Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.

Sun Pharma and its US Taro subsidiary have further criticized a recent CMS policy proposal that would see Medicare Part B drugs approved under the US hybrid 505(b)(2) pathway reimbursed at a lower rate applicable to multiple source products.

Laura Soucek, one of In Vivo’s 2020 Rising Leaders, is hoping to take Barcelona-based start-up Peptomyc to the next level. The company is nearing the clinic with an inhibitor of the transcription factor Myc, which is involved in the regulation of cellular proliferation, but can also be a driver of cancer.

With the impact of pandemic-prompted disturbances waning, analysts forecast better Q2 numbers for Indian pharma firms, with some including Glenmark and Cipla seen emerging winners. But after doing well in the quarter, Gilead’s licensees might see remdesivir demand tapering somewhat in Q3 post the WHO finding the antiviral ineffective in COVID-19 treatment.