San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ArcherDX, Eurobio Scientific, Extremity Medical, Perkinelmer.
Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
At the beginning of this week, the digitally-delivered Bio-Europe Spring 2020 conference launched with 6,000 partnering meetings, 45 company presentations, more than 50 virtual exhibits and 12 panel discussions scheduled.
HONG KONG – Singapore-based Proteona Pte. Ltd. has formed a couple of significant partnerships recently, including a Germany-Singapore partnership to develop a drug screening and discovery platform using single cell multi-omics analysis for patient-derived micro-tumors, and an international alliance to develop antibodies against coronaviruses.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Daiichi, EMD, Exelixis, Gilead, Infinity, Intrabio, Sumitomo, Takeda, Valneva.