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
Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.
In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.
Sandoz has truly established its position as the frontrunner in the denosumab race after a Canadian approval, but the path to the US market has been hindered by a lawsuit from the originator Amgen.
While a European decision is just around the corner, Outlook Therapeutics has more work to do in the US to convince the FDA about its bevacizumab product.
As two US governmental agencies launch an investigation into the potential causes of drug shortages, AAM says the generics industry faces “unprecedented threats.”
Biogen has yet again hinted about “strategic alternatives” for its biosimilars business albeit with no clear future plans, while its branded multiple sclerosis portfolio fights off generic and biosimilar competitors.