Sinclair Pharma Ltd
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Amneal is set to benefit from 180 days of US exclusivity for its norelgestromin and ethinyl estradiol contraceptive patch product after receiving FDA approval with a competitive generic therapy designation. The generic will be the only competitor to Mylan’s Xulane version.
Experts including renowned virologist Peter Piot, FDA’s Peter Marks and CEPI’s Richard Hatchett discussed multiple dimensions pertaining to coronavirus variants and existing vaccines at a recent conference, noting enhanced post-deployment surveillance is underway in the US. While there’s no need to panic for every variant that emerges, equitable access to vaccines is critical to ensure that gains made over last year are not undone, they said.
US FDA’s Peter Marks notes timeframe for sponsors to seek licensure at press call announcing emergency use authorization of J&J’s vaccine; Acting Commissioner Woodcock says effectiveness comparisons cannot be made between the three authorized vaccines since they have not been tested head-to-head.
As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals
J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.
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