Business Briefs: Novo, FDA, Biologics
Almost a week after the FDA took to the NEJM's pages to talk about uncoupling the cognitive and functional improvement requirements for Alzheimer's Disease therapies, the Alzheimer's Association released a study finding that a third of seniors die with Alzheimer's or another form of dementia. The Association's report notes that Alzheimer's-related deaths are on the rise even as death rates from other major killers fall, up 68% between 2000 and 2010. The dismal data comes as TransTech Pharma celebrates an FDA fast track designation for its experimental Alzheimer's therapy TTP488 -- one of several that help the regulator speed approvals. TransTech's approach targets interactions between amyloid beta, which is found in Alzheimer's patients, and an immunoglobulin family of molecules.
Even as FDA commissioner Peggy Hamburg frets that sequester cuts will slow approvals, the Government Accountability Office is encouraging the regulator to do a bit more when it comes to dietary supplement oversight. The GAO noted that the FDA has improved monitoring, but said in a report that the agency could do more -- for example, by tapping into poison center data and implementing a systematic collection of adverse event reports. GAO said the latter could help FDA “assess whether AERs are being used to their fullest extent.” GAO also recommended the FDA make potential safety concerns public – something it is not required to do – in the interest of consumer awareness of the impact supplements may have on health.
Biologics were major earners last year, according to Genetic Engineering & Biotechnology News, which reported that eight of last year's top-selling drugs were biologics, including: Amgen's Neulasta ($4 billion); Roche's Avastin ($6 billion); Roche's Herceptin ($6 billion); Sanofi's Lantus ($7 billion); Roche's Rituxan ($7 billion); Amgen/Pfizer's Enbrel ($8 billion); J&J/Merck's Remicaid ($8 billion); and Abbott/Abbvie's Humira ($9 billion).