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.
Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).
Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.
Bristol-Myers Squibb Company and the ADAP Crisis Task Force today announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs to provide antiretroviral medicines to people living with HIV and AIDS. Building on an agreement signed in March of 2010, today's announcement marks a multi-year enhancement to assist ADAPs in meeting the challenges of increasing patient case loads and strained government funding.
Following ongoing advocacy campaigns spearheaded by AIDS Healthcare Foundation (AHF) that targeted several of the largest AIDS drug companies over their pricing and rebate policies for the nation's AIDS Drug Assistance Programs (ADAPs), the federally funded, state run programs that supply lifesaving AIDS drugs to low-income Americans in need, that the last remaining major AIDS drug company, Bristol-Myers Squibb (BMS) today announced an agreement that will provide additional cost savings to cash-strapped ADAPs nationwide.
Bristol-Myers Squibb will soon announce an agreement that will provide additional cost savings to cash-strapped ADAPs nationwide. The agreement, with the ADAP Crisis Task Force (ACTF) of the National Alliance of State & Territorial AIDS Directors, is expected to be announced any day. BMS has been the target of a sustained advocacy campaign led by AHF over its pricing of its key AIDS drug Reyataz.
Today AIDS Healthcare Foundation (AHF) announced that it has banned pharmaceutical sales representatives from Bristol-Myers Squibb (BMS) from calling on AHF's medical providers and staff in its sixteen U.S. healthcare centers. The decision is based on BMS' refusal to lower the price of its key AIDS drug Reyataz for cash-strapped AIDS Drug Assistance Programs.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.
Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.
Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.
Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).
“All of AHF's efforts, including this protest, are designed to let people know that BMS is causing great harm to people with HIV/AIDS with its unwarranted pricing of Reyataz”
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).
Eisai Inc. (Headquarters: Woodcliff Lake, NJ; Chairman and CEO: Hajime Shimizu), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) today announced that the U.S. Food and Drug Administration has accepted Eisai's New Drug Application for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease, and for the treatment of symptomatic GERD.
Pfizer Oncology will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets. These results will be presented at the 46th Annual American Society of Clinical Oncology meeting in Chicago from June 4-8.
AIDS Healthcare Foundation will host a protest Wednesday morning, May 12th at 10:30am targeting New York-based Bristol Myers Squibb Co. over the pricing and policies for its key HIV/AIDS drug, Reyataz, one of the most expensive first-line AIDS treatment in the US, during the Bank of America-Merrill Lynch 2010 Health Care Conference.
Gilead Sciences, Inc. today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.
AIDS Healthcare Foundation (AHF) is pressing New York-based drug firm Bristol-Myers Squibb (BMS) to lower the price of its key AIDS drug, Reyataz—currently priced at over $13,000 per year—for lifesaving, but financially hard-hit AIDS Drug Assistance Programs (ADAPs) nationwide.
Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.
Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial, a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.
Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.
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