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
Glancing over at the changing development requirements for biosimilars in the US and Europe, the Chinese duo Chime Biologics and Beijing Libang Pharmaceutical are allying to develop a blinatumomab biosimilar rival to Amgen’s Blincyto.
Generics Bulletin reviews global regulatory developments across the world.
After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.
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.