Pharma News

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.

The U.S. Food and Drug Administration  approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant.

that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. The Agency is therefore recommending that the marketing authorisation of the medicine be revoked.

Scientists used brain signals recorded from epilepsy patients to program a computer to mimic natural speech — an advancement that could one day have a profound effect on the ability of certain patients to communicate. The study was supported by the National Institutes of Health’s Brain Research through Advancing Innovative Technologies (BRAIN) Initiative.

Miniaturized models of the lung and bone marrow, kidney, blood-brain barrier and bone cartilage will blast off on April 30 to the International Space Station National Lab (ISS National Lab) on a Falcon 9 rocket from Cape Canaveral, Florida.