Saniona clears obstacle ahead of new trial

The US health authorities have now received the all of the requested documentation for the capsule version of the biotech company's candidate Tesomet. Saniona's plans to begin a clinical trial with the drug before the end of year thus remain unchanged.

BY ELIZABETH MØNSTED JOHANSEN, TRANSLATED BY DANIEL PEDERSEN

Published: 19.10.21 at 11:54

After dialog with the US Food and Drug Administration (FDA), the biotech company Saniona is sticking to its plans to initiate a phase IIb trial of its drug Tesomet before the end of the year, it reports in a press release.

Saniona has finished submitting additional information to the authority, which the FDA requested after the company swapped out the tablet-based version of its candidate for a capsule ahead of its planned trial.

Already a subscriber? Log in.

Read the whole article

Get 14 days free access.
No credit card required.

Access all locked articles
Receive our daily newsletters
Access our app

Start a free company trial today

"Real world" patient data documents the long-term effects of ALK vaccines

Data from ALK's React study, which is a retrospective real-world evidence study including more than 92,000 patients with respiratory allergies, have just been published in the journal The Lancet Regional Health – Europe. | Foto: ALK / PR

In the largest study ever of its kind, patient data from the "real world" documents the long-term effects of up to nine years of ALK vaccines. Up until now, it has not been possible to demonstrate these in ordinary clinical studies where the follow-up period is shorter, and the new knowledge could be a turning point in ALK's dialog about prices and subsidies with authorities and payers.