The first treatment for Duchenne muscular dystrophy (DMD) has been approved in Canada. Santhera Pharmaceuticals announced that Health Canada approved the company’s Agamree (vamorolone) therapy for DMD in patients four years and older. DMD is a rare inherited X-chromosome-linked disease primarily affecting males. It is characterised by inflammation which is… Read More
News round-up for 25-29 August by DDW Senior Digital Content Editor Diana Turner. There have been some significant regulatory decisions this week, including a new orphan designation from the EMA and the FDA go-ahead for Rocket Pharma’s paused gene therapy trial. The top stories:… Read More
Health Canada has granted marketing authorisation for Bayer’s oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). This authorisation is based on results from the Phase III ARANOTE trial, which showed that darolutamide plus ADT reduced the risk of radiological progression… Read More
Bantam Pharmaceutical, a company targeting selective modulation of mitochondrial dynamics in cancer, is proceeding with a Phase I clinical trial evaluating BTM-3566 in relapsed/refractory (R/R) mature B-cell lymphomas, based on a recent Clinical Trial Application (CTA) cleared by Health Canada. This regulatory milestone enables Bantam to expand its ongoing clinical… Read More
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Following the news of cuts to medical research funding from the National Institutes of Health… Read More
News round-up for 17-21 February by DDW Senior Digital Content Editor Diana Spencer. Following the news of cuts to medical research funding from the National Institutes of Health (NIH), this week we focus on some positive drug discovery news from North America, including FDA priority review for… Read More
Health Canada has granted a Notice of Compliance for Fabhalta (iptacopan capsules), the first oral monotherapy treatment for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. In clinical trials, treatment with Fabhalta offered superior haemoglobin improvement in the absence of red blood cell (RBC) transfusions. Complement Component… Read More
The US Food and Drug Administration (FDA) and Health Canada have cleared Alys Pharmaceuticals’ Investigational New Drug (IND) / Clinical Trial Application (CTA) for the study of ALY-101 in patients suffering from Alopecia Areata (AA). The Phase IIa trial will evaluate the safety and efficacy of ALY-101, an intradermal injectable… Read More
