Illinois Science + Technology Blog

Drug Approvals hit highest figure since 1996

The FDA approved 39 new drugs during 2012, up from 31 in 2011 and 21 approved in 2010. This is the highest amount since 1996 when the FDA approved 53 new drugs. Analysts attribute this increase to key factors:  1) FDA's efforts to efficiently move new molecular entities (NME's) through the approval process and fast track some key drugs, and 2) industry's better understanding of how to navigate the regulatory pathway.

Benefiting the most were new cancer drugs which represented about one third of the approvals and new anti-infective therapy. In Europe, the European Medicine Authority (EMA - equivalent to FDA), 36 new drugs were approved in 2012 versus 35 in 2011. However approval of a drug in Europe is only a first step to launch as companies must then seek pricing approval and reimbursement on a country-by-country basis, a process which exists in the U.S. for medical devices but not drugs.

There are at least 30 new drugs queued up for approval in the U.S. in 2013 and 54 in Europe.

Big Pharma continues to transition

AstraZeneca announced plans last year to lay off 7,300 people of which 2,200 were R&D positions. Other companies like Pfizer and Sanofi have done similar layoffs particularly in R&D including sales of nonstrategic assets - Pfizer sold its infant nutrition business to Nestle for $11.8 billion; however both companies are sitting on at least $10 billion in cash which allows them to shop for smaller biotech companies in 2013. M&A activity in the industry fell 35% in 2012 versus 2011.  Big Pharma's shopping list in 2013 is expected to be companies in the $5 billion to $20 billion range.

Additionally, several Big Pharma companies have done large research deals with major universities and medical schools to enhance their own internal research productivity and this trend is expected to continue but for the moment is concentrated on a few select universities.