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.
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.
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.
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.
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.
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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Birchbiomed, Immutep, Nanoform, Regeneron, Sanofi, Senhwa, Windtree.
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