Ritonavir News and Research

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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.

Gilead Sciences gets FDA approval for once-daily single tablet HIV-1 regimen Complera

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.

13 Dec 2013

Medivir initiates phase IIa trial to evaluate efficacy of simeprevir combination therapy in HCV-infected patients

Medivir AB (STO:MVIR-B) (OMX: MVIR), announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor.

12 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration.

18 Nov 2013

Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.

18 Nov 2013

Merck to present pharmacokinetic data on once-daily ISENTRESS at EACS

Merck, known as MSD outside the United States and Canada, is presenting pharmacokinetic data this week on investigational formulations of a once daily dose of ISENTRESS at the 14th European AIDS Conference, sponsored by the European AIDS Clinical Society.

17 Oct 2013

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