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The FDA intends to publish draft guidance in the next several weeks outlining the data it will require for modifying authorized vaccines to address new COVID-19 viral variants, according to FDA Acting Commissioner Janet Woodcock. Read More
The AstraZeneca (AZ)/Oxford University COVID-19 vaccine remains effective against the fast-spreading UK viral variant, Oxford researchers have shown in a late-stage trial. Read More
A Lupin Pharmaceuticals facility in Somerset, N.J., has received a 38-page Form 483 with more than a dozen observations following a Sept. 10-Nov. 5, 2020, inspection by the FDA. The FDA’s options at this point are to do another inspection or to take regulatory action, such as a warning letter to the company. Read More
Consulting giant McKinsey has agreed to pay $573.9 million to settle a lawsuit brought by the attorneys general of 49 states, the District of Columbia and five U.S. territories over work it did for opioid painkiller manufacturers. Read More
Representatives of generic drugmakers put forward several ideas for the FDA to consider for manufacturing facility inspections during a January meeting to discuss the agency’s commitments as part of the reauthorization of the Generic Drug User Fee Act (GDUFA). Read More
Trials evaluating the effectiveness of a combined regimen of the Gamaleya Research Institute’s Sputnik V vaccine and the AstraZeneca/University of Oxford vaccine are set to begin next week in Azerbaijan, the United Arab Emirates and other Middle Eastern nations. Read More
UK researchers launched a new study yesterday to assess a combined COVID-19 vaccination regimen in older adults that includes the Pfizer/BioNTech and the AstraZeneca (AZ)/Oxford University vaccines. Read More
Johnson & Johnson (J&J) filed yesterday for FDA Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine — which if granted will help ease vaccine supply shortages and significantly ramp up the pace of inoculations in the U.S. Read More