U.K. watchdog fines GSK $54 million over 'pay-for-delay' drug deals | New York Times
Britain's Competition and Markets Authority fined the drugmaker over deals it cut with generics makers, including Germany's Merck KGaA, to delay launch of generic versions of GSK's depression drug Seroxat. The generics makers were also fined. It's the latest in a growing movement by regulators worldwide to curb such deals.
The FDA received a record 472 requests for orphan drug designation from manufacturers last year, and granted a record 354 designations, an increase of 22% over 2014. Orphan designation gives a drugmaker seven years of exclusivity for drugs that serve small patient populations with rare diseases.
Compound-drug maker Imprimis says it will produce an inexpensive alternative to Thiola, a kidney stone drug marketed by Retrophin since 2014. Retrophin, then under the leadership of pharma villain Martin Shkreli, acquired the drug and raised the price from $1.50 to $30 a pill. Imprimis also makes a $1 alternative to $750-a-pill Daraprim, the toxoplasmosis drug acquired and marketed using the same strategy by another of Shkreli's former companies, Turing Pharmaceuticals.
Labs at Harvard and MIT are taking very different paths to address the challenges diabetes presents sufferers. At Harvard, researchers are working on an artificial pancreas to help patients manage the disease. At MIT, researchers are trying to figure out how to keep type 1 diabetics' immune systems from attacking the pancreatic cells that control blood sugar levels.
Vanderbilt University and University of Washington researchers used the anonymized electronic health records of more than 28,000 patients of European ancestry in the Electronic Medical Records and Genomics (eMERGE) network to conduct research into the influence of Neanderthal genes in modern humans. The study, published in the journal Science, found Neanderthal genes were linked to traits such as depression, obesity, and smoking addiction.