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Despite the serious challenges the FDA faced in responding to the COVID-19 pandemic in 2020, the agency ended the year approving more novel drugs than in four of the five previous years. Read More
Regeneron has released positive initial results from an ongoing phase 1/2/3 study evaluating its antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients who require low-flow oxygen. Read More
China announced that it has granted conditional authorization for one of Sinopharm’s inactivated COVID-19 vaccines, a shot that the state-owned pharma company claimed is 79.3 percent effective according to an interim analysis of its phase 3 trial. Questions remain, however, due to a lack of details from the company. Read More
India on Sunday granted emergency use approval for the COVID-19 vaccine co-developed by AstraZeneca (AZ) and Oxford University — formerly known as AZD1222 but now called COVID-19 Vaccine AstraZeneca — along with a separate vaccine, Covaxin, developed by Bharat Biotech. Read More
On Wednesday, the UK authorized AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine for emergency use, characterized as a rapid temporary regulatory approval, becoming the first country to do so as the nation contends with a new contagious strain of the virus leading to a spike in cases. Read More
The pricing of COVID-19 vaccines is expected to draw closer scrutiny in the new year — and even closer attention once the vaccines are no longer being issued for free by governments. Read More
A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing, among other significant violations of current good manufacturing practice, according to an FDA warning letter to the firm. Read More
With COVID-19 vaccines from Pfizer/BioNTech and Moderna receiving Emergency Use Authorization and others from AstraZeneca (AZ) and Johnson & Johnson (J&J) edging closer to regulatory approval, vaccine developers are now facing a new challenge: What to call their vaccines to make them more attractive — or at least less scary — for the general public? Read More
The FDA has given the green light for the first generic version of glucagon for injection, a drug that’s long been approved for treating severe hypoglycemia (very low blood sugar) that may occur in diabetes patients. Read More