With more than 40 novel agents under FDA review – and seven approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.

With more than 40 novel agents under FDA review – and six approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.

Also, Rockwell’s iron deficiency treatment Triferic gains agency approval, but without a dose-sparing claim related to erythropoiesis-stimulating agents; Symplmed’s perindopril/amlodipine fixed-dose combination approved for hypertension.

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced June-August 2014.