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Top 10 Pipelines To Watch: 2019 Annual Report

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The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

ProQR Therapeutics N.V. announced that the company received Fast Track designation from the Food and Drug Administration for QR-421a for Usher syndrome type 2.

Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.

The FDA approved Azedra injection for intravenous use for treating patients age 12 and older with rare tumors of the adrenal gland that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.

The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox.

Alkermes plc announced the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration, seeking marketing approval of ALKS 5461. The once-daily, oral vestigational medicine with a novel mechanism of action is intended for the adjunctive treatment of major depressive disorder MDD).