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AstraZeneca Eyes EUA for COVID-19 Vaccine after Positive Results
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AstraZeneca s Pascal Soriot Was The Hottest CEO In Pharma Now He s In The Hot Seat
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Mar 3, 2021 10:50am
The FDA has sent a last-minute notification of an advisory committee review of FibroGen and AstraZeneca s first-in-class anemia candidate roxadustat, threatening another decision delay. (FDA)
FibroGen and AstraZeneca already endured a delay in the U.S. review of their anemia candidate roxadustat. Just as the pair was expecting to snag its first-in-class approval, as the revised date draws near, a capricious FDA has stunned the companies with a second blow.
The FDA will convene an advisory committee to review roxadustat’s application for treating anemia caused by chronic kidney disease, both in patients who require dialysis and those who don’t, the two companies said Monday.
The new coronavirus mutant strains are playing havoc with the already approved Covid-19 vaccines. The latest data shows AstraZeneca’s (AZN) vaccine, AZD1222 is ineffective against the South African variant, which has resulted in the halt of its rollout in the country. Last week, South Africa obtained its first 1 million doses of AstraZeneca’s vaccine, and jabs for the population were expected to begin in mid-February. It looks like the new strain is more infectious and now accounts for over 90% of the country’s Covid-19 cases. Many other African countries have been counting on the AstraZeneca shot, and the disappointing results against the variant could have far-reaching consequences; The vaccine’s developers have said a modified jab to deal with the South African variant could only be ready by autumn. AstraZeneca’s vaccine has shown to be effective against the U.K. variant, and the setback comes after it was approved for adult usage in the EU last we
Pfizer laid out its 2021 financial expectations on Tuesday.(Tracy Staton)
More and more COVID-19 vaccines are nearing the market, but mRNA shots from Pfizer and Moderna are still working off a head start in the global rollout. Now, Pfizer has revealed just what that head start could be worth this year.
Short answer: $15 billion. And it could be more.
The company said Tuesday that it s expecting that much in sales from its BioNTech-partnered mRNA shot this year. In last year’s fourth quarter, the vaccine chipped in $154 million.
The estimate, unveiled as part of Pfizer s 2021 guidance, is primarily based on doses set to be delivered in 2021 under existing contracts, the company said. The estimate could change if additional contracts are signed, according to the company s investor presentation.
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