VIIV-HEALTHCARE
21.12.2019 09:48:09 CET | Business Wire | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
The reasons given in the CRL relate to Chemistry Manufacturing and Controls (CMC). There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date. ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this New Drug Application.
Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC. The cabotegravir and rilpivirine long-acting regimen is an investigational product and not approved anywhere in the world.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com .
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com .
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person responsible for arranging the release of this announcement on behalf of GSK is V.A. Whyte, Company Secretary.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191221005008/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Cyble Positioned as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies8.5.2026 15:22:00 CEST | Press release
Cyble today announced it has been recognized as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies. The company believes this recognition underscores Cyble’s mission to make threat intelligence truly operational—delivering AI-native capabilities that enable enterprises, government agencies, and MSSPs to shift from reactive security to proactive, intelligence-driven defense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508164528/en/ Cyble Named a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies "Security teams are under constant pressure to respond faster with greater accuracy," said Beenu Arora, Co-Founder and CEO, Cyble. "We believe this recognition highlights our focus on delivering intelligence that drives real outcomes—cutting through noise, accelerating response, and enabling confident decision-making at scale." Intelligence That Acts
WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features8.5.2026 15:00:00 CEST | Press release
New updates introduce a more personalized, data-driven member experience—bridging the gap between continuous biometrics, real-world context, and clinical insight WHOOP, the human performance company, today announced a new suite of health and AI-driven enhancements and feature updates across the WHOOP memberships, marking a major step forward in its evolution into an intelligent health platform. These updates deepen the company’s commitment to delivering highly personalized, accurate, and actionable insights. They signal the company’s expansion beyond performance optimization into clinical-grade health support. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508464188/en/ WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features “WHOOP is a membership, and we take that seriously,” said Ed Baker, Chief Product Officer of WHOOP. “We’re always asking how we can deliver more value to our members, and the
Reply Presents the Jury of the Second Edition of the AI Music Contest: This Year Again, Finalists Will Perform on the NOVA Stage of Kappa FuturFestival in Turin8.5.2026 13:24:00 CEST | Press release
Agoria, Max Cooper, Fleur Shore, Tini Gessler, Ali Demirel, Albi Scotti, Oliver Bohl and Sarah Grimaldi join the jury of the second edition of the competition dedicated to the dialogue between artificial intelligence and live performance. Reply, [EXM, STAR: REY], an international group specialised in the development of new AI-enabled business models and always distinguished by a strong drive for innovation, renews its commitment to creative experimentation with the second edition of the ReplyAI Music Contest. The initiative, organised in collaboration with Kappa FuturFestival—one of Europe’s leading festivals dedicated to electronic music—takes the form of an international competition aimed at creatives and innovators who use AI technologies to explore new ways of integrating sound and image, enhancing the role of artificial intelligence in live performances. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508361016/en/ Th
CYNREN Launches Next Generation Advisory Firm Serving Family Offices, Funds and Institutions8.5.2026 13:00:00 CEST | Press release
Founded by former partners of KPMG and Citibank with decades of experience guiding businesses, funds and families CYNREN today announced its launch as an independent international advisory firm, built for a world where capital, technology and geopolitics now heavily intersect. Unlike traditional consulting firms, CYNREN combines institutional capability and experience with the agility of a true challenger model to operate at the highest level of advisory and execution. CYNREN was co-founded by Anthony Cowell, Sunil Nair and Scott Lennon, specializing in family office, fiduciary and directorship roles, board-level strategy, impact and philanthropic structuring and complex risk consulting. The firm is partner-led around the moments that matter most, with AI embedded from inception to enable sharper insights and more informed outcomes while remaining grounded in human judgement. Operating globally through a network of senior advisors, investors and partners, CYNREN serves clients across t
Telekom Srbija Secures U.S. EXIM Financing to Accelerate 5G Rollout8.5.2026 11:48:00 CEST | Press release
Approval from the Export-Import Bank of the United States will support Serbia’s next-generation telecoms expansion and strengthen U.S.–Serbia technology and economic ties Telekom Srbija Group today announced that the Export-Import Bank of the United States (EXIM) has granted final approval for financing to support the continued rollout of Telekom Srbija’s 5G network. The EXIM-supported financing will help fund the deployment of 5G telecommunications network equipment and related services in Serbia, supplied by U.S. technology companies. It marks a major milestone in Telekom Srbija’s long-term investment programme and strengthens the company’s relationship with leading U.S. financial and technology institutions. Telekom Srbija launched commercial 5G services in Serbia in December 2025 and is continuing to expand coverage nationwide. The company is targeting 5G coverage across all Serbian cities by the end of 2026, with full national coverage by the end of 2027. The financing follows EXI
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom