As we head into the fourth quarter of 2021, here is a recap of what happened on the regulatory front this month that caught our attention.
Samsung Bioepis’ Byooviz became the first biosimilar for Lucentis to treat macular degeneration disease and other eye conditions, following its FDA approval on September 17. To date, 31 biosimilars have been approved in the United States for a variety of medical ailments.
The first artificial intelligence (AI)-based digital pathology product to receive FDA approval, Paige Prostate that can help identify prostate cancer, received the regulatory nod on September 21.
In the face of the evolving pandemic and new data about vaccine safety and effectiveness becoming available every day, the FDA authorized a booster dose of Pfizer/BioNTech’s COVID-19 vaccine, which goes by the name Comirnaty, for certain populations on September 22.
The WHO has so far authorized 7 Covid-19 vaccines – Moderna’s mRNA-1273, Pfizer/BioNTech’s Comirnaty, Johnson & Johnson’s Ad26.COV2.S, Oxford/AstraZeneca’s AZD1222, Serum Institute of India’s Covishield, Sinopharm’s BBIBP-CorV and Sinovac’s CoronaVac.
In the U.S., as per the latest data available, 184.3 million people have been fully vaccinated, and 3.68 million people have received an additional dose since Aug.13, 2021.
The FDA has approved 39 novel drugs so far this year compared to 40 during the same period last year. A total of 53 novel drugs were approved in 2020.
Let’s take a look at the biotech stocks facing FDA decision in October.
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