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
Angelalign Technology Inc. (6699.HK) Says a Preliminary European Court Ruling on Certain Software Features Will Have Minimal Impact on Users12.2.2026 17:58:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) said a ruling by the Unified Patent Court of Düsseldorf, Germany that it preliminarily cease its use of certain software functions that automatically update treatment plans would have minimal impact on the orthodontists and patients who use its clear aligner products. The ruling applies to certain European countries and excludes Spain, Switzerland, United Kingdom and Ireland. Angel will launch iPlan for applicable European users, which is an upgrade feature that has the same reliability and more flexibility for users. Angel denies that the Live Now feature in its iOrtho treatment planning software infringes any valid patents of Align Technology Inc. (ALGN). Angel has already filed an opposition against the patent with the European Patent Office (EPO), arguing that the claimed invention is neither novel nor inventive over the prior art, and is seeking its permanent invalidation. Angel is confident it will overcome the first-instance, non-fi
Model ML Buys Captide to Give Financial AI Agents Citable Corporate Disclosure Data12.2.2026 17:43:00 CET | Press release
Deal follows AI workflow company’s $75m fundraise - one of the largest fintech Series As in history Model ML today announced the acquisition of Captide, the leading financial data layer that turns complex global corporate filings and disclosures into LLM-ready documents and data for AI agents. The acquisition, just weeks after the fintech raised $75m in funding from leading US and UK investors, expands Model ML’s AI workflow builder, enabling its AI agents to reliably retrieve, reason over, and cite global filings. Earlier in 2025, Model ML bought Flippr which added automated PowerPoint generation and verification agents to the platform. Founded in 2024 by Maurits Brinkman and Miquel Trafí Ruiz, Captide’s API takes SEC filings, earnings calls and more and structures them in a way AI models can easily and accurately understand at scale. Its platform already spans 2.5 million+ documents and supports 1 billion embeddings. By bringing Captide into Model ML, clients – including Big 4 accoun
i2c Named Finalist for Best Security or Anti-Fraud Development at Card & Payments Awards Middle East 202612.2.2026 15:00:00 CET | Press release
i2c’s AI-driven Fraud Risk Management solution recognized for delivering impactful results for Middle East clients i2c Inc., a global financial technology innovator, has been named a finalist in the Best Security or Anti-Fraud Development category at The Card & Payments Awards Middle East 2026. The region’s premier awards program recognizes organizations that deliver practical, high-impact innovations to strengthen payment security and protect customers in one of the world’s fastest-growing digital payments markets. i2c was recognized for its AI-driven Fraud Risk Management solution, embedded directly within its unified banking and payments platform and operating in real time at the point of transaction authorization—an increasingly critical capability as digital payments scale across Middle East markets. By evaluating risk at the moment a payment is initiated, rather than after funds are approved, the solution enables earlier detection of fraudulent activity while preserving approval
SLB Awarded Multiple Offshore Drilling Contracts by Mubadala Energy for Tangkulo Deepwater Development in Indonesia12.2.2026 14:00:00 CET | Press release
Contracts support offshore gas development with first gas targeted before end of 2028 Global energy technology company SLB (NYSE: SLB) has been awarded multiple offshore drilling services contracts by Mubadala Energy, the Abu Dhabi headquartered international energy company, for the Tangkulo natural gas deepwater development and associated exploration and appraisal drilling activities in the Andaman Sea, offshore Indonesia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260212809124/en/ The project will leverage SLB’s offshore and deepwater technologies, including real-time downhole monitoring, to reduce operational risk, improve well placement and strengthen project economics. Under the awards, SLB will work with Mubadala Energy to deliver integrated drilling and well services across the full well life cycle. The scope includes directional drilling, drilling fluids, cementing, wireline, slickline, coiled tubing, well testin
Align Partners Issues Formal Shareholder Proposals to Dentium12.2.2026 13:43:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Dentium Co., Ltd. (“Dentium” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Dentium’s upcoming 26th Annual General Meeting (“AGM”), urging the Company to strengthen governance practices and improve capital allocation discipline. Align Partners noted that, given shareholder proposals will be presented at this year’s AGM, Dentium should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date and adopting an electronic voting system to enhance shareholder participation. Dentium is widely recognized as a global leader in the dental implant industry, supported by superior technology and more than 23 years of long-term clinical data. Despite this strong positioning, Align Partners believes the Company continues to trade at a meaningful discount. As of February 11, 2026, Dent
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