Germany is the first country that has granted full approval to Adrenomed to conduct a Phase II study with the monoclonal antibody adrecizumab in patients with early septic shock. Within the ADR-02 study, 300 patients will be enrolled in Germany, Belgium, France and the Netherlands for proof of safety and efficacy.
Caisse de dépôt et placement du Québec (CDPQ) is set to acquire a minority stake in diagnostic electrophoresis player Sebia Group from private equity investors Astorg and Montagu.
Serial drug licensee Roivant Sciences GmbH (Basel) has cashed in US$1.1bn (€937m) in an equity financing led by SoftBank Vision Fund and co-financed by existing investor Dexcel Pharma.
The Leukemia & Lymphoma Society (LLS) and Polish drug developer Selvita SA have entered a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukaemia (AML).
In a multi-year collaboration with LEO Pharma A/S, Chinese Hitgen is poised to discover novel small molecule leads for multiple therapeutic targets chosen by the Danish skin treatment specialist.
British biotech company Vernalis has to deal with another Complete Response Letter by US authority FDA – this time regarding the New Drug Application for its cough and cold treatment CCP-08.
Sweden’s Hansa Medical AB presented data showing its experimental drug allowed doctors to perform successful kidney transplants in patients with a particularly high risk of organ rejection.
The Scottish biotech company TC Biopharm (TCB) has been awarded a €4m grant from the European Union’s Horizon 2020 programme.
Danish diabetes biotech Zealand Pharma has started its initial public offering in the US at Nasdaq Global Select Market. It plans to raise US$75m to fund clinical trails.
Italian pharma company Chiesi Farmaceutici withdraws from a co-development agreement with gene therapy pioneer Uniqure. This will add US$1.5m to Uniqure’s expenses this year.