Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of nonprofit Accumulus Synergy Inc., whose common, cloud-based platform is designed to make the regulatory process easier for everyone involved. The coalition’s initial membership is a Who’s Who of big pharma: Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd. Read More
PERTH, Australia – Sydney-based Immutep Ltd. announced that partner Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 (LAG-3) cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010. Read More
At the recent 39th J.P. Morgan Healthcare Conference, Biomarin Pharmaceutical Inc. popped the lid off top-line results from its ongoing phase III GENEr8-1 study with valoctocogene roxaparvovec – also known as valrox, now commonly called Roctavian. Data, though encouraging, may not have quelled controversy around the prospect. Read More
Clinical and regulatory data reported in 2020 are up 24% and 47%, respectively, over the prior year, proving to be the busiest 12 months on record for the biopharma industry, in spite of, or perhaps because of, a deadly global pandemic. Read More
Aging is not just wear and tear. It is an active process that is driven, at least in part, by chronic inflammation that is the result of immune cell dysfunction. Now, investigators at Stanford University have identified the metabolic switch underlying immune cell switch from function to dysfunction. Read More
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Birchbiomed, Immutep, Nanoform, Regeneron, Sanofi, Senhwa, Windtree. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alkido, Amarin, Aurinia, Biontech, Continuous, Edding, Eli Lilly, Esperion, Evgen, GSK, Humanigen, ICER, Innocan, Microba, Pfizer, Sartorius Stedim, Vaxess. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Clinigen, Exelixis, GC, Helsinn, Incyte, Ono, Viiv. Read More
