Through the first 11 months of 2012, FDA approved 31 new drugs and biologics, one more than approved for the same period a
year ago. These approvals included Vertex Pharmaceuticals' Kalydeco, a targeted therapy for cystic fibrosis patients who have
a specific gene mutation that drives their disease. Pfizer won approval for Xeljanz, the first oral disease-modifying drug
for rheumatoid arthritis in more than a decade. The year also saw the European Medicines Agency issue the first approval in
the western world for a gene therapy, UniQure's Glybera, a treatment for a rare, inherited disease where patients are unable
to handle fat particles in their blood plasma.
There were also some notable innovations in 2012 in the way approved drugs were made. Pfizer, along with its partner Protalix
Biotherapeutics, won approval for the Gaucher disease drug Elelyso, the first drug to be manufactured using genetically engineered
plant cells. Novartis, notably, won approval for Flucelvax, the first seasonal influenza vaccine licensed in the US and produced
using cultured animal cells instead of fertilized chicken eggs.
Despite ongoing financial concerns in Europe and the US, as well as tensions in the Middle East, the life-science industry
is poised for positive results in 2013. The arrival of the $1000 genome is rapidly advancing the clinical applications of
whole genome sequencing and the promise of personalized medicine to improve care and cut costs is starting to be realized.
Emerging digital health technologies are pushing this trend further. As the demand to transition healthcare to a value-based
system continues, the importance of digital health technologies will reverberate through virtually every aspect of healthcare.
In 2013, these technologies will grow in importance as they empower patients to take greater control over their own health
and wellness, provide real-time monitoring to improve efforts to prevent disease and improve outcomes, and help payers and
providers harness vast amounts of new data, transforming them into actionable information that improves care and reduces costs.
G. Steven Burrill is chief executive officer at Burrill & Company, San Francisco, CA, 415.591.5400, firstname.lastname@example.org
1. P.B. Bach, L.B. Saltz, and R.E. Wittes, The New York Times online, Oct. 14, 2012,
http://www.nytimes.com/2012/10/15/opinion/a-hospital-says-no-to-an-11000-a-month-cancer-drug.html?_r=0, accessed Dec. 12, 2012.
2. P. Goldberg, The Cancer Letter, 38 (42), 1–4 (2012).