SAN DIEGO—Armed with last month’s FDA approval, Sobi is rolling out its newly minted rare disease drug Gamifant with a small, targeted sales force, and Monday it unveiled more of the data that won the agency’s favor in the first place. In a phase 2/3 trial of Gamifant in primary haemophagocytic lymphohistiocytosis (HLH), 64.7% of… Read More »
Dive Brief: Breaches of protected health information can seriously harm an organization’s brand and finances, but little is known about how breaches occur and the steps organizations take to prevent a recurrence, according to a research letter in JAMA Internal Medicine. The researchers analyzed 1,138 breach cases that occurred between Oct. 21, 2009, and Dec. 31,… Read More »
Two industry initiatives that have worked together to advance interoperability are teaming again to further expand connectivity. Commonwell Health Alliance, a vendor-led organization that embeds interoperability services into health information systems, brings its 3-year-old health information exchange to the table. Carequality has been working on a governance framework that enables different networks to link to… Read More »
Amarin CEO John Thero shrugged off the stock’s decline on Monday, telling CNBC that any investor concerned about its latest clinical trial should take a better look at the data.
Pregabalin (marketed in the US as Lyrica) is approved by the US Food and Drug Administration for the treatment of epilepsy, fibromyalgia, and neuropathic pain. It is also used off-label to treat psychiatric disorders, most commonly generalized anxiety disorder. While it is not used as frequently as other anti-epileptic drugs, we do occasionally see women… Read More »