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ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.1 Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the H

But negative result doesn't rule out disease, FDA warns The U.S. Food and Drug Administration has approved a new test that may help doctors diagnose type 1 diabetes, the most common form diagnosed in children and adolescents. The Kronus ZnT8Ab Elisa Assay may help some people with type 1 diabetes receive faster diagnosis and treatment, the FDA said in a news release. People with type 1 diabetes produce little or no insulin because cells in the pancreas that produce the hormone are mistakenly attacked by the body's immune system. Insulin is a hormone that converts sugars (glucose) in food to fuel for the body. People who lack the hormone must inject insulin to regulate blood glucose and lower their risk of potential complications, including blindness, kidney failure and heart disease. The test was able to diagnose a key marker in 65 percent of samples from people diagnosed wi

RSV leading cause of hospitalization among infants, researchers note. An experimental drug shows promise in treating respiratory syncytial virus (RSV), a leading cause of pneumonia in infants, researchers report. "We are finally making major progress in being able to treat human RSV infections -- the world's second leading cause of serious viral pneumonia, second only to influenza virus," said study author Dr. John DeVincenzo, a professor of pediatrics at the University of Tennessee College of Medicine in Memphis. "There is no current treatment or vaccine for RSV pneumonia, and so patients were previously forced to get over the virus by themselves," he said. RSV is the leading cause of hospitalization among infants in the United States, the researchers noted. In this small study of 140 adults, the drug, dubbed GS-5806, reduced the amount of the virus in the s

20 August 2014 -- GlaxoSmithKline plc today announced that the Food and Drug Administration has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm. The approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio. Darrell Baker, Senior Vice President & Head, GSK Global Respiratory Franchise, said, “The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to p

In many parts of the world, leprosy and tuberculosis live side-by-side. Worldwide there are approximately 233,000 new cases of leprosy per year, with nearly all of them occurring where tuberculosis is endemic.   The currently available century-old vaccine Bacille Calmette-Guerin, or BCG, provides only partial protection against both tuberculosis and leprosy, so a more potent vaccine is needed to combat both diseases. UCLA-led research may have found a stronger weapon against both diseases.   In a study published in Infection and Immunity , the researchers found that rBCG30, a recombinant variant of BCG that overexpresses a highly abundant 30 kDa protein of the tuberculosis bacterium known as Antigen 85B, is superior to BCG in protecting against tuberculosis in animal models, and also cross protects against leprosy. In addition, they found that boosting rBCG30 with the Antigen 85B protein, a protein also expressed by the leprosy bacillus, provides considerably s

The Food and Drug Administration on Tuesday approved a new capsule-based drug to treat Gaucher's disease.   Regulators approved the new drug, Cerdelga, for patients with the Type 1 form of the rare genetic disorder, which causes excess fat to build up in the spleen, liver and bone marrow.   Cerdelga is from Genzyme, the specialty drugmaker that introduced the first drug for Gaucher's disease 20 years ago. The oral treatment could serve as an alternative to Genzyme's best-selling drug Cerezyme, which is given intravenously.   Cerezyme had sales of $935 million last year. The drug costs $300,000 for a year's supply, on average. Genzyme says it will soon release pricing for its new drug.   Type 1 is the most common form of Gaucher's disease and affects an estimated 6,000 people in the U.S.   Patients with Gaucher's disease lack a certain enzyme that helps the body break down fat. Cerdelga works by reducing levels of the fat that col

AstraZeneca and Mitsubishi Tanabe Pharma Corp. (MTPC) announced a three-year research collaboration in the area of diabetic nephropathy. The aim of the research collaboration is to leverage complementary strengths, expertise and assets to validate and progress novel research targets and molecules into clinical development.   The collaboration will span from target selection up to the delivery of small molecule candidate drugs. Targets from each company’s early research portfolios have been identified as approaches of common interest and additional targets may be included under the collaboration at a later stage, if mutually desired. The research will be performed in parallel at AstraZeneca’s Cardiovascular and Metabolic Disease Innovative Medicines Unit (CVMD iMed) in Mölndal, Sweden, and at MTPC’s facilities in Japan. The parties believe that the collaboration will yield high quality candidate drugs much faster than working alone. There is no financial commitment f