"These are tough-to-treat cancers and we knew they were tough-to-treat cancers going in," Oncomed Pharmaceuticals Inc. CEO Paul Hastings said, but results "all the way back to our xenograft data, as well as our phase Ib data, gave us every indication that these were indications which we should go forward with," and the company "did the right thing" by pursuing them, he said. Read More
Ampliphi Biosciences Corp., of San Diego, said the FDA provided positive feedback on the company's previously submitted detailed development proposal to start a phase II trial with its bacteriophage cocktail AB-SA01 for the treatment of antibiotic-resistant Staphylococcus aureus infections in patients with chronic rhinosinusitis. Read More
It looks as though the biopharmaceutical industry is back on track to make up for its poor return on research investments last year when only 22 new molecular entities (NMEs) received the FDA's green light, the fewest number for five years. In the first quarter of this year, 12 NMEs were approved, outperforming comparable periods since 2013. Read More
A dendritic cell vaccine against a viral antigen induced long-term survival in three out of 11 treated glioblastoma patients, scientists reported in the April 15, 2017, issue of Clinical Cancer Research. Read More
When going after macrophages, "in my view, you play directly with the immune system," said Maxime Ranger, president and CEO of 2016 startup Mperia Therapeutics Inc., which is advancing macrophage-targeting immunotherapies based on the CD36 scavenger receptor for diseases involving chronic inflammation such as dry age-related macular degeneration (AMD) and atherosclerosis. Read More
SHANGHAI – Chinese vaccine developer Cansino Inc., of Tianjin, has received $65 million in a financing round led by Future Industry Investment Fund to hasten the development of its later-stage vaccines and get a new vaccine plant up-and-running. Read More
Kalytera Therapeutics Inc., of Vancouver, British Columbia, said it applied for a $5 million grant from the Israel Innovation Authority (IIA) to fund development of its portfolio of cannabidiol (CBD) prodrugs including: K-1012, indicated for acute respiratory distress syndrome; K-1022, indicated for ulcerative colitis; K-1032, indicated for acne vulgaris; and K-1052, being studied as an inducible nitric oxide synthase inhibitor, indicated for sepsis-associated renal failure and severe traumatic brain injury. Read More
Amag Pharmaceuticals Inc., of Waltham, Mass., reported that it has submitted a supplemental new drug application to the FDA for Makena (Hydroxyprogesterone Caproate Injection) subcutaneous auto-injector, its drug-device product. Amag developed the new product with Antares Pharma Inc., of Ewing, N.J. Read More
