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
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.
Yesterday the U.S. Food and Drug Administration gave its approval to Mavyret (glecaprevir and pibrentasvir) for the treatment of adults with chronic hepatitis C infection. These patients are infected with the Hepatitis C virus (HCV) of genotypes 1-6 and are those that have not developed liver cirrhosis or those who have developed mild cirrhosis. The approval for Mavyret was given to AbbVie Inc.
The antiretroviral (ARV) drug atazanavir—sometimes included in treatments to prevent mother-to-child HIV transmission during pregnancy—may have small but significant effects on infant development, reports a study in the journal AIDS, official journal of the International AIDS Society.
The Medicines Patent Pool today announced a new licensing agreement with AbbVie, a global biopharmaceutical company, that seeks to address future demands for HIV treatment Lopinavir/Ritonavir (LPV/r) in South Africa and across Africa. The agreement has been reached in particular to help ensure sustainability of long-term supply of LPV/r, the most widely used second-line HIV treatment in South Africa and across Africa.
The Medicines Patent Pool today announced a collaboration with the University of Liverpool and a licence for the university's Solid Drug Nanoparticle (SDN) technology to accelerate the development of WHO-recommended antiretrovirals as nanomedicines.
Results from the first phase 3 HIV study to enroll only women show improved safety and efficacy of the drug Stribild over multi-pill antiretroviral drug regimens. The research was presented at ASM's 55th Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC/ICC).
AbbVie receives Health Canada approval for HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets), an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with cirrhosis.
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that data were presented regarding the use of STENDRA® (avanafil) tablets for the treatment of erectile dysfunction (ED) at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami from November 20-23, 2014.
MPP forges first agreement with a Chinese manufacturer Desano; and with Cipla, Mylan and Micro Labs; Extends Collaborations with Aurobindo, Laurus Labs and Emcure
FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Eisai Inc. to acquire exclusive U.S. marketing rights for AcipHex® Sprinkle™ (rabeprazole sodium), Delayed-Release Capsules, 5 mg and 10 mg, for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.
Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.
Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups.
Amneal Pharmaceuticals LLC today announced the launch of generic Esomeprazole strontium delayed-release capsules 49.3 mg. This new esomeprazole therapy is the generic equivalent of the recently launched brand Esomeprazole strontium. It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI brand Nexium (esomeprazole magnesium) and presents a potentially more affordable treatment option for GERD in adult patients.
Amneal Pharmaceuticals LLC today announced the launch of its branded Esomeprazole Strontium 49.3 mg delayed-release capsules. Esomeprazole Strontium contains the same active moiety (esomeprazole) in a different salt form as found in the branded proton-pump inhibitor Nexium (esomeprazole magnesium) and is a new option for adult patients for the short term treatment of gastroesophageal reflux disease.
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.
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.
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.
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.
Children who were exposed to HIV in the womb whose mothers received anti-HIV medications during pregnancy were no more likely to show language delays by age two than HIV-exposed children whose mothers were not treated during pregnancy, according to a study by University of Kansas Distinguished Professor Mabel L. Rice with researchers at the National Institutes of Health (NIH) and other universities.