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
Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.
Lupin has added two ADHD drugs to its Canadian portfolio, while also signing multiple branded deals in other global markets.
The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.
Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.
Generics Bulletin reviews several critical US bills and the off-patent industry’s response, along with budget calculations and new proposals.
The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.