Ritonavir, also known as Norvir, is a type of medicine called a protease inhibitor (PI). PIs act by blocking protease, a protein that HIV needs to make more copies of itself. Ritonavir was approved by the FDA on March 1, 1996, for use with other antiretroviral agents in the treatment of HIV infection in adults and children 2 years of age or older. Ritonavir is now approved with other anti-HIV drugs in the treatment of HIV-1 infection in children in individuals over 1 month in age. Studies have shown that ritonavir works as a booster for some other PIs. Taking ritonavir makes it possible to take a lower dose of the other PIs. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
An antiretroviral (ARV) drug given to HIV-positive children "can boost the preventive power of a key malaria drug," according to a study conducted in Uganda and presented last week at the 19th Conference on Retroviruses and Opportunistic Infections, ScienceNow reports.
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).
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.
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's (WHO) Prequalification of Medicines Programme. The products include:
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.
Gilead Sciences, Inc. and the Cardiovascular Research Foundation (CRF) today announced the initiation of RIVER-PCI (Ranolazine for Incomplete VEssel Revascularization post-PCI), a Phase 3 clinical trial evaluating the utility of ranolazine to prevent major adverse cardiovascular events (MACE) in patients with a history of chronic angina who have incomplete revascularization following percutaneous coronary intervention (PCI).
Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.
Bristol-Myers Squibb Company and Gilead Sciences, Inc. today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.
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.
Merck, known as MSD outside the United States and Canada, today announced results of new exploratory pre-specified analyses from the ongoing STARTMRK Phase III study of its integrase inhibitor ISENTRESS (raltegravir) Tablets in combination therapy compared to efavirenz in combination therapy in previously untreated adult HIV-1-infected patients.
Gilead Sciences Inc's four-drug experimental HIV pill worked as well as a regimen containing protease inhibitor Reyataz in the second pivotal trial of the drug, the company announced this Monday. Although the trial succeeded, it did not show the experimental pill, called the Quad, was superior to the Reyataz regimen and Gilead shares fell less than a percentage point.
Gilead Sciences, Inc. today announced that the second pivotal Phase 3 clinical trial of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada.
Bristol-Myers Squibb Company and AstraZeneca today announced results from an investigational Phase 3b clinical study in which the addition of ONGLYZA (saxagliptin) 5 mg to ongoing insulin therapy (with or without metformin) maintained reductions of blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes compared to the addition of placebo (with or without metformin) from 24 to 52 weeks.
Today, Bayer Inc. announced the Health Canada approval of STAXYN, the first orally disintegrating tablet for the treatment of erectile dysfunction (ED) that lasts up to eight hours.
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.
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.
Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for VELCADE® (bortezomib) for injection to add overall survival data after a five-year follow up to the product label.
Merck, known as MSD outside the United States and Canada, today announced final results from a Phase II clinical study, extending out to 240 weeks, of its integrase inhibitor ISENTRESS® (raltegravir) Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients.
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.
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.
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