FDA approves Research Medical's fibrinogen trials:
This article was originally published in Clinica
Research Medical has received permission from the US FDA to begin human clinical trials of its autologous fibrinogen delivery kit. The trials will comprise an initial 12-15 burn patient pilot study at the University of New York, Stony Brook, followed by an expanded, multi-centre clinical trial. The studies will evaluate the fibrinogen delivery kit as a means of achieving total haemostasis at a surgical site.
You may also be interested in...
Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020.
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.
AstraZeneca's research head admits that the half dose approach was a lucky mistake – but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.