a sponsor of the National Newspaper Publisher’s Association’s 2024 Mid-Winter Training Conference, a collaboration that’s part of one of the world’s premier biopharmaceutical company’s commitments to sustainable practices and environmental responsibility.
The NNPA, representing 250 African American newspapers and media companies in the United States, is hosting its annual mid-winter training conference in Fort Lauderdale, Fla., beginning on Wednesday, January 24, at the B Ocean Beach Resort. The theme of the 2024 conference is “Empower the Black Press, the Black Vote, and Black America.” Pfizer’s continued partnership with the Black Press reflects a commitment to impactful corporate partnerships.
“The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting TIVDAK as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” Dr. Roger Dansey, chief Development Officer, Oncology at Pfizer, said in a news release. “The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer.”
The sBLA is supported by efficacy and safety data from the global, randomized, Phase 3 innovaTV 301 trial (NCT04697628), in which TIVDAK demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), as assessed by the investigator, in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
According to a news release, the safety profile of TIVDAK in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information. In October 2023, results from the innovaTV 301 study were presented during a Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.
The U.S. Prescribing Information for TIVDAK includes a BOXED WARNING for Ocular Toxicity as well as the following Warnings and Precautions: peripheral neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, and embryo-fetal toxicity. Please see below for additional Important Safety Information.
“Therapeutic options for metastatic cervical cancer that not only demonstrate a survival advantage but also include a novel approach to treating this condition are needed,” said Jan van de Winkel, Ph.D., Chief Executive Officer at Genmab. “This milestone underscores our commitment to continuing to deliver TIVDAK as a treatment option to women in the U.S. diagnosed with cervical cancer whose disease has progressed after first-line treatment.”
TIVDAK was granted accelerated approval in the U.S. by the FDA in September 2021. The accelerated approval is based on tumor response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer. The data from innovaTV 301 will support global regulatory submissions.
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NNPA Sponsor Reynolds American Inc. Announces Appointment of Wade Huckabee as SVP, Strategy & Transformation
Reynolds American Inc. is a wholly owned subsidiary of the global BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, Inc., American Snuff Company, LLC, R.J. Reynolds Vapor Company, and Modoral Brands Inc.
By Stacy M. Brown, NNPA Newswire Senior National Correspondent @StacyBrownMedia
Reynolds American Inc. (Reynolds), the BAT Group’s U.S. subsidiary, kicked off 2024 by continuing its sponsorship of the upcoming National Newspaper Publishers Association’s (NNPA) Mid-Winter Training Conference and announcing the appointment of Wade Huckabee to the role of Senior Vice President, Strategy and Transformation.
Reynolds American Inc. is a wholly owned subsidiary of the global BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, Inc., American Snuff Company, LLC, R.J. Reynolds Vapor Company, and Modoral Brands Inc.
Huckabee, in his role, is now responsible for developing and realizing the U.S. strategy and serving on the Reynolds American Leadership Team, effective January 1, 2024.
According to a news release, Huckabee joined the Reynolds organization in April 2016 as Vice President of Strategy and Planning, overseeing the function’s development, including building more robust analytical capabilities and retail insights. He was named Senior Vice President of Combustibles in December 2018 and, in 2019, assumed the role of General Manager of the Reynolds organization’s traditional categories.
Huckabee was appointed Global Head of Revenue Growth in 2022, responsible for accelerating the BAT Group’s sales and category objectives in priority markets worldwide. In 2023, he became Group Head of Customer and Commercial, adding the development of global trade marketing to his accountabilities.
Before joining the Reynolds organization, his extensive experience in other consumer goods categories included strategy and investor relations roles at Hanesbrands, Inc., and progressive leadership roles in finance, revenue & margin management, and strategic accounts at Keurig Dr Pepper.
In his new role, Huckabee will lead and oversee Reynolds’ strategy, encompassing key pillars related to commercial, organizational, and regulatory strategies. A native Texan, Huckabee has a Bachelor of Arts in History and English from the University of Texas at Austin and an MBA in Finance from Pepperdine University in Malibu, CA.
Meanwhile, Reynold’s Inc., will host a lunch presentation and fireside chat at 1 p.m. on Friday, January 26, during the NNPA’s Mid-Winter Training Conference. Dr. Rahn Bailey, a professor and chair of Psychiatry at the LSU Health New Orleans School of Medicine, will join NNPA President and CEO Dr. Benjamin F. Chavis Jr., to discuss the topic, “The importance of doing away with diversity and inclusion. How will this impact you?”
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NNPA Sponsor Diageo Expands Global Efforts for Sustainable Glass Production with Seed Funding
Diageo will provide seed funding to facilitate the expansion of Glass Futures activities into North America and India, two of the company’s largest markets.
