Qiagen's Therascreen wins supplemental PMA to be used as CDx with BI's Gilotrif
Qiagen NV has received an expanded PMA indication for its Therascreen diagnostic test to be used in conjunction with Boehringer Ingleheim GmbH's lung cancer therapy, Gilotrif (afatinib).
The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of metastatic non-smal-cell lung cancer (NSCLC) patients for whom Gilotrif is indicated.
Boston Scientific becomes contender in DBS market with Vercise approval
Boston Scientific Corp. is entering into the deep brain stimulation (DBS) market in the U.S. with its latest FDA-approved technology. The Marlborough, Mass.-based company revealed on Monday that it has received approval for the Vercise deep brain stimulation system. News of the FDA-nod caused Boston Scientific (NYSE:BSX) shares to increase by 2 percent in after-hours trading Monday. The slight increase comes on the heels of a 7.5 percent drop in shares the company experienced in late November, when it said it would delay commercialization efforts of its Lotus Edge aortic valve system. (See BioWorld MedTech, Nov. 30, 2017.)
Edwards snags whale of a deal with its $250M Harpoon buy
Structural heart disease-focused device firm, Edwards Lifesciences Corp., has acquired privately held Harpoon Medical Inc., which specializes in mitral valve repair devices while the heart is beating. The agreement will begin with an initial cash payment of $100 million and up to $150 million in milestone payments over the next decade.