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Latest From CardioMEMS, Inc.
Concerns about cases of heart muscle inflammation occurring in older male adolescents and young men shortly after the second dose of Pfizer and Moderna mRNA vaccines hung over FDA advisory committee discussions on pediatric safety data requirements for COVID-19 vaccines; CDC’s ACIP will take up the myocarditis issue at an 18 June meeting.
Biolyse is seeking a compulsory license for J&J’s COVID-19 vaccine but achieving its goal is proving to be far from easy. The Canadian company argues that its experience illustrates the need for a change in approach to intellectual property rights at a local and global level.
Pieris and Genentech try partnering again after a disappointing IO tie-up before. Biogen’s hectic May includes partnerships with Ginkgo, Envisagenics, Capsigen and an opt-in on TMS’s stroke candidate.
Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says
COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.