Spark Therapeutics Now Targets 2017 For US Approval Of First Retinal Gene Therapy
Two manufacturing control assays have taken longer to develop than previously thought, putting back completion of a BLA submission to early 2017 for US company Spark Therapeutics, while further progress has been made in the company’s early-stage hemophilia gene therapy program.
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Keeping Track Of New Drugs: US FDA Review Queue Adds Spark Gene Therapy, Amgen Migraine Antibody, Bayer Oncologic
The latest news about novel agent applications from our FDA Performance Tracker.
The company agreed to pay $60m upfront to buy privately-held RetroSense, the developer of a novel gene therapy in Phase I/II clinical testing for retinitis pigmentosa. The investment in early R&D helps Allergan catch up with other eye care research.
Biopharma financing decreased by 16% in Q2 to $4.8 billion, while the total value of acquisitions nearly doubled to $22 billion, including AbbVie's $9.8 billion takeover of Stemcentrx. Alliances garnered an aggregate potential deal value of $23.1 billion, led by Allergan's CNS agreement with Heptares.