Monday, May 15, 2017
Flexion Therapeutics announced that Yamo Deniz, M.D., has been named chief medical officer (CMO). This appointment strengthens the company’s leadership with an industry veteran who brings extensive experience leading medical and clinical development teams at major biotechnology and pharmaceutical companies.
Regeneron Pharmaceuticals and Sanofi announced that Health Canada approved Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Synlogic, a privately held biopharmaceutical company developing novel medicines based on its proprietary synthetic biology and microbiome platform, today announced the appointment of biotech industry veteran Samantha Truex as chief operating officer (COO) and head of Corporate Development.
bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, has announced two new appointments as part of the company’s ongoing preparation for commercial readiness. Susanna High was named chief operating officer and Andrew Obenshain was named senior vice president and head of Europe.
Halloran Consulting Group, a national consultancy guiding life science companies to optimize development and performance, has announced the expansion of its regulatory and development team with the hiring of additional, highly specialized consultants, Iva Toudjarska, Ph.D., MBA, as principal consultant, Amanda Ceres, MS, as senior consultant and Keri Siggers, Ph.D., as consultant II. Earlier this year, Michelle Rose, Ph.D., was hired as principal consultant, to further enhance the company’s ability to deliver regulatory strategies and services.
Merus Labs International has announced two key additions to its executive leadership team effective July 1, 2016, Dr. Michael Bumby as chief financial officer and Frank Fokkinga as Vice president, Global Regulatory Affairs, Quality and Compliance.
Sanofi Genzyme, the specialty care global business unit of Sanofi, has announced a research collaboration with the Johns Hopkins School of Medicine that will focus on novel strategies aimed at advancing the understanding of underlying causes of disease progression in multiple sclerosis (MS). The collaboration, under guidance by a joint committee of representatives from Sanofi Genzyme and the Johns Hopkins Multiple Sclerosis Center, will leverage certain technologies and methodologies designed to inform new therapeutic approaches to treating disease progression.
Epizyme, a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, has expanded its senior leadership team with the addition of Matthew Ros, who joins the company as chief operating officer. In this role, Ros will be responsible for directing and operationalizing Epizyme’s launch readiness efforts for tazemetostat, and will report to Epizyme’s president and chief executive officer, Robert Bazemore.
Efforts to reduce the number of phantom investigators—principal investigators (PIs) who are not adequately supervising their staff and clinical trials—appear to be having a measurable impact. But problems associated with, and the issues that cause, phantom PIs and their causes linger.