Receives option for exclusive license from Takeda for chemotherapeutic maytansine, a highly toxic compound which Immunogen will use in a monoclonal antibody conjugate. Cambridge, Mass.-based Immugen plans to be in the clinic within six weeks.
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While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year.
The recently US FDA-cleared Velys robotic-assisted system from DePuy Synthes has distinct features. It also has a small footprint that makes it well-suited for ambulatory surgery centers. See what Larry Biegelsen, an analyst with Wells Fargo, said about it here.
The tactic aims to allow the new Biden administration to scrutinize so-called “midnight rules” issued in the final days of the Trump administration before they take effect. One reg targeted by the freeze is the recent SUNSET rule from the HHS, which would require the department and its agencies – including the FDA – to review all regulations every 10 years to determine whether they’re still necessary.