Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months
TITUSVILLE, N.J., February 24, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA (consisting of Janssen’s long-acting rilpivirine and ViiV Healthcare’s cabotegravir). The sNDA seeks to expand the CABENUVA label to include administration every two months for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per mL) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA was approved by the FDA in January 2021 as a once-monthly, long-acting regimen for the treatment of HIV-1 infection in virologically suppressed adults.1 The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. ViiV Healthcare is the marketing authorization holder for CABENUVA in the U.S.“Today’s submission marks another important milestone on our journey to improving the lives of those living with HIV through the development of innovative new treatments,” said Brian Woodfall, M.D., Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. “First, with the introduction in the U.S. of CABENUV...
AbstractHuman trafficking is an egregious violation of basic human rights that has reached global proportions. Despite the gradual proliferation of social science research and policy endeavors, a contemporary understanding of state human trafficking statutes has received limited discussion. Existing commentary tends to underserve survivor experiences in the law. Using a database of 982 human trafficking state statutes, this study seeks to describe the landscape of how the law acknowledges survivors. In doing so, we found that states acknowledge survivors through 1. formal agency guidelines, 2. survivor rights and services,...
The company has grown from about 20 people to 100 since CEO Andrei Floriou came aboard 18 months ago.
Prolonged exposure to the blue-tinted light in LED bulbs has been linked to cataracts, insomnia and fatigue. NSF-funded researchers at the University of Houston are working to reduce the amount of blue light generated by LED bulbs, improving our sleep and protecting our eyes as well. Learn more ...This is an NSF Multimedia Gallery item.
This time around, it ’ll be a much smoother experience than the ones earlier this year when there wasn’t enough vaccine to meet demand.
Environ. Sci.: Processes Impacts, 2021, Accepted Manuscript DOI: 10.1039/D1EM00202C, CommunicationMayomi Omebeyinje, Adewale Adeluyi, Chandrani Mitra, Paramita Chakraborty, Gregory Gandee, Nalit Patel, Bindhu Verghese, Christine Farrance, Matthew Hull, Paramita Basu, Kwonmoo Lee, Atin Adhikari, Burcu Adivar, Jennifer Horney, Anindya Chanda Indoor flooding is a leading contributor to indoor dampness and the associated mold infestations in the coastal United States. Whether the prevalent mold genera that infest the coastal flood-prone buildings... The content of this RSS Feed (c) The Royal Society of Chemistry
History of TBI tied to 52 percent increased odds of prescription opioid use, 65 percent increased odds of prescription opioid misuse
Adverse childhood experiences, including abuse and neglect, are tied to neurologic disorders in adulthood ― as well as to comorbidities, anxiety, and depression.Medscape Medical News
President Joe Biden announced the new pledge during a virtual COVID-19 summit on Wednesday. The plan will increase the US contribution to more than 1 billion doses.WebMD Health News
Although more Californians than ever had health insurance in 2020, disparities in access to health care among the state ’s racial and ethnic groups was magnified during a year of unprecedented challenges and changes.Those are among the key findings of the latestCalifornia Health Interview Survey, which is conducted by theUCLA Center for Health Policy Research. The survey included responses from 22,661 California households, including 21,949 adults, 1,365 adolescents and 3,548 children.“This is one of the most important data releases in the survey’s 20-year history because it sheds light on how impactful t...
CORK, IRELAND, March 6, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson today presented positive long-term data from the global Phase 3b trial of the first complete, long-acting (LA), two-drug injectable regimen (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The 96-week findings of the Antiretroviral Therapy as Long-Acting Suppression Every 2 Months (ATLAS-2M) trial confirmed the primary endpoint, met at Week 48, and met the secondary endpoint, showing efficacy of both monthl...
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