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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
In observance of the holiday season, Drug Industry Daily will not be published Thursday, Dec. 31 or Friday, Jan. 1. The next issue will be published Monday, Jan. 4. Read More
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) appears ready to authorize AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine as soon as this week, a move that could help lighten the load on Pfizer/BioNTech vaccinations as the country scrambles to deal with a new, mutated strain of coronavirus. Read More
Novavax has launched a phase 3 study in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, after deferring the trial for two months because of holdups in securing doses. Read More
Santa Fe, Calif.-based over-the-counter (OTC) drugmaker Creative Essences drew a lengthy Form 483 report with eleven observations following an FDA inspection of its facility in late August and early September. Read More