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The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check out our Q2 recalls infographic.
There was a dramatic increase in the number of high-risk class I medical device recalls in the second quarter of 2017. There were 15 class I recall events logged with US FDA from April through June, up 88% from the first quarter of the year, when only eight were posted, according to consulting firm Stericycle, which gathered its recalls data from FDA Enforcement Reports. Overall, recalls fell 3% in Q2 '17, to 275 (compared to Q1's 284). Meanwhile, the number of recalled device units increased by a massive 628%, climbing to nearly 67.6 million units in Q2 '17, from 9.2 million in Q1. For a snapshot of Q2 results, see the infographic of Stericycle data below.
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Scrip: industry news and insights
The Swiss major's pharma chief tells Scrip that its gene therapy for SMA offers much more than Biogen's Spinraza for both patients and payers, noting that the company is ready with alternative payment models for the pricey treatment as soon as approvals for Zolgensma are granted.
Topics Business strategies Drug approval Drug development landscape Drug review
Scrip: industry news and insights
By Emily Hayes
In second Phase III diabetes study to report, oral GLP-1 agonist semaglutide misses some weight loss goals when compared with Boehringer/Lilly's SGLT-2 inhibitor Jardiance.
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