Ritonavir News and Research

RSS

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.

Janssen seeks European marketing approval for combination of once-daily darunavir with cobicistat

Janssen-Cilag International NV, today announced it has submitted a Marketing Authorisation Application to the European Medicines Agency seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product containing darunavir, a protease inhibitor developed by Janssen, with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences, Inc. for use in combination with other human immunodeficiency virus medicines.

15 Oct 2013

Phase III EINSTEIN trial program: XARELTO reduces risk of DVT and PE

Janssen Pharmaceuticals, Inc. announced today a newly published, pooled analysis of the Phase III EINSTEIN trial program, showing XARELTO (rivaroxaban) is as effective as the standard of care in reducing the risk of deep vein thrombosis and pulmonary embolism in people with symptomatic DVT or PE, while reducing the incidence of major bleeding by 46 percent.

21 Sep 2013

Scientists create polymer additives that enhance orally administered drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed - a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness.

29 Aug 2013

New polymer additives enhance ability of oral drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed — a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness.

28 Aug 2013

Spectrum Pharmaceuticals enters into agreement to acquire Talon Therapeutics

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that, through a wholly-owned subsidiary, the company entered into an agreement to acquire Talon Therapeutics, Inc., a biopharmaceutical company based in South San Francisco, California, and expects to complete the acquisition within one day.

17 Jul 2013

Bristol-Myers Squibb, Pfizer announce FDA acceptance of Eliquis sNDA for review

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration has accepted for review a Supplemental New Drug Application for Eliquis (apixaban), for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in adult patients who have undergone hip or knee replacement surgery.

11 Jul 2013

Key HIV drug prices continue to fall, but newer medicines still priced too high

International medical humanitarian organisation Médecins Sans Frontières today released its annual report Untangling the Web of ARV Price Reductions,at the International AIDS Society conference in Kuala Lumpur.

3 Jul 2013

Study shows that PCCs can reverse blood thinning effects of XARELTO in healthy subjects

Janssen Research & Development, LLC announced today results of an open label, single-center, parallel group study showing that a type of medication called prothrombin complex concentrates can reverse the blood thinning effects of XARELTO (rivaroxaban) in healthy subjects.

2 Jul 2013

WHO's new HIV treatment guidelines call for immediate ART for HIV-infected children

The World Health Organization's new HIV treatment guidelines, released today at the 2013 International AIDS Society Conference, include new antiretroviral therapy recommendations for HIV-infected children, and will mean that more children will be on better treatments.

1 Jul 2013

Janssen receives complete response letter from FDA for XARELTO sNDA

Janssen Research & Development, LLC today announced the U.S. Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application for XARELTO (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

28 Jun 2013

Bristol-Myers Squibb and AstraZeneca announce top line results of Phase 4 SAVOR-TIMI-53 clinical trial of Onglyza

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin).

20 Jun 2013

GRACE study reports colored women are poorly represented in HIV drug trials

Enrollment of women in clinical trials of new anti-HIV drugs is extremely low, representing only about 15% of all treatment-experienced patients. For women of color it is even lower.

3 Jun 2013

FDA approves Arbor Pharmaceuticals' NDA for Nymalize oral solution

Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution.

14 May 2013

Merck's LIPTRUZET tablets get FDA approval for treatment of elevated LDL cholesterol

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved LIPTRUZET (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

4 May 2013

Studies demonstrate encouraging results for new direct-acting antiviral agents

New data from a number of clinical trials presented for the first time at the International Liver Congress- 2013 demonstrate encouraging results in the use of new direct-acting antiviral agents (DAAs) for the treatment of hepatitis C.

25 Apr 2013

Phase IIb Aviator study demonstrates high SVR rates against genotype 1 HCV

Results from "Aviator," AbbVie's phase IIb clinical trial of its investigational direct-acting antivirals for the treatment of hepatitis C virus infection, continue to demonstrate high sustained viral response rates against genotype 1 HCV, across patient types.

24 Apr 2013

Janssen announces safety results from two Phase 3 studies of simeprevir in hepatitis C patients

Janssen R&D Ireland today announced primary efficacy and safety results from two global Phase 3 studies demonstrating that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80 and 81 percent, respectively, of treatment-naive genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis, when administered once daily with pegylated interferon and ribavirin.

24 Apr 2013

New data on Enanta's lead HCV protease inhibitor to be presented at International Liver Congress

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, announced today that new Phase 2b data related to ABT-450, Enanta's lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie, as well as new preclinical data on Enanta's proprietary cyclophilin inhibitor, EDP-546, will be presented at the International Liver Congress, which is the 48th Annual Meeting of the European Association for the Study of the Liver taking place in Amsterdam April 24-28, 2013.

23 Apr 2013

Clinical data on simeprevir for treatment of hepatitis C patients to be presented at EASL meeting

Medivir AB today announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of genotype 1 hepatitis C patients.