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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
Jazz Pharmaceuticals is set to acquire GW Pharmaceuticals, a UK drugmaker known for its CBD products Epidiolex (cannabidiol) and Sativex (nabiximols), for a whopping $7.2 billion. Read More
Bristol Myers Squibb (BMS) has struck a deal with Rockefeller University for the global rights to a monoclonal antibody being developed by the university to treat COVID-19. Read More