Emerging Markets Regulatory Tracker: Australia, Brazil, China and India (Vol. 2 No. 35)
This article was originally published in PharmAsia News
The Emerging Markets Regulatory Tracker is a periodic PharmAsia News feature that summarizes and links to important regulatory developments impacting the biopharma and medical device industries in the Asia Pacific region and other emerging markets.
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Medtronic will launch the LINQ II remotely programmable insertable cardiac monitor in the US and Europe this summer following FDA clearance. This week, the agency also approved Abbott's Gallant ICD and CRT-D devices, which communicate with Abbott's myMerlinPulse mobile app.
India clears Opdivo patent, turning down pre-grant representations from four opposing parties including Dr Reddy's. The patent office rejected the opponents' arguments including those around obviousness and "inherent anticipation."
BD Diagnostics has gained emergency use authorization (EUA) for a handheld rapid COVID-19 antigen test that could play a pivotal role in fighting an ongoing surge of coronavirus outbreaks. See what US FDA commissioner Stephen Hahn said about it here.