Three different drugs developed in Finland have received a marketing authorization during the past year, and a positive decision is expected on the application of a fourth marketing authorization.
The FDA has granted a marketing authorization for two drugs developed in Turku, Finland--the IUD Skyla, developed, by Bayer and intended for women who have not given birth, and Hormos Medical’s Ophena for postmenopausal symptoms. With the marketing authorization of Selincro, a Biotie drug intended for the treatment of alcohol addiction, granted by the EMA, that brings the total number of drugs developed in Turku and granted marketing authorizations to three, with a fourth expected to follow.
There are only about 30 new drugs that receive the marketing authorization in Europe per year, a number that makes the turnout from Turku even more significant.
Read the full release here.
Semaglutide Significantly Improves Steatohepatitis, Fibrosis in Phase III MASH Trial
May 2nd 2025Interim results from the Phase III ESSENCE trial published in The New England Journal of Medicine show once-weekly semaglutide improved liver histology, metabolic markers, and weight loss in patients with biopsy-confirmed metabolic dysfunction–associated steatohepatitis and stage 2 or 3 fibrosis.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.