Massachusetts federal court jury finds that Barr breached an agreement with Copley when it backed out of an 1985 arrangement covering the development of a generic version of Parke-Davis' delayed-release erythromycin product Eryc. In a Nov. 10 verdict, the jury awarded Copley $ 1.2 mil. in damages. A final decision by Judge Douglas Woodlock is expected in December or January. . . .
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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.