Updated on 5 January 2015
The 2014 figure is second only to the all-time high of 53 approvals reached in 1996
Singapore: If reports are to be believed, the year 2014 saw a huge rise in number of approvals for pharmaceutical drugs from the FDA. The agency approved 41 drugs, primarily for cancer and rare diseases. While the uptick in innovation came as a good news, the industry suffered from issues related to drug pricing and patent conflicts throughout the year.
The drug approvals are considered a barometer for industry innovation and the federal government's efficiency in reviewing new therapies. The 2014 figure is second only to the all-time high of 53 approvals reached in 1996.
The 2014 approval list included 15 drugs for so-called orphan diseases, in comparison to 13 drugs approved in 2013. Analysts commended that the record-setting number reflected the drug industry's ongoing shift toward specialty drugs for niche conditions, which often come with extra patent protections, streamlined approvals and higher price tags.
Drug approval "highlights" included Merck's Keytruda and Bristol-Myers Squibb's Opdivo, novel cancer treatments that provide long-lasting treatment with fewer side effects. Analysts have suggested that such drugs mark the start of a wave of immunotherapies that could yield more than $30 billion annually in sales.
According to Reuters, the surge in new approvals helped biotech initial public offerings hit record highs last year. The Nasdaq Biotechnology Index rose by 34 percent, while the S&P 500 Health Care Index rose by 23 percent.