Urtė has previously worked as a Healthcare Reporter at GlobalData Media, primarily writing for Clinical Trials Arena. She mostly focused on clinical trial data management, strategy, and regulatory updates as well as clinical trial data readouts and exclusive interviews with C-level pharma and biotech executives. Urtė holds an MA in International Journalism from City, University of London.
Latest from Urtė Fultinavičiūtė
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.
While the long-awaited pembrolizumab biosimilar deal certainly boosts Formycon’s financials, it is unclear whether it will be enough to meet its annual guidance.
Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.