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
LTIMindtree Introduces New Brand Identity and Positioning: LTM — The Business Creativity Partner11.2.2026 10:37:00 CET | Press release
LTIMindtree today unveiled their new brand identity and positioning, which marks a defining moment for the Company. Its Board of Directors has also approved a proposal to change the Company name as 'LTM Limited', subject to shareholder and regulatory approvals. The new identity and positioning as the Business Creativity partner reflects how LTM’s technology capabilities and deep domain expertise converge to create meaningful stakeholder value. This defines how competitive advantage is built in the Agentic Enterprise era, where access to technology alone is no longer a differentiator. LTM brings the very best of human insights and intelligent systems for its clients — applying technology with creativity, precision, and accountability. With the new name and positioning, the Company is also signaling a clear call to action: "It’s time to Outcreate". For its clients, Outcreate is how LTM thinks disruptively, reframes industries, and owns business outcomes through Business Creativity. Toget
Vonage and C3 AI Partner on Network-Enabled, Agentic AI Field Services Solution for Mobile Workforces11.2.2026 09:30:00 CET | Press release
Designed for mission-critical field operations, the joint solution combines autonomous and assisted AI with Vonage communications and network APIs for those working beyond the enterprise edge Vonage, part of Ericsson (NASDAQ: ERIC), today announced a strategic collaboration with C3 AI (NYSE: AI), a leading Enterprise AI application software provider, to launch C3 AI Field Services, a module of the C3 AI Asset Performance Suite of products, integrated with Vonage APIs. The AI-first module combines C3 AI’s powerful Enterprise AI capabilities with Vonage’s cutting-edge Communications APIs (Voice and Video) and Network APIs (Quality on Demand and Verify), to deliver superior performance, reliability and experiences for mobile enterprise field operations. This collaboration builds on a broader network-powered solutions offering from Vonage where application-aware networking, including advanced connectivity capabilities such as Quality on Demand (QoD), can be applied to support critical fiel
Mobileum and NOHOLD Launch White-Labeled AI Assistant Offering for Telecom Enterprise Customers11.2.2026 09:00:00 CET | Press release
First product release following the companies’ strategic AI alliance enables operators to monetize AI services for SME/SMBs through existing telco channels Mobileum Inc. (“Mobileum”), a leading global provider of analytics and network solutions, and NOHOLD, a leader in enterprise-grade AI assistant platforms, have announced the launch of a new white-labeled AI Assistant solution designed specifically for telecom operators serving small and medium-sized enterprises (SME/SMBs). The new offering builds on the strategic AI alliance announced in September 2025, moving from concept to a market-ready solution. Telecom operators can now offer branded AI Assistant services that help SME/SMBs enhance customer engagement, drive sales, and improve productivity through AI technology, with operators providing the tools so SME/SMBs avoid managing complex AI themselves. As traditional connectivity revenues continue to be under pressure, SME/SMBs are seeking value-added digital services from their tele
Merus Power leverer et energilagringssystem til ekstreme arktiske forhold11.2.2026 08:00:00 CET | Pressemeddelelse
Merus Power Oyj har indgået en aftale om levering af et batterienergilagringssystem til en værdi af cirka 13 mio. euro med Neve Oy. Anlægget på 30 MW/80 MWh er designet til at fungere under ekstremt kolde forhold og vil blive leveret til Rovaniemi ved udgangen af 2026. Virksomhederne har desuden indgået aftale om omfattende drifts- og vedligeholdelsestjenester for energilagringsanlægget. Der er multimedier i denne pressemeddelelse. Se hele meddelelsen her: https://www.businesswire.com/news/home/20260205135896/da/ Merus Power delivered the first grid forming battery energy storage systems in the Nordics last year. The grid forming BESS to be deployed in Lapland is also designed to withstand extreme Arctic conditions. Energilagringsanlægget er konstrueret til at fungere pålideligt under arktiske forhold og kan modstå temperaturer helt ned til -50 °C samt kraftigt snefald og is. Systemet anvender grid forming-teknologi, som understøtter elnettets inerti og styrker stabiliteten i el-system
Galderma Expands Restylane® Portfolio in Japan With Launch of OBT™ Hyaluronic Acid Injectables Restylane Defyne™ and Refyne™11.2.2026 07:00:00 CET | Press release
Restylane® Refyne™ and Restylane Defyne™ are the first Optimal Balance Technology (OBT™) hyaluronic acid injectables ever approved and launched in Japan, bringing advanced flexibility and natural movement to the market1,2 This expands Galderma’s Restylane portfolio in Japan to four products, enabling treatment of a wider spectrum of patient and practitioner needs3,4 These two new launches underscore Galderma’s accelerating growth across the Japan & Asia Pacific (JPAC) region Galderma (SIX: GALD), the pure-play dermatology category leader, has announced the launch of Restylane Defyne and Restylane Refyne: the first OBT‑based hyaluronic acid injectables ever authorized in Japan.1,2 The products – designed for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds – are now commercially available in the market.1,2 Restylane Defyne and Refyne leverage the unique balance of softness, flexibility, and support delivered by Galderma’s proprieta
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