Lopinavir News and Research

RSS

FDA assigns Priority Review designation to JRD's XARELTO sNDA

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

27 Feb 2012

Gilead Sciences receives FDA approval for Viread to treat pediatric HIV infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.

19 Jan 2012

Janssen announces FDA label update approval for PREZISTA HIV tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for PREZISTA (darunavir) tablets to include 192-week data from the ARTEMIS study.

22 Oct 2011

FDA approves Gilead's Complera for treatment of HIV-1 infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.

11 Aug 2011

Boosted REYATAZ shows durable viral suppression in women with HIV

Bristol-Myers Squibb Company announced results from a long-term, retrospective, European cohort study, which included 1,294 antiretroviral (ARV)-experienced patients from Germany, France and Sweden, that were presented today at the Sixth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.

21 Jul 2011

Infants treated with certain HIV medication more likely to experience adrenal dysfunction

Infants of human immunodeficiency virus 1 (HIV-1) infected mothers who were treated before and after birth with the protease inhibitor lopinavir-ritonavir were more likely to experience adrenal dysfunction, including life-threatening adrenal insufficiency in premature infants, compared with a zidovudine-based regimen, according to a preliminary report in the July 6 issue of JAMA.

6 Jul 2011

Tibotec, Gilead Sciences enter license agreement for new combination product of PREZISTA and cobicistat

Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent.

28 Jun 2011

Lopinavir can combat HPV-related cervical cancer

A widely used HIV drug could be used to prevent cervical cancer caused by infection with the human papilloma virus, say scientists.

3 May 2011

AHF advocates to attend drug giant Abbott Laboratories' Annual General Meeting

A group of advocates from AIDS Healthcare Foundation will attend drug giant Abbott Laboratories' Annual General Meeting Friday April 29 at 9:00am in Abbott Park, Illinois planning to speak at and question Abbott executives regarding Abbott's pricing and policies on its HIV/AIDS medications.

30 Apr 2011

Study shows possibility of women living with AIDS to breastfeed with lower risk

In low-income countries, 1.4 million women are living with the Aids virus. If no prevention measures are taken, the risk for future mothers of transmitting HIV to their child in utero, during delivery or when breastfeeding is 35%.

20 Apr 2011

Gilead's elvitegravir Phase III trial against HIV-1 meets primary objective

Gilead Sciences, Inc. today announced that the Phase III clinical trial of its investigational antiretroviral agent elvitegravir, a novel oral integrase inhibitor being evaluated for the treatment of HIV-1 infection in treatment-experienced patients, met its primary objective.

24 Mar 2011

HIV prevention, treatment highlighted at Conference on Retroviruses and Opportunistic Infections

Today was the last day of the 18th Conference on Retroviruses and Opportunistic Infections, a key HIV/AIDS research meeting being held at the Hynes Convention Center in Boston from February 27 through March 2. Highlighted below are selected presentations from March 2nd on research supported by the National Institute of Allergy and Infectious Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, both components of the National Institutes of Health.

5 Mar 2011

Pediatrician unveils latest findings of IMPAACT HIV/AIDS study during 2011 CROI

A clinical study of anti-HIV/AIDS medicines in the developing world is on the verge of turning "the whole treatment world on its head," according to Dartmouth pediatrician Paul Palumbo.

4 Mar 2011

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vertex Pharmaceuticals Incorporated announced today interim results from an ongoing, two-part, Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.

3 Mar 2011

Indian government rejects Abbott's patent application for second-line ARV

India's patent office "has rejected American drug maker Abbott Laboratories' patent application for an HIV combination drug, allowing low-cost local drug makers to make and sell their generic versions in India and other countries where the medicine is not patented," Economic Times reports (1/4).

5 Jan 2011

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.

29 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

Phase III study influences WHO to change guidelines for HIV-infected women receiving nevirapine

Findings from a study, which appear in the Oct. 14, 2010 New England Journal of Medicine, helped influence the World Health Organization (WHO) to change its guidelines this year for the treatment of HIV-infected women who receive a single dose of the antiretroviral drug nevirapine to prevent HIV transmission to their babies.

18 Oct 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010