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
Ciauru Wins the Second Edition of the Reply AI Music Contest, the International Competition Dedicated to Experimentation Across AI, Music and Live Performance6.7.2026 20:30:00 CEST | Press release
The winner was announced on the Kappa FuturFestival stage, following the performances of the five finalists selected by the international jury.German duo PARAFRAME & Avis Vox received the special Reply AI Studios Grand Prix award. The second edition of the Reply AI Music Contest, the international competition created by Reply to explore new forms of expression combining artificial intelligence, music and live performance, concluded with the announcement of the winner on the Nova Stage powered by Reply during Kappa FuturFestival. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706007611/en/ The second edition of the Reply AI Music Contest, the international competition created by Reply to explore new forms of expression combining artificial intelligence, music and live performance, concluded with the announcement of the winner on the Nova Stage powered by Reply during Kappa FuturFestival First place went to Ciauru, the stag
Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 20266.7.2026 15:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced it will report earnings after market close on July 30, 2026. The company will host a conference call and webcast on that date to discuss the second quarter 2026 results and the second half 2026 outlook at 5:00 p.m. Eastern / 2:00 p.m. Pacific time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706560476/en/ Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 2026 A live webcast of the event will be available on Rimini Street’s Investor Relations site via the Rimini Street IR events link and directly via the webcast link. Dial-in participants can access the conference by dialing 1-800-836-8184. A replay of the webcast will be available for one year following the event. About Rimini Street, Inc. Rimini Street, Inc. (Nasda
Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe6.7.2026 15:00:00 CEST | Press release
Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe. Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity. Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product developm
No-Loss Trading Platform UpsideOnly Surpasses 100,000 Users Within Weeks of Launch6.7.2026 14:48:00 CEST | Press release
Rapid growth shows strong demand for a new trading model where users can make market predictions without risking their own capital Perpetuals.com Ltd (Nasdaq: PDC), today announced that UpsideOnly, its risk-free trading and market prediction platform, has seen a surge in new user sign-ups, surpassing the important milestone of 100,000 traders within weeks of its launch on May 19. UpsideOnly lets users make predictions about where global equity, commodity, forex, and crypto markets are heading without ever placing a real trade themselves. Perpetuals uses its own capital to trade on the strongest signals identified by its proprietary AI. If those trades win, Perpetuals shares the profits with the users who helped generate the signal. If the trade doesn’t make money, users lose nothing. Reaching 100,000 users so quickly after launching is a reflection of the enormous demand for a platform that flips the traditional retail trading model on its head, with early platform data showing strong
Klarna Submits Application for U.S. Banking License6.7.2026 14:30:00 CEST | Press release
Klarna (NYSE: KLAR), the global digital bank and flexible payments provider, today announced it has submitted applications to the Utah Department of Financial Institutions and the Federal Deposit Insurance Corporation (FDIC) to establish Klarna Bank USA, a proposed Utah-chartered industrial bank. Klarna has operated as a licensed bank in Europe since 2017 and serves U.S. customers through valued partner banks. Since 2019, Klarna has provided Americans with access to over $91.3 billion in responsible credit, saving them more than $5.1 billion in interest compared to revolving credit card debt. Today, 30 million Americans use Klarna each year, and hundreds of thousands of merchants rely on Klarna to grow their businesses. "Banking is built on trust," said Sebastian Siemiatkowski, co-founder and CEO of Klarna. "We've seen firsthand the appetite for a fairer, more transparent approach in the U.S., and our own banking license is the natural next step, giving customers tools to borrow respon
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