title: The year's new drugs & biologics, 2013: Part II.
abstract: The demise of the pharmaceutical industry, so pessimistically predicted by many in recent years, has not come to pass and in fact the patient is alive and well. New programs enacted by drug regulators have been enthusiastically taken up by the industry, including the FDA's breakthrough therapy and qualified infectious disease product (QIDP) designations, as well as the now-consolidated orphan drug programs in many countries. Pharma companies pragmatically wean nonperformers from the pipeline in an efficient manner, resulting in somewhat leaner but higher-quality pipelines. Mergers and acquisitions also continue to drive consolidation and efficiency in the industry, a trend that continued during 2013. This article provides an updated review of these and other trends in the pharmaceutical industry in the year just passed.
authors.affiliation: Thomson Reuters, Barcelona, Spain. ann.graul@thomsonreuters.com.
authors.forename: A I
authors.initials: AI
authors.lastname: Graul
authors.affiliation: Thomson Reuters, Barcelona, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Navarro
authors.affiliation: Thomson Reuters, Barcelona, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Dulsat
authors.affiliation: Thomson Reuters, Barcelona, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Cruces
authors.affiliation: Thomson Reuters, Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Tracy
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000627:therapeutic use; D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D017277:Drug Approval; D004345:Drug Industry / Q000639:trends; D004358:Drug Therapy; D006801:Humans; D009965:Orphan Drug Production; D004364:Pharmaceutical Preparations; D057051:Product Recalls and Withdrawals; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000890:Anti-Infective Agents; D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D004364:Pharmaceutical Preparations
keywords: Biosimilars; Breakthrough therapy designation; Discontinuations and withdrawals; Orphan drugs; Qualified infectious disease products