By Stacy M. Brown, NNPA Newswire Senior National Correspondent @StacyBrownMedia
In a move to accelerate the decarbonization of the glass industry on an international scale, Diageo, a prominent sponsor for the 2024 National Newspaper Publishers Association’s (NNPA) annual mid-winter training conference, has announced a strategic initiative. Diageo will provide seed funding to facilitate the expansion of Glass Futures activities into North America and India, two of the company’s largest markets.
Glass Futures, a leading glass research and technology organization, is partnering with Diageo to explore effective pathways to decarbonize the glass industry. This collaboration is part of Diageo’s commitment to sustainable practices and environmental responsibility.
With additional funding from Diageo, Glass Futures aims to delve into new technologies and system-wide approaches. The focus is reducing carbon emissions associated with glass production in North America and India, where Diageo has significant market influence.
While glass is inherently recyclable, addressing the carbon footprint of its production poses a challenge for the industry. Technological advancements and the limited availability of renewable energy infrastructure have contributed to this challenge. As a proactive supporter of Glass Futures, Diageo has been integral to driving innovative solutions.
“We’re looking forward to expanding our partnership with Glass Futures into North America and India to look into lower-carbon glass production,” stated Andy Griffiths, head of Sustainable Procurement at Diageo.
“This is key for the success of Diageo’s and the wider glass industry’s decarbonization efforts. Partnering on innovative approaches is vital to making a net-zero world a reality, and we are hopeful that this collaboration will bring great results in other markets going forward.”
Officials said that the collaboration between Diageo and Glass Futures has already yielded positive results in the UK. A 2021 trial involving Glass Futures, Diageo, and Encirc showcased waste-based biofuel-powered furnaces for Diageo’s Black & White Scotch whisky brand. This innovative approach resulted in a remarkable 90% reduction in the carbon footprint of the bottle-making process.
Diageo’s seed investment in Glass Futures’ international expansion reportedly aligns with the company’s broader commitment to environmental, social, and governance (ESG) targets. The initiative contributes to Diageo’s goal of reducing Scope 3 carbon emissions by 50%, measured against its 2020 baseline by 2030.
Meanwhile, Diageo’s Vice President Stephanie Childes plans to sit with NNPA President and CEO Dr. Benjamin F. Chavis Jr. during the NNPA’s popular fireside chat at 11:50 a.m. on Thursday, January 25, at the midwinter training conference in Fort Lauderdale. The discussion will center on harnessing the power of community, the Black Press, and inclusive corporate leadership.
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NNPA Sponsor Hyundai Motor America Celebrates Prestigious Great Place To Work Certification
The certification affirms that 73% of employees consider Hyundai a Great Place to Work, surpassing the average U.S. company by an impressive 16 points.
By Stacy M. Brown NNPA Newswire Senior National Correspondent @StacyBrownMedia
Hyundai Motor America, a prime sponsor of the 2024 National Newspaper Publishers Association’s (NNPA) annual mid-winter training conference, has achieved the prestigious Great Place to Work Certification, a recognition based on feedback from its current employees. The certification affirms that 73% of employees consider Hyundai a Great Place to Work, surpassing the average U.S. company by an impressive 16 points.
“This achievement is more than just an accolade; it stands as a testament to the outstanding efforts and contributions from our employees each and every day,” José Muñoz, president and global COO, Hyundai Motor Company, president and CEO, Hyundai, and Genesis Motor North America, said in a news release. “Their commitment to excellence, collaboration, and fostering a positive work environment has been the driving force behind this incredible accomplishment.”
Great Place to Work is a globally recognized authority on workplace culture, employee experience, and leadership behaviors. Employees at Hyundai mentioned the inclusive culture, benefits, work-life balance, and quality of the people as key factors contributing to the company’s status as a great workplace.
Matt Little, Vice President of Human Resources and Administrative Services at Hyundai Motor North America, emphasized that the certification reflects Hyundai’s commitment to collaboration and people-focused core values at all organizational levels.
Sarah Lewis-Kulin, Vice President of Global Recognition at Great Place to Work, commended Hyundai’s consistent dedication to the overall employee experience, positioning the company as one of the top workplaces globally. “By successfully earning this recognition, it is evident that Hyundai stands out as one of the top companies to work for, providing a great workplace environment for its employees,” Lewis-Kulin asserted.
Research by Great Place to Work indicates job seekers are 4.5 times more likely to find a great boss at a certified great workplace. Certified workplaces also see employees who are 93% more likely to look forward to coming to work, twice as likely to be paid fairly, earn a fair share of the company’s profits, and have a fair chance at promotion.
Great Place to Work Certification is a coveted achievement, representing official recognition earned through real-time employee feedback regarding their company culture.
