Category: Approval

January 7, 2019 Off

Mirati and BMS to combine sitravatinib and nivolumab for certain non-small cell lung cancer patients in Mirati’s expected Phase 3 trial

By Dino Mustafić

Mirati Therapeutics and Bristol-Myers Squibb will work together on evaluating the combination of sitravatinib and nivolumab (OPDIVO), in Mirati’s planned Phase 3 trial in second line non-small cell lung cancer (NSCLC) patients who have progressed following treatment with a platinum-based regimen and a checkpoint inhibitor.

January 7, 2019 Off

Allergan with positive topline results for Bimatoprost implant for reduction of IOP

By Dino Mustafić

Allergan announced positive 3-month topline results from the second pivotal clinical trial of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension, while the global pharmaceutical leader noted the positive results from the first Phase 3 trial were reported in June 2018.

January 7, 2019 Off

Dutch ProQR Therapeutics OKd by FDA to take sepofarsen (QR-110) into the next phase of development

By Dino Mustafić

A Dutch maker of of transformative RNA medicines for the treatment of severe genetic rare diseases, ProQR Therapeutics, has got the U.S. Food and Drug Administration (FDA) tips for a Phase 2/3 pivotal trial Illuminate for sepofarsen, in patients with Leber’s congenital amaurosis 10 (LCA10) due to the p.Cys998X mutation in the CEP290 gene, the leading genetic cause of childhood blindness.