Atazanavir News and Research

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Atazanavir, also known as Reyataz, is a type of medicine called a protease inhibitor (PI). PIs block protease, a protein that HIV needs to make more copies of itself. Atazanavir was approved by the FDA on June 20, 2003, for use with other antiretroviral medication in the treatment of HIV infection. This medicine does
not cure or prevent HIV infection or AIDS and
does not reduce the risk of passing the virus to
other people.

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

Gilead, Mylan expand license deal for HIV/AIDS medicines

Mylan Inc. today announced an expanded licensing agreement between Gilead Sciences Inc. and Mylan's Matrix Laboratories Limited.

12 Jul 2011

Bristol-Myers Squibb and Mylan expand access to HIV drug Reyataz in sub-Saharan Africa and India

Bristol-Myers Squibb Company today announced a new agreement to expand access to Reyataz (atazanavir sulfate). The immunity-from-suit agreement signed with Matrix Laboratories Limited, a Mylan Company, enables the generic company to manufacture and sell atazanavir, as well as stavudine and didanosine, in sub-Saharan Africa and India.

29 Jun 2011

Concert earns $4M milestone payment from GSK collaboration

Concert Pharmaceuticals, Inc. today announced that it has achieved a milestone in its strategic alliance with GlaxoSmithKline for its HIV protease inhibitor development program, resulting in a $4 million milestone payment to Concert.

20 Jun 2011

AstraZeneca receives FDA approval for NEXIUM I.V. to treat GERD with erosive esophagitis

AstraZeneca announced today that the U.S. Food and Drug Administration has approved the use of NEXIUM I.V. for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease with erosive esophagitis when oral therapy is not possible or appropriate.

3 May 2011

Results of study evaluating potential inhibitory effects of PPIs on Plavix presented at ACC 2011

Takeda Pharmaceuticals North America, Inc. announced the presentation of new study results, which evaluated the potential inhibitory effects of certain proton pump inhibitors (PPIs) on Plavix (clopidogrel bisulfate). The results showed that in healthy subjects, clopidogrel's active metabolite and inhibition of platelet function were reduced less by the co-administration of clopidogrel with dexlansoprazole or lansoprazole, rather than esomeprazole.

6 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

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

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 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

Study investigates long-term outcome of REYATAZ/ritonavir regimens in ARV-experienced patients

Results from a European Observational Study, which included 1,294 antiretroviral (ARV)-experienced patients presented today at the Tenth International Congress on Drug Therapy in HIV Infection (HIV10), demonstrated a low rate of discontinuation and sustained virologic suppression with REYATAZ- (atazanavir)/ritonavir-based regimens over a follow-up period of up to five years.

11 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

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.

20 Oct 2010

Bristol-Myers, Otsuka launch My SPRYCEL Support program to assist patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced the launch of My SPRYCEL (dasatinib) Support, a useful resource to assist adult patients with chronic myeloid leukemia (CML) who are taking SPRYCEL.

15 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010