Hyundai Motor America offers U.S. consumers a technology-rich lineup of cars, SUVs, and electrified vehicles, aligning with Hyundai Motor Company’s Progress for Humanity vision. The company’s significant operations in the U.S., including its North American headquarters in California, the Hyundai Motor Manufacturing Alabama assembly plant, and cutting-edge R&D facilities contribute $20.1 billion annually and 190,000 jobs to the U.S. economy, according to a recent economic impact report.
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NNPA Sponsor Nissan Starts Year with Two Big Announcements
The automaker has named Vinay Shahani as senior vice president, U.S. Marketing and Sales. His appointment is effective January 18. Additionally, Nissan announced that its popular 2024 Rogue, which offers the most standard safety features and best gas-engine fuel economy in its class, will be on sale soon with a Manufacturer’s Suggested Retail Price of just $28,320.
By Stacy M. Brown, NNPA Newswire Senior National Correspondent@StacyBrownMedia
As a sponsor of the National Newspaper Publishers Association’s (NNPA) 2024 Mid-Winter Training Conference, has began the new year with two major moves.
The automaker has named Vinay Shahani as senior vice president, U.S. Marketing and Sales. His appointment is effective January 18. Additionally, Nissan announced that its popular 2024 Rogue, which offers the most standard safety features and best gas-engine fuel economy in its class, will be on sale soon with a Manufacturer’s Suggested Retail Price of just $28,320.
The 2024 Rogue is the first Nissan available with Google built-in, featuring Google Assistant, Google Maps and more from Google Play on a 12.3-inch color touchscreen (SL, Platinum grades).
Meanwhile, Shahani replaces Mike Colleran, who is retiring from Nissan on March 31, after more than 12 years in top regional and global leadership positions.
According to a news release, as senior vice president, Shahani will be responsible for all sales and marketing activities for the Nissan brand in the United States. He will also have oversight of INFINITI Americas.
“As we accelerate the transformation, we started with Nissan NEXT, Vinay brings a unique blend of Nissan background and experience with successful global automotive brands,” said Jérémie Papin, chairperson, Nissan Americas. “Vinay is an ideal choice to lead our brands into the future, driving performance and innovation while maintaining our people-centric culture.”
Shahani’s career highlights include:
2021-2024: Vice President of Marketing, Lexus USA
2017-2021: Vice President, Integrated Marketing Operations, Toyota North America
2013-2017: Senior Vice President & Chief Marketing Officer, Volkswagen of America
Shahani’s work history includes nearly a decade at Nissan North America. After starting a job as an engineering manager at the Smyrna Vehicle Assembly Plant in 2004, he quickly moved into a managerial role within the company’s marketing and sales function. From there, he held roles of increasing responsibility in sales operations; aftersales; product marketing; field sales; and marketing communications and media.
Mike Colleran joined Nissan in 2011 as vice president of Sales for Nissan Canada, and then moved to oversee Nissan’s Northeast region in the U.S. He also held leadership positions overseeing the INFINITI brand, first as group vice president for INFINITI Americas, and then as global divisional vice president and vice chairman for INFINITI Motor Company, Ltd. He returned to the U.S. as senior vice president, U.S. Marketing and Sales in 2020, to implement the Nissan NEXT transformation.
“Mike Colleran has been instrumental in our Nissan NEXT transformation, providing strong and steady leadership inside the company while rebuilding the critical relationships with our U.S. dealer network,” Papin stated. “Mike has led Nissan and INFINITI through challenging times, and he has our utmost gratitude as he moves onto a well-deserved retirement.”
The moves and Nissan’s refreshed 2024 Rogue have helped the company begin the year on a high note. With class-exclusive Google built-in5 integrated directly into the vehicle, all the new features in the 2024 Rogue can be used without pairing or plugging in a phone. They also allow a more seamless use of existing Google Account information: for instance, addresses or points-of-interest saved on the Google Maps website or mobile app (when signed in) can easily be selected in Rogue’s touchscreen for use as a navigation destination.
Apple CarPlay and Android Auto are standard on all Rogue grades (wired on S/SV, wireless on SL/Platinum), ensuring drivers can choose the connectivity functions they’re most comfortable using.
The 2024 Nissan Rogue features new front and rear fascias, a new version of Nissan’s V-motion grille, new inner taillights, and satin-finish exterior badges. The premium look and feel of Rogue Platinum are further elevated with enhancements including gloss-Black fender, lower exterior, and front fascia trim pieces, a new 19-inch wheel design, and a new available Chestnut brown leather upholstery with a richer, darker color.
The collaboration between the automaker and NNPA is part of Nissan’s commitment to sustainable practices and environmental responsibility.
The NNPA, representing 250 African American newspapers and media companies in the United States, is hosting its annual mid-winter training conference in Fort Lauderdale, Fla., beginning on Wednesday, January 24, at the B Ocean Beach Resort. The theme of the 2024 conference is “Empower the Black Press, the Black Vote, and Black America.” Nissan’s involvement reflects a commitment to impactful corporate partnerships.
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