Regulatory
Spherix’s investment portfolio into emerging biotech stocks has resulted in substantial gains, turning a roughly $860,000 investment into a position worth more than $11 million at current share price levels, and marking a Price to Book ratio of less than 100%. The recently announced asset-purchase agreement of CBM BioPharma extends pipeline promise.
The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has approved an investigational new drug application to initiate a U.S.-based clinical Phase 3 registration trial in order to test the efficacy of T-Guard for treating steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
Government agencies in the United States and U.K. are scrutinizing Roche’s planned acquisition of the gene therapy company.
The guidance tends to focus on getting sponsor companies to include more historically underserved populations in clinical trials, including women, the elderly and minorities.
Frontage Holdings Corporation, the parent company of Frontage Laboratories, Inc., a fast-growing contract research organization, specializing in R&D product development services, with operations in both the United States and China, announced on May 30th that the Company’s Shares have initiated trading on the Main Board of The Stock Exchange of Hong Kong.
Accsense Monitoring System Automates Data Archive and Alarming
Medtronic plc announced U.S. Food and Drug Administration clearance and commercial launch for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing.
TARA Biosystems, Inc. announced the execution of an exclusive worldwide license agreement with Columbia University for intellectual property relating to engineered human heart tissues.
The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.
ADL Bionatur Solutions recently reported Q119 results, showing positive €0.11m EBITDA, and over 134% year-on-year revenue growth to €10m, driven by 180% growth in contract manufacturing.
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