VIIV-HEALTHCARE
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
Zycus Named a Leader in the 2026 Gartner® Magic Quadrant™ for Source-to-Pay Suites23.1.2026 20:00:00 CET | Press release
This acknowledgment reflects Zycus’ momentum in Agentic AI, comprehensive S2P suite, brand trust and customer outcomes. Zycus, a global provider in Source-to-Pay (S2P) technology, today announced that it has been recognized as a Leaderin the 2026 Gartner® Magic Quadrant™ for Source-to-Pay Suites. We believe the report points to Zycus’ continued investment in Merlin Intake to streamline user experience and Agentic AI to support workflows such as tail-spend management via autonomous negotiation. This aligns with Zycus’ “Intake to Outcomes” (I2O) belief: simplify how work enters procurement, orchestrate execution with Agentic AI, and deliver outcomes with the right governance and control. “Being recognized as a Leader in the Gartner Magic Quadrant for Source-to-Pay Suites reflects our long-term commitment to innovation, customer outcomes, and responsible AI,” said Aatish Dedhia, Founder & CEO of Zycus. “Merlin Agentic AI is designed to move beyond task automation towards end-to-end outcom
Bureau Veritas to Acquire a Leading Sustainability Specialist for Consumer Products in Italy23.1.2026 18:13:00 CET | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the acquisition of SPIN360, a leading Italian consulting firm specialized in sustainable innovation and development across primary premium fashion and luxury brands. This acquisition aligns with Bureau Veritas’ LEAP | 28 strategy to create new strongholds in the Consumer Product Services (CPS) industry, and to accelerate its growth in key markets such as Italy. The transaction will deliver on value creation opportunities, by combining SPIN360's proprietary Life Cycle Assessment (LCA) tools and data-driven advisory services with Bureau Veritas' certification and supply chain auditing expertise. It will also help position Bureau Veritas as a global center of excellence for premium fashion and luxury. Created in 2009 and based in Milan, SPIN360 provides technical advisory services covering LCA, life cycle costing, environmental product declarations, carbon footprint, supply chain engagement
HCLTech to Acquire Singapore-based Finergic to Boost Digital Transformation Offerings for Wealth Management Industry23.1.2026 17:55:00 CET | Press release
HCLTech, a leading global technology company, today announced that it has signed a definitive agreement to acquire Finergic Solutions Pte Ltd, a boutique wealth consulting firm headquartered in Singapore. The transaction is expected to close by April 30, 2026. Founded in 2019, Finergic focuses on core banking and wealth management transformation and has a strong, well-established global presence. The addition of Finergic’s niche capabilities, combined with the scale of HCLTech, is expected to unlock stronger synergies and enhance service delivery across the financial services and wealth management industry. HCLTech brings 25+ years of global experience in serving leading financial institutions. By integrating Finergic’s specialized transformation strategy, consulting and wealth-architecture capabilities, HCLTech will accelerate the delivery of next-generation, platform-enabled wealth management solutions anchored by advanced AI-native workflows. These capabilities will complement HCLTe
Saudi Arabia to Host World Economic Forum Global Collaboration and Growth Meeting: Building Common Ground and Reviving Growth on 22-23 April 202623.1.2026 16:29:00 CET | Press release
Saudi Arabia will host the World Economic Forum (WEF) Global Collaboration and Growth Meeting: Building Common Ground and Reviving Growth in Jeddah on 22-23 April 2026, it was announced on the closing day of the 56th Annual Meeting of the Forum in Davos, Switzerland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260123725881/en/ HE Faisal F. Alibrahim, Saudi Arabia’s Minister of Economy and Planning, announces that the Kingdom will host the World Economic Forum Global Collaboration and Growth Meeting in Jeddah in April 2026 (Photo: AETOSWire) His Excellency Faisal F. Alibrahim, Saudi Arabia’s Minister of Economy and Planning today confirmed the details for the regular high-level WEF meeting, which was announced at the 2025 WEF Annual Meeting. Calling for pragmatism and collaboration against a backdrop of geopolitical fragmentation, HE Alibrahim said “stability can’t be quickly built, and it can’t be bought”. “Stability need
Philip Morris International Urges FDA Advisory Committee to Recommend Authorizing ZYN as a Modified Risk Tobacco Product23.1.2026 15:15:00 CET | Press release
In January 2025, ZYN became the first nicotine pouch product authorized for marketing by the FDA Experts from Philip Morris International (PMI) (NYSE: PM) yesterday presented scientific evidence to the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s process for a Modified Risk Tobacco Product (MRTP) designation for their ZYN nicotine pouch products. This designation would allow PMI’s U.S. family of businesses to communicate to U.S. legal-aged, 21+ adult cigarette smokers that switching completely to ZYN reduces their risk of many smoking-related diseases and we look forward to a decision by FDA. "The FDA’s Center for Tobacco Product’s (CTP) mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, Chief External Affairs Officer for PMI U.S. “Smoke-free products, like ZYN, play a critical role in helping CTP achieve this mission and provide adults who smoke with important inf
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