Moderna Looks To Catch Up In COVID-19 For Kids, While Still Branching Out In Other Areas
Biotech Teases Non-COVID Respiratory Programs
The company hopes to expand Spikevax’s reach beyond the current approved population while also looking to take the lead in mRNA vaccines in other diseases.
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Cardiovascular Catch-Up: Cardiac Implants Puts Ring Around Tricuspid Annulus; Boston Scientific’s Acurate neo2 TAVR Progresses; Medtronic Promotes New Stroke Plan
This edition of Medtech Insight’s regular round-up of some recent cardiovascular technology news and conversations you may have missed, including updates from Cardiac Implants, Boston Scientific, HeartBeam and Medtronic.
Califf Previews US FDA’s Authorization Rationale For COVID Bivalent Boosters
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
Coronavirus Update: Pfizer/BioNTech, Moderna Submit Omicron EUAs For Fall Season
Under FDA guidance, the companies submitted clinical data for BA.1-targeting bivalent vaccines together with BA.4/BA.5 preclinical data. Novavax got a nod for its COVID-19 vaccine in adolescents, but its own Omicron development efforts remain behind the two mRNA heavyweights.