The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide. ARAMIS is…
Bayer Sells Prescription Dermatology Unit To LEO Pharma
LEO Pharma has entered into a definitive agreement to buy Bayer’s global prescription dermatology unit. The portfolio to be acquired includes branded topical prescription treatments for acne, fungal skin infections, and rosacea, and a range of topical steroids with an annual turnover in 2017 of more than 280 million euros. It will enable LEO Pharma…
Bayer Completes Submission Of New Drug Application
Bayer announced that its collaboration partner Loxo Oncology, Inc. has completed the rolling submission of a New Drug Application (NDA) to FDA for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The rolling submission was initiated in Dec. 2017. NTRK gene…
