Biogen Inc., of Cambridge, Mass., reported that its total revenues in the third quarter 2017 were $3.1 billion, a 4 percent increase vs. the prior year or a 13 percent increase excluding hemophilia revenues from Q3 2016 (in Q1 2017 the company completed the separation of its global hemophilia business into Bioverativ Inc., a public company). Read More
Bergenbio ASA, of Bergen, Norway, said the first patient was dosed in a phase II trial evaluating its lead candidate, BGB-324, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with previously treated advanced non-small-cell lung cancer who have progressive disease. Read More
Gilead Sciences Inc., of Foster City, Calif., reported results from a phase II trial testing GS-0976, an inhibitor of acetyl-coA carboxylase, in 126 patients with nonalcoholic steatohepatitis. Read More
Vascular Biogenics Ltd., also known as VBL Therapeutics, announced the opening of its new gene therapy manufacturing plant in Modiin, Israel. Read More
Scpharmaceuticals Inc., of Burlington, Mass., has filed to raise up to $100 million in an IPO. The company is developing an innovative platform that may improve patient care through subcutaneous delivery of IV-equivalent drugs. Read More
If Puerto Rico's power grid isn't restored by the end of the year, many of the drug and device companies with manufacturing facilities there may need to relocate some of their production, FDA Commissioner Scott Gottlieb told a House subcommittee Tuesday. Read More
The question of NIH research dollars going toward facilities and administrative costs underwent a second going-over this year in the U.S. House of Representatives, and Keith Yamamoto of the University of California-San Francisco (UCSF) told a congressional committee that a hard cap of 10 percent on these indirect costs would have "a very strong detrimental effect on capacity to start up new [life science] companies and keep them healthy." Read More
CLEVELAND – Cleveland Clinic CEO Toby Cosgrove called genomics and precision medicine the "fastest-moving elements of today's medical universe. Barely on the radar 15 years ago, today they fill the screen." As this year's focus at the Medical Innovations Summit, genomics and precision medicine are considered the future in health care, but, as many panelists noted, as the technology side of the equation continues advancing toward the end goal, clinicians and regulators will need to keep up. Read More
CLEVELAND – The genomics field holds the key to providing critical insight and eliminating some of the most debilitating diseases. However, diagnostic companies in the space face significant hurdles to innovation via issues with reimbursement and costs to conduct clinical trials. Read More
SHANGHAI – Suzhou-based Cstone Pharmaceuticals Co. Ltd. is now a clinical-stage company with the dosing of its first Chinese patient with CS-1001, an anti-PD-L1 monoclonal antibody. In a full field of PD-1 antibodies, Cstone is betting CS-1001 will differentiate it as the first of its kind for China, a fully human and full length programmed cell death protein ligand 1 (PD-L1). Read More
Arnon Rosenthal, CEO of Alector LLC, told BioWorld that his firm is "opening a new modality, a new concept in therapeutics for Alzheimer's disease [AD]," and made a believer out of Abbvie Inc., which put down $205 million up front for the option rights to two candidates. Read More