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
TetraMem Announces 22nm Multi-Level RRAM Analog In-Memory Computing SoC Milestone16.5.2026 10:43:00 CEST | Press release
TetraMem Inc., a Silicon Valley–based semiconductor company developing analog in-memory computing (IMC) solutions, today announced the successful tape-out, manufacturing, and initial silicon validation of its MLX200 platform, a 22nm multi-level RRAM-based analog IMC system-on-chip (SoC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260516556464/en/ Photograph of the MLX200 chip with a five-cent coin for size reference The achievement marks a significant step toward the commercialization of analog computing architectures based on emerging non-volatile memory technologies, addressing the growing challenges of data movement, power consumption, and thermal constraints in modern AI systems. As AI workloads continue to scale, system performance is increasingly constrained by the cost of moving data between memory and compute units. Analog in-memory computing offers a fundamentally different approach by performing computation dir
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 18:15:00 CEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 16:00:00 CEST | Press release
Accelerates AI‑driven transformation through expanded agentic AI and data engineering capabilities that underpin NTT DATA’s AI strategy Adds 1,000 Azure engineers and AI specialists to scale cloud and AI delivery capabilities Advances NTT DATA’s North America leadership position, scaling industry aligned AI led innovation across its cloud services and Microsoft Business Unit Builds on NTT DATA’s position as the fastest-growing Microsoft GSI partner, accelerating co-innovation in enterprise AI NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 16:00:00 CEST | Press release
Accelerates AI‑driven transformation through expanded agentic AI and data engineering capabilities that underpin NTT DATA’s AI strategy Adds 1,000 Azure engineers and AI specialists to scale cloud and AI delivery capabilities Advances NTT DATA’s North America leadership position, scaling industry aligned AI led innovation across its cloud services and Microsoft Business Unit Builds on NTT DATA’s position as the fastest-growing Microsoft GSI partner, accelerating co-innovation in enterprise AI NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s
Experian Expands Agent Trust Partner Ecosystem with Akamai to Advance Trusted AI Driven Commerce15.5.2026 15:00:00 CEST | Press release
Collaboration strengthens secure, scalable agentic commerce and supports emerging Know Your Agent standards Experian today announced that Akamai Technologies has joined its growing partner ecosystem, designed to further advance secure, trusted AI driven commerce through the Experian Agent Trust™ framework, alongside partner Skyfire supporting emerging payment innovation. As AI agents begin to search, decide, and transact autonomously, they introduce a fundamental challenge for businesses: how to trust an action when it is no longer directly initiated by a human. Without a verified connection between humans and AI agents, autonomous commerce introduces new risks in fraud, misrepresentation, and unauthorized transactions. Experian Agent Trust is designed to address this challenge by establishing identity, accountability, and trust in agent driven interactions. “Trust, security, and performance must scale alongside the growing role of AI agents in digital commerce,” said Kathleen Peters,
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