Urtė Fultinavičiūtė
Reporter
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
Celltrion Wins Korean Approval For Xolair Biosimilar
It has been a busy few weeks for Celltrion – a Korean approval for omalizumab biosimilar Omlyclo, three biosimilar supply contracts with France’s largest pharmaceutical procurement group, and new long-term data for subcutaneous infliximab.
Regulatory Recap: FDA’s Rx Advertising Draft Needs A Stronger Voice, Say Commentators
Generics Bulletin recaps the most recent regulatory news and updates from the FDA.
US FDA Deems Synapse’s Clinical Trials ‘Unacceptable’
The FDA followed the EMA’s lead and declared Synapse’s trials “unacceptable” forcing drug firms that used CRO’s services to repeat studies to regain therapeutic equivalence ratings.
FDA Deems Synapse’s Clinical Trials ‘Unacceptable’
The FDA has followed the EMA’s lead and declared Synapse’s trials as “unacceptable.” Now, drug firms that used CRO’s services need to repeat their studies to regain therapeutic equivalence ratings.
US Product Hopping Legislation Could Offer $3bn In Savings
A bill that would prevent product hopping was estimated to save US taxpayers $3bn by the US Congressional Budget Office, increasing the likelihood it could be enacted to help pay for other congressional priorities.
US Product Hopping Legislation Could Offer $3bn In Savings
In the ongoing fight for fair market competition and improved medication access, the US Congressional Budget Office calculated $3bn in savings from a bill that would prevent originators from product hopping.