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It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?
Only one last step remains before the approval of South Korea’s first home-grown COVID-19 vaccine as SK Bioscience’s SKYCovione (GBP510) receives positive assessments from review committees. Any nod, which could happen this week, would mark a milestone for the country's ambitions of becoming a global vaccine hub.
FDA advisors will vote 28 June on whether an Omicron component should be included in new COVID-19 booster vaccines. Following WHO recommendations, the FDA may no longer also be looking to update the primary vaccine series at this time.
The bivalent vaccine is likely to get regulatory support, along with government contracts, but competitors, notably Moderna, will also step into the ring.
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