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Under the terms of a patent-litigation settlement from April 2017, Endo’s Par subsidiary has launched the first US generic versions of BioMarin’s Kuvan (sapropterin) tablet and powder formulations. Rival ANDA sponsor Dr Reddy’s has followed suit on the tablet formulation.
In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.
The new collaboration announced 17 August is worth up to $475m in near-term upfront payments plus undisclosed milestone fees and royalties up to 24%.
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 in October 2017.
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Egen, Inc.
- Expression Genetics