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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
Kobo Products, a South Plainfield, New Jersey drug manufacturer drew a Form 483 from the FDA detailing six issues observed during an August inspection. Read More
AstraZeneca’s (AZ) and Oxford University’s coronavirus vaccine may earn its first authorization this week if the UK or India moves to clear it as anticipated, but it’s unlikely to see emergency clearance in the EU until at least February, a European Medicines Agency (EMA) official said. Read More