Drug Approval | October 06, 2021
EMA authorises booster dose of Moderna’s Spikevax
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan
CuraTeQ Biologics is on track for filing a second oncology biosimilar
Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
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