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The FDA hit an Albuquerque, New Mexico firm with a warning letter after finding it committed drug repackaging violations and had no quality unit. Read More
Pfizer and BioNTech are nearing the finish line for a COVID-19 vaccine supply agreement with the European Commission (EC), wrapping up exploratory talks Wednesday and beginning the contract negotiation process for 200 million doses of their candidate. Read More
A second government agency, the Biomedical Advanced Research and Development Authority (BARDA), is now scrutinizing contracts awarded to Moderna, examining whether the vaccine maker failed to disclose millions of dollars it got in federally funded awards in several patents and patent applications the firm has filed for its vaccines. Read More
In a Senate hearing yesterday, National Institutes of Health Director Francis Collins applauded AstraZeneca’s decision to halt its phase 3 COVID-19 vaccine trial due to an unexplained illness — and said the incident should reassure the public that companies are not compromising when it comes to the safety of their vaccine candidates. Read More
Reports “are incorrect” that a participant in AstraZeneca’s COVID-19 vaccine trial that was paused Tuesday suffered from transverse myelitis, an AstraZeneca spokesperson told FDAnews Wednesday. Read More
AbbVie has signed a collaboration agreement with Chinese biotech I-Mab to develop and commercialize, lemzoparlimab (TJC4), I-Mab’s monoclonal antibody under development for multiple cancers. Read More