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
Inspirit Capital to Acquire Kaplan Languages Group20.4.2026 17:15:00 CEST | Press release
Inspirit Capital, a specialist investor in corporate carve-outs, is pleased to announce its plans to acquire KLG Kaplan Languages Group (“KLG”), a leading global language education platform, from Kaplan. All conditions for the sale have been met, and completion is due to take place on 1 May. KLG comprises Kaplan International Languages, Alpadia Language Schools, Azurlingua, and ESL Education. Since 2006, KLG has provided high-quality language education, supporting students in achieving their language goals through academic excellence, cultural immersion, and life-changing experiences. Inspirit Capital will support KLG in delivering on its ambitious growth plans, whilst continuing its fundamental mission to transform lives through language education. This next phase of ownership will also see the development of a refreshed standalone brand identity for KLG, with further announcements to follow on this in due course. Paul Youens, Investment Director, Inspirit Capital: “KLG has built a st
Cleaner by Design: SaniSure Introduces PETG PharmaTainer™ Ultra-Clean Bottles & Carboys20.4.2026 16:00:00 CEST | Press release
Industry’s most widely adopted PETG material meets industry-leading cleanliness, compliance, and RNase/DNase-free validation—now available across the full bioprocessing workflow. SaniSure® today announced the launch of PETG PharmaTainer™, a new line of bioprocessing bottles and carboys combining widely accepted, medical-grade Eastman Eastar® PETG 6763 resin (DMF#9987) with SaniSure’s proprietary process and advanced automation. This launch expands SaniSure’s established PharmaTainer® platform—extending its proven cleanliness, robustness, and performance attributes to include industry-standard PETG alongside its existing PET and PC offerings. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260420641769/en/ PETG PharmaTainer™ bottles and carboys—RNase/DNase-free, ultra-clean, ready-to-use containers for bioprocessing applications. Available in volumes from 10 mL stability vials to 10 L carboys — in sterile (gamma-irradiated) an
Leaders of Dubai-Based Unicorns Hail City as Global Innovation Hub Shaping Future Technology and Driving the Digital Economy20.4.2026 15:08:00 CEST | Press release
Leaders of Dubai-based unicorn companies have reaffirmed the emirate’s status as a global hub for digital innovation and technology-led growth. The senior executives highlighted Dubai’s forward-looking regulatory environment, advanced infrastructure, and ability to attract international talent as key factors strengthening its appeal for high-growth digital businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260420503062/en/ Leaders of Dubai-based unicorns hail city as global innovation hub shaping future technology and driving the digital economy (Photo: AETOSWire) They noted that Dubai has evolved into a strategic launchpad for ambitious companies, offering an agile business environment that supports innovation and enables expansion into regional and international markets. The business leaders also praised the strong alignment between the public and private sectors within Dubai’s digital ecosystem, supported by Dubai
Capcom’s All-New IP PRAGMATA Surpasses One Million Units Sold in Two Days!20.4.2026 15:00:00 CEST | Press release
– Highly innovative and original gameplay earns strong reception from players around the globe – Capcom Co., Ltd. (TOKYO:9697) today announced that worldwide sales of PRAGMATA, the company’s all-new IP released on April 17, 2026*, have surpassed one million units. PRAGMATA is a science-fiction action-adventure game that depicts the journey of Hugh Williams and Diana, an android girl, in a near-future lunar world. A completely new IP, PRAGMATA was developed primarily by a team of younger Capcom developers, who created an innovative gameplay experience by fusing action gameplay with puzzle elements set within a distinctive world ruled over by artificial intelligence. In the absence of an established fan base or preexisting brand recognition, Capcom implemented a range of marketing initiatives—beginning with the early release of a playable demo—to communicate the unique features of the game to a wider audience. In addition, in line with the company’s multi-platform strategy, Capcom broade
Following Oral Presentation of Phase I Data at AACR 2026, Debiopharm Announces FDA Fast Track Designation for Lunresertib in Combination With Zedoresertib for Genomic-Defined Platinum-Resistant Ovarian Cancer20.4.2026 14:30:00 CEST | Press release
Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of its PKMYT1 inhibitor, lunresertib (Debio2513), and its WEE1 inhibitor, zedoresertib (Debio 0123). The designation is for the treatment of adult patients with CCNE1 amplified, or a deleterious mutation in either FBXW7 or PPP2R1A, platinum-resistant/refractory ovarian cancer. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and fill an unmet medical need. Programs granted Fast Track designation benefit from more frequent communication with the FDA and, if relevant criteria are met, may be eligible for Priority Review and Accelerated Approval of a New Drug Application (NDA). Momentum Following AACR O
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