Company news: MedMira; FDA device ID
Diagnostics firm MedMira said the US Army has awarded it a contract to develop and commercialize a rapid test capable of detecting HIV and hepatitis B/C within three minutes using a single blood drop. The contract is worth $4.2 million to MedMira, if all options are exercised. MedMira said it is developing the test for use in emergency screening of transfusion-transmitted diseases at the front, where it says no FDA-approved donor screening tests are available.
The FDA is proposing regulation establishing a unique device identification system for medical devices, as mandated by Congress in 2007. “Effective post-market surveillance of medical devices depends on having UDI in place,” said Consumers Union senior policy analyst Lisa Swirsky. “Once it is fully implemented, this system will enhance the FDA's ability to identify problem medical devices more quickly and inform patients when their safety is at risk.” The UDI would consist of codes identifying the device and how it was produced, and implementation would begin with the most high-risk medical devices, with low-risk devices exempt from some or all regulations.
Sanofi is continuing the shrinking-pharma game and is poised to lay off up to 2,000 employees in France, reported Le Figaro, via Pharmalot. The purported layoffs are repoted to be part of the company's stated drive to pare costs by $2.9 billion as a way to cope with a slew of patent expirations that includes blood thinner Plavix. Pharmalot reports that the cuts would hit R&D, vaccine manufacturing and headquarters. Pharmalot said Sanofi had a meeting with a work council to discuss “strategic considerations in France through 2015,” but said it didn't talk headcount.Purdue Pharma is set to test oxycontin in children between the ages of 6 and 16 reported CNN. The opioid drug has garnered a lot of attention over the past few months, including a government investigation about how the category has been promoted as a whole. The latest trials, however, are getting attention because an approved use could tack on an additional 6 months of patent protection in 2013. The Daily reported that the private company isn't going to start going after minors, but told the news source “we feel it is beneficial for clinicians who are treating pediatric patients with chronic, moderate-to-severe pain to have access to this information in scientific publications and in the product's label.” The company has been dinged over how it has promoted the narcotic in the past, getting slapped with a $600 million settlement in 2007 for misbranding the drug, in addition to having company execs plead to criminal violations, for an added $34.5 million in fines.