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 latest global regulatory news, changes and updates affecting medical devices and technologies, including: Antibodiescheck.com, Medakit, Sonrisa Family Dental.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aethlon, Icotec, Naviswiss, Pear Therapeutics, Sirakoss.
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).
After 30 years of following the same rules to ensure Medicaid receives the lowest price available for prescription drugs, the U.S. Centers for Medicare & Medicaid Services (CMS) is starting to adapt those rules for the 21st century.
About six months after Epizyme Inc. won FDA clearance of Tazverik (tazemetostat) for epithelial sarcoma (ES), the firm scored accelerated approval in the larger indication of relapsed or refractory (r/r) follicular lymphoma (FL). Specifically, U.S. regulators cleared the methyltransferase inhibitor for adults whose tumors test positive for an EZH2 mutation who have received at least two prior systemic therapies and for those with no satisfactory alternative treatment options – language that “gives physicians a lot of flexibility to use their clinical judgement in how to best prescribe” the drug, CEO Robert Bazemore noted.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aligos, Beigene, Cynata, Dicerna, Epizyme, Hutchison, Linnaeus, Pear, Protagonist, TFF, Ultragenyx.
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