Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis.
Smart assisted surgery company Naviswiss AG, of Brugg, Switzerland, has gained U.S. FDA clearance for its miniature navigation technology for hip replacement surgery. The hand-held system, with an open platform that supports all implant vendors, is being offered on a fee per-use basis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Ampio, Ascentage, Beigene, Innovent, Nymox, Ovid, Plakous, Redhill, Regeneron, Sanofi.
LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic calcium phosphate-based Osteo3 Zp putty consists of the granules suspended in a fully synthetic resorbable carrier.
The U.S. District Court for the Northern District of West Virginia ruled against Biogen Inc., of Cambridge, Mass., and in favor of Mylan NV, of Hertfordshire, U.K., in a patent dispute regarding Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate).