After one volunteer died and four others were seriously injured during a clinical study in France in 2016, the European Medicines Agency revised its rules for first-in-human studies to tighten the requirements for the dosing of experimental drugs in humans. Introducing the changes in 2017, the agency said that clinical trial protocols are now more complex than ever before and sponsors will need to work harder to exercise oversight.
The checkpoint antibody avelumab has failed to meet its primary endpoint of improving overall survival in a Phase 3 trial of patients with PD-L1 expressing non-small lung cancer. The JAVELIN Lung 200 trial compared avelumab with docetaxel chemotherapy.
An experimental cancer therapy that combines the Roche checkpoint antibody Tecentriq (atezolizumab) and Avastin (bevacizumab) met its co-primary endpoint of progression-free survival in a Phase 3 trial of patients with metastatic renal cell carcinoma.
A new agreement for fighting cancer by targeting the tumour microenvironment has been announced by the AstraZeneca Plc unit MedImmune and Innate Pharma SA of France. The goal is to overcome some of the limitations of the current checkpoint inhibitors.
The first patient to be treated with a wireless sub-retinal implant designed to correct for damage caused by dry age-related macular degeneration (AMD) has responded to the therapy, according to the developer Pixium Vision SA of France.
France-based Adocia SA has reported positive early results from a new formulation of existing diabetes medicines that is intended to act faster and last longer than the current standard of care.
An experimental therapy for chronic obstructive pulmonary disease (COPD) which combines three compounds into single treatment has delivered statistically significant results in a Phase 3 trial, according to AstraZeneca Plc.
Novartis has reported positive results from a late-stage clinical trial showing that its monoclonal antibody erenumab provided relief to patients with migraine who have been unsuccessful in treating their disease with two to four other therapies.
Bristol-Myers Squibb Co has reported positive results for a checkpoint inhibitor combination therapy in patients with a specific type of metastatic colorectal cancer. It combines Opdivo (nivolumab), a PD-1 inhibitor, and Yervoy (ipilimumab), an inhibitor of CTLA-4.
A Phase 3 trial of a novel anticancer drug developed by Spain’s PharmaMar SA for platinum-resistant ovarian cancer failed to reach its primary endpoint of progression free survival compared with topotecan chemotherapy or liposomal doxorubicin. The drug, Zepsyre (lurbinectedin), inhibits RNA polymerase II.