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Piling more criticism on the already-embattled Emergent Biosolutions, the FDA has issued a warning letter citing significant sterility issues at the company’s Camden facility in Baltimore, Md., and stating that Emergent’s management oversight and control over the manufacture of drugs is inadequate. Read More
Drug and biologics manufacturers submitting electronic individual case safety reports (ICSR) and ICSR attachments to the FDA Adverse Event Reporting System database should follow a new technical guide the agency released yesterday. Read More
Merck and Orna Therapeutics announced that they are joining in a new partnership to advance development of the Cambridge, Mass., startup company’s RNA and lipid nanoparticle delivery platform to treat cancer, genetic disorders and infectious diseases. Read More
The bivalent vaccine also elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the Spikevax booster, Moderna said. Read More