11 November 2015
JenaValve Technology, Inc., a developer, manufacturer and marketer of next-generation transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, today announced it has received EN ISO 13485:2012 certification for its wholly-owned manufacturing facility in Leeds, United Kingdom.
11 November 2015Genkyotex’s GKT137831 Granted Orphan Drug Designation in the US and EU for the Treatment of Systemic Sclerosis
Genkyotex, the leading developer of selective NOX inhibitors, announced today that GKT137831, its lead NOX1&4 inhibitor, was granted Orphan Drug designation for the treatment of systemic sclerosis from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
4 November 2015Arsanis Appoints David Mantus as Executive Vice President, Regulatory Affairs, Clinical and Technical Operations
Arsanis, Inc., a development- stage biopharmaceutical company focused on monoclonal antibody therapeutics for severe infectious diseases, today announced that David Mantus, Ph.D., has joined the company as Executive Vice President, Regulatory Affairs, Clinical and Technical Operations. Dr. Mantus will oversee all facets of Arsanis’ global regulatory affairs, including filings and interactions with the major regulatory authorities around the world as well as clinical operations, manufacturing and quality. Dr. Mantus will report to Rene Russo, PharmD, BCPS, Arsanis’ Chief Development Officer.
23 October 2015Sequana Medical AG Raises CHF 9 million (USD 9.3M) in a Series C Extension - Transaction Includes New Investors Salus Partners and Quest for Growth
Sequana Medical AG, a privately held medical device company focused on the development and commercialization of innovative implantable pump systems that manage excess fluid within the body, announced today that it has raised CHF 9 million ($9.3 million) in a Series C extension round. Existing investors including NeoMed Management AS, VI Partners AG, Biomed Invest AG, Capricorn Health-tech Fund, Entrepreneurs Fund and Life Science Partners participated for a total of CHF 5.3M, with a further CHF 3.7M raised from new investors including Salus Partners SA and Quest for Growth NV. Sequana Medical will use these funds to expand current business for its proven fluid management systems through new indications in heart disease and to pursue U.S. marketing approvals.
20 October 2015
Wilson Therapeutics AB, a privatelyheld biopharmaceutical company, today announced that Andrew Kay has been appointed as Chairman of its Board of Directors. The company’s previous Chairman, Hugh Rienhoff, M.D. will continue to advise the company as a consultant.