This article was originally published in The Gray Sheet
Executive SummaryLaser maker anticipates third or fourth quarter FDA clearance to proceed with Phase II of its Laser Angioplasty for Critical Ischemia (LACI) trail examining excimer laser technology to treat limb-threatening vascular blockages below the knee. Phase I, for which enrollment is now complete, involved four U.S. centers and 25 patients. Spectranetics expects to enroll a few hundred patients all together, but is discussing specifics with FDA
You may also be interested in...
GNC hires Josh Burris as chief US officer; Clasado BioSciences adds Bellchambers as commercial director; and Barentz plans expansion with Cinven investment.
The House passage of a Democratic bill authorizing the federal government to negotiate drug prices in Medicare has sharpened the debate over how prices feed innovation, but the underlying policy stands little chance of being enacted without a Democratic wave in the next election. Pink Sheet's table highlights the key provisions of HR 3 and other pending pricing legislation.