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Report: Number of drug approvals by FDA may increase

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

Indeed, such big drug companies as Pfizer, Merck and Bristol-Myers Squibb have been plowing money into research and development over the last couple of years in anticipation of the patent cliff, when several blockbuster drugs are expected to lose patent protection and face generic competition. They have made particularly heavy investments in the development of specialty drugs — treatments for rare, serious and chronic conditions, such as cancer, autoimmune disorders and genetic diseases — especially biologics.

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