Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Vericel Corporation
Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.
Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.
The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.
Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Aastrom Biosciences, Inc.
- Genzyme Biosurgery