Johnson & Johnson said on April 20 the company will resume rolling out its Covid-19 vaccine in Europe after the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.
Burlingame, California-based Humanigen reported positive data from the company’s Phase Ib ZUMA-19 trial of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). Lenzilumab is being investigated for the drug compound’s ability to tamp down the hyper-immune response known as a cytokine storm.
One month after acquiring Five Prime Therapeutics and the company’s Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion, Amgen announced that the U.S. Food and Drug Administration awarded Breakthrough Therapy Designation to the asset as a first-line treatment for certain types of gastric cancer.
Europe’s drug regulator found a possible link between Johnson & Johnson’s Covid-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.
The U.S. Food and Drug Administration placed a clinical hold on KalVista Pharmaceuticals’ proposed Phase II trial of KVD824, a prophylactic treatment of hereditary angioedema. The regulatory agency requested additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.
Vertex Pharmaceuticals expanded the company’s collaborative partnership with CRISPR Therapeutics to develop and commercialize a possible cure for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT). The focus is on the development of CTX001, an autologous, ex vivo CRISPR-CAS9 gene-edited therapy.